food and drug administration 1390 piccard drive jun … · te department of health & human...

te DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

JUN 2 5 1991

Mr. Steve Aperavich

Vice President, Manufacturing Official Correspondent

Surgitek/Medical Engineering Corp.

3037 Mt. Pleasant Street

Racine, Wisconsin 53404

Dear Mr. Aperavich:

Media System

Dated: May 7, 1991

Received: May 8, 1991

Regulatory Class: 11

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to

May 28. 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the

device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). General controls provisions of the Act include requirements for annual registration, listing of devices, good

manufacturing practice, labeling, and prohibitions against misbranding and adulteration,

If your device is classified (see above) into either class 11 (Special Controls) or class III (Premarket Approval) t may be subject to such additional controls. Existing major regulations affecting your device can be found ;r, the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Reqlster. Please note: this response to your premarket notification submission does not affect any obligation you micht have under the Radiation Control for Health and Safety Act of 1968. or other Federal Laws or

his letter immediately will allow you to begin marketing your device as described. A FDA finding of sut-)s:antial equivalence for your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but a does not mean that FDA approves your device. Therefore, you may not promote or in anyway represent your device --r its labeling as being aPproved by FDA. If you desire specific advice on the labeling for your device, please contact the Division of Compliance Operations, Regulatory Guidance Branch (HFZ-323) at (301) 4.27-1116. Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductive,

Abdominal, Ear, Nose and Throat, and Radiological Devices

Office of Device Evaluation Center for Devices and Radiological Health

Food and Drug AdminiStration 1390 Piccard Drive Rockville, MD 20850

Re: K910769/A

Surgitek(R) ERCP Contrast

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Records processed under FOIA Request # 2015-4314; Released by CDRH on 12-29-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118



DEPARTMENT OF HEALTH & HUAMN SERVICES

Date - 6. /z/ (I- (

Frofn REVIEWER(S) - NJQ4E(S) L Cwot

Subject 510(k) NOTIFICATION

1 1-1-1/

Pubsc Health serwce

Memorandun

O4F

To THE RECORD

It is my recommendation that the subject 510(k) Notification:

-"ý-(A) Is substantially equivalent to-

marketed devices.

(B Requires premarket approval. NOT substantially equivalent to marketed devices.

(C) Requires more data.

(D) Other (e.g., exempt by regulation, not a device,

duplicate, etc.)

Addicional Comments:

The submitter requests under

21 CFR §807.95:

No Confidentiality

Confidentiality for 90 days

Continued Confidentiality

exceeding 90 days

22, "ýý REV IEW:

(BRANCH CHIEF)

FINAL REVIEW:

ION D

-9-7 (b. I E;CO Predicate Product Code w/Panel

and class:

K-D G -7

Additional Product Code(s) w/Panel

(optional):

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D 6 BRANCH CODE) (M

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K910769 "SUBSTANTIAL EQUIVALENCE" (SIB) DECISION-KAKING DOCUMENTATION

Reviewer: John Guest Division/Branch: DRAERD/ADOU/ULDB

Trade Name: Contrast media delivery system for ERCP

Co =o n Name: Surgitek ERCP Contrast Media System

Panel: 78 Product Code: KOG Class: II

Product To Which CoKpared: Surgitek Irri-Flo (K891339) Becton-Dickinson ERCP Hand Injection Pistol and

connecting tube assembly

YES NO

1. IS PRODUCT A DEVICE? X IF NO STOP

2. DEVICE SUBJECT TO 510(K)? X IF NO STOP

3. SAME INDICATION STATEMENT? X IF YES GO TO 5

4. DO DIFFERENCES ALTER THE EFFECT OR RAISE NEW ISSUES OF SAFETY OR EFFECTIVENESS? IF YES STOP > NE

5. SAME TECHNOLOGICAL CHARACTERISTICS? X IF YES GO TO 7

6. COULD THE NEW CHARACTERISTICS AFFECT SAFETY OR EFFECTIVENESS? IF YES GO TO 8

7. DESCRIPTIVE CHARACTERISTICS PRECISE IF YES STOP > SE

ENOUGH? X IF NO GO TO 10

B. NEW TYPES OF SAFETY OR EFFECTIVENESS QUESTIONS? IF YES STOP > NSE

9. ACCEPTED SCIENTIFIC METHODS EXIST? IF NO STOP > NSE

10. PERFORMANCE DATA AVAILABLE? IF NO REQUEST DATA

11. DATA DEMONSTRATE EQUIVALENCE? >

"yes" responses to 4, 6, 8, and 11, and every "no" response requires an explanation below

-1,/

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NARRATIVE DMCE DESCRIPTI

1. INTENDED USE: The device is intended to be used during an ERCP (endoscopic

retrograde cholangiopancreatograph) for the bolus injection of contrast media.

2. DEVICE DESCRIPTION: Provide a statement of how the device is either similar to and/or different from other marketed devices, plus data (if

necessary) to support the statement.

General Description: This device incorporates a spring loaded syringe, tubing, and a three way connector. The three way connector couples the spring loaded syringe, a reservoir of contrast media, and a delivery catheter (that transports the contrast media to the desired site via an endoscope). In operation, contrast media flows from the reservoir into the connector and syringe where the user can inject the media into the delivery catheter. The syringe has a spring incorporated into the plunger which enables it to automatically refill with contrast media after each bolus injection, thus the user never has to disconnect the syringe to refill it with contrast media. There are two one way valves incorporated into the connector. These valves prevent retrograde flow of contrast media back to the reservoir of contrast media and also, back into the three way connector and syringe from the delivery catheter. The connector has a male luer lock to be used to secure the delivery catheter. The device is intended for single use.

