WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20

K031582 · Nihon Seimitsu Sokki Co., Ltd. · MNW · Aug 1, 2003 · Cardiovascular

Device Facts

• Record ID: K031582
• Device Name: WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20
• Applicant: Nihon Seimitsu Sokki Co., Ltd.
• Product Code: MNW · Cardiovascular
• Decision Date: Aug 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Combination unit for measuring systolic and diastolic blood pressures and pulse rates in adult patients with arm circumference between 4.9" to 8" inches as well as body composition, i.e. estimation of body fat, a noninvasive bioimpedance analyzer for use in estimating the human's body fat volume (mass) and percentage by weight. Age range 10-80 years normal subjects, 18-80 years for athletic subjects.

Device Story

The WT-20 is a wrist-worn combination device for home use. It measures blood pressure and pulse rate using standard oscillometric methods and estimates body fat percentage and mass using bioelectrical impedance analysis (BIA). Users input personal data (height, weight, age, sex) to calculate BMI and body fat. The device displays blood pressure, pulse, body fat percentage, and BMI classification. It stores up to 10 measurement results for 4 user profiles. The device provides users with self-monitoring data for health tracking.

Clinical Evidence

Bench and user testing performed. No clinical trial data provided. Testing confirmed the device functions as intended for blood pressure and body fat measurement compared to predicate devices.

Technological Characteristics

Wrist-worn monitor; BIA sensing for body fat; oscillometric sensing for blood pressure; battery-powered (2 AAA); digital display; memory for 4 user profiles; dimensions 93 x 75 x 37.5 mm; weight ~150g with batteries.

Indications for Use

Indicated for adult patients (age 10-80 normal, 18-80 athletic) with wrist circumference 4.9"-8" for non-invasive measurement of systolic/diastolic blood pressure, pulse rate, and body fat estimation via bioimpedance.

Regulatory Classification

Identification

An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Omron HBF-306 Body Fat Analyzer (K011652)
• Nissei WS-500 Digital Wrist Blood Pressure Monitor (K003444)

Submission Summary (Full Text)

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## AUG - 1 2003

# EXHIBIT 2 Summary of Safety and Effectiveness

Image /page/0/Picture/3 description: The image shows the logo for NIHON SEIMITU SOKKI CO., LTD. The logo is in black and white and features the company name in both Japanese and English. The Japanese name is 日本精密測器株式会社, and the English name is NIHON SEIMITU SOKKI CO., LTD. The logo is simple and modern.

## 2508-13 Nakago Komochi-Mura, Kitagunma-Gun, Gunma-Ken 377-0293, Japan Phone: [phone] Fax: [phone] Contact: Y. Shibata, Chief Engineer

#### 1. Identification of the device

Proprietary-Trade Name: Model WT-20 Wrist Blood Pressure Monitor & Fat Meter Classification Names: DXN, SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE, 74 MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Wrist blood pressure monitor/Body fat meter

#### 2. Equivalent legally marketed devices

This product is similar in function and design to the Omron HBF-306 Body Fat Analyzer K011652, and has the blood pressures and pulse rate measurement of Nihon Seimitsu Sokki Co., Ltd. (Nissei) WS-500 Digital Wrist Blood Pressure Monitor K003444.

#### 3. Indications for Use (intended use)

Combination unit for measuring systolic and diastolic blood pressures and pulse rates in adult patients with arm circumference between 4.9" to 8" inches as well as body composition, i.e. estimation of body fat, a noninvasive bioimpedance analyzer for use in estimating the human's body fat volume (mass) and percentage by weight. Age range 10-80 years normal subjects, 18-80 years for athletic subjects.

#### 4. Description of the Device

The Model WT-20 Wrist Blood Pressure Monitor & Fat Meter combines the familiar wrist blood pressure monitor found over the counter in drug stores with a body composition/body fat meter.

#### 5. Safety and Effectiveness, comparison to predicate device

The results of bench and user testing indicate that the new device is as safe and effective as the predicate devices.

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| Designation | OMRON Body Fat Analyzer HBF-306<br>K011652 | Nissei WT-20 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating Principle | Bioelectrical Impedance Analysis (BIA) | SAME (Also measures blood pressure) |
| Display | Body fat percentage (4.0 to 50.0%)<br>BMI (7.0 to 90.0)<br>BMI classification (4 levels) | 5.0 to 50.0 % (body fat)<br>5 to 100 (BMI)<br>BMI classification (4 levels) |
| Measurement Time | 7 Seconds | 5 to 10 seconds |
| Set ranges | Height: 3'4" to 6'6" (101cm. to 198cm.)<br>Weight: 23lbs. to 440 1/2 lbs (10kg.to220kg.)<br>Age: NORMAL; 10 to 80 years old<br>ATHLETE; 18 to 60 years old<br>Gender: Male / Female | M1, M2, M3 and M4 or neutral (registration number)<br>22 to 440pounds(weight)<br>36 to 79inches (height)<br>10 to 80 (age)<br>Male or female (sex) |
| Power supply | 2 AAA batteries (R03) | SAME (Alkaline recommended) |
| External dimensions | 197(L) × 128(H) × 49mm(W) | 93 (W) × 75 (H) × 37.5 (D) mm |
| Memory | 9 personal profile memories | 4 sets of weight, height, age, sex and 10 measurement<br>results of blood pressure and body fat |
| Weight | Approx.230 g (not including batteries) | Approx, 113g (without batteries), 150 g with batteries |
| Accessories | 2 AAA batteries for monitor use<br>Instruction manual<br>Body Logic Fitness and Nutrition Guide | 2 AAA batteries for monitor use<br>Instruction manual |

#### Comparison matrix - new vs. Predicate device 6.

#### 7. Conclusion

After analyzing both bench and clinical testing data, it is the conclusion of Nissei that the "WT-20" Wrist Blood Pressure Monitor and Fat Meter is as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread. The eagle is facing to the right and has three stripes on its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2003

Nihon Seimitsu Sokki Co., Ltd. c/o Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, IL 60015

## Re: K031582

Trade Name: Model WT-20 Wrist Blood Pressure Monitor & Fat Meter Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance plethysmograph. Regulatory Class: Class II (two) Product Code: MNW Dated: May 7, 2003 Received: May 21, 2003

### Dear Mr. Kamm:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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### Page 2 - Mr. Daniel Kamm

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

W. Zuckertill
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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9. Indications for Use

KO31582 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Device Name: Nissei Model WT-20 Wrist Blood Pressure Monitor & Fat Meter

Indications for Use: Combination unit for measuring systolic and diastolic blood pressures and pulse rates in adult patients with arm circumference between 4.9" to 8" inches as well as body composition, i.e. estimation of body fat, a noninvasive bioimpedance analyzer for use in estimating the human's body fat volume (mass) and percentage by weight. Age range 10-80 years normal subjects, 18-80 years for athletic subjects.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________ OR Over the Counter Use__ X . (Per 21 CFR 801.109)

X. Qerth