(90 days)
510(k) 011652, 510(k) K003444
No
The description focuses on standard bioelectrical impedance analysis and blood pressure measurement techniques, with no mention of AI or ML.
No
The device is a monitor intended for measurement and assessment, not for treating or providing therapy for a medical condition.
Yes
The device is described as "measuring the systolic and diastolic blood pressure, and pulse rate (heart rate)" and also "estimate body fat by bioelectrical impedance analysis." These are measurements related to physiological states, indicating that the device provides information for diagnosis or monitoring.
No
The device description explicitly lists hardware components such as an inflatable cuff, LCD display, semiconductor sensor, internal air pump, battery power source, and keys for operation.
Based on the provided information, the Delwa-Star® WS-FM Blood Pressure and Body Fat Monitor 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.
- Device Function: The Delwa-Star® WS-FM measures blood pressure and pulse rate using a cuff on the wrist (a non-invasive method) and estimates body fat using bioelectrical impedance analysis (also a non-invasive method). These measurements are taken directly from the body, not from a sample taken from the body.
- Intended Use: The intended use describes measuring physiological parameters (blood pressure, pulse rate, body fat) directly from the user.
Therefore, the device's function and intended use clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
74 DXN, 74 MNW
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
adults
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
510(k) 011652, 510(k) K003444
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
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.
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.
1
6. TECHNOLOGICAL CHARACTERISTICS
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.
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
4
510(k) Number (if known): Not assigned yet
| Device Name: | Trade Name: Delwa-Star® WS-FM Blood Pressure and Body Fat
Monitor |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | 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. |
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