iHealth Wireless Blood Pressure Monitor

K162144 · Andon Health Co, Ltd. · DXN · Feb 1, 2017 · Cardiovascular

Device Facts

• Record ID: K162144
• Device Name: iHealth Wireless Blood Pressure Monitor
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Feb 1, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The BPM1 (Electronic Sphygmomanometer) is intended for use in a professional setting or at home and is a non-invasive blood pressure measurement system. It is designed to measure the systolic and diastolic blood pressures and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the upper arm. The measurement range of the cuff circumference is 8.6" to 18.9" (22cm-48cm)

Device Story

The iHealth BPM1 is an electronic sphygmomanometer for professional or home use. It utilizes an inflatable upper-arm cuff and a silicon-integrated pressure sensor to perform oscillometric blood pressure measurements. The device calculates systolic and diastolic blood pressure and pulse rate; it also includes an irregular heartbeat detection feature and a blood pressure classification indicator. The device connects to iOS or Android mobile devices via WiFi to display measurement results. It is operated by the patient or a healthcare professional. The output allows users and clinicians to monitor blood pressure trends, facilitating clinical decision-making regarding hypertension management.

Clinical Evidence

No clinical data was generated for this submission; clinical data was transferred from the predicate devices.

Technological Characteristics

Oscillometric measurement using silicon-integrated pressure sensor. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 80601-2-30. Features WiFi connectivity for data transmission to mobile devices (iOS/Android). Form factor is an upper-arm cuff system (8.6"-18.9" circumference).

Indications for Use

Indicated for adult individuals requiring non-invasive measurement of systolic and diastolic blood pressure and pulse rate via an upper arm cuff.

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-927 Fully Automatic Electronic Blood Pressure Monitor (K141984)
• KD-936 Fully Automatic Wireless Blood Pressure Monitor (K120672)
• KD-931 Fully Automatic Electronic Blood Pressure Monitor (K102939)

Submission Summary (Full Text)

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Public Health Service

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

February 1, 2017

Andon Health Co., Ltd Mr. Liu Yi President No 3 Jinping Street Ya An Road Nankai District Tianjin, 300190 CHINA

Re: K162144

Trade/Device Name: iHealth Wireless Blood Pressure Monitor (BPM1) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 23, 2016 Received: December 27, 2016

Dear Mr. Liu 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 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

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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 contact the Division of Industry and Consumer Education 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely

Sincerely,

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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## Indications for Use

510(k) Number (if known) K162144

Device Name

iHealth Wireless Blood Pressure Monitor (BPM1)

Indications for Use (Describe)

The BPM1 (Electronic Sphygmomanometer) is intended for use in a professional setting or at home and is a non-invasive blood pressure measurement system. It is designed to measure the systolic blood pressures and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the upper arm. The measurement range of the cuff circumference is 8.6" to 18.9" (22cm-48cm)

Type of Use (Select one or both, as applicable)

| <span></span> Prescription Use (Part 801 Subpart D) | <span></span> Over-The-Counter Use (81 CFR 801 Subpart C) |
|-----------------------------------------------------|-----------------------------------------------------------|
|-----------------------------------------------------|-----------------------------------------------------------|

_ | Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 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 Street Ya An Road, Nankai District, Tianjin, |
| | P.R. China |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Preparation: 7/27/2016 | |

#### 2.0 Device information

Trade name: iHealth BPM1 Wireless Blood Pressure Monitor

Device name: iHealth Wireless Blood Pressure Monitor

Classification name: Noninvasive blood pressure measurement system

#### 3.0 Classification

Production code: DXN- Noninvasive blood pressure measurement system. Requlation number: 870.1130 Classification: II Panel: Cardiovascular

#### 4.0 Predicate device information

Manufacturer: Andon Health Co., Ltd. KD-927 Fully Automatic Electronic Blood Pressure Monitor Device: 510(k) number: K141984

Manufacturer: Andon Health Co., Ltd. Device: KD-936 Fully Automatic Wireless Blood Pressure Monitor 510(k) number: K120672

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Manufacturer: Andon Health Co., Ltd. KD-931 Fully Automatic Electronic Blood Pressure Monitor Device: 510(k) number: K102939

#### 5.0 Intended use

BPM1(Electronic Sphygmomanometer) is intended for use in a The professional setting or at home and is a non-invasive blood pressure measurement system. It is designed to measure the systolic and diastolic blood pressures and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the upper arm. The measurement range of the cuff circumference is 8.6" to18 .9"(22cm-48cm) intended use and the indication for use of The iHealth BPM1 Wireless Blood Pressure Monitor, as described in its labeling are the same as the predicate device KD-927 (K141984).

#### 6.0 Device description

iHealth BPM1 Wireless Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irreqular heartbeat is detected, it can be shown to the user. The new devices can connect to iOS or Andriod devices to show the results.

| Technological Characteristics | Comparison result |
|-------------------------------|-------------------|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Similar |
| Performance | Similar |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Similar |

# 7.0 Summary comparing technological characteristics with predicate device

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### 8.0 Discussion of non-clinical and clinical test performed

#### Non-clinical Tests have been done as follows:

a. Electromagnetic compatibility test according to IEC 60601-1-2;

- b. Electrical safety according test to IEC 60601-1;
c. Safety and performance characteristics of the test according to IEC 80601-2-30

None of the test demonstrates that BPM1 Wireless Blood Pressure Monitor bring new questions of safety and effectiveness.

### 9.0 Performance summary

iHealth BPM1 Wireless Blood Pressure Monitor conforms to the following standards:

- 60601-1:2005/(R)2012 And A1:2012.C1:2009/(R)2012 And ● IEC A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- · IEC 60601-1-2:2014.Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
- IEC 80601-2-30:2009 & A1:2013,Medical Electrical Equipment Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers
- Clinical data have been transferred from the predicates. .

#### 10.0 Comparison to the predicatedeviceand theconclusion

BPM1 Wireless Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-927 whose 510(k) number is K141984.

The new device BPM1 is very similar with its predicate device in the intended use, the design principle, the material, the performance and the applicable standards.

Their appearance, the memory capacity, electrical power, memory average function, average measure function and the MCU are different, and a new

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software platform has been added. More over, the new device BPM1 can transmitting data to a mobile device via WiFi.

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