questions? contact fda/cdrh/oce/did at cdrh ...510(k) notification cover letter 1. application type:...

Records processed under FOIA Request 2014-1304; Released 11/5/14

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

(b)(4) Trade Secret Process Records processed under FOIA Request 2014-1304; Released 11/5/14

Table of contentItem Page

1 Medical device user fee cover sheet……………………………1-12 CDRH Premarket Review cover sheet…………………………2-1 to 2-53 510(k) Cover Letter……………………………………………….3-14 Statement of Indications for Use………………………………..4-15 510(k) Summary…………………………………………………..5-1 to 5-26 Truthful and accurate statement…………………………………6-17 Class Ⅲ Summary and certification……………………………7-18 Financial Certification form 3454………………………………..8-19 Form 3654………………………………………………………….9-110 Executive summary……………………………………………….10-1 to 10-211 Device description………………………………………………...11-1 to 11-212 SE comparison…………………………………………………….12-1 to 12-213 Proposed labeling…………………………………………………13-1to13-4214 Sterilization and shelf life…………………………………………14-115 Biocompatibility……………………………………………………15-116 Software validation………………………………………………..16-1 to 16-6417 EMC and Electrical Safety……………………………………….17-118 Performance Testing-Bench……………………………………..18-119 Performance Testing-Animal…………………………………….19-120 Performance Testing-Clinical…………………………………….20-121 Form 3674…………………………………………………………21-1 to 21-2

Ihealth Cloud FDA 510(k) Files

510(k) notification Cover Letter1. Application Type: Traditional 510(K)2. Common Name: Data Management Software3. Submitter: Mr. Yi Liu4. Official contact person authorized by the submitter: Ms. Yang Wang5. Company name: Andon Health Co., Ltd.

Address: No 3, Jinping Road, Ya’an street TIANJIN,300193Phone Number: 86-22-60526161Fax Number: 86-22-6052 6162

6. Device Class: Class II7. Product Code: DXN, NBW, MNW8. C.F.R. Section: 21 CFR 870.2770, 21 CFR 862.1345, 21 CFR

870.11309. Classification Panel: 870 Cardiovascular, 862 Clinical Chemistry

Design and Use of the DeviceQuestion YES NO

Is the device intended for prescription use (21 CFR 801Subpart D)?A

Is the device intended for over-the-counter use (21 CFR807 Subpart C)?A

Does the device contain components derived from a tissueor other biologic source?

Is the device provided sterile? √

Is the device intended for single use? √

Is the device a reprocessed single use device? √

If yes, does this device type require reprocessed validationdata?

Does the device contain a drug? √

Does the device contain a biologic? √

Does the device use software? √

Does the submission include clinical information? √

Is the device implanted? √

Ihealth Cloud FDA 510(k) Files

Indication for Use510(k) Number (if known):

Device Name: Ihealth Cloud

Indication For Use:

IHealth cloud's intended use is to retrospectively display and analyzerelated medical data. The Web Application is not intended for emergencyuse or real-time monitoring.

Prescription Use Yes And/Or Over the Counter Use Yes(21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety(OIVD)

______________________________Division Sign-OffOffice of In Vitro Diagnostic DeviceEvaluation and Safety

510(k)__________________

of ____

iHealth cloud FDA 510(k) Files

510(k) SummaryThis summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirement of SMDA and 21 CFR 807.92.

1.0 submitter’s information

Name: Andon Health Co., Ltd.Address: No 3, Jinping Road, Ya’an street TIANJIN,300193Phone number: 86-22-60526161Fax number: 86-22-6052 6162Contact: Yi LiuDate of Application: 4/24/2013

2.0 Device information

Trade name: iHealth cloudCommon name: Patient Vital Signs Monitor Viewing StationClassification name: Patient Vital Signs Monitor Viewing Station

3.0 Classification

Production code: DXN, NBW, MNWRegulation number: 21 CFR 870.2770, 21 CFR 862.1345, 21 CFR 870.1130Classification: Ⅱ

Panel: 870 Cardiovascular, 862 Clinical Chemistry

4.0 Predict device information

Manufacturer: Watermark MedicalDevice: Connected Care Clinical Application510(k) number: K120320

5.0 Device descriptionIHealth cloud is a cloud based, web software system. It is accessedfrom commercially available PC systems with a web browser andminimum performance specifications consistent with typical PChardware and equipment specifications. IHealth cloud accepts databoth electronically as well as from manually input.

