(162 days)
The device is noninvasive bioimpedance analyzer for use in providing the human's body fat counts (index) and percentage by estimating body fat in athletic subjects. The applicable age range is 10 to 80 years old.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Omron HBF-306 Body Fat Analyzer. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, the document does not contain the specific details required to answer your questions about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
This type of FDA letter typically confirms regulatory clearance based on a submission, but it doesn't usually include the detailed study methodology and results that would be found in the 510(k) submission itself or a separate clinical study report.
Therefore, I cannot extract the information requested from the provided text.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes forming its wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2001 NOV
Mr. Iwao Kojima Director of Technology Omron Healthcare, Inc. 300 Lakeview Parkway VERNON HILLS, ILLINOIS 60061
Received: September 14, 2001
Re: K011652 Trade/Device Name: HBF 306 Body Fat Analyzer Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: undated
Dear Mr. Kojima:
This letter corrects our substantially equivalent letter of November 7, 2001, regarding the HBF 306 Body Fat Analyzer, which listed the device model number incorrectly as the HBF 1000 Body Composition Analyzer.
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). 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.
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Page 2 - Mr. Kojima
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 that I Dr lass intess and regulations administered by other Federal agencies. You must of any I oderal statures including, but not limited to: registration and listing comply with and Not Not (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 007), 1200mmg (25) regulation (21 CFR Part 820); and if applicable, the electronic fordination control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) This ictier wifi anow you to consideratial equivalence of your device of your device to a legally premarket notineation: "The 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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KD11652
3. INDICATION FOR USE
Omron Healthcare, Inc. Applicant's Name :
K011652 510(k) Number :
Omron Body Fat Analyzer HBF-306 Device Name :
The device is noninvasive bioimpedance analyzer for use in Indications for Use : The device is nonlineasive blommpoumes and percentage by estimating numan's bouy far vounts (indes) and proving the proving weight. The applicable ago frange in athletic subjects.
Nancy C brigdon
Division Sign. tive. Ahdo Division of Renro and Radiological Devices 510(k) Numb
Over-The-Counter Use
§ 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.