DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES

K133618 · Grandway Technology (Shenzhen) Limited · DXN · Mar 5, 2014 · Cardiovascular

Device Facts

• Record ID: K133618
• Device Name: DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES
• Applicant: Grandway Technology (Shenzhen) Limited
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series is for use by medical professional or home user. The WBPM22 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate of an 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 WBPM22 Series is a non-invasive device for measuring blood pressure and pulse rate. It utilizes the oscillometric methodology; an electric pump automatically inflates and deflates a cuff wrapped around the user's wrist. A pressure sensor detects brachial artery blood movement; an electronic control module processes these signals to calculate systolic/diastolic pressure and pulse rate. Readings are displayed on a digital panel. The device is intended for use by medical professionals or home users. It includes features for irregular heartbeat detection and WHO classification. The device provides objective blood pressure data to assist healthcare providers in monitoring cardiovascular health and managing hypertension.

Clinical Evidence

Clinical accuracy testing was conducted in accordance with ISO 81060-2:2009. The study included 100 patients (49 males, 51 females). The device was compared against the standard auscultation method using measurements taken on the same arm. Results demonstrated clinical equivalence to the predicate device.

Technological Characteristics

Materials include ABS plastic cabinet/buttons, pressure sensor, CPU, PCB, and electronic components. Operates via oscillometric sensing principle. Powered by batteries. Form factor is a wrist-worn monitor with an inflatable cuff. Complies with standards including IEC 60601-1:2012, EN 60601-1-2:2007, ISO 10993-5:2009, ISO 10993-10:2010, and IEC 81060-2:2009.

Indications for Use

Indicated for adults aged 16 and older for non-invasive measurement of systolic and diastolic blood pressure and pulse rate. 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

• WBPM15 Series (K120673)

Submission Summary (Full Text)

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# 510(k) Summary

ﺓ

## Submitter Identification 1.

| 510(k) Submitter | GRANDWAY TECHNOLOGY (SHENZ |
|--------------------|------------------------------------------|
| Address | Block 6 and 7, Zhu Keng Industrial Zon |
| | District, Shenzhen, Guang Dong, People's |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Contact Person | Mr. Patrick Chow |
| Date of Submission | 19th November, 2013 |

### Device Identification 2.

| Trade Name | Digital Automatic Wrist Blood P<br>Series<br>[Model No.: MD22xy]<br><br>x --- The first character (2 & 3)<br>cabinet (housing).<br><br>y --- The second character (0, 1)<br>change revision of device. The<br>refers to those device changes<br>conformity test results of EMC<br>performance, i.e. IEC60601-1 and |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Non-invasive Blood Pressure Me |

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#### 4. Device Description

Digital Automatic Wrist Blood Pressure Monitor WBPM22 Serie pressure measurement system for use by medical professional or measure the systolic and diastolic blood pressure, and pulse rate measurement and then display the readings on a digital panel.

The device utilizes the oscillometric methodology, in which an i around the Wrist of an individual, for blood pressure measuremen detects your blood's movement through your brachial artery and co a digital reading.

The table below illustrate the feature presence in Digital Autom Monitor WBPM22 Series.

| Model | Blood Pressure<br>Measurement | Pulse Rate<br>Measurement | WHO<br>Classification | Irregular<br>Heartbeat |
|--------|-------------------------------|---------------------------|-----------------------|------------------------|
| MD2220 | ✓ | ✓ | ✓ | ✓ |
| MD2222 | ✓ | ✓ | ✓ | ✓ |
| MD2223 | ✓ | ✓ | ✓ | ✓ |
| MD2230 | ✓ | ✓ | ✓ | ✓ |
| MD2231 | ✓ | ✓ | ✓ | ✓ |
| MD2232 | ✓ | ✓ | ✓ | ✓ |

#### Indication for Use 5.

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## Comparison of Technological Characteristics betwe 6. Predicate Devices

Digital Automatic Wrist Blood Pressure Monitor WBPM22 Se predicate device, WBPM15 Series (K120673) in the device compar

| Item | Predicate Device | WBPM22 Series | |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Indication for Use | Digital Automatic Wrist Blood Pressure<br>Monitor WBPM15 Series is for use by<br>medical professional or at home. The<br>WBPM15 Series is intended to measure<br>the systolic and diastolic blood pressure,<br>and pulse rate (heartbeat rate) of an<br>individual by using a non-invasive<br>technique, in which an inflatable cuff is<br>wrapped around the wrist of an individual.<br>The inflatable cuff circumference is<br>limited to 13.5cm - 19.5cm. | Digital Automatic Wrist<br>Monitor WBPM22 Series is for use by<br>medical professional or at home. The<br>WBPM22 Series is intended to measure<br>the systolic and diastolic blood pressure,<br>and pulse rate of an individual by<br>using a non-invasive technique, in which<br>an inflatable cuff is wrapped around the<br>wrist. | |
| Measurement Method | Non-invasive, Oscillometric | Non-invasive, Oscillometric | |
| Irregular Heartbeat<br>Detection<br>(IHB) | Yes | Yes | |
| Patient<br>Population | Age 16 or above | Age 16 or above | |
| Blood Pressure<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 | |
| Number of<br>User | 2 independent users | 2 independent users | |
| Memory Space | 2 users × 120 memory space | 2 users × 60 memory space<br>2 users × 120 memory space | |
| Blood Pressure<br>Measurement<br>Accuracy | $\pm$ 3 mmHg or 2% of reading | $\pm$ 3 mmHg or 2% of reading | |
| Pulse Rate | 30 - 180 beats/min | 30 - 180 beats/min | |
| Item | Predicate Device | WBPM22 Series | Comment |
| Storage and<br>Transportation<br>Condition | Temperature: -20 - 60 °C<br>Humidity: 10 - 95 % R.H. max<br>Atmospheric Pressure: 700 - 1060 kPa | Temperature: -20 - 60 °C<br>Humidity: 10 - 95 % R.H. max<br>Atmospheric Pressure: 700 - 1060 kPa | Identical |
| Material | Resistances, capacitance, transistors,<br>amplifiers, pressure sensor, CPU, PCB,<br>cuff ABS button, ABS cabinet, batteries<br>and packaging | Resistances, capacitance, transistors,<br>amplifiers, pressure sensor, CPU, PCB,<br>cuff ABS button, ABS cabinet, batteries<br>and packaging | Identical |
| Compatibility<br>with<br>Environment<br>and Other<br>Devices | No influence with environment and other<br>device | No influence with environment and other<br>device | Identical |
| Applicable<br>Standard | ◇ EN 1060-1:1995/A2:2009<br>◇ EN 1060-3:1997/A2:2009<br>◇ IEC 60601-1:2005+<br>CORR.1(2006)+CORR. 2 (2007)<br>◇ EN 60601-1-2:2007<br>◇ FCC Part 15<br>◇ ISO 10993-5:2009<br>◇ ISO 10993-10:2002 + A1:2006<br>◇ EN 60601-1-4:2007<br>◇ ANSI/AAMI SP-10:2002 | ◇ 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 | Equivalent,<br>change upon<br>FDA's<br>recognized<br>standard |

