TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M

K091415 · Truly Instrument Co., Ltd. · DXN · Sep 4, 2009 · Cardiovascular

Device Facts

• Record ID: K091415
• Device Name: TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M
• Applicant: Truly Instrument Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 4, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Truly Automatic Wrist Blood Pressure Monitor ,Models DW100, DW200, DW500, DW700, DW701M, DW702M, DW703 are a series devices 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 wrist. The devices features include irregular pulse rhythm detection during measurement. and display a warning signal with the reading once the irregular heartbeat is detected.

Device Story

Automatic wrist blood pressure monitor; uses oscillometric method to measure systolic/diastolic blood pressure and pulse rate. Input: cuff pressure signals via electronic sensor; microprocessor analyzes signals to calculate BP and pulse. Output: digital display of BP, pulse, and irregular heartbeat warning. Used by adults in home or clinical settings. Device consists of main unit (ABS housing), inflatable wrist cuff (135-220mm), pump, electromagnetic deflation valve, and LCD. Irregular heartbeat detection triggers warning if pulse interval variation exceeds 25%. Powered by AAA batteries.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and performance specifications compared to predicate devices.

Technological Characteristics

Oscillometric measurement; electronic pressure sensor; automatic pump/deflation; ABS housing; nylon/bladder wrist cuff (135-220mm); LCD display; battery-powered (2x AAA); irregular heartbeat detection algorithm.

Indications for Use

Indicated for adult individuals to measure systolic/diastolic blood pressure and pulse rate via non-invasive wrist cuff. Includes irregular pulse rhythm detection.

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

• Digibio Digital Blood Pressure Monitor, Model D11 (K014141)
• Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BPW100) (K073398)

Submission Summary (Full Text)

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## K091415

# 510(k) Summary

Date of Summary Preparation: 4.20.2009

SFP - 4 2009

## 1. Submitter's Identifications

Submitter's Name: Truly Instrument Limited

Address: Truly Industrial Area, Shanwei City, Guangdong Province China Contact Person:___ Manager Yang Jian-Hao Telephone: [phone] Fax: [phone]

#### 2. Name of the Device

Device Classification Name: System, Measurement, Blood-Pressure, 1

Non-invasive

Models: DW100, DW200, DW500, DW700, DW701M, DW702M, DW703 Classification Panel: cardio-vascular Common/Usual Name: Automatic Wrist Blood Pressure Monitor Product Code: DXN Device Classification: Class II Contraindications : N/A

### 3. The Perdicate Devices

a. Digibio Digital Blood Pressure Monitor, Model D11, K014141

- b. Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BPW100), K073398
#### 4. Device Description

Truly Automatic Wrist Blood Pressure Monitor DW series, Models DW100, DW200, DW500, DW700, DW701M, DW702M, DW703 are designed 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.

Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".

Truly Automatic Wrist Blood Pressure Monitor DW series are single-mounted devices of the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to wrist circumfernan approximately between 135 and 220 mm, includes the inflatable bladder and

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nylon shell. All models of the wrist blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by two AAA alkaline batteries.

The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.

#### 5. Intended use of device

Truly Automatic Wrist Blood Pressure Monitor DW series, Models DW100, DW200, DW500, DW700, DW701M, DW702M, DW703 are a series devices 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 wrist.

The devices features include irregular pulse rhythm detection during measurement, and display a warning signal with the reading once the irregular heartbeat is detected.

## 6. Summary of Substantial Equivalence

Table 1: The difference between Truly Automatic Wrist Blood Pressure Monitor DW series and Digibio Digital Blood Pressure Monitor, Model D11.

| Parameter | Predicate<br>Devices D11 | DW<br>100 | DW<br>200 | DW<br>500 | DW<br>700 | DW<br>701M | DW<br>702M | DW<br>703 |
|-------------------------------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------|-----------|------------|------------|-----------|
| Measurement<br>algorithm<br>Method | Oscillometric<br>method | No change ,all same | | | | | | |
| Measurement<br>site of body | Arm | Wrist | | | | | | |
| Pressure Sensor | MPS-2107 | No change ,all same | | | | | | |
| Cuff | Arm cuff | Wrist cuff. | | | | | | |
| Software | | D11 software + Irregular heartbeat detection. | | | | | | |
| Irregular<br>heartbeat<br>detection | | More than ±25% to the mean interval of pulse intervals:<br>About the more detailed description of the IH detection algorithm,<br>please refer to "Software validation report I-5. Algorithm description<br>4. Determination method of irregular heartbeat".<br>DW701M, DW702M and DW703 have the IH feature. | | | | | | |
| Memory Size | 2 x 60 | 2 x 60 | 2 x 60 | 1 x 99 | 1 x 99 | 4 x 99 | 4 x 99 | 1 x 99 |
| Measurement<br>Pressure Range | 20 ~ 280 mmHg | No change ,all same | | | | | | |
| Measurement<br>Pulse Range | 40 ~ 195<br>beats/min | No change ,all same | | | | | | |
| Measuring | 1 mmHg | No change ,all same | | | | | | |

