Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series

K152483 · Grandway Technology (Shenzhen) Limited · DXN · Sep 29, 2015 · Cardiovascular

Device Facts

• Record ID: K152483
• Device Name: Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series
• Applicant: Grandway Technology (Shenzhen) Limited
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 29, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure on an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.

Device Story

Digital Automatic Blood Pressure Monitor (BPM30/BPM31 series) measures systolic/diastolic blood pressure and pulse rate via oscillometric method; uses inflatable cuff on upper arm. Device components include pressure sensor, electric pump, electric valve, and electronic control module. Operated by medical professionals or home users; readings displayed on digital panel. Device detects blood movement through brachial artery; converts to digital reading. Includes IHB (Irregular Heart Beat) detection and WHO blood pressure classification. Supports multiple users (up to 4) and memory storage. Provides non-invasive monitoring for clinical or home settings; aids in hypertension management and cardiovascular health tracking.

Clinical Evidence

Clinical study conducted per ISO 81060-2 with 100 patients (49 male, 51 female). Compared subject device against standard auscultation method. Measurements performed alternatively in the same arm. Results demonstrate clinical accuracy equivalent to the predicate device.

Technological Characteristics

Oscillometric measurement principle. Components: pressure sensor, electric pump, electric valve, CPU, PCB. Power: 4x1.5V AAA batteries or AC adapter. LCD display (various types: positive/negative, reflective/transmissive). Standards: EN 1060-1, EN 1060-3, IEC 60601-1, IEC 60601-1-2, FCC Part 15 Subpart B, IEC 81060-2:2013.

Indications for Use

Indicated for adult individuals to measure systolic and diastolic blood pressure and pulse rate using a non-invasive oscillometric technique with an upper arm cuff. 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

• Digital Automatic Blood Pressure Monitor BPM18 Series (K133619)

Submission Summary (Full Text)

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Public Health Service

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

September 29, 2015

Grandway Technology (shenzhen) Limited Mr. Patrick Chow General Manager Block 7, Zhu Keng Industrial Zone, Ping Shan District, Shenzhen, 518118 CN

Re: K152483

Trade/Device Name: Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 31, 2015 Received: August 31, 2015

Dear Mr. Patrick Chow,

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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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 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.

Mitchell Stein

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) K152483

### Device Name

Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series

Indications for Use (Describe)

This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure on an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K152483

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# 1. Submitter identification

| 510(k) Submitter | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
|--------------------|-------------------------------------------------------------------------------------------------------------------|
| Address | Block 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District, 518118,<br>Shenzhen, People's Republic of China |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Contact Person | Mr. Patrick Chow |
| Date of Submission | 28-Aug-2015 |

#### Device identification 2.

| Trade Name | Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series |
|---------------------|----------------------------------------------------------------------------------------------|
| Common Name | Non-invasive Blood Pressure Measurement System |
| Classification Name | Non-invasive Blood Pressure Measurement System<br>(CFR 870.1130, Class II, Product Code DXN) |

# 3. Predicate device

| Predicate Device | Digital Automatic Blood Pressure Monitor BPM18 Series | | | | |
|------------------|-------------------------------------------------------|--|--|--|--|
| Manufacturer | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED | | | | |
| 510(k) Number | K133619 | | | | |

#### Device Description 4.

Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel.

The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.

The table below illustrate the feature presence in Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series.

| Model | BP<br>Measurement | Pulse Rate<br>Measurement | WHO<br>Classification | IHB | LCD Type | Backlight | DC<br>Jack | V.A Size |
|--------|-------------------|---------------------------|-----------------------|-----|---------------------|-----------|------------|------------|
| MD3000 | ✓ | ✓ | ✓ | ✓ | Positive reflective | X | X | 60 x 70 mm |
| MD3010 | ✓ | ✓ | ✓ | ✓ | Positive reflective | X | ✓ | 60 x 70 mm |