Substantial Eauivalence: The device is substantially equivalent to Surgitek's Irri-Flo system and Becton-Dickison's ERCP Connecting Tube Assembly and ERCP Hand Injection Pistol. The Irri-Flo system incorporates a spring loaded syringe and three way connector (without one way valves) to deliver irrigation fluid during endoscopic procedures. The Irri-Flo device and the Surgitek ERCP device operate in essentially the same manner: contrast media/irrigation fluid can be injected in controllable boluses, without the user having to interrupt the procedure to refill the syringe. The Becton-Dickison ERCP Connecting Tube Assembly and ERCP Hand Injection Pistol incorporate a similar design. The hand pistol is used with a standard syringe to inject contrast media during an ERCP procedure (Surgitek comments that their device can be used with a hand pistol also). The Connecting Tube Assembly consists of a three way connector which connects the syringe (this syringe has no spring), the contrast media reservoir, and the delivery catheter. This device functions similarly to the Surgitek device: it allows the infusion of contrast media during an ERCP without requiring the user to disconnect the syringe to obtain additional contrast media.

General Informatio : The labeling submitted is adequate for use. The package insert contains an indications statement and the instructions for use are adequate.

Surgitek has provided certification that the materials used in the device have passed biocompatibility testing. All materials have passed acute system toxicity, intracutaneous toxicity, and cytotoxicity or implantation. Since the use of this device will result in only short term

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1ý1ý exposure to contrast media, and not to any tissue, these tests are

appropriate for insuring biocompatibility.

Sterilization information: a. method:

b. validation cycle:

c. SAL:

d. packaging:

Eto

AAMI overkill method

10-6

Tyvek

e. residues of ethylene oxide: 250 ppm ethylene chlorohydrin: 250 ppm ethylene glycol: 5,000 ppm

f. pyrogen free: No

g. radiation dose: N/A

In conclusion the Surgitek ERCP Contrast Media System is substantially equivalent to the Becton-Dickinson ERCP device and Surgitek irrigation device with respect to design and materials; and the Surgitek ERCP device

is substantially equivalent to the Becton-Dickinson ERCP device with respect to indications.

J L 4Gu e s ta-4ý

mi-e 9

-I,/

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1ý1/

I,,/

MEMO TO THE RECORD

Date: June 21, 1991

From: John Guest, Electrical Engineer DRAERD/ADOU/ULDB

Subject: K910769, Surgitek ERCP contrast media system, additional

information

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(b) (4)





John Guest

-1.11/

I,,/

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(b) (4)





DEPARTIOW OF HEALTH AND HUNAN SERVICES Public Health Service

Food and DrU9 Adninietration

Center for Devices aad Radiological Roalth

office of Device 3valuation,

Document Mail Coster (NFZ-401) 1390 Piccard Drive

Rockville, Maryland 20850

MAY 9, 1991

SURGITEK/MEDICAL ENGINEERING CORP. 510(k) Number: K910769 ATTN: STEVE APERAVICH Received: 05-08-91 3037 MT. PLEASANT STREET Product: SURGITEK(R) ERCP

RACINE, WI 53404 CONTRAST MEDIA SYSTEM

The additional information you have submitted has been received.

We will notify you when the processing of this submission has been completed or if any additional information is required. Please remember that all correspondence concerning your submission MUST be sent to the Document Mail Center (HFZ-401) at the above letterhead address. Correspondence sent to any address other than the one above will not be considered as part of your official premarket notification submission. Because of equipment and personnel limitations we cannot accept telefaxed material as part of your official premarket notification submission, unless

specifically requested of you by an FDA official.

he Safe Medical Devices Act of 1990, signed on November 28, states that Ný-_Iou may not place this device into commercial distribution until you

receive a letter from FDA allowing you to do so. As in the past, we intend to complete our review as quickly as possible. Generally we do so within 90 days. However, the complexity of a submission or a requirement for additional information may occasionally cause the review to extend beyond 90 days. Thus, if you have not received a written decision or been contacted within 90 days of our receipt date you may want to check with FDA to determine the status of your submission.

If you have procedural or policy questions, please contact the Division of Small Manufacturers Assistance at (301) 443-6597 or at their toll-free number (800) 638-2041, or contact me at (301) 427-1190.

Sincerely yours,

Robert I. Chissler Chief, Premarket Notification Section Office of Device Evaluation Center for Devices and Radiological Health

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Page - I

K -SUBSTANTIAL EQUIVALENCE- (Sk) DECISION MAKING DOCUM ENT ATION

REVIEWER: DIVISION/BRANCH:

TRADE NAKE: COMMON NAME:

PRODUCT TO WHICH C014PARED:

(510(k) NUMBER IF KNOWN)

1. IS PRODUCT A DEVICE?

2. DEVICE SUBJECT TO 510(k)?

3. SAME INDICATION STATEMENT?

DO DIFFERENCES ALTER THE EFFECT

OR RAISE NEW-ISSUES OF SAFETY.OR

EFFECTIVENESS?

5. SAME TECHNOLOGICAL CHARACTERISTICS?

COULD THE NEW.CHARACTEPLISTICS AFFECT .0

SAFkTY OR EFFECTIVENES'S?

7. DESCRIPTIVE CHARACTERISTICS PRECISE

ENOUGH?

/1-1\r

Qd NEW TYPES OF SAFETY OR EFFECTIVENESS

QUESTIONS?

9. ACCEPTED SCIENTIFIC METHODS EXIST?

YES (NOfl

IF NO STOP

IF NO STOP

IF YES GO TO 5

IF-YES STOP

IF YES GO TO 7

IF YES GO TO 8

IF NO GO TO 10A IF YES STOP -ZýEN

IF YES STOP -ZNE I

IF NO STOP - ANE

10. PERFORMANCE DATA AVAILABLE? IF NO REQUEST DAT

DATA DEMONSTRATE EQUIVALENCE?

