records processed under foia request # 2017-10380, released … · 2018-08-30 · records processed...

Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18

Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118

TABLE OF CONTENTS

Special 510(k)

HEALICOIL PK Suture Anchor

(formerly Next Generation Fully Threaded Suture Anchor)

Title Page(s)

SECTION I Required Elements for all 510(k) submissions

Cover Letter

Medical Device User Fee Cover Sheet 2

CDRH Submission Cover Sheet 3

Certification of Compliance with ClinicalTrials.gov Data Bank 8

Table of Contents 9

Screening Checklist For All Premarket Notification [510(k)] Submissions 10

Standards Data Report for 510(K)s - FDA 3654 14

Premarket Notification Truthful and Accurate Statement Certification 20

Indications for Use 22

SECTION II Required Elements for all 510(k) submissions: General Information

A. Device Name: trade, common or proprietary and classification name 23

B. Submitter Information 23

C. Establishment Registration Number(s) 23

D. Device Classification: Regulation Number and Regulatory Status 23

E. Performance Standards 23

SECTION III Required Elements for all 510(k) submissions: Device Modification A. Introduction 24

B. Unmodified Predicate Device 25

C. Description of Modification(s) 25

D. Design Control Activities Summary 28

a. Risk Analysis Method

b. Verification Validation Activities

E. Substantial Equivalence Comparison 29

SECTION IV 510(k) Summary of Safety and Effectiveness 31

Exhibit A Engineering Drawings

Exhibit B Current Labeling

Exhibit C Animal Study Report:

Exhibit D Report

Exhibit E Declaration of Conformity with Design Controls

(b)(4)

SCREENING CHECKLIST

Special 510(k) Do Sections 1 and 2

Abbreviated 510(k) Do Sections 1, 3 and 4

Traditional 510(k) Do Sections 1 and 4

Section 1: Required Elements for All Types of 510(k) submissions:

Present Inadequate or

Missing

Cover letter, containing the elements listed on page 3-2 of the Premarket

Notification [510)] Manual.

Section I

Table of Contents. Section I,

Truthful and Accurate Statement. Section I,

Device’s Trade Name, Device’s Classification Name and Establishment

Registration Number.

Section II,

Device Classification Regulation Number and Regulatory Status (Class I,

Class II, Class III or Unclassified).

Section II,

Proposed Labeling including the material listed on page 3-4 of the Premarket

Exhibit B

Statement of Indications for Use that is on a separate page in the premarket

submission.

Section I,

Substantial Equivalence Comparison, including comparisons of the new

device with the predicate in areas that are listed on page 3-4 of the Premarket

Section III,

510(k) Summary or 510(k) Statement. Section IV,

Description of the device (or modification of the device) including diagrams,

engineering drawings, photographs or service manuals.

Section III &

Exhibit A

Identification of legally marketed predicate device. * Section III,

Compliance with performance standards. * [See Section 514 of the Act and

21 CFR 807.87 (d).]

Class III Certification and Summary. ** N/A

Financial Certification or Disclosure Statement for 510(k) notifications with a

clinical study. * [See 21 CFR 807.87 (i)]

510(k) Kit Certification *** N/A

* - May not be applicable for Special 510(k)s.

** - Required for Class III devices, only.

*** - See pages 3-12 and 3-13 in the Premarket Notification [510)] Manual and the Convenience

Kits Interim Regulatory Guidance.

Section 2: Required Elements for a SPECIAL 510(k) submission:

Missing

Name and 510(k) number of the sponsor’s own, unmodified predicate device. Section III,

A description of the modified device and a comparison to the sponsor’s

predicate device.

Section III,

Pages 25 - 29

A statement that the intended use(s) and indications of the modified device,

as described in its labeling, are the same as the intended uses and indications

for the sponsor’s unmodified predicate device.

Section III,

A statement that the modification has not altered the fundamental technology

of the sponsor’s predicate device.

Section III,

A Design Control Activities Summary that includes the following elements

(a-e):

(no entry here) (no entry here)

a. Identification of Risk Analysis method(s) used to assess the impact of the

modification on the device and its components, and the results of the analysis.

Section III,

b. Based on the Risk Analysis, an identification of the required verification

and validation activities, including the methods or tests used and the

acceptance criteria to be applied.

