(90 days)
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No
The provided text only describes basic body composition measurements and does not mention any AI or ML technologies.
No
The device measures various body composition metrics and metabolic rates. It does not describe any function related to treating or alleviating a medical condition.
Yes
The device measures various body composition parameters and metabolic rates, which are typically used to assess a person's health status, identify potential health risks, or monitor the effectiveness of a health intervention. This falls under the definition of a diagnostic device.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. The "Intended Use" section lists measurements that could potentially be derived from either software analysis of data from external hardware (like a scale or impedance device) or from a device that integrates both hardware and software. Without a device description, it's impossible to definitively classify it.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the measurement of various body composition parameters (fat, lean mass, water, metabolic rates, BMI, waist/hip ratio, impedance). These measurements are taken directly from the body, not from a sample of bodily fluid or tissue in vitro (outside the body).
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples. IVDs are specifically designed for testing such samples to provide information about a person's health status.
Therefore, this device appears to be a body composition analyzer, which is a type of medical device, but not an IVD.
N/A
Intended Use / Indications for Use
MEASUREMENT OF: ESTIMATED: Body FAT BODY LEAN+ DRY LEAN TOTAL BODY WATER METABOLIC RATES ACTUAL: BODY MASS INDEX (BMI) WAIST / HIP RATIO IMPEDANCE AT 50 kHZ
Product codes
74 MNW
Device Description
Bodystat® 1500MDD Body Composition Monitoring Unit
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2000
Mr. I. J. Meeuwsen Managing Director Bodystat® Limited P. O. Box 50 Douglas Isle of Man IM99 1DQ BRITISH ISLES
Re: K994242
Bodystat® 1500MDD Body Composition Monitoring Unit Dated: December 6, 1999 Received: December 16, 1999 Requiatory Class: II 21 CFR §870.2770/Procode: 74 MNW
Dear Mr. Meeuwsen:
We have reviewed your Section 510(k) notification of intent to market the device and we 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 Cosmelic 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 recisitation, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 (QS) 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 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) 594-4591. 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" (21CFR 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/odrh/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
1
510(k) Number (if known): BODYSTAT (1.500 M. Device Name:_________
Indications For Use:
MEASUREMENT OF:
ESTIMATED: Body FAT
BODY LEAN+
DRY LEAN
TOTAL BODY WATER
METABOLIC RATES
ACTUAL: BODY MASS INDEX (BMI)
WAIST / HIP RATIO
IMPEDANCE AT 50 kHZ
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use__
(Per 21 CFR 801.109)
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices ળીવ 510(k) Number
Over-The-Counter Use V
(Optional Format 1-2-96)