Digital Automatic Wrist Blood Pressure Monitor MD3200

K151587 · Grandway Technology (Shenzhen) Limited · DXN · Aug 7, 2015 · Cardiovascular

Device Facts

• Record ID: K151587
• Device Name: Digital Automatic Wrist Blood Pressure Monitor MD3200
• Applicant: Grandway Technology (Shenzhen) Limited
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 7, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you to quickly and easily measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the wrist, save the measurements and display the development of the measurements.

Device Story

Digital Automatic Wrist Blood Pressure Monitor MD3200; non-invasive oscillometric device for adult use. Input: brachial artery blood movement detected via inflatable wrist cuff. Processing: electronic control module converts movement to digital readings. Output: systolic/diastolic blood pressure and pulse rate displayed on LCD panel. Used by medical professionals or patients at home. Benefits: quick, easy blood pressure monitoring; irregular heartbeat detection; memory storage for 2 users (60 readings each).

Clinical Evidence

Clinical study conducted with 100 patients (45 male, 55 female) per ISO 81060-2:2013. Compared MD3200 against standard auscultation method. Results demonstrated clinical accuracy equivalent to predicate device.

Technological Characteristics

Oscillometric measurement; automatic inflation/deflation. Components: pressure sensor, electric valve, electric pump, CPU, PCB, ABS cabinet/button. Power: 2x1.5V AAA batteries. LCD display. Standards: ISO 81060-1:2007, EN 1060-3:1997+A2:2009, IEC 60601-1:2012, IEC 60601-1-2:2007, FCC Part 15 Subpart B, ISO 10993-5:2009, ISO 10993-10:2010, IEC 62304:2006, ISO 81060-2:2013.

Indications for Use

Indicated for non-invasive measurement and monitoring of arterial blood pressure (systolic/diastolic) and pulse rate in human adults.

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 Wrist Blood Pressure Monitor SWBPM22 Series (K142088)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

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

August 7, 2015

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

Re: K151587

> Trade/Device Name: Digital Automatic Wrist Blood Pressure Monitor MD3200 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: Not dated Received: June 11, 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 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

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the quality systems (OS) 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,

Bram D. Zuckerman -S

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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K151587

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510(k) Number (if known): K 151587

Device Name: Digital Automatic Wrist Blood Pressure Monitor MD3200

## Indications For Use:

The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you to quickly and easily measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the wrist, save the measurements and display the development of the measurements.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Over - The Counter Use X

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# 510(k) Summary

#### Submitter Identification 1.

| 510(k) Submitter | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
|--------------------|-------------------------------------------------------------------------------------------------------|
| Address | Block 7, Zhu Keng Industrial Zone, Ping Shan District, 518118<br>Shenzhen, PEOPLE'S REPUBLIC OF CHINA |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Contact Person | Mr. Patrick Chow |
| Date of Submission | 10-Jun-2015 |

#### 2. Device Identification

| Trade Name | Digital Automatic Wrist Blood Pressure Monitor MD3200<br>[Model No.: MD3200] |
|---------------------|----------------------------------------------------------------------------------------------|
| 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 Wrist Blood Pressure Monitor SWBPM22 Series |
|------------------|---------------------------------------------------------------|
| Manufacturer | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| 510(k) Number | K142088 |

#### 4. Device Description

Digital Automatic Wrist Blood Pressure Monitor MD3200 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 wrist of an individual, for blood pressure measurement. This means the monitor

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## K151587

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detects your blood's movement through your brachial artery and converts the movement into a digital reading.

The table below illustrates the feature presence in Digital Automatic Wrist Blood Pressure Monitor MD3200.

| Model | Blood Pressure<br>Measurement | Pulse Rate<br>Measurement | WHO<br>Classification | Irregular<br>Heartbeat | LCD Type | User ×<br>Memory |
|--------|-------------------------------|---------------------------|-----------------------|------------------------|------------------------|------------------|
| MD3200 | ✓ | ✓ | ✓ | ✓ | Positive<br>Reflective | 2 × 60 |

#### Indication for Use 5.

The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you to quickly and easily measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the wrist, save the measurements and display the development of the measurements

### Comparison of Technological Characteristics between New Device and 6. Predicate Devices

Digital Automatic Wrist Blood Pressure Monitor MD3200 is compared to the predicate device, SWBPM22 Series (K142088) in the device comparison table below.

