(75 days)
The device is a non-invasive bio-impedance analyzer with scale for use in estimating human's body fat percentage by calculation using the individual's BMI (body mass index) and determination of body weight. The OMRON HBF-400 is intended to be used by healthy individuals between the age of 10 to 80 years.
The device is a non-invasive bio-impedance analyzer with scale.
This FDA Premarket Notification (510(k)) letter for the OMRON Model HBF-400 Fat Loss Monitor and Scale does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The document primarily focuses on the FDA's "substantial equivalence" determination, indicating that the device is similar enough to previously approved devices to be marketed. It states the indications for use of the device but does not provide details about a specific study testing its performance against defined acceptance criteria.
To answer your request, the following information would typically be found in a separate study report or a more detailed section of the 510(k) submission, which is not provided in this document:
- A table of acceptance criteria and the reported device performance: This would include specific metrics (e.g., accuracy, precision) and the thresholds the device needed to meet.
- Sample size used for the test set and the data provenance: Details on how many participants were in the test, their demographics, and whether the data was collected prospectively or retrospectively.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Information on who determined the reference standard and their expertise.
- Adjudication method for the test set: How disagreements in ground truth determination were resolved.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This usually applies to devices that assist human interpretation, which might not be directly relevant for a standalone measurement device like this body fat monitor.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This would be expected for a device like the OMRON HBF-400.
- The type of ground truth used: For a body fat monitor, this would ideally be a gold standard method like DEXA (Dual-energy X-ray absorptiometry), hydrostatic weighing, or a similar highly accurate body composition assessment.
- The sample size for the training set: (If a machine learning model was involved)
- How the ground truth for the training set was established: (If a machine learning model was involved)
Based on the provided document, I cannot fulfill your request for the specific acceptance criteria and study details. The 510(k) letter confirms the device's regulatory approval for marketing based on its substantial equivalence to a predicate device, but it does not elaborate on the specific performance studies and their results.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of protecting the health of all Americans and providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 2005
Mr. Larry Lepley Manager, Regulatory/Clinical Affairs OMRON Healthcare, Inc. 1200 Lakeside Drive BANNOCKBURN IL 60015-1243
Re: K043060
Trade/Device Name: OMRON Model HBF-400 Fat Loss Monitor and Scale Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: November 5, 2004 Received: November 15, 2004
Dear Mr. Lepley:
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. Iisting 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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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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmadsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy 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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Indications for Use
510(k) Number (if known): Ko 430 GO
OMRON Model HBF-400 Fat Loss Monitor and Scale Device Name:
The device is a non-invasive bio-impedance analyzer Indications For Use: with scale for use in estimating human's body fat percentage by calculation using the individual's BMI (body mass index) and determination of body weight. The OMRON HBF-400 is intended to be used by healthy individuals between the age of 10 to 80 years.
Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR -
Over-The-Counter Use _ × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dorint A. Legmm
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devi
510(k) Number
§ 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.