The Delwa-Star® WS-FM Blood Pressure and Body Fat Monitor is intended for use by adults with moderately active to inactive lifestyles for measuring the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflated cuff which is wrapped around the wrist. The device is also intended to estimate body fat by bioelectrical impedance analysis.

Device Description

The Delwa-Star® WS-FM Blood Pressure and Body Fat Monitor uses bioelectrical impedance analysis, a well established technique, for body fat assessment. It measures the systolic and diastolic blood pressure, and pulse rate (heart rate) by use of an inflatable cuff that is wrapped around the wrist, a LCD display, a semiconductor sensor, and internal air pump, a battery power source and keys for operation.

AI/ML Overview

The provided text describes a 510(k) summary for the Delwa-Star® WS-FM Blood Pressure and Body Fat Monitor. It details the device's intended use and the general testing performed. However, it does not contain specific acceptance criteria, study details, or performance results in the format requested, nor does it include information about AI/ML models, training/test sets, expert ground truth, or MRMC studies.

The document states that the device was tested for "compliance with numerous technical specifications, including general performance under certain environmental conditions, influences of static electrical discharges, influences of irradiated electromagnetic field, and radio screening." This is a high-level statement about general safety and performance testing, not detailed clinical performance or accuracy studies against acceptance criteria.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's a response based on the available information:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the Delwa-Star® WS-FM Blood Pressure and Body Fat Monitor describes general device testing but does not detail specific acceptance criteria for accuracy (e.g., blood pressure measurement accuracy against a gold standard or body fat estimation accuracy) or present a study proving the device meets such criteria.

The document mentions that the device was "tested for compliance with numerous technical specifications, including general performance under certain environmental conditions, influences of static electrical discharges, influences of irradiated electromagnetic field, and radio screening." This indicates engineering and safety testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria (from document)	Reported Device Performance (from document)
Blood Pressure Monitoring	Not specified for accuracy	General performance under various environmental conditions, influences of static electrical discharges, irradiated electromagnetic field, and radio screening were tested.
Body Fat Monitoring	Not specified for accuracy	General performance under various environmental conditions, influences of static electrical discharges, irradiated electromagnetic field, and radio screening were tested.
Other technical specs	Compliance with numerous technical specifications	Compliance demonstrated for general performance, static electrical discharges, irradiated electromagnetic field, and radio screening.

2. Sample size used for the test set and data provenance:

Sample Size: Not specified.
Data Provenance: Not specified. (The document describes the device's general testing, not clinical study data provenance.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. The document does not describe a clinical study involving expert-established ground truth for the test set.

4. Adjudication method for the test set:

Not applicable/Not specified. The document does not describe a clinical study or ground truth adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a standalone blood pressure and body fat monitor, not an AI-assisted diagnostic tool for human readers. No AI/ML component is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

A standalone performance assessment was conducted for the device's technical specifications and general performance, as stated under "Device Testing." However, this does not refer to an algorithm in the context of AI/ML, but rather the device's overall functionality.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not specified. The document refers to "technical specifications" as the basis for testing, implying engineering standards rather than clinical ground truth from expert consensus or pathology.

8. The sample size for the training set:

Not applicable. The device described does not appear to involve a machine learning component requiring a training set. It uses "bioelectrical impedance analysis, a well established technique, for body fat assessment" and standard blood pressure measurement techniques.

9. How the ground truth for the training set was established:

Not applicable. No training set is mentioned for this device.

Summary

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K024077 PAGE 1 OF 2

MAR 1 0 2003

SECTION 16 510(K) SUMMARY

1. DATE PREPARED

November 25, 2002

2. SPONSOR INFORMATION

Zewa Inc. Mr. Thomas Zeindler 10438 N.W. 31st Terrace Miami, Florida 33172

(305) 463-7551 (telephone) (305) 463-7553 (facsimile)

3. DEVICE NAME

Proprietary Name:	Delwa-Star® WS-FM Blood Pressure and Body Fat Monitor
Common/Usual Name:	WS-FM Blood Pressure and Body Fat Monitor
Classification Name:	System, Measurement, Blood Pressure, Non Invasive/Plethysmograph, impedance

DEVICE DESCRIPTION AND INTENDED USE 4.

ડ. PREDICATE DEVICE

It is substantially equivalent to the Omron Body Fat Analyzer Model HBF-306 cleared by FDA on November 7, 2001 under 510(k) 011652 and the WS-500 Noninvasive Blood Pressure Measurement System cleared by FDA on March 5. 1999, under 510(k) K003444.

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6. TECHNOLOGICAL CHARACTERISTICS

7. DEVICE TESTING

The Delwa-Star® WS-FM Blood Pressure and Body Fat Monitor was tested for compliance with numerous technical specifications, including general performance under certain environmental conditions, influences of static electrical discharges, influences of irradiated electromagnetic field, and radio screening.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, with flowing lines suggesting movement or progress. The overall design is simple and conveys a sense of health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2003

Vice President Zewa Inc. 10438 N.W. 31st Terrace MIAMI FL 33172 Re: K024077 Trade/Device Name: Delwa-Star® WS-FM Blood Pressure and Body Fat Monitor Regulation Number: 21 CFR 8870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: II Product Code: 74 DXN Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: December 9, 2002 Received: December 10, 2002

Dear Mr. Zeindler:

Mr. Thomas Zeindler

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 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 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.

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Page 2

This letter will allow you to begin marketing your device as described in your 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 one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Nancy C. Brogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Not assigned yet

Device Name:	Trade Name: Delwa-Star® WS-FM Blood Pressure and Body FatMonitor
Indications for Use:	The Delwa-Star® WS-FM Blood Pressure and Body Fat Monitor isintended for use by adults with moderately active to inactivelifestyles for measuring the systolic and diastolic blood pressure,and pulse rate (heart rate) by using an inflated cuff which iswrapped around the wrist. The device is also intended to estimatebody fat by bioelectrical impedance analysis.

Over-The-Counter Use.

PLEASE DO NOT WRITE BELOW THIS LINE (Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segner

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices (02407 510(k) Number _

Prescription Use (Per 21 CFR 801.109) or

Over-The-Counter Use 1/

WDC99 467861-2.041671.0011

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
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.(b)
Classification. Class II (performance standards).