(210 days)
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Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The intended use is for measurement of body water components, which is a diagnostic or monitoring function, not a therapeutic intervention.
No
The device measures water compartments (extra-cellular, intra-cellular, and total body water) which are physiological parameters, not conditions or diseases. While these measurements can be used in a clinical context, the device itself is for measurement, not diagnosis.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "MEASUREMENT OF ESTIMATED EXTRA-CELLULAR WATER; ESTIMATED INTRA-CELLULAR WATER. ESTIMATED TOTAL BODY WATER". This describes a measurement of physiological parameters within the body, not the analysis of samples taken from the body (like blood, urine, tissue, etc.). IVDs are specifically designed to analyze these in vitro samples.
- Lack of IVD-related information: The provided text lacks any mention of:
- Analyzing biological samples.
- Reagents or kits used for analysis.
- Specific analytes being measured in a sample.
- Any processes related to laboratory testing.
Conclusion:
The intended use and the absence of any information related to the analysis of in vitro samples strongly suggest that this device is not an In Vitro Diagnostic. It appears to be a device that measures body composition parameters directly on the patient.
N/A
Intended Use / Indications for Use
MEASUREMENT OF ESTIMATED EXTRA-CELLULAR WATER; ESTIMATED INTRA-CELLULAR WATER. ESTIMATED TOTAL BODY WATER; AND
Product codes
74 MNW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 1997
Mr. I. J. Meeuwsen Managing Director BodyStat Limited P.O. Box 50 Douglas Isle of Man IM99 IDQ British Isles
Re:
K971554 BodyStat® MultiScan 5000 Dated: September 22, 1997 Received: September 26, 1997 Regulatory Class: II 21 CFR §870.2770/Product Code: 74 MNW
Dear Mr.Meeuwsen:
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 Office of Compliance at (301) 594-4613. Additionally, for question 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/cdrh/dsmamain.html".
Sincerely vours.
W. Liao Yu
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
1
AT
Page ol
210(k) Number (if known):
K971554
Device Name: BODYSTATⓇ MULTI SCAN 5000
Indications For Use:
MEASUREMENT
OF
ESTIMATED EXTRA-CELLULAR WATER;
ESTIMATED INTRA-CELLULAR WATER.
ESTIMATED TOTAL BODY WATER; AND
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
UE
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ryber R. Sather/
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971134
iption Use
Per 21 CFR 801.109)
OR
Over-The-Counter Use L