| Comparison between Digital Automatic Wrist Blood Pressure Monitor MD3200 and Predicate device | | | |
|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Item | Predicate Device | Digital Automatic Wrist Blood<br>Pressure Monitor MD3200 | Comment |
| Indication for<br>Use | 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 of an adult<br>individual by using a non-invasive<br>technique, in which an inflatable cuff<br>is wrapped around the wrist. | The wrist blood pressure monitor is<br>used to carry out non-invasive<br>measurement and monitoring of<br>arterial blood pressure values in<br>human adults. This allows you to<br>quickly and easily measure your<br>systolic and diastolic pressure, and<br>pulse rate through an inflatable cuff<br>wrapped around the wrist, save the<br>measurements and display<br>the<br>development of the measurements | Equivalent |
| Measurement<br>Method | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical |
| IHB Detection | Yes | Yes | Identical |
| Patient<br>Population | Adult | Adult | Identical |
| BP 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 | 2 independent users | Identical |
| Memory Space | 2 users × 120 memory space | 2 users × 60 memory space | Similar |

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| Comparison between Digital Automatic Wrist Blood Pressure Monitor MD3200 and Predicate device | | | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Item | Predicate Device | Digital Automatic Wrist Blood Pressure Monitor MD3200 | Comment |
| Resolution of Measurement | Blood Pressure: 1 mmHg or 0.1kPa<br>Pulse Rate: 1 beat/ min | Blood Pressure: 1 mmHg<br>Pulse Rate: 1 beat/ min | Similar |
| Blood Pressure Measurement Accuracy | ± 3 mmHg | ± 3 mmHg | Identical |
| Pulse Rate Measurement Range | 40 - 180 beats/min | 40 - 180 beats/min | Identical |
| Pulse Rate Measurement Accuracy | ± 5 % of the reading | ± 5 % of the reading | Identical |
| Display Type | LCD | LCD | Identical |
| Power Source | 2 × 1.5 V AAA-batteries | 2 × 1.5 V AAA-batteries | Identical |
| Pressurization Mode | Automatic Inflation | Automatic Inflation | Identical |
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical |
| Operating 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 Transportation 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, amplifiers, pressure sensor, CPU, PCB, cuff ABS button, ABS cabinet, batteries and packaging | Resistances, capacitance, transistors, amplifiers, pressure sensor, CPU, PCB, cuff ABS button, ABS cabinet, batteries and packaging | Identical |
| Compatibility with Environment and Other Devices | No influence with environment and other device | No influence with environment and other device | Identical |
| Applicable Standard | - 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>- ISO 10993-5:2009<br>- ISO 10993-10:2010<br>- IEC 62304:2006<br>- IEC 81060-2:2009 | - ISO 81060-1:2007<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>- ISO 10993-5:2009<br>- ISO 10993-10:2010<br>- IEC 62304:2006<br>- IEC 81060-2:2013 | Equivalent |

Digital Automatic Wrist Blood Pressure Monitor MD3200 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, an electronic control module, and an electric pump. 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 81060-2:2013 as documented in Clinical Test report.

Digital Automatic Wrist Blood Pressure Monitor MD3200

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### K151587

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One hundred patients (45 males and 55 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left wrist. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013.

### Non-Clinical Test Summary

Digital Automatic Wrist Blood Pressure Monitor MD3200 has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests include the follows:

- ISO 81060-1:2007 <>
- EN 1060-3:1997+A2:2009 や
- IEC 60601-1:2012 <>
- IEC 60601-1-2:2007 <>
- や FCC Part 15 Subpart B
- や ISO 10993-5:2009
- や ISO 10993-10:2010
- IEC 62304:2006 や

All of the clinical and non-clinical testing performed on Digital Automatic Wrist Blood Pressure Monitor MD3200 is same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Wrist Blood Pressure Monitor MD3200 is equivalent to the predicate device.

#### Conclusion 8.

Digital Automatic Wrist Blood Pressure Monitor MD3200 has the equivalent intended use and same technological characteristics as the predicate device, Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series (K142088). Moreover clinical testing has demonstrated that no differences in the technological characteristics and questioning on safety or effectiveness to be raised. Thus, Digital Automatic Wrist Blood Pressure Monitor MD3200 is substantially equivalent to the predicate device.