0- NOTE: IN ADDITION TO COMPLETING PAGE TWO, "YES" RESPONSES TO QUESTIONS 4. 6, 8. ANI

11, AND EVERY *NO" RESPONSE REQUIRES AN EXPLANATION ON PACE THREE AND/OR FOUI

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H&PLRAIrIVE DEVICE DESCRIPTION

1. INTENDED USE:

Page - 2

2. DEVICE DESCRIPTION: Provide a statement of how the device is either similar to

and/or different from other marketed devices, plus data (if necessary) to

support the statement. The following should be considered when preparing the

summary of the statement. Is the device life-supporting or life sustaining? Is

th- clevice implanted (short-term or long-term)? Does the device design use

software? Is the device sterile? Is the device for single use? Is the device

for home use or prescription use? Does the device contain drug or biological

py-duct as a component? Is this device a kit? Provide a summary about the

dcvices design, materials, physical properties and toxicology profile if

important.

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Page - 3

EXPLANATIONS TO "YESO AND wNOo ANSWERS TO QUESTIONS ON PACE I AS MEEZED

1. EXPLAIN WHY NOT A DEVICE:

2. EXPLAIN WHY NOT SUBJECT TO 510(k):

3. HOW DOES THE NEW INDICATION DIFFER FROM THE PREDICATE DEVICE'S INDICATION:

4. EXPLAIN WHY THERE-IS OR-IS NOT A NEW-EFFECT-OR SAt%m OR EFFECTIVENESS

ISSUE:-5. DESCRIBE THE NEW TECHNOIDGICAL CHARACTERISTICS:

6- EXPLAIN HOW NEW CHARACTERISTICS COULD OR COULD NOT AFFECT SAFEYY OR EFFECTIVENESS:

1-1-1

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Pige 4

7. EXPLAIN HOW CHARACTERISTICS AM NOT PRECISE ENOUGH:

8. EXPLAIN NEW TYPE,ý' OF SAFETY OR EFFECTIVENESS QUESTIONS RAISED OR WHY THE QUESTIONS ARE W'" NFW:

9. EXPLAIN WHY EaCr'ý SCIENTIFIC METHODS CAN NOT BE USED:

10. EXPLAIN WHAT FEi,ý'iAZKANCE DATA IS NEEDED:

11. EXPLAIN HOW TH"'. -PERFORMANCE DATA DEKONSTR&TES THAT THE DEVICE IS OR IS NOT

SUBSTANTIALLY 0,ýILJ'(VALENT:

ATTACH ADDITIONAT, S,L)'ý?PORTING INFORMATION

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SURGITEK 3037 Mt. Pleasant Street Racine, Wl 53404 414 639-7205

ManufacturinS

Steve Aperavich Vice President

Office of Device Evaluation

(PMA, 510(K) or IDE as appropriate) Document Mail Center (HFZ-401) Center of Devices & Radiological Health Food and Drug Administration 1390 Piccard Drive


CONFIDENTIAL

1991 May 7

/ý M 1144

RE: 510(K) Notification - SURGITEK0 ERCP Contrast Media System K910769

Dear Sirs:

The following information has been requested by the FDA as additional data required in the review of the 510(K) submitted for the Surgitek* ERCP Contrast Media System.

Surgitek believes that the following information will be sufficient for the FDA to reach a decision on this notification. However, should additional information be required, it will be promptly furnished upon request. Medical Engineering Corporation regards its intent to market the ERCP Contrast Media System as confidential commerical information. We request that the FDA does not disclose the existence of this premarket notification for at least 90 days or as required.

Medical Engineering Corporation appreciates the administrative scientific considerations relevant to this submission. We hope, however, that the FDA will reach its decision on this matter in a period of time less than that provided in that Act.

Sincerely,

e /

Steve Aperavich, Vice President, Manufacturing Official Correspondent

Enclosure J sa/vjw Salo

AVA A Bristol-Myers Company # IVAV BEST COPY AVAIEABLII





CONFIDENTIAL

MEDICAL ENGINEERING CORPORATION

SURGITZKO

ZRCP CONTRAST MEDIA SYSTEM

PREKARKET NOTIFICATION 510(X)

SUBMISSION

SUPPLEMENT NO. I

111-ý

SURGITEX6

Medical Engineering Corporation 3037 Mt. Pleasant Street Racine, Wisconsin 33404

SUBMISSION DATE:

May 7. 1991

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PREMARKET NOTIFICATION SUBMISSION 510(K) SURGITEK* ERCP CONTRAST MEDIA SYSTEM Supplement #01

1-1ý

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PREMARKET NOTIFICATION SUBMISSION 510(K) SURGITEK* ERCP CONTRAST MEDIA SYSTEM Supplement #01

1ý1__/ ercpsup

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PREMARKET NOTIFICATION SUBMISSION 510(K) SURGITEK0 ERCP CONTRAST MEDIA SYSTEM Supplement #01

Component/ Material Test

Results/

11ý

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PREMARKET NOTIFICATION SUBMISSION 510(K) SURGITEKO ERCP CONTRAST MEDIA SYSTEM Supplement #01 Exhibit 1 (Contd)

Component/ RGSUltS/ Nater al Test Comments

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PREMARKET NOTIFICATION SUBMISSION 510(K) SURGITEKO ERCP CONTRAST MEDIA SYSTEM Supplement #01 Exhibit 1 (Contd.)

