Digital Automatic Wrist Blood Pressure Monitor MD2400

K143733 · Grandway Technology (Shenzhen) Limited · DXN · Apr 3, 2015 · Cardiovascular

Device Facts

• Record ID: K143733
• Device Name: Digital Automatic Wrist Blood Pressure Monitor MD2400
• Applicant: Grandway Technology (Shenzhen) Limited
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 3, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you quickly and easily measure your systolic pressure, and pulse rate through an inflatable cuff wrapped around the wrist, save the measurements and display the development of the measurements.

Device Story

Digital Automatic Wrist Blood Pressure Monitor MD2400 is a non-invasive device for clinical or home use. It utilizes oscillometric methodology to measure arterial blood pressure and pulse rate. Input: brachial artery movement detected via inflatable wrist cuff. Processing: electronic control module (CPU) converts pressure sensor signals into digital readings. Output: systolic/diastolic blood pressure and pulse rate displayed on an LCD panel. Features include irregular heartbeat detection and memory storage for two users. The device is operated by the patient or a healthcare professional. It provides objective physiological data to assist in monitoring cardiovascular health.

Clinical Evidence

Clinical accuracy testing performed per ISO 81060-2:2013. Study included 100 patients (49 male, 51 female). Reference method was standard auscultation. Measurements were taken alternatively with the device and auscultation on the same arm. Results demonstrated performance equivalent to the predicate device.

Technological Characteristics

Materials: ABS plastic, electronic components (resistors, capacitors, transistors, amplifiers, pressure sensor, CPU, PCB). Sensing: Oscillometric pressure sensor. Energy: 2 x 1.5V AAA batteries. Connectivity: Standalone. Software: IEC 62304 compliant. Standards: EN 1060-1/3, IEC 60601-1, IEC 60601-1-2, ISO 10993-5/10, IEC 81060-2, IEC 80601-2-30.

Indications for Use

Indicated for non-invasive measurement and monitoring of systolic/diastolic blood pressure and pulse rate in human adults using an inflatable wrist cuff.

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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Public Health Service

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

April 3, 2015

Grandway Technology (Shenzhen) Limited Patrick Chow General Manager Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District, Shenzhen, Guang Dong 518118 CN

Re: K143733

Trade/Device Name: Digital Automatic Wrist Blood Pressure Monitor MD2400 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: February 27, 2015 Received: February 27, 2015

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

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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 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 vours.

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K143733

K143733 Page 1 of 1

Device Name

Digital Automatic Wrist Blood Pressure Monitor, MD2400

Indications for Use (Describe)

The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you quickly and easily measure your systolic pressure, and pulse rate through an inflatable cuff wrapped around the wrist, save the measurements and display the development of the measurements.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|--------------------------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements 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 79 hours per response, including the

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any 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 PRAStaff(@fda.hhs.gov

"An agency 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."

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| 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 | 29-Dec-2014 |

#### Submitter Identification 1.

#### Device Identification 2.

| Trade Name | Digital Automatic Wrist Blood Pressure Monitor MD2400 |
|---------------------|----------------------------------------------------------------------------------------------|
| 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) |

#### Predicate Device 3.

| 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 MD2400 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 MD2400.

| Model | Blood Pressure<br>Measurement | Pulse Rate<br>Measurement | WHO<br>Classification | Irregular<br>Heartbeat | LCD Type | User ×<br>Memory |
|--------|-------------------------------|---------------------------|-----------------------|------------------------|------------------------|------------------|
| MD2400 | ✓ | ✓ | ✓ | ✓ | Positive<br>Reflective | 2 × 60 |

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#### Indication for Use 5.

The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you quickly and easily measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the wrist, save the measurements and display the development of the measurements.

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

Digital Automatic Wrist Blood Pressure Monitor MD2400 is compared to the predicate device, WBPM22 Series (K133618) in the device comparison table below.

| Comparison between WBPM22 Series and Predicate device | | | |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Item | Predicate Device | MD2400 | Comment |
| Indication for Use | Digital Automatic Blood Pressure Monitor<br>WBPM22 Series is for use by medical<br>professional or home user. The WBPM22<br>Series is intended to measure the systolic and<br>diastolic blood pressure, and pulse rate of an<br>adult individual by using a non-invasive<br>technique, in which an inflatable cuff is<br>wrapped around the wrist. | The wrist blood pressure monitor is used<br>to carry out non-invasive measurement<br>and monitoring of arterial blood pressure<br>values in human adults. This allows you<br>quickly and easily measure your systolic<br>and diastolic pressure, and pulse rate<br>through an inflatable cuff wrapped<br>around the wrist, save the measurements<br>and display the development of the<br>measurements. | Equivalent |
| Measurement<br>Method | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical |
| IHB Detection | Yes | Yes | Identical |
| Patient Population | Adult | Adult | Identical |
| BP 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 | Identical |
| Number of User | 2 independent users | 2 independent users | Identical |
| Memory Space | 2 users × 120 memory space | 2 users × 60 memory space | Equivalent |
| Resolution of<br>Measurement | Blood Pressure: 1 mmHg or 0.1kPa<br>Pulse Rate: 1 beat/ min | Blood Pressure: 1 mmHg<br>Pulse Rate: 1 beat/ min | Identical |
| Blood Pressure<br>Measurement<br>Accuracy | $\pm$ 3 mmHg or 2% of reading | $\pm$ 3 mmHg | Equivalent |
| Pulse Rate<br>Measurement<br>Range | 40 - 180 beats/min | 40 - 180 beats/min | Identical |
| Pulse Rate<br>Measurement<br>Accuracy | $\pm$ 5 % of the reading | $\pm$ 5 % of the reading | Identical |
| Display Type | LCD | LCD | Identical |
| Power Source | 2 × 1.5 V AAA-batteries | 2 × 1.5 V AAA-batteries | Equivalent |
| Pressurization<br>Mode | Automatic Inflation | Automatic Inflation | Identical |
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical |
| Operating<br>Condition | Temperature: +5 to +40 oC<br>Humidity: 15 to 93 % R.H. max<br>Atmospheric Pressure: 700 - 1060 hPa | Temperature: +5 to +40 oC<br>Humidity: 15 to 93 % R.H. max<br>Atmospheric Pressure: 700 - 1060 hPa | Identical |
| Storage and<br>Transportation<br>Condition | Temperature: -25 to +70 oC<br>Humidity: up to 93% R.H. max<br>Atmospheric Pressure: 700 - 1060 hPa | Temperature: -25 to +70 oC<br>Humidity: up to 93% R.H. max<br>Atmospheric Pressure: 700 - 1060 hPa | Identical |

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| Comparison between WBPM22 Series and Predicate device | | | |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Item | Predicate Device | MD2400 | Comment |
| 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 with<br>Environment and<br>Other 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 60601-1:2012<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 81060-2:2013 | Equivalent |

Digital Automatic Wrist Blood Pressure Monitor MD2400 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 81060-2:2013 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 81060-2:2013.

## Non-Clinical Test Summary

Digital Automatic Wrist Blood Pressure Monitor MD2400 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 <>
- >> EN 1060-3:1997+A2:2009
- ◆ IEC 60601-1:2012
- ゃ IEC 60601-1-2:2007
- ◆ 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 MD2400 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 MD2400 is equivalent to the predicate device.

#### Conclusion 8.

Digital Automatic Wrist Blood Pressure Monitor MD2400 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 MD2400 is substantially equivalent to the predicate device.