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| Model | BP<br>Measurement | Pulse Rate<br>Measurement | WHO<br>Classification | IHB | LCD Type | Backlight | DC<br>Jack | V.A Size |
|--------|-------------------|---------------------------|-----------------------|-----|-----------------------|-----------|------------|------------|
| MD3020 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | X | 60 x 70 mm |
| MD3030 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | ✔ | 60 x 70 mm |
| MD3040 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | X | 60 x 70 mm |
| MD3050 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | ✔ | 60 x 70 mm |
| MD3001 | ✔ | ✔ | ✔ | ✔ | Positive reflective | X | X | 50 x 60 mm |
| MD3011 | ✔ | ✔ | ✔ | ✔ | Positive reflective | X | ✔ | 50 x 60 mm |
| MD3021 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | X | 50 x 60 mm |
| MD3031 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | ✔ | 50 × 60 mm |
| MD3041 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | X | 50 x 60 mm |
| MD3051 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | ✔ | 50 x 60 mm |
| MD3100 | ✔ | ✔ | ✔ | ✔ | Positive reflective | X | X | 60 x 70 mm |
| MD3110 | ✔ | ✔ | ✔ | ✔ | Positive reflective | X | ✔ | 60 × 70 mm |
| MD3120 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | X | 60 x 70 mm |
| MD3130 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | ✔ | 60 x 70 mm |
| MD3140 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | X | 60 x 70 mm |
| MD3150 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | ✔ | 60 x 70 mm |
| MD3101 | ✔ | ✔ | ✔ | ✔ | Positive reflective | X | X | 50 x 60 mm |
| MD3111 | ✔ | ✔ | ✔ | ✔ | Positive reflective | X | ✔ | 50 x 60 mm |
| MD3121 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | X | 50 x 60 mm |
| MD3131 | ✔ | ✔ | ✔ | ✔ | Negative transmissive | ✔ | ✔ | 50 x 60 mm |
| MD3141 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | X | 50 x 60 mm |
| MD3151 | ✔ | ✔ | ✔ | ✔ | Positive transmissive | ✔ | ✔ | 50 x 60 mm |

# 5. Indication for use

This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure on an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.

### Comparison of technological characteristics between new Device and 6. predicate Devices

Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series is compared to the predicate device, Digital Automatic Blood Pressure Monitor BPM18 Series (K133619) in the device comparison table below.