Component/ Material Test

RSSUlts/ comments

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PREMARKET NOTIFICATION SUBMISSION 510(K) SURGITEK* ERCP CONTRAST MEDIA SYSTEM Supplement #01 Exhibit 1 (Contdj

Component/ ResUlts/ Material Test Comments

supercp

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OF ="TN AND HURM SERVICES Public Bealth Service

Food and Drug Administration Center for Devices and Radiological Realth Office Of Device RV&lUation Document nail Center (MY$-401) 1390 PicCard Drive


APRIL 16, 1991

SURGITEK/MEDICAL ENGINEERING CORP. 510(k) Number: K910769 ATTN; STEVE APERAVICH Product: SURGITEK(R) ERCP 3037 MT. PLEASANT STREET CONTRAST MEDIA RACINEt WI 53404 SYSTEM

Ve are holding your above-rtferenced Premarket Notification (510(k)) for 30 days pending receipt of the additional information that was requested by the Office of Device Evaluation. Please remember that all correspondence concerning your submission MUST be sent in duplicate to the Document Mail Center (HFZ-401) at the above letterhead address. Correspondence sent to any address other than the one above will not be considered as part of your official premarket notification submission. Because of equipment and personnel limitationst we cannot accept telefax material as part of your official premarket notification submission unless specifically requested of you by an FDA official.

If after 30 days the requested information is not received, we will N,-.-Idiscontinue review of your submission and proceed to delete your file from

our review system. Pursuant to 21 CFR 20.29, a copy of your 510(k) submission will remain in the Office of Device Evaluation. If you then wish to resubmit this 510(k) notification, a new number will be assigned and your submission will be considered a new premarket notification submission.

Please remember that the Safe Medical Devices Act of 1990 states that you may not place this device into commercial distribution until you receive a decision letter from FDA allowing you to do so.

If you have procedural or policy questions, please contact the Division of Small Manufacturers Assistance at (301) 427-6597 or at their toll-free number (800) 638-2041, or contact me at (301) 427-1190.

Sincerely yours,


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DO NOT REMOVE THIS ROUTE SLIP1111

X-91-0769 4/16/91

rRom: ILETTER DATE ILOUIN DATE IDUS VATZ

SURGITEK/MEDICAL ENGINEERING CORP. 1 02/21/91 1 02/22/91 1 05/23/91 ATTN: STEVE APERAVICH I

------------------------ I

----------3037 MT. PLEASANT STREET ITYPE OF DOCUMENT: ICONTROL #

510 (k) I K910769

RACINE, WI 53404 ------------------------ I ----------PHONE NO: 414-639-7205

SHORT NAME: SURGMEDIENGI ESTABLISHMENT NO: 2124979

-----------------------------------------------------------------TO: ICONT. CONF.: ?

ODE/DMC ISTATUS : H

IREV PANEL : GU

JPAN/PROD CODE(S): GU/

----------------------------------------------------------------------------SUBJECT:

SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM

----------------------------------------------------------------------------DECISION: ROST INFO DATE: 04/16/91 JINFO DUE DATE: 05/16/91 DECISION DATE: DATE: DATE:

DATE: DATE:

DATE: DATE:

DATE: DATE:

DATE: DATE: ------------------------- --------------------------------------------------

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, 0 4e

DEPARTMENT OF HEALTH & HUMAN SERVICES Pubic Health Service

Memorandum Date

From REVIEWER(S) - NAKE(S) 'J

VI-P

Subi8ct 510(k) NOTIFICATION ý7o ýO To THE RECORD

It is my recommendation that the subject 510(k) Notification:

(A) Is substantially equivalent to marketed devices.

(B) Requires premarket approval. NOT substantially equivalent to marketed devices.

(C) Requires more data.

(0) Other (e.g., exempt by regulation, not a device, duplicate, etc.)

Additional Comments:

The submitter requests under Predicate Product Code w/Panel 21 CFR §807.95: and class:

No Confidentiality 460 G w"""

Confidentiality for 90 days Additional Product Code(s) w/Panel (optional):

Continued Confidentiality exceeding 90 days

REVIEW: ý)ý (-01 1 it (BRANCH CHIEF) I(BRANCH CODE)

F-

FINAL REVIEW: (DIVISION DIRECTOR) (DATE)

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service

Food and DrUg Adainistration

Center for Devices and Radiological Health office of Device Zvaluation

DOCUMOUt Mail Center (HTZ-401) 1390 Piccard Drive


FEBRUARY 26, 1991

SURGITEK/MEDICAL ENGINEERING CORP. ATTN: STEVE APERAVICH 3037 MT. PLEASANT STREET RACINE, WI 53404

510(k) Number: K910769 Received: 02-22-91 Product: SURGITEK(R) ERCP

CONTRAST MEDIA SYSTEM

We have received the Premarket Notification you submitted in accordance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act (Act) for

the above referenced product. We have assigned your submission a unique

510(k) number that is cited above. Please refer prominently to this 510(k) number in any future correspondence that relates to this submission. We will notify you when the processing of your premarket notification has been completed or if any additional information is required.

The Safe Medical Devices Act of 1990, signed on November 28, states that

you may not place this device into commercial distribution until you receive a letter from FDA allowing you to do so. As in the past, we intend

complete our review as quickly as possible. Generally we do so within 90 days. However, the complexity of a submission or a requirement for additional information may occasionally cause the review to extend beyond 90 days. Thus, if you have not received a written decision or been contacted within 90 days of our receipt date you may want to check with FDA to determine the status of your submission.

This legislation also requires anyone who asserts that a device is

substantially equivalent to a class III device to: (1) certify that they have conducted a reasonable search of all information known, or otherwise

available, about the generic type of device; and (2) provide a summary description of the types of safety and effectiveness problems associated with the type of device and a citation to the literature, or other sources of information, upon which they have based the description. The description should be sufficiently comprehensive to demonstrate that an applicant is fully aware of the types of problems to which the device is susceptible. If you have not provided this certification and description (with citations) in your premarket notification, please provide it as soon as possible. We cannot complete the review of your submission until you do SO.

Please note that the Safe Medical Devices Act of 1990 may have additional requirements affecting your device. You will be informed of these requirements as they become effective.