Section III,

c. A Declaration of Conformity with design controls that includes the

following statements:

Exhibit E

A statement that, as required by the risk analysis, all verification and

validation activities were performed by the designated individual(s) and

the results of the activities demonstrated that the predetermined

acceptance criteria were met. This statement is signed by the individual

responsible for those particular activities.

Exhibit E

A statement that the manufacturing facility is in conformance with the

design control procedure requirements as specified in 21 CFR 820.30

and the records are available for review. This statement is signed by the

individual responsible for those particular activities.

Exhibit E

Section 3: Required Elements for an ABBREVIATED 510(k)* submission:

Missing

For a submission, which relies on a guidance document and/or special

control(s), a summary report that describes how the guidance and/or special

control(s) was used to address the risks associated with the particular device

type. (If a manufacturer elects to use an alternate approach to address a

particular risk, sufficient detail should be provided to justify that approach.)

N/A (Special)

For a submission, which relies on a recognized standard, a declaration of

conformity , For a listing of the required elements of a declaration of

conformity, SEE Required Elements for a Declaration of Conformity to a

Recognized Standard.

For a submission, which relies on a recognized standard without a declaration

of conformity, a statement that the manufacturer intends to conform to a

recognized standard and that supporting data will be available before

marketing the device.

For a submission, which relies on a non-recognized standard that has been

historically accepted by FDA, a statement that the manufacturer intends to

conform to a recognized standard and that supporting data will be available

before marketing the device.

For a submission, which relies on a non-recognized standard that has not

been historically accepted by FDA, a statement that the manufacturer intends

to conform to a recognized standard and that supporting data will be available

before marketing the device and any additional information requested by the

reviewer in order to determine substantial equivalence.

Any additional information, which is not covered by the guidance document,

special control, recognized standard and/or non-recognized standard, in order

to determine substantial equivalence.

- When completing the review of an abbreviated 510(k), please fill out an Abbreviated Standards Data

Form and list all the guidance documents, special controls, recognized standards and/or non-

recognized standards, which were noted by the sponsor.

Section 4: Additional Requirements for ABBREVIATED and TRADITIONAL

510(k) submissions (If Applicable):

Missing

a) Biocompatibility data for all patient-contacting materials, OR certification

of identical material/formulation:

N/A (Special)

b) Sterilization and expiration dating information:

i) sterilization process

ii) validation method of sterilization process

iii) SAL

iv) packaging

v) specify pyrogen free

vi) ETO residues

vii) radiation dose

viii) Traditional method or non traditional method

c) Software Documentation:

Indications for Use

510(k) Number (if known): ___________________________________________

Device Name: HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture

Anchor)

Indications For Use:

The HEALICOIL PK Suture Anchor (formerly Smith & Nephew Next Generation Fully

Threaded PEEK Suture Anchor) is intended for use for the reattachment of soft tissue to bone for

the following indications:

Shoulder:

Bankart lesion repairs

Slap lesion repairs

Capsular shift or capsulolabral

reconstructions

Acromioclavicular separation repairs

Deltoid repairs

Rotator cuff tear repairs

Biceps tenodesis

Foot & Ankle:

Hallux valgus repairs

Medial or lateral instability

repairs/reconstructions

Achilles tendon repairs/reconstruction

Midfoot reconstructions

Metatarsal ligament/tendon

repairs/reconstructions

Extra-capsular repairs:

Medial collateral ligament

Lateral collateral ligament

Posterior oblique ligament

Patellar realignment and tendon repairs:

Vastus medialis obliquous advancement

Iliotibial band tenodesis.

Elbow:

Ulnar or radial collateral ligament reconstructions

Lateral epicondylitis repair

Biceps tendon reattachment

Hip: Gluteal tendon repairs

- Gluteus medius and gluteus minimus repair

Prescription Use ___x___ AND/OR Over-The-Counter Use ______

(Per 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

SECTION II

Required Elements for all 510(k) submissions: General Information

A. Device Name (Unmodified):

Device Trade Name HEALICOIL PK Suture Anchor

(formerly Next Generation Fully Threaded

Suture Anchor)

Common/Classification Name Fastener, fixation, non-degradable, soft tissue

B. Submitter Information:

Company Name Smith & Nephew, Inc., Endoscopy Division

Address 150 Minuteman Road, Andover, MA 01810

Contact Elizabeth Lavelle,

Senior Regulatory Affairs Specialist

C. Establishment Registration Number(s):

Owner/Operator Name Smith & Nephew, Inc. Endoscopy Division

Address 150 Minuteman Road, Andover, MA 01810

Establishment Registration # ER# 3003604053

Owner Operator # 1216828

Manufacturing Site

Address

Establishment Registration #

Owner Operator #

Sterilization Site Name

Address

Establishment Registration #

D. Device Classification: Regulation Number and Regulatory Status

Class Class II

Regulation Number 21 CFR §888.3040

Procode MBI

Panel Orthopedics

E. Performance Standards

There are no known performance standards or special controls promulgated under

section 514 of the Act for this device.

