(111 days)
The Omron HBF-500 body composition monitor with scale is intended to be used to calculate and display the estimated value of body fat percentage, skeletal muscle percentage, resting metabolism, BMI and visceral fat levels using the BI (Bioelectrical Impedance) Method and indicates the BMI (Body Mass Index).
The Omron HBF-500 is intended to be used by healthy individuals in the age range of 18 to 80 years for the skeletal muscle percentage, resting metabolism and visceral fat level. The age range for body fat percentage is intended to be used by healthy individuals between the age of 10 to 80 years.
Body Composition Monitor and Scale Model HBF-500
The provided text is a 510(k) summary from the FDA for a Body Composition Monitor and Scale. It outlines the regulatory approval for the OMRON Body Composition Monitor and Scale Model HBF-500. However, the document does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.
The document states:
"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... to legally marketed predicate devices..."
This indicates that a comparison to a predicate device was performed to demonstrate substantial equivalence, but the specific acceptance criteria and performance data from internal studies that supported this claim are not present in this particular FDA letter. Such detailed study information would typically be found in the manufacturer's 510(k) submission itself, which is not fully included here.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies based on the provided text.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Donna Diinovich Regulatory Affairs Manager OMRON Healthcare, Inc. 1200 Lakeside Drive BANNOCKBURN IL 60015-1243
NOV - 7 2006
Re: K062043
Trade/Device Name: Body Composition Monitor and Scale Model HBF-500 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: July 18, 2006 Received: August 9, 2006
Dear Ms. Djinovich:
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 cither class II (Special Controls) or class III (Premarket Approval), 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.
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roling Public S
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Please be advised that FDA's issuance of a substantial equivalence determination docs 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.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.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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| 510(k) Number: | K062043 |
|---|---|
| ---------------- | --------- |
Device Name:
Body Composition Monitor and Scale Model HBF-500
Indications for Use:
The Omron HBF-500 body composition monitor with scale is intended to be used to calculate and display the estimated value of body fat percentage, skeletal muscle percentage, resting metabolism, BMI and visceral fat levels using the BI (Bioelectrical Impedance) Method and indicates the BMI (Body Mass Index).
The Omron HBF-500 is intended to be used by healthy individuals in the age range of 18 to 80 years for the skeletal muscle percentage, resting metabolism and visceral fat level. The age range for body fat percentage is intended to be used by healthy individuals between the age of 10 to 80 years.
Prescription Use (Part 21 CFR 801 Subpart D) or
Over-the-counter use XX (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C hogdon
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 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.