BEST COPY AVAKABL11 ?/





Please remember that all correspondence concerning your submission MUST be sent to the Document Mail Center (HFZ-401) at the above letterhead address. Correspondence sent to any address other than the Document Mail Center will not be considered as part of your official premarket notification submission. Because of equipment and personnel limitations we cannot accept telefaxed material as part of your official premarket notification submission, unless specifically requested of you by an FDA official.

If you have procedural or policy questions, please contact the Division of Small Manufacturers Assistance at (301) 443-6597 or their toll-free number (800) 638-2041, or contact me at (301) 427-1190.

Sincerely yours,


4r BEST COPY AVAWABL11 V4





MEMO TO THE RECORD

Date: April 15, 1991

From: John Guest, Electrical Engineer DGGD/GU1

Subject: K910769, Surgitek ERCP contrast media system, additional information needed

Surgitek's device allows the infusion of contrast media through an infusion catheter or infusion guidevire. The device uses a special

spring loaded syringe, tubing to connect to the contrast media bottle, and a luer hub to connect these two components to an infusion catheter. This connector has two one-way valves that prevent any retrograde flow of the contrast media. The spring loaded syringe refills itself after each expulsion of contrast media.

Mr. Steve Aperavich of Surgitek was called on March 26, 1991 and the

following items were discussed:

Until this information is submitted, I recommend that the application be placed on hold.

ohn Guest

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SURGITEK 7 3037 Mt. Pleasant Street Racine, Wl 53404 414 639-7205 Ef, L E L

Steve Aperavich

Vice President

Manufacturing February 21, 1991

rM Food and Drug Administration

Document Mail Center (HFZ-401)

Center for Devices and Radiological Health

1390 Piccard Drive

Rockville, MD 20850 rIj

RE: 510 (K) Notification - Surgitek* ERCT Contrast Media System

Dear Sirs:

According to Section 510(K) of the Federal Food, Drug and Cosmetic Act,

Medical Engineering Corporation proposes to introduce into interstate

commerce, for commercial distribution, a device intended for human use.

Here is the report to the Food and Drug Administration as required by

law. This premarket notification report is being submitted at least

ninety (90) days prior to the date upon which Medical Engineering Corporation proposes to begin the introduction of the device described

o" here.

Medical Engineering Corporation believes that the enclosed information

will be sufficient for the FDA to reach a decision on this notification.

However, should additional information be required, it will be promptly furnished upon request.

Medical Engineering Corporation regards its intent to market the SurgitekO ERCP Contrast Media System as confidential commercial

information. We request that the FDA not disclose the existence of the

premarket notification for at least 90 days or as required.

Medical Engineering Corporation appreciates the administrative and

scientific considerations relevant to this submission. We hope, however, that the FDA will reach its decision on this matter in a period of time

less than that provided for in the Act.

Sincerely,

Steve Aperavich, Vice President, Manufacturing

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CONHOINTIAL

MEDICAL ENGINEERING CORPORATION

SURGITZKO

HRCP CONTRAST MEDIA SYSTEM

PREMARKET NOTIFICATION 510(K)

SUBMISSION

SURGITZX@ SUBMISSION DATE: Medical Engineering corporation February 21, 1991 3037 Xt. Pleasant Street

Racine, Wisconsin 53404

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PREMARKET NOTIFICATION SUBMISSION 510(K) SURGITEKO ERCP CONTRAST MEDIA SYSTEM PAGE 2

TABLE OF CONTENTS

A. CLASSIFICATION NAME

B. COMMON/USUAL NAME

C. TRADE/PROPRIETARY NAME

D. ESTABLISHMENT REGISTRATION NUMBER

E. CLASSIFICATION

F. PERFORMANCE STANDARD

G. LABELING/PROMOTIONAL MATERIAL

H. PRODUCT INFORMATION

I. STERILIZATION

J. SUBSTANTIAL EQUIVALENCE

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PREMARKET NOTIFICATION SUBMISSION 510(K) SURGITEK0 ERCP CONTRAST MEDIA SYSTEM

PAGE 3

In accordance with Section 510(k) of the Federal Food, Drug, and

Cosmetic Act, and in conformance with 21 CFR 807, this premarket

notification is being submitted at least 90 days prior to the

date when SURGITEK MEDICAL ENGINEERING CORPORATION proposes to

introduce into interstate commerce a;

SURGITZKO ZRCP CONTRAST MEDIA SYSTE

A. CLASSIFICATION NAME:

Endoscope and Accessories

B. COMMON/USUAL NAKE:

SURGITEKO ERCP Contrast Media System

C. TRADZZPROPRIETARY NAME:

N1.1/ SURGITEKO ERCP Contrast Media System

D. EBTABLIBEMNT REGIGTRATION NUMBER:

Medical Engineering Corporation's Establishment Registration Number is 2124979.

Z. CLASSIFICATION:

This product has a classification of CLASS II based on 21CFR

876.1500, Endoscope and Accessories.

F. PBRFORXANCE STANDARD:

None established under Section 514.

G. LABBLINGZPRON-OTIONAL MATERIAL:

A draft of the package labeling for the product subject to this 510(k) is shown in this premarket notification.

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PREMARKET NOTIFICATION SUBMISSION 510(K) SURGITEK6 ERCP CONTRAST MEDIA SYSTEM PAGE 4

H. PRODUCT INFORXKTION:

The SURGITEK8 ERCP CONTRAST MEDIA SYSTEM is comprised of medical grade materials and consists of the

following components (see diagrammatic representation, Attachment A:

a. Calibrated piston syringe.

b. Two one-way valves.

C. Male/female luer disconnect.

d. Plastic tubing (PVC: 1/411 OD and 1/811 ID) and vented spike connector and,

e. Tubing clamp

The SURGITEKO ERCP CONTRAST MEDIA SYSTEM can be used with infusion guidewires or catheters with a standard female luer-lock connection.

Labeling information:

SURGITEK* ERCP CONTRAST MEDIA SYSTEM

- Inner package will be Tyvek/Mylar pouch.

