iHealth View BP7S Wireless Blood Pressure Wrist Monitor

K152379 · Andon Health Co, Ltd. · DXN · Sep 23, 2015 · Cardiovascular

Device Facts

• Record ID: K152379
• Device Name: iHealth View BP7S Wireless Blood Pressure Wrist Monitor
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 23, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

iHealth View BP7S Wireless Blood Pressure Wrist Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm-22cm.

Device Story

Device is a non-invasive, wrist-worn blood pressure monitor; utilizes oscillometric measurement principle with silicon-integrated pressure sensor. Input: pressure signals from inflatable cuff. Processing: MCU calculates systolic/diastolic blood pressure and pulse rate; detects irregular heartbeats; classifies results. Output: data transmitted via Bluetooth to iOS or Android mobile devices; results also displayed on integrated LED screen. Used by medical professionals or patients at home. Healthcare providers/patients view output via mobile app or device display to monitor blood pressure trends and identify potential cardiac irregularities. Benefits include convenient, portable, and frequent blood pressure monitoring for hypertension management.

Clinical Evidence

Bench testing only. Device performance validated against IEC 80601-2-30, IEC 60601-1, and IEC 60601-1-2 standards. No clinical data provided.

Technological Characteristics

Oscillometric measurement; silicon-integrated pressure sensor; 3.7V Li-ion 400mAh power supply; wrist cuff (13.5-22cm); Bluetooth connectivity; integrated LED display; iOS/Android software platform. Standards: IEC 80601-2-30, IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for adult individuals requiring non-invasive measurement of systolic/diastolic blood pressure and pulse rate via wrist-worn inflatable cuff (13.5cm-22cm circumference). Suitable for use by medical professionals or home users.

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-972 Fully Automatic Wireless Blood Pressure Wrist Monitor (K121470)

Submission Summary (Full Text)

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

September 23, 2015

Andon Health Co., Ltd Ms. Liu Yi President No 3, Jinping Street Ya' An Rd Nankai District Tianjin, 300190 CN

Re: K152379

> Trade/Device Name: iHealth View Wireless Blood Pressure Wrist Monitor (BP7S) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 19, 2015 Received: August 26, 2015

Dear Ms. 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

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Page 2 - Ms. Liu Yi

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 devicerelated 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 yours,

M.A. Hilleman

for

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) K152379

Device Name

iHealth View Wireless Blood Pressure Wrist Monitor (BP7S)

Indications for Use (Describe)

iHealth View BP7S Wireless Blood Pressure Wrist Monitor is for use by medical professionals or at home and is a noninvasive blood pressure measurement system intended to measure the diastolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm-22cm.

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

| <span></span> | For use in identifying a U.S. Vehicle Safety Standard |
|---------------|--------------------------------------------------------------|
| <span></span> | To correct the information in a U.S. Vehicle Safety Standard |

| | 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<br>P.R. China |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Preparation: | 08/21/2015 |

## 2.0 Device information

Trade name: iHealth View Wireless Blood Pressure Wrist Monitor (BP7S)

Device name: Wireless Blood Pressure Monitor

Classification name: Noninvasive blood pressure measurement system

# 3.0 Classification_

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

## 4.0 Predicate device information

Manufacturer: Andon Health Co., Ltd. KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor Device: 510(k) number: K121470

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#### 5.0 Intended use

iHealth View BP7S Wireless Blood Pressure Wrist Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm-22cm.

The intended use and the indication for use of iHealth BP7S View Wireless Blood Pressure Wrist Monitor, as described in its labeling are the same as the predicate device KD-972(K121470).

## 6.0 Device description

iHealth View BP7S Wireless Blood Pressure Monitors are 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 irregular heartbeat is detected, it can be shown to the user. The new devices achieves its function by an iOS or Andriod devices. .

| Item | Predicate device<br>BP7 (K121470) | Subject device<br>BP7S(K152379) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Intended use and<br>indication for use | For use by medical professionals or at home<br>and is a non-invasive blood pressure<br>measurement system intended to measure<br>the diastolic and systolic blood pressures and<br>pulse rate of an adult individual by using a<br>non-invasive technique in which an inflatable<br>cuff is wrapped around the wrist. The cuff<br>circumference is limited to 13.5cm-22cm. | Same as predicate |
| Method of<br>measurement | Oscillometric | Same as predicate |
| Unit Weight | About 106g | About 114g |
| Average function | Yes | No |

#### 7.0 Summary comparing technological characteristics with predicate device

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| Memory function | Yes | No |
|--------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Power Supply | 1*3.7V Li-ion 400mAh | Same as predicate |
| Accuracy | Pressure $\pm$ 3mmHg<br>Pulse $\pm$ 5% | Same as predicate |
| Range of<br>measurement | Cuff pressure Range<br>0 ~ 300 mmHg<br><br>Determination Range<br>40 ~ 260 mmHg | Cuff pressure Range<br>0 ~ 300 mmHg<br><br>Determination Range<br>40 ~ 260 mmHg |
| Storage<br>Environment | -20~55°C<br><95%RH | -20~55°C<br>≤85%RH |
| Operating<br>Environment | 5~40°C<br><90%RH | 10℃~40℃<br>≤85%RH |
| Data transmission | Bluetooth | Same as predicate |
| Measurement<br>display | iOS device | 1. iOS device or<br>Android device,<br>2. LED display on<br>blood pressure<br>meter, |
| Software platform | iOS | iOS and Android |
| Performance<br>Standard | ISO 80601-2-30 | Same as predicate |

#### 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 BP7S Wireless Blood Pressure Wrist Monitor bring new questions of safety and effectiveness.

#### 9.0 Performance summary

iHealth View BP7S Wireless Blood Pressure Wrist Monitor conforms to the following standards:

- AAMI ANSI ES 60601-1:2005/(R) 2012 And C1:2009(R)2012 And A2:2010 (Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests)
- · IEC60601-1-2 Edition 3: 2007-03, (Medical electrical equipment -- Part 1-2:

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General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests)

- IEC 80601-2-30:2009+Cor.2010/EN 80601-2-30:2010(Medical electrical equipment -Part 2-30: Particular requirements for the basic safety and essential performance of of of automated sphygmomanometers)AAMI IEC80601-2-30:2002, Manual, electronic or automated sphygmomanometers.
#### 10.0 Comparison to the predicate device and the conclusion

iHealth View BP7S Wireless Blood Pressure Wrist Monitor is substantially equivalent to KD-972 blood pressure monitor whose 510(K) number is K121470

The new device BP7S is very similar with its predicate device in the intended use, the design principle, the material, the performance and the applicable standards. Only their data transmission function, the MCU, the memory function and the appearance are different, and a new software platform has been added.

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