APPS-HEALTH01

K122098 · Andon Health Co, Ltd. · DXN · Mar 21, 2013 · Cardiovascular

Device Facts

• Record ID: K122098
• Device Name: APPS-HEALTH01
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 21, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Apps-Health01 is intended for use in home settings as an aid for people to review, analyze, and evaluate test results which are measured from a blood pressure monitor or scale.

Device Story

Apps-Health01 is an iOS-based data management software application. It interfaces with external health devices (blood pressure monitors and scales) via Bluetooth or Wi-Fi to retrieve, store, and display measurement data. Users operate the app on mobile devices (iPhone, iPad, iTouch) to view trends in blood pressure, weight, and calories; log food and activity; and set reminders for medication or measurements. The software provides a historical view of data to assist users in monitoring their health metrics. It does not perform measurements itself but acts as a repository and visualization tool for data collected by peripheral hardware. The output is presented to the user on the mobile device screen to facilitate self-management of health goals.

Clinical Evidence

No clinical data. Performance validation was limited to software unit and system testing, wireless coexistence testing, and compliance with IEC 60601-1, IEC 60601-1-2, and FCC standards.

Technological Characteristics

iOS software application; operates on iPhone, iPad, iTouch; connectivity via Bluetooth and Wi-Fi; data management and visualization functionality; software validation performed.

Indications for Use

Indicated for home users to review, analyze, and evaluate blood pressure and weight measurements obtained from compatible blood pressure monitors or scales.

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

• KD-931 (K102939)

Submission Summary (Full Text)

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# MAR 2 1 2013

# 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: 7/11/2012

#### 2.0 Device information

| Trade name: | Apps-Health01 |
|----------------------|--------------------------|
| Common name: | Data management software |
| Classification name: | Data management software |

## 3.0 Classification

Production code: DXN, MNW Regulation number: 21 CFR 870.2770, 21 CFR 870.1130 Classification: II Panel: 870 Cardiovascular

#### 4.0 Predict device information

Manufacturer: Andon Health Co., Ltd. Device: KD-931 510(k) number: K102939

#### 5.0 Device description

Apps-Health01 iHealth App is an iOS software for using with health devices, such as Blood Pressure Monitor and Scale. When used with the health devices, iHealth App could transfer data from the device's memory and count, manage, share the data.

#### 6.0 Intended use

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#### Apps-Health01 FDA 510(k) Files

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The Apps-Health01 is intended for use in home settings as an aid for people to review, analyze, and evaluate test results which are measured from a blood pressure monitor or scale. .

| item | Apps-Health01 | KD-931 (K102939) |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product type | software | System(include meter<br>and software) |
| Indications for<br>use | The Apps-Health01 is intended<br>for use in home settings as an<br>aid for people to review,<br>analyze, and evaluate test<br>results which are measured<br>from a blood pressure monitor<br>or scale. | KD-931 Fully Automatic<br>Electronic Blood<br>Pressure Monitor are for<br>use by medical<br>professionals or at home<br>and are non-invasive<br>blood pressure<br>measurement system<br>intended to measure the<br>diastolic and systolic<br>blood pressures and<br>pulse rate of an adult<br>individual by using a<br>non-invasive technique<br>in which an inflatable<br>cuff is wrapped around<br>the upper arm. The cuff<br>circumference is limited<br>to 22cm-48cm. |
| Software<br>platform | iOS | iOS |
| Hardware<br>requirements | iPhone, iTouch, iPad | iPhone,iTouch,iPad |
| Function | Blood pressure: Test or manually input blood pressure data. | Blood pressure: Test blood pressure data. |
| | Weight: Test or manually input body composition data. | My BP trends: View your blood pressure trends. |
| | My calorie Trends: View your calories consumed vs. calories burned. | History: A customizable view of your historical data. |
| | Reminders: Set reminders (Medicine/Measure blood pressure /Measure weight/Sport) to stay focused on your goals. | |
| | My plan: Add and modify your weight goals. | |
| | My BP trends: View your blood pressure trends. | |
| | My weight Trends: View your weight data. | |
| | History: A customizable view of your historical data. | |
| | My Diary: Log food and activities to stay on track. | |
| Meter<br>Compatibility | Scales, Blood Pressure Monitor | Blood Pressure Monitor |
| Connection with peripheral<br>device by | Bluetooth (HS5 with WIFI additionally, KD-931 by apple 30PIN) | Apple 30PIN |
| Performance<br>test provided | Software validation | Software validation |

## 7.0 Summary comparing technological characteristics with predicate device

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## Apps-Health01 FDA 510(k) Files

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## 8.0 Performance summary

Software validation of Apps-Health01 included system test and unit test. We also performed the Wireless coexistence test, as well as test according to IEC 60601-1 and 60601-1-2, FCC test.

### 9.0 Comparison to the predict device and the conclusion

Apps-Health01 is similar with the predicted device FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL(K102939), However, Apps-Health01 is only a software, it doesn't include meter. And it can used together with Scales, Blood Pressure Monitor instead of Blood Pressure Monitor only.

However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

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

March 21, 2013

Andon Health Co., Ltd. c/o Ms. Yi Liu No 3, Jinping Road, Ya' an Street Tianjin China 300190 CN

Re: K122098

Trade/Device Name: Apps-Health01 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN, MNW Dated: January 3, 2013 Received: January 11, 2013

Dear Ms. Yi:

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

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Page 2 - Ms. Liu Yi

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Owen Faris -S

for

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

Enclosure

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Apps-Health01 FDA 510(k) Files

# Indication for Use

510(k) Number (if known): K122098

Device Name: Apps-Health01

Indication For Use:

The Apps-Health01 is intended for use in home settings as an aid for people to review, analyze, and evaluate test results which are measured from a blood pressure monitor or scale.

Prescription Use Yes (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use Yes (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)

Oliver L. Owen P. Faris - S
2013.03.21 15:27:35
-04'00'

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

510(k)

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