iHealth BP3L Wireless Blood Pressure Monitor

K152003 · Andon Health Co, Ltd. · DXN · Sep 24, 2015 · Cardiovascular

Device Facts

• Record ID: K152003
• Device Name: iHealth BP3L Wireless Blood Pressure Monitor
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 24, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

iHealth BP3L Wireless Blood Pressure 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 upper arm. The cuff circumference is limited to 22cm-48cm.

Device Story

The iHealth BP3L is a non-invasive blood pressure monitor for clinical or home use. It utilizes an inflatable upper arm cuff and an oscillometric silicon pressure sensor to measure systolic/diastolic blood pressure and pulse rate. The device connects via Bluetooth to an iOS or Android mobile device, which serves as the display and interface. The system performs automated analysis to classify blood pressure results and detect irregular heartbeats. Healthcare providers or patients view measurements on the mobile app to monitor cardiovascular status. The device benefits patients by enabling convenient, remote-capable blood pressure tracking.

Clinical Evidence

Bench testing only. Testing included electromagnetic compatibility (IEC 60601-1-2), electrical safety (IEC 60601-1), and performance characteristics per IEC 80601-2-30. No clinical data was required or provided.

Technological Characteristics

Oscillometric measurement using silicon pressure sensor. Bluetooth connectivity for data transmission to iOS/Android devices. Power: 5V Li-ion. Cuff circumference: 22-48cm. Standards: IEC 80601-2-30, AAMI ANSI ES 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for adult individuals requiring non-invasive measurement of diastolic and systolic blood pressure and pulse rate via upper arm cuff (22cm-48cm circumference).

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

• iHealth BP3 Fully Automatic Arm Cuff Electronic Blood Pressure Dock (K102939)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, layered on top of each other.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 24, 2015

Andon Health Co., Ltd. Liu Yi President No. 3 Jin Ping Street, Ya An Road Nankai District Tianjin, China 300190

Re: K152003

Trade/Device Name: iHealth BP3L Wireless Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 25, 2015 Received: August 28, 2015

Dear 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 vours.

M.A. Hillebrand

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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## Statement of Indications for Use

| <b>510(k) Number :</b> | K152003 |
|------------------------|---------|
|------------------------|---------|

iHealth BP3L Wireless Blood Pressure Monitor Device name:

#### Indications for use:

iHealth BP3L Wireless Blood Pressure 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 upper arm. The cuff circumference is limited to 22cm-48cm.

Prescription use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use YES (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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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: | 07/14/2015 |

#### 2.0 Device information

| Trade name: | iHealth BP3L Wireless Blood Pressure Monitor |
|-------------|----------------------------------------------|
|-------------|----------------------------------------------|

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. iHealth BP3 Fully Automatic Arm Cuff Electronic Blood Device: Pressure Dock 510(k) number: K102939

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#### 5.0 Intended use

iHealth BP3L Wireless Blood Pressure 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 upper arm. The cuff circumference is limited to 22cm-48cm.

The intended use and the indication for use of iHealth BP3L Wireless Blood Pressure Monitor, as described in its labeling are the same as the predicate device BP3 (K102939).

#### 6.0 Device description

iHealth BP3L 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>BP3 (K102939) | Subject device<br>BP3L(K152003) |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| 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 upper arm. The<br>cuff circumference is limited to 22cm-48cm. | Same as predicate |
| Method of<br>measurement | Oscillometric | Same as predicate |
| Unit Weight | About 260g | About 240g |
| Average function | Yes | No |

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

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| Memory function | Yes | No |
|--------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Power Supply | 5V Li-ion | Same as predicate |
| Accuracy | Pressure $\pm$ 3mmHg<br>Pulse $\pm$ 5% | Same as predicate |
| Range of<br>measurement | Cuff pressure Range<br>0 ~ 295 mmHg<br><br>Determination Range<br>30 ~ 280 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 | 0~35°C<br><90%RH | 10℃~40℃<br>≤85%RH |
| Data transmission | iPhone 30 pin | Bluetooth |
| Measurement<br>display | iOS device | iOS device or Android<br>device |
| Software platform | iOS | iOS and Android |
| Performance<br>Standard | SP-10 | ISO 80601-2-30 |

### 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 BP3L and BP7S Wireless Blood Pressure Monitor bring new questions of safety and effectiveness.

#### 9.0 Performance summary

iHealth BP3L Wireless Blood Pressure 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: General requirements for basic safety and essential performance -

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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 non-invasive sphygmomanometers)AAMI IEC80601-2-30:2002, Manual, electronic or automated sphygmomanometers.
#### 10.0 Comparison to the predicate device and the conclusion

BP3L Wireless Blood Pressure Monitor is substantially equivalent to the Fully Automatic Arm Cuff Electronic Blood Pressure Dock BP3 whose 510(k) number is K102939.

The new device BP3L 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 and the memory function 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.