- Outer package will be Tyvek/Mylar pouch.

- Label will be attached to the outer pouch.

- Package insert will be between inner and outer packaging.

Xanufacturing Information:

Attachment B presents a flow diagram of the manufacturing process for the SURGITEK* ERCP CONTRAST MEDIA SYSTEM.

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OEM VENDOR SUPPLIER IS:

Delivery System

Ackrad Laboratories 70 Jackson Drive P. 0. Box 1085 Cranford, NJ 07016

1. STERILIZATION:

The SURGITEKO ERCP CONTRAST MEDIA SYSTEM is sterilized by_Athylene Oxide. The Sterility Assurance level is 10'. The sterilization cycle is validated by the sterility testing of spored carrier devices. Devices are spored with 106

Bacillus subtilis. Double pouched Tyvek is used to maintain sterility.

Residual release criteria are as follows:

EtO - 250ppm EC - 250ppm EG - 5,000ppm

These are the maximum EtO residual limits as suggested by the proposed ethylene oxide device residual limits per the Federal Register, Vol 43: Number 22: June 23, 1978 (pp 27474-27483).

No claims are made as to the product being pyrogen-free.

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PREMARKET NOTIFICATION SUBMISSION 510(K) SURGITEK@ ERCP CONTRAST MEDIA SYSTEM PAGE 6

J. SUBSTANTIAL ZOUIVALENCE:

The BURGITER19 ZRCP CONTRAST MEDIA SYSTEM:

The SURGITEKO ERCP CONTRAST MEDIA SYSTEM is substantially equivalent to the following delivery systems:

- E.R.C.P. CONNECTING TUBE ASSEMBLY

Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-Salem, MA 27105

SYRINGE INJECTION GUN

Applied Medical Technology 6551 Breckville Road Independence, OH 44131

IRRI-FLO IRRIGATION DELIVERY SYSTEM

Medical Engineering Corporation 3037 Mt. Pleasant Street Racine, WI 53404

Irri-Flo 510(K) #K891339

The above cited predicate devices and the SURGITEKO

ERCP CONTRAST MEDIA SYSTEM are similar in that:

a. All devices utilize a piston syringe.

b. All devices interpose a connector or stopcock between the syringe and a plastic supply line.

C. All devices use a plastic supply line to a vented spike connector and,

d. All devices use a plastic vented spike connector to a fluid reservoir.

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PREMARKET NOTIFICATION SUBMISSION 510(K) SURGITEK'* ERCP CONTRAST MEDIA SYSTEM PAGE 7

The difference between the SURGITEK6 ERCP CONTRAST MEDIA SYSTEM and the predicate devices is:

a. There are two one-way valves at the syringe, disconnect, outlet junction. These valves are used to prevent the back-flow of contrast media.

b. The SURGITEKO ERCP CONTRAST MEDIA SYSTEM may be used with or without a syringe injection gun.

C. The SURGITEKO ERCP CONTRAST MEDIA SYSTEM includes a 304 stainless steel spring for automatic syringe filling.

d. The SURGITEKO ERCP CONTRAST MEDIA SYSTEM is used to deliver contrast media during cholangiopancreatography and the SURGITEKO IRRI-FLO is to deliver irrigation.

Attachment C presents promotional materials for the Connecting Tube Assembly by Wilson-Cook Medical and the Syringe Injection Gun by Applied Medical Techologies.

We consider our intent to market this device as confidential commercial information and request that it be considered as such by the FDA. To the best of my knowledge, we have not disclosed the intent to market this device to anyone except employees of the company, paid consultants, to individuals in an advertising or law firm pursuant to commerical arrangements with appropriate safeguards for secrecy.

Should you require further information, please contact me at:

(414) 639-7205, Extention 4160

or by facsimile transmission at (414) 636-8123

Sincerely,

Steve Aperavich, Vice President of Manufacturing

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PACKAGE LABELING;

1. Outer container label

Peel Back to Open

SURGITEK* ERCP CONTRAST MEDIA SYSTEM

STERILE: Contents of unopened and undamaged package are sterile and ready for use. Product cannot be returned if seal has been broken.

DO NOT REUSE: PRODUCT IS INTENDED FOR SINGLE USE ONLY.

CONTENTS: 1 ERCP CONTRAST MEDIA SYSTEM

PRODUCT NUMBER:

LOT NUMBER:

CAUTION: U.S. Federal law restricts the sale of this device to or on the order of a physician.

SURGITEK 3037 Mt. Pleasant Street Racine, Wisconsin 53404

Manufactured for Surgitek

Toll Free: (800) 558-9494 (414) 639-7205

Cable: MEDENGCO Telex: 269582 MEDICALENG

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2. Package Insert

DESCRIPTION

The SURGITEKO ERCP CONTRAST MEDIA SYSTEM is a single use device for the bolus infusion of contrast media during cholangiopancreatography. Continuous flow enables contrast media to reach the optical field by gravity. Depressing an attached spring action self-refilling syringe permits bolus delivery of contrast media to enter into the optical field via the catheter.

The device is designed with inflow tubing which consists of an infusion guidewire inserted into a contrast media bottle for fluid delivery. A luer lock connection allows the device to be securely attached to the inlet luer of a catheter.

The SURGITEKO ERCP CONTRAST MEDIA SYSTEM incorporates a specially designed dual check valve which prevents retrograde flow from the contrast media supply line or the patient delivery line.

INDICATIONS

The SURGITEK6 ERCP CONTRAST MEDIA designed for ERCP procedures when media is indicated.

NOTE: STERILE UNITS are ready package is intact. Do PRODUCT IS INTENDED FOR DO NOT RESTERILIZE.

CONTRAINDICATIONS

SYSTEM is bolus contrast

for use if .qOT REUSE. SINGLE USE ONLY.

