(72 days)
Not Found
No
The summary describes standard blood pressure and bioimpedance measurements, and there is no mention of AI or ML terms, image processing, or data sets for training/testing.
No
The device is strictly for measurement (blood pressure, pulse, and body fat estimation) and does not provide any therapy or treatment.
Yes
The device is described as measuring systolic and diastolic blood pressures, pulse rates, and estimating body fat, all of which are diagnostic measurements of a patient's physiological state.
No
The device description explicitly states it is a "Combination unit" and a "Model WT-20 Wrist Blood Pressure Monitor & Fat Meter," indicating it is a physical hardware device that combines blood pressure monitoring and body composition measurement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The device described measures blood pressure, pulse rate, and estimates body composition (body fat) using bioimpedance. These measurements are taken directly from the body (in vivo) and do not involve analyzing samples taken from the body.
- Intended Use: The intended use is for measuring physiological parameters (blood pressure, pulse rate) and estimating body composition, not for diagnosing diseases or conditions based on analysis of bodily samples.
Therefore, the device falls under the category of a medical device but not specifically an IVD.
N/A
Intended Use / 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.
Product codes
MNW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arm
Indicated Patient Age Range
10-80 years normal subjects, 18-80 years for athletic subjects.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of bench and user testing indicate that the new device is as safe and effective as the predicate devices.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2770 Impedance plethysmograph.
(a)
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.(b)
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.
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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: +81-0279-20-2311 Fax: +81-0279-20-2411 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.
1
| Designation | OMRON Body Fat Analyzer HBF-306
K011652 | Nissei WT-20 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating Principle | Bioelectrical Impedance Analysis (BIA) | SAME (Also measures blood pressure) |
| Display | Body fat percentage (4.0 to 50.0%)
BMI (7.0 to 90.0)
BMI classification (4 levels) | 5.0 to 50.0 % (body fat)
5 to 100 (BMI)
BMI classification (4 levels) |
| Measurement Time | 7 Seconds | 5 to 10 seconds |
| Set ranges | Height: 3'4" to 6'6" (101cm. to 198cm.)
Weight: 23lbs. to 440 1/2 lbs (10kg.to220kg.)
Age: NORMAL; 10 to 80 years old
ATHLETE; 18 to 60 years old
Gender: Male / Female | M1, M2, M3 and M4 or neutral (registration number)
22 to 440pounds(weight)
36 to 79inches (height)
10 to 80 (age)
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
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
Instruction manual
Body Logic Fitness and Nutrition Guide | 2 AAA batteries for monitor use
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
3
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
4
- 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