IHEALTH CLOUD

K131203 · Andon Health Co, Ltd. · DXN · Jul 19, 2013 · Cardiovascular

Device Facts

• Record ID: K131203
• Device Name: IHEALTH CLOUD
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jul 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

iHealth Cloud is a cloud-based web software system for retrospective display and analysis of medical data. It accepts data electronically from iHealth home monitoring devices (e.g., blood pressure monitors, scales, activity trackers) and via manual input. Accessed via standard PC web browsers; intended for use by patients and healthcare providers. The system functions as a medical device data system (MDDS) to organize and present historical health information. It does not provide real-time monitoring or emergency alerts. By aggregating data from various iHealth peripherals, it assists users and clinicians in reviewing health trends over time to support clinical decision-making.

Clinical Evidence

Bench testing only. Software validation results confirmed the application complies with FDA guidelines and standards for medical device software and performs within specified functional requirements.

Technological Characteristics

Cloud-based web application; accessed via standard PC web browsers. Functions as a medical device data system (MDDS). Connectivity via electronic data transfer from iHealth home monitoring devices (e.g., KD-931, KD-936, KD-972, HS3, HS5, AG-631, AG-632, AM3, PO3) and manual user input. Software-based analysis of historical data.

Indications for Use

Indicated for retrospective display and analysis of medical data for patients using iHealth home monitoring devices. Suitable for both prescription and over-the-counter use. Not for emergency use or real-time monitoring.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• Connected Care Clinical Application (K120320)

Submission Summary (Full Text)

{0}------------------------------------------------

# 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

| Manufacturer: | Watermark Medical |
|----------------|-------------------------------------|
| Device: | Connected Care Clinical Application |
| 510(k) number: | K120320 |

## 5.0 Device description

lHealth 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

{1}------------------------------------------------

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.

{2}------------------------------------------------

Public Health Service

July 19, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Andon Health Co., Ltd Yi Liu President No. 3 Jinping Road, Ya' An Street Tianjin, China 300193

> K131203 Trade/Device Name: IHealth Cloud Regulation Number: 21 CFR 870.2770 Regulation Name: Patient Vital Signs Monitor Viewing Station Regulatory Class: Class II Product Code: DXN, NBW, MNW Dated: May 20, 2013 Received: May 30, 2013

Dear Yi Liu:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Yi Liu

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Owen P. Faris -S

for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Ihealth Cloud FDA 510(k) Files

K131203

# Indication for Use

510(k) Number (if known):

Device Name: Ihcalth Cloud

## Indication For 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.

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

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

And/Or

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

Digitally signed by Owen P.
Faris -S
Date: 2013.07.19 16:15:42
-04'00'

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)__

Page 1 of