It is the physician's responsibility to determine the circumstances under which the device should not be used.

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PREMARKET NOTIFICATION SUBMISSION 510(K) SURGITEX0 ERCP CONTRAST MEDIA SYSTEM PAGE 10

WARNING

Should the product be received in a DAMAGED CONTAINER, DO NOT USE, return to Surgitek/Medical Engineering corporation for reinspection and/or replacement.

HANDLING THE DEVICE

Great care has been taken to keep the device free from contaminants such as dust, lint and oil. The package of the enclosed device should be opened in as clean an atmosphere as can be provided.

INSTRUCTIONS FOR USE

Each physician is responsible for the proper procedures and techniques used. This protocol is provided for informational purposes.

Clamp off the constrast media (inflow) tubing using the attached clamp.

2. Using aseptic technique, remove the protective cap from the spike and insert the spike into the bottle of contrast media.

3. Disconnect the inflow tubing at the luer lock connection from the syring/valve assembly.

4. Elevate the luer lock end of the inflow tubing above the contrast media bottle and release the clamp on the tubing. Gradually lower the tubing and allow the contrast media to fill the tubing. Care should be taken to fill the tubing with a single flow of media until it reaches the outlet of the luer lock connector. This continuous flow will minimize bubbles in the system.

5. Clamp the inflow tubing and reconnect to the syringe/valve assembly.

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6. With the outlet of the in a downward position, plunger completely.

syringe/valve assembly depress the syringe

7. With the syringe plunger in a depressed position, release the clamp on the inflow tubing. Keeping the syringe in a downward position, slowly release the plunger and allow media to fill the syringe.

8. When the plunger has reached its original position, gently rotate the syringe to an upward position. Gently depress the plunger to expel the trapped air. Release the plunger and the syringe will fill with contrast media.

9. Connect the male luer lock end of the syringe/valve assembly to the catheter. Turn the luer lock clockwise to secure the SURGITEKO ERCP CONTRAST MEDIA SYSTEM onto the catheter. DO NOT OVERTIGHTEN.

10. Depressing the plunger will deliver contrast media to the site. Releasing the plunger will refill the syringe.

COKPLICATIONS

The physician is responsible for determining the complications associated with the use of this device. Complications may include the risks associated with the medication and the procedure, as well as the patient's degree of intolerance to the procedure.

RZTURNED GOODS POLICY

Authorization must be received from SURGITEK/Medical Engineering Corporation prior to returning. Product returned must have all package seals intact and be received within 30 days of date of invoice to be eligible for credit or replacement. Returned products may be subject to restocking charges.

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WARRANTY

1 11--.,/

SURGITEK/Medical Engineering Corporation warrants that the product is free from defect in materials and workmanship. At our option we will repair, replace or provide a refund for any products manufactured by us and found to be defective, so long as the product is returned to SURGITEK/Medical Engineering Corporation according to the Returned Goods instructions in our Sales Policy. SURGITEK/Medical Engineering Corporation shall not be liable for any consequential loss, damage or expense, directly or indirectly arising from the use of, or inability to use, this product. THE FOREGOING WARRANTY IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, HOWSOEVER ARISING, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR.PURPOSE, AGAINST INFRINGEMENT OR OTHERWISE. SURGITEK/Medical Engineering Corporation neither assumes, nor authorizes any person to assume for it, any other additional liability or responsibility with respect to this product.

CAUTION: U.S. Federal lav restricts the sale of this device to or on the order of a physician.

SURGITEK Medical Engineering corporation 3037 Mt. Pleasant Street Racine, Wisconsin 53404

Toll Free: (800) 558-9494 (414) 639-7205 Cable: MEDENGCO Telex: 269582 MEDICALENG

A Bristol-Myers Squibb Company

Advanced Technology in Biocompatible Materials

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ATTACMIZNT A

Diagrarmatic Representation of the SURGITEK6 ERCP CONTRAST MEDIA SYSTEM.

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ATTACHIONT B

Manufacturing Flow Chart for the SURGITEKO ERCP CONTRAST MEDIA SYSTEM

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ATTACMMNT C

Promotional Materials for:

E.R.C.P. CONNECTING TUBE ASSEMBLY (WILSON-COOK MEDICAL)

SYRINGE INJECTION GUN (APPLIED MEDICAL TECHNOLOGY)

IRRI-FLO IRRIGATION DELIVERY SYSTEM (SURGITEK/MEDICAL ENGINEERING CORPORATION)

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CONTENTS

PR 0 D U CT PAGE 41 "A"',

-4 Am gamwWW'S

GENERAL INFORMATION ........................................... 1-4

WILSON-COOK GASTROSCOPE BIOPSY FORCEPS ......................... 5

WILSON-COOK COLONOSCOPE BIOPSY FORCEPS ......................... 6 WILSON-COOK HOT BIOPSY FORCEPS SET .............................. 7 WILSON-COOK BRONCHOSCOPE BIOPSY FORCEPS ........................ 8 WILSON-COOK RETRIEVAL FORCEPS ................................... 9 WILSON-COOK GRASPING FORCEPS ................................... 10 WILSON-COOK CAREY CAPSULE SET .................................. 11

E.R.C.P. CATHETERS ............................................... 13 HUIBREGTSE-KATONT"E.R.C.P. CATHETERS ............................... 14 E.R.C.P. HAND INJECTION PISTOL ..................................... 15 E.R.C.P. CONNECTING TUBE ASSEMBLY ................................. 15 STRICTURE MEASURING CATHETER ................................... 16

COTTON-HUIBREGTSE BILIARY STENT SETS .............................. 17 HUIBREGTSE BILIARY STENT SETS ..................................... 18 ZIMMON ENDOSCOPIC BILIARY STENT SETS ............................. 19 SOEHENDRA ENDOSCOPIC BILIARY STENT SETS .......................... 20 COTTON-LEUNG BILIARY STENT SETS .................................. GEENEN PANCREATIC STENT SETS ....................................