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## Page 4 of 5

## K133618

### 510(k) PREMARKET NOTIFICATION

## GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

Digital Automatic Wrist Blood Pressure Monitor WBPM22 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.

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

## 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 (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 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.

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## Non-Clinical Test Summary

Digital Automatic Wrist Blood Pressure Monitor WBPM22 Serie non-clinical tests to show that all requirement specifications and met. The tests includes the follows:

- EN 1060-1:1995+A2:2009 �
- や EN 1060-3:1997+A2:2009
- � IEC 60601-1:2012
- � EN 60601-1-2:2007
- � FCC Part 15 Subpart B
- � ISO 10993-5:2009
- � ISO 10993-10:2010
- � IEC 62304:2006

As all of the clinical and non-clinical testing performed on Digit Pressure Monitor WBPM22 Series are same as the predicate devic is conducted to show the performance of Digital Automatic Wris WBPM22 Series is equivalent to the predicate device.

#### 8. Conclusion

Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series and same technological characteristics as the predicate device, Digi Pressure Monitor WBPM15 Series (K120673). Moreover both testing has demonstrated that no differences in the technolo questioning on safety or effectiveness to be raised. Thus, Digital Pressure Monitor WRPM22 Series is substantially equivalent to the

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.

March 5, 2014

Grandway Technology (Shenzhen) Limited Patrick Chow Zhu Keng Industrial Zone Ping Shan, Long Gang District Shenshen, Guang Dong, 518118 CH

Re: K133618

Trade/Device Name: Digital Automatic Wrist Blood Pressure M Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement Sy Regulatory Class: Class II Product Code: DXN Dated: February 12, 2014 Received: November 25, 2013

Dear Patrick Chow,

We have reviewed your Section 510(k) premarket notification of intent to referenced above and have determined the device is substantially equival for use stated in the enclosure) to legally marketed predicate devices mar commerce prior to May 28, 1976 the engatment date of the Medical Develop

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## Page 2 - Patrick Chow

found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In ad publish further announcements concerning your device in the Federal Rep

Please be advised that FDA's issuance of a substantial equivalence detern that FDA has made a determination that your device complies with other or any Federal statutes and regulations administered by other Federal age with all the Act's requirements, including, but not limited to: registration Part 807); labeling (21 CFR Part 801); medical device reporting (reporting related adverse events) (21 CFR 803); good manufacturing practice require the quality systems (QS) regulation (21 CFR Part 820); and if applicable, radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

If you desire specific advice for your device on our labeling regulation (2 contact the Division of Small Manufacturers, International and Consume free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.h Also, please note the regulation entitled, "Misbranding by reference to pr (2) CFR Part 807.97). For questions regarding the reporting of adverse e regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postm

You may obtain other general information on your responsibilities under Division of Small Manufacturers, International and Consumer Assistance [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.l

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## 510(k) PREMARKET NOTIFICATION

## GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

## Section 5 Indication for Use Statement

| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|-----------------------------------------|------------------------------------|
| Food and Drug Administration | Expiration Date: December 31, 2013 |
| Indications for Use | See PRA Statement on last page. |

510(k) Number (if known)

(if known) ਤ ।ਐਮ.) ਅਨ

Device Name

Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series

#### Indications for Uso (Dosenbe)

Digital Automatic Wrist Blood Pressure Manitor WBPM22 Series is for use by medical professional or home user. The WBPM22 Scrics is intended to measure the systelle blood pressure. and puble rate of un allult intisitiativity using a not-invasit c technique, in which an inflatable cuff is wrapped around the wrist.

| Type of Use (Select one or both, as applicable) | <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | <div> <img alt="Signature" src="signature.jpg"/> </div> <div>Date: 2014.03.05</div> <div>16:08:17 -05'00'</div> <div>for Bram Zuckerman</div> |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|

| FORM FDA 3881 (9/13) | Page 1 of 2 |
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|----------------------|-------------|

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#### 5 10(k) PREMARKET NOTIFICATION

### K133618

## p.2 of 2

## GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

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Digital Automatic Blood Pressure Monitor BPM18 Series

Section 5-2