DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES

K142088 · Grandway Technology (Shenzhen) Limited · DXN · Oct 31, 2014 · Cardiovascular

Device Facts

• Record ID: K142088
• Device Name: DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES
• Applicant: Grandway Technology (Shenzhen) Limited
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 31, 2014
• Decision: SESE
• Submission Type: Traditional
• 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 of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the wrist.

Device Story

Digital Automatic Wrist Blood Pressure Monitor (SWBPM22 Series) measures systolic/diastolic blood pressure and pulse rate via oscillometric method. Device consists of pressure sensor, electric valve, electronic control module, and electric pump. User wraps inflatable cuff around wrist; device automatically inflates/deflates cuff to detect brachial artery blood movement. Readings displayed on digital LCD panel. Used by medical professionals or patients at home. Output provides blood pressure and pulse rate data, aiding clinical assessment of cardiovascular status. Includes WHO classification and irregular heartbeat detection. Benefits include convenient, non-invasive, self-administered blood pressure monitoring.

Clinical Evidence

Clinical study conducted per ISO 81060-2:2009 with 100 patients (46 male, 54 female). Compared subject device against standard auscultation method. Results demonstrated clinical accuracy equivalent to predicate device.

Technological Characteristics

Oscillometric non-invasive blood pressure measurement. Components: pressure sensor, electric valve, CPU, PCB, ABS plastic housing. Power: 2x 1.5V AAA batteries. Standards: EN 1060-1/3, IEC 60601-1, IEC 60601-1-2, FCC Part 15, ISO 10993-5/10, IEC 62304, IEC 81060-2, IEC 80601-2-30. Connectivity: None (standalone).

Indications for Use

Indicated for adult individuals for non-invasive measurement of systolic and diastolic blood pressure and pulse rate. 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 Wrist Blood Pressure Monitor WBPM22 Series (K133618)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three human profiles forming the body.

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

October 31, 2014

Grandway Technology (Shenzhen) Limited Patrick Chow General Manager Block 6 and 7. Zhu Keng Industrial Zone. Ping Shan, Long Gang District, Shenzhen, Guang Dong, China

Re: K142088

Trade/Device Name: Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 30, 2014 Received: September 30, 2014

Dear 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

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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.

Melissa A. Torres -S

Bram D. Zuckerman, M.D. For 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)

K142088

Device Name

Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series, MD2200, MD2210

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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 of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the wrist.

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

- Prescription Use (Part 21 CFR 801 Subpart D)

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

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| 510(k) Submitter | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
|--------------------|---------------------------------------------------------------|
| Address | Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang |
| | District, Shenzhen, Guang Dong, People's Republic of China |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Contact Person | Mr. Patrick Chow |
| Date of Submission | 30th July, 2014 |

#### Submitter Identification 1.

#### Device Identification 2.

| Trade Name | Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series<br>[Model No.: MD22x0]<br>x --- The first character (0 and 1) is for the identification of outlook. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 WBPM22 Series |
|------------------|--------------------------------------------------------------|
| Manufacturer | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| 510(k) Number | K133618 |

#### Device Description 4.

Digital Automatic Wrist Blood Pressure Monitor SWBPM22 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 wrist 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 Wrist Blood Pressure Monitor SWBPM22 Series.

| Model | Blood Pressure<br>Measurement | Pulse Rate<br>Measurement | WHO<br>Classification | Irregular<br>Heartbeat | LCD Type | User ×<br>Memory |
|--------|-------------------------------|---------------------------|-----------------------|------------------------|------------------------|------------------|
| MD2200 | ✓ | ✓ | ✓ | ✓ | Positive<br>Reflective | 2 × 120 |
| MD2210 | ✓ | ✓ | ✓ | ✓ | Positive<br>Reflective | 2 × 120 |

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#### 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 of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the wrist.

