DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0

K123073 · Grandway Technology (Shenzhen) Limited · DXN · Mar 11, 2013 · Cardiovascular

Device Facts

• Record ID: K123073
• Device Name: DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0
• Applicant: Grandway Technology (Shenzhen) Limited
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Digital Automatic Blood Pressure Monitor BPM03 Series is for use by medical professional or at home. The BPM03 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.

Device Story

Digital Automatic Blood Pressure Monitor BPM03 Series; non-invasive system for measuring systolic/diastolic blood pressure and pulse rate. Input: brachial artery pressure oscillations detected via inflatable upper arm cuff. Operation: oscillometric methodology; automated inflation/deflation via electric pump and valve; pressure sensor converts arterial movement to digital signal. Output: digital display of blood pressure and pulse readings. Usage: clinical or home setting; operated by medical professionals or patients. Benefit: provides convenient, non-invasive monitoring of cardiovascular vitals to assist in health management.

Clinical Evidence

Clinical validation conducted per ANSI/AAMI SP-10-2002 requirements. Results demonstrate performance compliance. Additional safety/EMC testing performed per EN1060-1, EN1060-3, IEC60601-1, EN60601-1-2, FCC Part 15, ISO10993-5, ISO10993-10, and EN60601-1-4.

Technological Characteristics

Oscillometric measurement principle. Components: pressure sensor, electric valve, electronic control module, electric pump. Cuff sizes: 17-22cm, 22-32cm, 32-44cm. Standards: IEC 60601-1, EN 60601-1-2, EN 1060-1, EN 1060-3, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for individuals requiring non-invasive measurement of systolic/diastolic blood pressure and pulse rate via upper arm cuff (17-44cm circumference). Suitable for use by medical professionals or patients at home.

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

• AVITA BPM6 Series Blood Pressure Meter (or Monitor) (K033397)

Submission Summary (Full Text)

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K123073 Page 1 of 3

# Section IV: 510k Summary

MAR 1 ,1 2013

| Applicant's Identification | |
|----------------------------|----------------------------------------|
| Applicant | Grandway Technology (Shenzhen) Limited |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Contact Person | Mr. Patrick Chow |
| Date of Application | 21st September 2012 |

### Device's Identification

Device Proprietary Name

Digital Automatic Blood Pressure Monitor BPM03 Series

#### Model No.: MD03x0

x --- The first character (0, 1, 2, 3, 4, 5 or 6) is for the minor change revision of device. The mentioned "minor change" refers to those device changes not to be affected the conformity test results of EMC & safety as well as device performance, i.e. IEC 60601-1 and EN 60601-1-2.

Common Name Classification Name Non-invasive Blood Pressure Measurement System Non-invasive Blood Pressure Measurement System (Class Il per 21 CFR 870.1130)

#### Marketed Devices to which Equivalence is Claimed

| DEVICE | MANUFACTURER | 510(k) Number |
|--------------------------------------------------------|--------------|---------------|
| AVITA BPM6 Series Blood Pressure Meter<br>(or Monitor) | AViTA Corp | K033397 |

#### Device Description

Digital Automatic Blood Pressure Monitor BPM03 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 (heartbeat rate) of an individual in each measurement and then displays the readings on a digital panel.

The BPM03 Series utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for the blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movements into a digital reading.

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#### Intended Use (Indication for Use)

Digital Automatic Blood Pressure Monitor BPM03 Series is for use by medical professional or at home. The BPM03 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.

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

The Digital Automatic Blood Pressure Monitor BPM03 Series is a non-invasive measuring device and utilizes the oscilliometric methodology to measure the blood pressure reading. The key components of device are a pressure sensor, electric valve and an electronic control module together with an electric pump, which inflate (and deflate) the inflatable cuff automatically according to our designed architecture. The predicate device adopts exactly same methodology and key components for measuring the blood pressure reading.

## Clinical & Non-clinical Tests

A systematic & independent clinical test was conducted to validate the performance of the Digital Automatic Blood Pressure Monitor BPM03 Series. The results demonstrated that BPM03 Series meets the requirement of ANSI/AAMI SP-10-2002.

Comprehensive safety and EMC tests were performed and compiled to demonstrate BPM03 Series is safe for use. Tests include

EN1060-1:1995/A1:2002 EN1060-3:1997/A1:2005 IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) EN60601-1-2:2007 FCC Part 15 ISO10993-5:2009 ISO10993-10:2010 EN60601-1-4:2007

### Conclusion

Digital Automatic Blood Pressure Monitor BPM03 Series has the same intended use and similar technological characteristics as predicate device (K033397). Moreover, bench testing contained in this submission and clinical testing supplied demonstrated that no differences in the technological characteristics and questioning on safety or effectiveness

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

March 11, 2013

Grandway Technology (Shenzhen) Limited c/o Mr. Patrick Chow Building 6 and 7, Zhu Keng Industrial Zone Ping Shan, Long Gang District, Shenzhen CHINA 518118

Re: K123073

Trade/Device Name: Digital Automatic Blood Pressure Monitor BPM03 Series Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 17, 2013 Received: February 8, 2013

Dear Mr. 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.

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Page 2 - Mr. Patrick Chow,

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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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

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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# Section V: Statement of Indications for Use

K123073 510(k) Number (if known):

Device Name:

Digital Automatic Blood Pressure Monitor BPM03 Series

### Model No.: MD03x0

x --- The first character (0, 1, 2, 3, 4, 5 or 6) is for the minor change revision of device. The mentioned "minor change" refers to those device changes not to be affected the conformity test results of EMC & safety as well as device performance, i.e. IEC 60601-1 and EN 60601-1-2.

## Indications For Use:

Digital Automatic Blood Pressure Monitor BPM03 Series is for use by medical professional or at home. The BPM03 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR . .

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Owen P. Faris -S
2013.03.11
11:03:52 -04'00'