DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES

K133619 · Grandway Technology (Shenzhen) Limited · DXN · Mar 5, 2014 · Cardiovascular

Device Facts

• Record ID: K133619
• Device Name: DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 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 Blood Pressure Monitor BPM18 Series is for use by medical professional or home user. The BPM18 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate of 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 BPM18 Series is a non-invasive oscillometric device for measuring systolic/diastolic blood pressure and pulse rate. It consists of an inflatable cuff, pressure sensor, electric valve, pump, and electronic control module. Operated by medical professionals or patients at home, the device automatically inflates/deflates the cuff, detects brachial artery blood movement, and converts signals into digital readings displayed on an LCD panel. It includes irregular heartbeat detection and memory storage for two users. The device provides objective blood pressure data to assist healthcare providers in clinical decision-making and patient monitoring.

Clinical Evidence

Clinical accuracy was validated per ISO 81060-2:2009. The study included 100 patients (49 male, 51 female). The device was compared against the standard auscultation method using measurements taken on the left upper arm. Results demonstrated clinical equivalence to the predicate device.

Technological Characteristics

Oscillometric non-invasive blood pressure measurement. Components: pressure sensor, electric valve, electric pump, CPU, PCB, ABS housing. Power: 4x 1.5V AAA batteries or 6V/600mA AC adapter. Connectivity: None. Standards: IEC 60601-1:2012, EN 60601-1-2:2007, ISO 10993-5:2009, ISO 10993-10:2010, IEC 62304:2006, IEC 81060-2:2009.

Indications for Use

Indicated for adult individuals (age 16+) for non-invasive measurement of systolic/diastolic blood pressure and pulse rate via upper arm cuff. 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

• Digital Automatic Blood Pressure Monitor BPM11 Series (K120675)

Submission Summary (Full Text)

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# 510(k) Summary

MAR 0 5 2014

#### Submitter Identification 1.

| 510(k) Submitter | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Address | Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang<br>District, Shenzhen, Guang Dong, People's Republic of China |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Contact Person | Mr. Patrick Chow |
| Date of Submission | 19th November, 2013 |

#### Device Identification 2.

| Trade Name | Digital Automatic Blood Pressure Monitor BPM18 Series<br>[Model No.: MD18xy]<br><br>x --- The first character (0, 1, 2, 3, 4, 5, 6 & 7) is for the<br>minor change revision of device. The mentioned "minor<br>change" refers to those device changes not to be affecting<br>the conformity test results of EMC & safety as well as<br>device performance, i.e. IEC 60601-1 and EN 60601-1-2.<br><br>y --- The second character (0 & 1) is for the identification<br>of cabinet (housing) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 BPM11 Series |
|------------------|-------------------------------------------------------|
| Manufacturer | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| 510(k) Number | K120675 |

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#### 4. Device Description

Digital Automatic Blood Pressure Monitor BPM18 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 BPM18 Series.

| Model | Blood Pressure<br>Measurement | Pulse Rate<br>Measurement | WHO<br>Classification | Irregular<br>Heartbeat | LCD Type | Backlight<br>Illumination | DC<br>Jack | Memory |
|--------|-------------------------------|---------------------------|-----------------------|------------------------|--------------------------|---------------------------|------------|--------|
| MD1800 | ✓ | ✓ | ✓ | ✓ | Positive<br>Reflective | x | ✓ | 2*120 |
| MD1810 | ✓ | ✓ | ✓ | ✓ | Positive<br>Transmissive | Blue | ✓ | 2*120 |
| MD1820 | ✓ | ✓ | ✓ | ✓ | Positive<br>Transmissive | Orange | ✓ | 2*120 |
| MD1830 | ✓ | ✓ | ✓ | ✓ | Negative<br>Transmissive | White | ✓ | 2*120 |
| MD1840 | ✓ | ✓ | ✓ | ✓ | Positive<br>Reflective | x | x | 2*120 |
| MD1850 | ✓ | ✓ | ✓ | ✓ | Positive<br>Transmissive | Blue | x | 2*120 |
| MD1860 | ✓ | ✓ | ✓ | ✓ | Positive<br>Transmissive | Orange | x | 2*120 |
| MD1870 | ✓ | ✓ | ✓ | ✓ | Negative<br>Transmissive | White | x | 2*120 |
| MD1801 | ✓ | ✓ | ✓ | ✓ | Positive<br>Reflective | x | ✓ | 2*120 |
| MD1811 | ✓ | ✓ | ✓ | ✓ | Positive<br>Transmissive | Blue | ✓ | 2*120 |
| MD1821 | ✓ | ✓ | ✓ | ✓ | Positive<br>Transmissive | Orange | ✓ | 2*120 |
| MD1831 | ✓ | ✓ | ✓ | ✓ | Negative<br>Transmissive | White | ✓ | 2*120 |
| MD1841 | ✓ | ✓ | ✓ | ✓ | Positive<br>Reflective | x | x | 2*120 |
| MD1851 | ✓ | ✓ | ✓ | ✓ | Positive<br>Transmissive | Blue | x | 2*120 |
| MD1861 | ✓ | ✓ | ✓ | ✓ | Positive<br>Transmissive | Orange | x | 2*120 |
| MD1871 | ✓ | ✓ | ✓ | ✓ | Negative<br>Transmissive | White | x | 2*120 |

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#### Indication for Use ഗ്

Digital Automatic Blood Pressure Monitor BPM18 Series is for use by medical professional or home user. The BPM18 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.

