Digital Blood Pressure Monitor-Automatic Upper Arm Style

K163606 · Shenzhen Combei Technology Co., Ltd. · DXN · May 9, 2017 · Cardiovascular

Device Facts

• Record ID: K163606
• Device Name: Digital Blood Pressure Monitor-Automatic Upper Arm Style
• Applicant: Shenzhen Combei Technology Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: May 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff (size: 22~32cm(8.7~12.6in) is wrapped around the single upper arm. The Subject device is not intended to be diagnostic device.

Device Story

Battery-powered automatic non-invasive blood pressure monitor; utilizes oscillometric technique via inflatable upper arm cuff (22-32cm). Device consists of main control unit, LCD, and cuff. Operates by automatically inflating/deflating cuff to measure systolic/diastolic blood pressure and pulse rate. Used in hospitals, hospital-type facilities, and home environments by adults. Output displayed on LCD for user review. Assists in monitoring blood pressure trends; not intended for diagnostic purposes.

Clinical Evidence

Clinical validation study per ISO 81060-2:2013 conducted with 87 subjects (36 male, 51 female). Used manual mercury sphygmomanometer as reference. Results confirmed accuracy within acceptable scope specified in ISO 81060-2. No adverse events reported.

Technological Characteristics

Materials: ABS, PMMA. Power: 4x AA alkaline batteries. Sensing: Oscillometric method. Form factor: Automatic upper arm style with 22-32cm cuff. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-5, ISO 10993-10, IEC 80601-2-30, ISO 81060-2.

Indications for Use

Indicated for adult individuals in hospitals, hospital-type facilities, and home environments for the measurement of diastolic and systolic blood pressure and pulse rate using a non-invasive oscillometric technique. Not intended for diagnostic use.

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

• Arm blood pressure monitor (K150430)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in public health and human services.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 09, 2017

Shenzhen Combei Technology Co., Ltd % Migo Yang Consultant Shenzhen Joyantech Consulting Co, Ltd. 1122#, International Mayor Communication Center, Baishizhong Nanshan District, Shenzhen, 518000 TW

Re: K163606

Trade/Device Name: Digital Blood Pressure Monitor-automatic Upper Arm Style: BP100A, BP200A, BPCB0A 3A, BP800A, BPCB0A-2A, BP866A, BP105A, BP106A, BP108A, BP116A, BP118A, BP880A, BP168A, BP126A, BP156A; Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN

Dated: April 1, 2017

Received: April 10, 2017

Dear Migo Yang:

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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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 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.

M.A. Hillebrand
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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K163606

#### Device Name

Digital Blood Pressure Monitor: Automatic Upper Arm Style: BP100A, BPCB0A-3A, BP800A, BPCB0A-2A, BP866A, BP105A, BP106A, BP108A, BP116A, BP118A, BP880A, BP168A, BP126A, BP156A;

#### Indications for Use (Describe)

The subject device intended to measure the diastolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff (size: 22~32cm(8.7~12.6in) is wrapped around the single upper arm. The Subject device is not intended to be diagnostic device.

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

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

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Product: NIBP

# 510(k) Summary

This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR §807.92.

### 1 Administrative Information

| Submission Date | Oct 8, 2016 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer information | Submitter's Name: Shenzhen Combei Technology Co.,Ltd<br>Address: Floor 5, Block B, Building G, Jinxiongda Science<br>Park, South Huanguan Road, Guanlan,<br>Longhua New District, Shenzhen, 518110,<br>Guangdong, China<br><br>Contact person: Huaguang.Meng<br>TEL: [phone]<br>FAX: [phone]<br>E-Mail: [e-mail] |
| Submission Correspondent | Image: Logo of "卓远天成"<br><br>Contact person: Miss Migo. Yang<br>E-Mail: [e-mail]<br>Shenzhen Joyantech Consulting Co., Ltd.<br>1122#, International Mayor Communication Center,<br>Baishizhong Road 55#, Nanshan District, Shenzhen,<br>Guangdong, P.R.China.<br><br>Contact person: Mr. Field.Fu<br>E-Mail: [e-mail]<br>Shenzhen Joyantech Consulting Co., Ltd.<br>1122#, International Mayor Communication Center,<br>Baishizhong Road 55#, Nanshan District, Shenzhen,<br>Guangdong, P.R.China |
| Establishment registration number | NA |

### 2 Device Information

Common name of System, Measurement, Blood-Pressure, Non-Invasive the device Trade name of the Digital Blood Pressure Monitor- Automatic Upper Arm Style; device Type/Model of the Automatic Upper Arm Style: BP100A, BP200A, BPCB0A-

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Product: NIBP

Version: A/0

| device | 3A, BP800A, BPCB0A-2A, BP866A, BP105A, BP106A, BP108A, BP116A, BP118A, BP880A, BP168A, BP126A, BP156A;<br>Classification panel: Cardiovascular |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification<br>information | Classification name: System, Measurement, Blood-<br>Pressure, Non-Invasive<br>Regulation Number: 870.1130<br>Device Class: II<br>Product Code: DXN |
| type of 510(k)<br>submission | Traditional |

#### 3 Predicate Device Information

Fudakang Industrial Co., Ltd Sponsor: Arm blood pressure monitor Device: 510(K) Number: | K150430

#### 4 Device Descriptions

The Subject device is battery driven automatic non-invasive Blood Pressure Monitor. It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique.

The Automatic Upper Arm style utilizes an inflatable cuff that is wrapped around the upper arm; the cuff circumference is limited to: 22cm~32cm (8.7in~12.6in).