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

Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is compared to the predicate device, WBPM22 Series (K133618) in the device comparison table below.

| | Comparison between SWBPM22 Series and Predicate device | | | |
|--------------------|--------------------------------------------------------|--------------------------------------------|------------|--|
| Item | Predicate Device | WBPM22 Series | Comment | |
| Indication for Use | Digital Automatic Wrist Blood Pressure | This device is for use by medical | Equivalent | |
| | Monitor WBPM22 Series is for use by | professional or home users. It is intended | | |
| | medical professional or home user. The | to measure the systolic and diastolic | | |
| | WBPM22 Series is intended to measure | blood pressure of an adult individual by | | |
| | the systolic and diastolic blood pressure, | using a non-invasive technique, in which | | |
| | and pulse rate of an adult individual by | an inflatable cuff is wrapped around the | | |
| | using a non-invasive technique, in which | wrist. | | |
| | an inflatable cuff is wrapped around the | | | |
| | wrist. | | | |
| Measurement | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical | |
| Method | | | | |
| IHB Detection | Yes | Yes | Identical | |
| Patient Population | Adult | Adult | Identical | |
| BP Measurement | Cuff Pressure: 0 - 300 mmHg | Cuff Pressure: 0 - 300 mmHg | Identical | |
| Range | Systolic Pressure: 50 - 250 mmHg | Systolic Pressure: 50 - 250 mmHg | | |
| | Diastolic Pressure: 30 - 200 mmHg | Diastolic Pressure: 30 - 200 mmHg | | |
| Number of User | 2 independent users | 2 independent users | Identical | |
| Memory Space | 2 users × 60 memory space; | 2 users × 120 memory space | Equivalent | |
| | or 2 users × 120 memory space | | | |
| Resolution of | Blood Pressure: 1 mmHg or 0.1kPa | Blood Pressure: 1 mmHg or 0.1 kPa | Identical | |
| Measurement | Pulse Rate: 1 beat/ min | Pulse Rate: 1 beat/ min | | |
| Blood Pressure | ± 3 mmHg or 2% of reading | ± 3 mmHg | Equivalent | |
| Measurement | | | | |
| Accuracy | | | | |
| Pulse Rate | 30 - 180 beats/min | 30 - 180 beats/min | Identical | |
| Measurement | | | | |
| Range | | | | |
| Pulse Rate | ± 5 % of the reading | ± 5 % of the reading | Identical | |
| Measurement | | | | |
| Accuracy | | | | |
| Display Type | LCD | LCD | Identical | |
| Power Source | 2 × 1.5 V AAA-batteries | 2 × 1.5 V AAA-batteries | Identical | |
| Pressurization | Automatic Inflation | Automatic Inflation | Identical | |
| Mode | | | | |
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical | |
| Operating | Temperature: +5 to +40 °C | Temperature: +5 to +40 °C | Identical | |
| Condition | Humidity: 15 to 93 % R.H. max | Humidity: 15 to 93 % R.H. max | | |
| | Atmospheric Pressure: 700 - 1060 hPa | Atmospheric Pressure: 700 - 1060 hPa | | |
| Storage and | Temperature: -25 to +70 °C | Temperature: -25 to +70 °C | Identical | |
| Transportation | Humidity: up to 93% R.H. max | Humidity: up to 93% R.H. max | | |
| Condition | Atmospheric Pressure: 700 - 1060 hPa | Atmospheric Pressure: 700 - 1060 hPa | | |

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| Comparison between SWBPM22 Series and Predicate device | | | |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Item | Predicate Device | WBPM22 Series | Comment |
| 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>- EN 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 | - 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 | Equivalent |

Digital Automatic Wrist Blood Pressure Monitor SWBPM22 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, a electric valve and an electronic control module together with 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 81060-2:2009 as documented in Clinical Test report.

One hundred patients (46 males and 54 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 81060-2:2009.

## Non-Clinical Test Summary

Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series has performed several nonclinical 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
- や IEC 60601-1-2:2007
- や FCC Part 15 Subpart B
- ◆ ISO 10993-5:2009
- >> ISO 10993-10:2010
- >> IEC 62304:2006

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All of the clinical and non-clinical testing performed on Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series are same as the predicate device.

Also, bench testing, IEC 80601-2-30, is conducted to show the performance of Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is equivalent to the predicate device.

#### Conclusion 8.

Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series has the same intended use and same technological characteristics as the predicate device, Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series (K133618). 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 Wrist Blood Pressure Monitor SWBPM22 Series is substantially equivalent to the predicate device.