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

Digital Automatic Blood Pressure Monitor BPM18 Series is compared to the predicate device, BPM11 Series (K120675) in the device comparison table below.

| Item | Predicate Device | BPM18 Series | Comment |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indication for Use | Digital Automatic Blood Pressure Monitor<br>BPM11 Series is for use by medical professional or at home. The BPM11 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm of an individual. The inflatable cuff circumference is limited to 17cm - 44cm via 3 different size of cuff. 3 different cuff sizes are 17-22cm, 22-32cm and 32-44cm. | Digital Automatic Blood Pressure Monitor<br>BPM18 Series is for use by medical professional or home user. The BPM18 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm. | Equivalent |
| Measurement Method | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical |
| Irregular Heartbeat Detection (IHB) | Yes | Yes | Identical |
| Patient Population | Age 16 or above | Age 16 or above | Identical |
| Blood Pressure Measurement 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 x 120 memory space | 2 users x 120 memory space | Identical |
| Blood Pressure Measurement Accuracy | $\pm$ 3 mmHg or 2% of reading | $\pm$ 3 mmHg or 2% of reading | Identical |
| Pulse Rate Measurement Range | 30 - 180 beats/min | 30 - 180 beats/min | Identical |
| Pulse Rate Measurement Accuracy | $\pm$ 5 % of the reading | $\pm$ 5 % of the reading | Identical |

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### K133619

#### 510(k) PREMARKET NOTIFICATION

#### GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

| Item | Predicate Device | BPM18 Series | Comment |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Power Source | 4 x 1.5 V AA-batteries; and/or<br>AC adaptor (6V/600mA) | 4 x 1.5 V AAA-batteries; and/or<br>AC adaptor (6V/600mA) | Identical |
| Pressurization Mode | Automatic Inflation | Automatic Inflation | Identical |
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical |
| Operating<br>Condition | Temperature: 10 - 40 °C<br>Humidity: 30 - 85 % R.H. max<br>Atmospheric Pressure: 700 - 1060 kPa | Temperature: 10 - 40 °C<br>Humidity: 15 - 85 % R.H. max<br>Atmospheric Pressure: 700 - 1060 kPa | Equivalent,<br>improved<br>specification |
| 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 |
| Cuff Size (Arm<br>circumference) | 17.0 - 22.0 cm<br>22.0 - 32.0 cm<br>32.0 - 44.0 cm | 17.0 - 22.0 cm<br>22.0 - 32.0 cm<br>32.0 - 44.0 cm | 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 |

Digital Automatic Blood Pressure Monitor BPM18 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.

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#### 5 10(k) PREMARKET NOTIFICATION

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 upper arm. 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 Blood Pressure Monitor BPM18 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 や
- � EN 1060-3:1997+A2:2009
- � IEC 60601-1:2012
- や EN 60601-1-2:2007
- や FCC Part 15 Subpart B
- � ISO 10993-5:2009
- ゃ ISO 10993-10:2010
- ゃ IEC 62304:2006

As all of the clinical and non-clinical testing performed on Digital Automatic Blood Pressure Monitor BPM18 Series are same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Blood Pressure Monitor BPM18 Series is equivalent to the predicate device.

#### 8. Conclusion

Digital Automatic Blood Pressure Monitor BPM18 Series has the same intended use and similar technological characteristics as the predicate device, Digital Automatic Blood Pressure Monitor BPM11 Series (K120675). Moreover 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 BPM18 Series is substantially equivalent to the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES. USA

Public Health Service

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

March 5, 2014

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

Re: KI33619

> Trade/Device Name: Digital Automatic Blood Pressure Monitor BPM18 Series Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System 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 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

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Page 2 - Patrick Chow

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely your

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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## p.1 of 2 к133619

### 5 10(k) PREMARKET NOTIFICATION

#### GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

# Section 5 Indication for Use Statement

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | |
|-------------------------------------------------------------------------|--|
| Indications for Use | |

Form Approved: OMB No. 0910-0120 Expiration Dato: Dacember 31, 2013 Son PRA Statement on last page.

510(k) Number (if known)

Device Name

Digital Automatic Blood Pressure Monitor BPM18 Series

Indications for Use (Describe)
Digital Autonatic Blood Pressure Meatin IS Series is for use by medical professional or home user. The BPM18 Scries is intended to messure the systelle bloud presure, and pulse rate of an addit individual by ming a non-invasive technique,
in which and is warged annund the upper arm.

| 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) | <img alt="Signature" src="signature.png"/> |
|------------------------------------------------------------------------------|--------------------------------------------|
| Date: | 2014.03.05 |
| | 16:19:16 -05'00' |
| | for Bram Zuckerman |

FORM FDA 3681 (9/13) Page 1 of 2

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### p.2 of 2 K133619

#### 5 10(k) PREMARKET NOTIFICATION

### GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

This section applies only to roquirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of Information is estimated to average 70 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and revise the collection of information. Send comments regarding this burden estimate or sny other aspect of this Information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff [e-mail]

"An egency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

Form FDA 3881 (8/13)

Page 2 of 2

Digital Automatic Blood Pressure Monitor BPM18 Series

Section 5-2