| Item | Predicate Device | New device | Comment |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Indication for Use | Digital Automatic Blood Pressure<br>Monitor BPM18 Series is for use by<br>medical professional or home user.<br>The BPM18 Series is intended to<br>measure the systolic and diastolic<br>blood pressure, and pulse rate of an<br>adult individual by using a non-<br>invasive technique, in which an<br>inflatable cuff is wrapped around the<br>upper arm. | This device is for use by medical<br>professional or home users. It is<br>intended to measure the systolic and<br>diastolic blood pressure on an adult<br>individual by using a non-invasive<br>technique, in which an inflatable cuff<br>is wrapped around the upper arm. | Equivalent |
| Measurement<br>Method | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical |
| IHB Detection | Yes | Yes | Identical |
| Item | Predicate Device | New device | Comment |
| Patient<br>Population | Adult | Adult | Identical |
| BP<br>Measurement<br>Range | Cuff Pressure: 0 - 300 mmHg<br>Systolic Pressure: 50 - 250 mmHg<br>Diastolic Pressure: 30 - 200 mmHg | Cuff Pressure: 0 - 300 mmHg<br>Systolic Pressure: 50 - 250 mmHg<br>Diastolic Pressure: 30 - 200 mmHg | Identical |
| Number of User | 2 independent users | 4 independent users | More user |
| Memory Space | 2 users × 120 memory space | 4 users × 120 or 240 memory space | More user<br>memory |
| Resolution of<br>Measurement | Blood Pressure: 1 mmHg or 0.1kPa<br>Pulse Rate: 1 beat/ min | Blood Pressure: 1 mmHg or 0.1kPa<br>Pulse Rate: 1 beat/ min | Identical |
| Blood Pressure<br>Measurement<br>Accuracy | ± 3 mmHg or 2% of reading | ± 3 mmHg | Equivalent |
| Pulse Rate<br>Measurement<br>Range | 40 - 180 beats/min | 40 - 180 beats/min | Identical |
| Pulse Rate<br>Measurement<br>Accuracy | ± 5 % of the reading | ± 5 % of the reading | Identical |
| Display Type | LCD | LCD | Identical |
| Power Source | 4 × 1.5 V AAA-batteries and/or AC<br>Adaptor | 4 × 1.5 V AAA-batteries and/or AC<br>Adaptor | Identical |
| Pressurization<br>Mode | Automatic Inflation | Automatic Inflation | Identical |
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical |
| Operating<br>Condition | Temperature: +5 to +40 °C<br>Humidity: 15 to 93 % R.H. max<br>Atmospheric Pressure: 700-1060 hPa | Temperature: +5 to +40 °C<br>Humidity: 15 to 93 % R.H. max<br>Atmospheric Pressure: 700-1060 hPa | Identical |
| Storage and<br>Transportation<br>Condition | Temperature: -25 to +70 °C<br>Humidity: up to 93% R.H. max<br>Atmospheric Pressure: 700-1060 hPa | Temperature: -25 to +70 °C<br>Humidity: up to 93% R.H. max<br>Atmospheric Pressure: 700-1060 hPa | Identical |
| Material | Resistances, capacitance, transistors,<br>amplifiers, pressure sensor, CPU,<br>PCB, cuff ABS button, ABS cabinet,<br>batteries and packaging | Resistances, capacitance, transistors,<br>amplifiers, pressure sensor, CPU,<br>PCB, cuff ABS button, ABS cabinet,<br>batteries and packaging | Identical |
| Compatibility<br>with<br>Environment<br>and Other<br>Devices | No influence with environment and<br>other device | No influence with environment and<br>other device | Identical |
| Applicable<br>Standard | - EN 1060-1:1995+A2:2009<br>- EN 1060-3:1997+A2:2009<br>- IEC 60601-1:2012<br>- EN 60601-1-2:2007<br>- FCC Part 15 Subpart B<br>- IEC 81060-2:2009 | - EN 1060-1:1995+A2:2009<br>- EN 1060-3:1997+A2:2009<br>- IEC 60601-1:2012<br>- IEC 60601-1-2:2007<br>- FCC Part 15 Subpart B<br>- IEC 81060-2:2013 | Equivalent |

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Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series is a non-invasive measuring device and utilizes the oscillometric methodology to measure the blood pressure reading. The key components of device are: a pressure sensor, an electric valve and an electronic control module together with an electric pump.

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### K152483

### Page 4 of 4

The electric pump inflate (and deflate) the inflatable cuff automatically according to our designed architecture. The predicate device adopts exactly same methodology and key components for measuring blood pressure.

#### Clinical and Non-clinical Tests 7.

## Clinical Test Summary

Testing to insure clinical accuracy of the device in accordance with ISO 81060-2 as documented in Clinical Test report.

One hundred patients (49 males and 51 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2.

### Non-Clinical Test Summary

Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests includes the follows:

- � EN 1060-1:1995+A2:2009
- � EN 1060-3:1997+A2:2009
- � IEC 60601-1:2012
- � IEC 60601-1-2:2007
- ゃ FCC Part 15 Subpart B

All of the clinical and non-clinical testing performed on Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series are same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series is equivalent to the predicate device.

#### Conclusion 8.

Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series has the same intended use and same technological characteristics as the predicate device, Digital Automatic Blood Pressure Monitor BPM18 Series (K133619). Moreover both clinical and non-clinical testing has demonstrated that no differences in the technological characteristics and questioning on safety or effectiveness to be raised. Thus, Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series is substantially equivalent to the predicate device.