IHealth cloud is a medical device data system that displays andanalyzes data received from iHealth home monitoring devices as wellas manually input data. iHealth home monitoring devices include theapps and the device, such as KD-931, KD-936, KD-972 and Scale HS3

and HS5, AG-631, AG-632, AM3, PO3 and iHealth MyVitals.6.0 Intended use

IHealth cloud's intended use is to retrospectively display and analyzerelated medical data. The Web Application is not intended foremergency use or real-time monitoring.

7.0 Performance summary

The software validation results demonstrated that the ClinicalApplication was in compliance with the guidelines and standardsreferenced in the FDA reviewer's guides and that it performed within itsspecifications and functional requirements for software.

This summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirements of FDA regardingMedical device software.

iHealth Cloud FDA 510(k) Files

This section does not apply

Executive summary1. A concise summary

(b)(4) Trade Secret Process

Device description

1 Device name and type

iHealth cloud

2 Intended use

3 Performance specification(b)(4) Trade Secret Process

(b)(4) Trade Secret Process -Draft LabelingRecords processed under FOIA Request 2014-1304; Released 11/5/14

ihealth Cloud FDA 510(k) Files

This section does not apply.

Software Validation of iHealthCloud

(b)(4) Trade Secret Process -Software Validation ReportRecords processed under FOIA Request 2014-1304; Released 11/5/14

This section doesn’t apply.

(b)(4) Trade Secret Process -Verification ReportRecords processed under FOIA Request 2014-1304; Released 11/5/14

(b) (4)Records processed under FOIA Request 2014-1304; Released 11/5/14

Table of content of

response to RTA of K131203

This is a replacement copy of the K131203 RTA response sent to DMC on May20th, 2013.

I have reorganized the reply to the questions, so that it can be reviewed better,however, all the content is exactly the same as before.

Item Content Pages

001 Table of content of response to RTA of K131203 1

002 Response to RTA of K131203 4

003 Attachment 1. 510(K) Summary 2

004 Attachment 2. SE comparison 7

005 Attachment 3. Software Validation 68

510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92. 1.0 submitter’s information Name: Andon Health Co., Ltd. Address: No 3, Jinping Road, Ya’an street TIANJIN,300193 Phone number: 86-22-60526161 Fax number: 86-22-6052 6162 Contact: Yi Liu Date of Application: 4/24/2013 2.0 Device information Trade name: iHealth cloud Common name: Patient Vital Signs Monitor Viewing Station Classification name: Patient Vital Signs Monitor Viewing Station 3.0 Classification Production code: DXN, NBW, MNW Regulation number: 21 CFR 870.2770, 21 CFR 862.1345, 21 CFR 870.1130 Classification: Ⅱ Panel: 870 Cardiovascular, 862 Clinical Chemistry 4.0 Predict device information 1 Manufacturer: Andon health co., LTD

Device: Apps-Health01

510(k) number: k122098

2 Manufacturer: Andon Medical Co., Ltd.

Device: BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM

510(k) number: K123935

5.0 Device description

IHealth cloud is a cloud based, web software system. It is accessed from commercially available PC systems with a web browser and minimum performance specifications consistent with typical PC

hardware and equipment specifications. IHealth cloud accepts data both electronically as well as from manually input. IHealth cloud is a medical device data system that displays and analyzes data received from iHealth home monitoring devices as well as manually input data. iHealth home monitoring devices include the apps and the device, such as KD-931, KD-936, KD-972 and Scale HS3 and HS5, AG-631, AG-632, AM3, PO3 and iHealth MyVitals.

6.0 Intended use IHealth cloud's intended use is to retrospectively display and analyze related medical data. The Web Application is not intended for emergency use or real-time monitoring. 7.0 Performance summary The software validation results demonstrated that the Clinical Application was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements for software. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of FDA regarding Medical device software.

3．Final conclusion According to the above illustration, in the same intended use, iHealth Cloud is as same safe and effective as the predicated device.

Software Validation of iHealth Cloud

(b)(4) Trade Secret Process - Software Validation ReportRecords processed under FOIA Request 2014-1304; Released 11/5/14

(b)(4) Trade Secret Process - Software Validation Report

questions? contact fda/cdrh/oce/did at cdrh ...510(k) notification cover letter 1. application type:...

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