(b)(4)

SECTION III

Required Elements for all 510(k) submissions: Device Modification

A. Introduction

Smith and Nephew, Inc. has a long history marketing suture anchors for the

reattachment of soft tissue to bone. These anchors are available in a range of

materials, both permanent and absorbable, and include various size and design

configurations to meet the needs of orthopedic surgeons.

The purpose of this premarket notification is to gain clearance for marketing

claims for Smith & Nephew’s Next Generation Fully Threaded PEEK Suture

Anchor (now named the HEALICOIL PK Suture Anchor) regarding bone in-

growth.

The HEALICOIL PK Suture Anchor (K110545) consists of a non-absorbable

anchor manufactured from PEEK (polyetheretherketone), loaded with up to three

strands of suture and pre-assembled onto a stainless steel insertion device. One of

the main design features of HEALICOIL PK Suture Anchor is its open core

architecture (Figure 1). The integrated inserter/awl extends through the full

length of the anchor and beyond the distal end. Accessories specific to the

HEALICOIL PK Suture Anchors, including spade tip drills and awl-dilators,

which are recommended for hole preparation per the Instructions for Use.

FIGURE 1. Photo and Illustrations of the HEALICOIL PK (formerly Next

Generation Fully Threaded) Suture Anchor

(b)(4)

(b)(4) Testing

TABLE 2. Design Verification Activity

E. Substantial Equivalence Comparison

The subject of this 510(k), the HEALICOIL PK Suture Anchor, is substantially

equivalent to the Next Generation Fully Threaded Suture Anchor (K110545)

because there are no changes to the design, material, fundamental technology,

intended use, or indications for use (other than minor modifications made to

dimensions and labeling documented internally per FDA guidance document

K97-1, “Deciding When to Submit a 510(k) for a Change to an Existing Device.”)

Please refer to Table 3 below.

The purpose of this submission is to obtain clearance for bone in-growth claims to

be used in Smith & Nephew promotional materials, supported by a 12 week in

vivo ovine study.

(b)(4)

TABLE 3. Comparison of Proposed Device to Predicate Device

Characteristic Predicate Device K110545

NGFTSA PK

(now called HEALICOIL

PK Suture Anchor)

Subject of this 510(k)

HEALICOIL PK

Suture Anchor

(Same)

Indications for

Reattachment of soft tissue

to bone in shoulder, foot,

knee, ankle, elbow, and hip

Outer Diameter 4.5 and 5.5mm Same

Sterilization

Method

Ethylene Oxide Same

Material PEEK Same

Profile Same

How Supplied Anchor preloaded with # 2

suture and preassembled

onto insertion device

Shelf Life 5 years Same

Thread design Single lead thread Same

Insertion

Technique

Screw-in Same

Labeling claims Mean fixation strength is

greater than 24.48N (5.465

lbf) in 5, 45/15, and 30 pcf

bone block densities.

Please refer to K110545

for all values.

Same plus the following

bone in-growth claims

supported by a sheep

study:

The open architecture of the

HEALICOIL PK Suture

Anchor allows for new bone

to fill the fenestrations

between threads and into the

central channel.

The Smith and Nephew

HEALICOIL PK Suture

Anchor contained 63% of the

bone volume of control bone

by 12 weeks post-

implantation.

EXHIBIT A

Engineering Drawings

(b)(4) Engineering Drawings

EXHIBIT B Current Labeling

EXHIBIT C

Animal Study Report: “Evaluation of a New Suture Anchor Design in an Ovine

Bone Defect Model: A Pilot Study

(b)(4)

(b)(4) Testing

EXHIBIT D

Report (b)(4) Testing

Smith & Nephew Research Centre Work Report

(b)(4), (b)(6)

(b)(4) Testing

EXHIBIT E

Declaration of Conformity with Design Controls

records processed under foia request # 2017-10380, released … · 2018-08-30 · records processed...

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