(87 days)
ESTIMATED MEASUREMENT OF: FAT, LEAN, WATER, INTRA-CELLULAR WATER, EXTRA-CELLULAR WATER, TOTAL ESTIMATED WATER AND IMPEDANCE VALUES AT 50 KHZ
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Bodystat® LTD. DuelScan 2005 Dual-Frequency Monitoring Unit). This document primarily focuses on regulatory approval and the device's substantial equivalence to previously marketed devices.
It does not contain the detailed information required to answer your questions regarding acceptance criteria, study design, performance results, or ground truth establishment. The letter refers to indications for use but does not provide the specifics of a study proving those indications or device performance against acceptance criteria.
Therefore, I cannot extract the information required to populate the table and answer the study-related questions based on this document.
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Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
વિવેત્ક JUN | |
Mr. I. J. Meeuwsen Managing Director Bodystat® Limited P.O. Box 50 Douglas Isle of Man IM99 IDQ BRITISH ISLES
Dear Mr. Meeuwsen:
Re: K980971 Bodystat® LTD. DuelScan 2005 Dual-Frequency Monitoring Unit (Body Composition Analyzer) Dated: March 11, 1998
Received: March 16, 1998 Regulatory Class: II 21 CFR 870.2770/Procode: 74 MNW
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (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 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Offive of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ISTAT O JUAL Device Name: Indications For Use: OF: MEASURE MENT WATER R WATER INTRA- CELLULAR THATED WATER TOTAL ESTIMATED AND PE DANCE VALUES AT S KH2
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Satting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number . 804
Prescription Use (Per 21 CFR 801.109)
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Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.