### 5 Intended Use

The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric

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technique in which an inflatable cuff (size: 22~32cm(8.7~12.6in) is wrapped around the single upper arm. The Subject device is not intended to be diagnostic device.

## 6 Indications for Use

The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff (size: 22~32cm(8.7~12.6in) is wrapped around the single upper arm.

The Subject device is not intended to be diagnostic device.

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# 7 SE Comparison

| Characteristics | Subject device | Predicate device (k150430) | Remark |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Device Name | Digital Blood Pressure Monitor-Automatic<br>Upper Arm Style | Arm Blood Pressure Monitor | NA |
| Device Model | BP100A, BP200A, BPCB0A-3A, BP800A,<br>BPCB0A-2A, BP866A, BP105A, BP106A,<br>BP108A, BP116A, BP118A, BP880A,<br>BP168A, BP126A, BP156A; | FT-C21Y, FT-C22Y, FT-C23Y, FT-<br>C24Y, FT-C11B, FT-C12B, FT-<br>C21Y-V, FT-C22Y-V, FTC-23Y-V,<br>FT-C24Y-V, FT-C11B-V, FT-C12B-<br>V, FT-C11B-UR, FT-C11B-BT | NA |
| Manufacturer | Shenzhen Combei Technology Co.,LTD | Fudakang Industrial Co., Ltd | NA |
| Intended Use/<br>Indication for<br>Use | The Subject device is non-invasive blood<br>measurement system intended to measure<br>the diastolic, systolic blood pressures and<br>pulse rate of an adult individual in hospitals,<br>hospital-type facilities and home<br>environments.<br>The Subject device is not intended to be<br>diagnostic device.<br>NA | Fudakang Arm Blood Pressure<br>Monitor and Wrist Blood Pressure<br>Monitor are non-invasive blood<br>measurement system intended to<br>measure the diastolic, systolic<br>blood pressures and pulse rate of<br>an adult individual in hospitals,<br>hospital-type facilities and home<br>environments.<br>Fudakang Arm Blood Pressure<br>Monitor and Wrist Blood Pressure<br>Monitor are not intended to be<br>diagnostic device<br>The Fudakang BT series Blood<br>Pressure Monitors are of Bluetooth<br>transmission function, which enable<br>user to transfer the measurement<br>record from the device to a mobile<br>phone or PC through Bluetooth. | same |
| Intended<br>Population | adult | | same |
| Intended<br>Anatomical<br>site | upper arm | | |
| Prescription &<br>OTC | OTC | | |
| Working<br>Principle | Oscillometric method | | |
| Internal Power<br>supply | 4- size "AA" alkaline Batteries | 4- size "AA" alkaline Batteries | same |
| Characteristics | Subject device | Predicate device (k150430) | Remark |
| Working<br>Current | <30mV | | same |
| Contact<br>Material | ABS, PMMA | | same |
| Memory<br>Function | 2×120 memory | 1×60 memory | SE |
| Cuff Size | 22cm~32cm (8.7in~12.6in) | | Same |
| Measuring<br>range | Pressure: 30 to 280 mmHg (in 1 mmHg<br>increment); | Pressure: (40mmHg~280mmHg); | Similar |
| | Pulse: 40 to 200 beat/minute | Pulse rate range(40-160)<br>hypo/minute | Note01 |
| Accuracy | Pressure: ±3mmHg; Pulse: ±5% | Pressure: ±5mmHg; Pulse ±5%. | SE |
| Operating<br>Environment | 5~40°C, | | same |
| | 15%~85%RH | | same |
| Storage &<br>Transport<br>Environment | -10~55°C | | same |
| | 10%~95%RH | | same |

#### Table 1. Substantial Equivalence Comparison

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Product: NIBP

Version: A/0

Note01: The subject device has a larger measuring range of pressure and pulse than predicate device. Both the subject device and predicate device have been tested by ISO81060-2.

The subject device is as same as predicate device in Working Principle, Intended use/Indications for Use, Intended patient population, Intended application site, Intended Environments, Working Current, Cuff size, Operating Environment Storage & Transport Environment. Only their Measuring range are a little bit different. However, the minor difference does not raise any safety or effectiveness issue based on tests.

Thus, the subject device is Substantially Equivalent (SE) to the predicate device which is legally marketed in US.

#### 8 Brief discussions of the non-clinical tests

The subject device conforms to the following quidances and standards:

- Non-Invasive Blood Pressure (NIBP) Monitor Guidance や
- ゃ IEC 60601-1:2005+A1:2012: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
- ゃ IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests.
- IEC 60601-1-11: 2010 Medical Electrical Equipment Part 1-11: General や

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Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment;

- ISO 10993-5: 2009 /(R)2014 Biological evaluation of medical devices Part 5: ゃ Tests for In Vitro cytotoxicity:
- ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for や irritation and skin sensitization;
- ゃ IEC 80601-2-30: 2013 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers

### 9 Brief discussions of clinical tests

- ISO 81060-2:2013 Non-invasive sphygmomanometers Part 2: Clinical や validation of automated measurement type;
In this clinical investigation, eighty seven patients (36 males and 51 females) participated in the clinical study. Same arm sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect. The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2.

### 10 Other information (such as required by FDA guidance)

No other information.

### 11 Conclusions

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The subject device: Digital Blood Pressure Monitor-Automatic Upper Arm Style; manufactured by Shenzhen Combei Technology Co.,Ltd is respectively substantially equivalent to the predicate device Arm Blood Pressure Monitor manufactured by Fudakang Industrial CO.,LTD(K150430).