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| Parameter | Predicate<br>Devices D11 | DW<br>100 | DW<br>200 | DW<br>500 | DW<br>700 | DW<br>701M | DW<br>702M | DW<br>703 | |
|------------------------------------------|-----------------------------------------|---------------------|------------------------------------------------------------------------------------------------------|-----------|-----------|------------|------------|-----------|--|
| resolution | | | | | | | | | |
| Accuracy<br>Pressure | $\pm$ 3mmHg | No change ,all same | | | | | | | |
| Accuracy Pulse | $\pm$ 5% | No change ,all same | | | | | | | |
| Pressurization<br>Source | Automatic<br>internal pump | No change ,all same | | | | | | | |
| Cuff Deflation | Automatic<br>deflation | No change ,all same | | | | | | | |
| Operating<br>Environment | 10~40℃<br>15~90%RH | No change ,all same | | | | | | | |
| Power | 4X 1.5V AAA | | 2 x 1.5V AAA | | | | | | |
| Hardware power<br>circuit | 6V power<br>voltage change<br>to 4V | | 3V power voltage change to 4V | | | | | | |
| Hardware other<br>circuit | | | No change ,all same | | | | | | |
| Electronic<br>element<br>(power circuit) | DC-DC BL8503<br>and relation<br>element | | DC-DC BL8530 and relation element | | | | | | |
| Electronic<br>element<br>(other circuit) | | | No change ,all same | | | | | | |
| PCB | difference | | There is difference from D11, but all PCB are same in the wrist blood<br>pressure monitor DW series. | | | | | | |
| Display Type | Liquid crystal<br>display | No change ,all same | | | | | | | |
| Cover | | Difference | | | | | | | |

Table 2: The difference between Truly Automatic blood pressure monitor DW series and Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BPW100).

| Parameter | Predicate Devices<br>BP3MK1-3<br>(BPW100) | DW<br>100 | DW<br>200 | DW<br>500 | DW<br>700 | DW<br>701M | DW<br>702M | DW<br>703 |
|--------------------------|-------------------------------------------|----------------------|-----------|-----------|-----------|------------|------------|-----------|
| Measurement<br>Method | Oscillometric<br>Method | No change - the same | | | | | | |
| Pressure Sensor | Capacitive | No change - the same | | | | | | |
| Measurement<br>Range: BP | 30~280mmHg | 20 ~ 280 mmHg | | | | | | |
| Measurement<br>Range: BP | 40~200 beats/min | 40 ~ 195 beats/min | | | | | | |

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| Parameter | Predicate Devices<br>BP3MK1-3<br>(BPW100) | DW<br>100 | DW<br>200 | DW<br>500 | DW<br>700 | DW<br>701M | DW<br>702M | DW<br>703 |
|----------------------------------|--------------------------------------------------------------|-----------------------------------------------|----------------------|----------------------|----------------------|----------------------|----------------------|----------------------|
| Measuring<br>resolution | 1mmHg | No change - the same | | | | | | |
| Accuracy<br>Pressure | ±3mmHg | No change - the same | | | | | | |
| Accuracy<br>Pulse | ±5% | No change - the same | | | | | | |
| Pressurization<br>Source | Automatic internal<br>pump | No change - the same | | | | | | |
| Cuff Deflation | Automatic deflation | No change - the same | No change - the same | No change - the same | No change - the same | No change - the same | No change - the same | No change - the same |
| Memory Size | 99 | 2 × 60 | 2 × 60 | 1 × 99 | 1 × 99 | 4 × 99 | 4 × 99 | 1 × 99 |
| Irregular Heartbeat<br>Detection | More than ±25% to<br>the mean interval of<br>pulse intervals | DW701M, DW702M and DW703 have the IH feature. | | | | | | |
| Power Source | 2 X1.5V AAA<br>batteries | No change - the same | | | | | | |
| Operating<br>Environment | 10~40℃<br>15~90%RH | No change - the same | | | | | | |
| Cuff Attachment<br>Method | By plastic hose<br>connected to<br>monitor | No change - the same | | | | | | |
| Display Type | Liquid<br>crystal<br>display | Liquid crystal display | | | | | | |

### 7. Conclusions

The subject devices have all features of the predicate device D11 except the new features of irregular heartbeat detection, wrist cuff and the battery power. These differences do not affect the safety and effectiveness of the subject devices.

l rregular heartbeat detection technology is same as what is used Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BPW100), K073398.

Thus, the subject devices are substantially equivalent to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

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

Truly Instrument Co., Ltd. c/o Mr. Yang Jian-Hao Manager Truly Industrial Area Shanwei. Guangdong 516600 China

#### SEP - 4 2009

Re: K091415

> Trade/Device Name: Truly Automatic Wrist Blood Pressure Monitor Models DW100. DW200, DW500, DW700, DW701M, DW702M and DW703 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated Received: August 7, 2009

Dear Mr. 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 confrols 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.

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. Yang Jian-Hao

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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**TRULY**®

# Indication for Use

510(k) Number (if known):

Device Name: Truly Automatic Wrist Blood Pressure Monitor DW Series, Models DW100,DW200,DW500,DW700,DW701M,DW702M,DW703

Indication For Use:

Truly Automatic Wrist Blood Pressure Monitor ,Models DW100, DW200, DW500, DW700, DW701M, DW702M, DW703 are a series devices 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 wrist.

The devices features include irregular pulse rhythm detection during measurement. and display a warning signal with the reading once the irregular heartbeat is detected.

Prescription Use

OR Over the Counter Use

(21 CFR Part 801 Subpart D)

(21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

W.M.D.

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091415

HongKong: 2/F, Chung Shun Knitting Centre, 1-3 Wing Yip Street, Kwai Chung, N.T., Hong Kong, TEL: [phone] (20 Lines) FAX: [phone] URL: http://www.trulyinstrument.com E-MAIL: [e-mail] China: Truly Industrial Area .ShanWei City. Guangdong Province ,China . TEL:[phone] FAX · 86- 0660- 33 803 77