21 22

ZIMMON ENDOSCOPIC PANCREATIC STENT SETS ......................... 23 ENDOSCOPIC NASAL BILIARY DRAINAGE SETS ........................... 24 LIGUORY ENDOSCOPIC NASAL BILIARY DRAINAGE SETS .................... 25 NAGARAJA NASAL BILIARY DRAINAGE SETS ............................. 26 NASAL BILIARY DRAINAGE CATHETERS ................................. 27 CUNNINGHAM-COTTON SLEEVE ...................................... 28 BILIARY STENT INTRODUCER SETS .................................... 28a COMBINED PROCEDURE SET ........................................ 28b NASAL PANCREATIC DRAINAGE SET ................................... 28c CRAMPTON-TSANG PERCUTANEOUS ENDOSCOPIC BILIARY STENT SETS ........ 28d HUIBREGTSE 8.5 BILIARY STENT SETS ................................. 28e COTTON -H UIBREGTSE 8.5 BILIARY STENT SETS .......................... 28e COTTON-LEUNG 8.5 BILIARY STENT SETS ............................... 28f ZIMMON ENDOSCOPIC PANCREATIC STENT SETS ......................... 28g

WILSON-COOK WIRE GUIDES ........................................ 29 SAVARY-GILLIARD4D WIRE GUIDES ..................................... 30

ZIMMON PAPILLOTOMES/SPHINCTEROTOMES ............................ 31 SWENSON WIRE GUIDED PAPILLOTOMES/SPHINCTEROTOMES ................ 32 HUIBREGTSE-KATONý PAPILLOTOMES/SPHINCTEROTOMES .................. 33 SHARK FIN PAPILLOTOMES/SPHINCTEROTOMES .......................... 34 CREMER-IKEDA PAPILLOTOMES/SPHINCTEROTOMES ....................... 35 SOEHENDRA PAPILLOTOME/SPHINCTEROTOME ........................... 36 SOEHENDRA PRECUT PAPILLOTOMEISPHINCTEROTOME .................... 36 WIRE GUIDED PAPILLOTOMES/SPHINCTEROTOMES ........................ 37 LARGE CHANNEL INSTRUMENTS ...................................... 38 FRI M BERG ER-KARPIEL 12 O'CLOCK PAPILLOTOMES/SPHINCTEROTOMES ....... 38a

@COPYRIGHT WILSON-COOK MEDICAL INC. 1990 BEST COPY AVAI LABLE





E.R.C.P. CATHETERS 15

E.R.C.P. HAND INJECTION PISTOL

00 Used for controlled injection of contrast for performing E.R.C.P. Uses a standard 10 cc B-DTI (Becton - Dickinson) disposable syringe (not included) or the E.R.C.P. Connecting Tube Assembly. Supplied non-sterile.

ORDER NUMBER Remarks

0% H11-1 Used with balloons and any device that allows contrast injection when biliary

operifiention is renuired.

E.R.C.P. CONNECTING TUBE ASSEMBLY

Used with the E.R.C.P. Hand Injection Pistol to reduce the chance of inadvertent disconnection during contrast injection. Uses a standard 10 cc B-DTI (Becton -Dickinson) syringe with a fixed three-way stopcock and two, 100 cm connecting tube lines. Supplied sterile in peel-open packages. Intended for one-time use.

=7',l TO RESERVOIR

TO E.R.C.P. CATHETER

ORDER NUMBER

0"k CTA-1 10 per package

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SYRINGE INJECTION GUN A uniquely designed syringe

infection gun device that allows controlled fluid delivery ideal for ERCP injections, lavage, schlerotherapy and other uses.

-&Reduces hand fatigue " Controlled volume deliveries " Compatible with se veral syringe sizes " Durable reusable design " Pressure gauge

SYRINGE INJECTIONGUN

Each kit contains: a Syringe fnýectlon Gui i - 30cc Synnoe A daDler

Aor 4 60cc Syringe a Pressure Gauge and Slop Cock a

REORDER SIZE UNITIBOX 1004010 60cc and 30cc Adapter 1/Box NOTE. Product packaged non-sterile.

ESOPHA GEAL ENUOSCOPIC 0 VER TUBE

Efth POCkage Contains I Flexibie Esophageal Endoscopic Overtube

REORDER #COLOR SUE UNITIROX 1003014 Clear

,

I.D. 14mm I/box 1003114 Black I.D. 14mm 1/box 1003015 Clear

0

I.D. 15mm 1/box

4

1003115 Black I.D. 15mm I/box NOTE., Product packaged non-sterile.

imuttiundi gastrointestinal accessones are also avananie from AMV

'PP!_,'5 D A 1E Cý 7:

6551 Brecksville Road. Independence. Ohio 44131

Phone: (2161524-9199

FAX: (216) 524-536 7 Foll Free: 1 -6'D0-8(;9-;382 BEST COPY AVAILABLE





10cc syringe vviith spring loaded plunger, connects to any encloscope for controlled pressure delilvlcrv.

C ysto tubu'ig vnth spike, connects directly to solution bag hclplng to rcduce set-up and procedure time.

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Convenient, liahtwcight and casv to use.





SURGITEK IRRI-FLO Irrigation Delivery System Enhances irrigation flow through small channel endoscopes

Product Number: 5920000 10 steri'le units per box

To order, cA SURCTITEK Customer Scnice 800-558-9494

5UKU -Ur=K IfAAGES OF TOMORROW'S TECHNOLOGY

Cc) 1989, Medical Engineering Corp-3037 Mt. Pleasant St.

fUcinc, W1 53404 Toll Free: 800-558-9494 (414) 639-7205 Cable: MEDENGCO, Telex: 269582 MEDICAUNG LK01046-00 3/99

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