(109 days)
For the purposes of performing a non-invasive bio-impedance analysis (BIA) measurements on normal healthy human adults to determine their Body Composition status.
This device measures bio-electrical impedance when a 50 kHz signal is applied at specific locations on the subject. From this and the subject's age, gender, weight, height, waist and hip circumferences (optional), the device calculates the following estimated values: fat%, fat weight, lean%, lean weight, total body water%, total body water, dry lean weight, basal metabolic rate, basal metabolic rate/body weight ratio, average requirement (EAR), and actual body mass index and waist/hip ratio.
OPTIONAL ACCESSORIES: Bodystat (1) BODY MANAGER and (2) WELLNESS SOFTWARE PROGRAMS.
The Body Manager Program is ideal when a client returns to be tested in order to track their changes in body composition over a period of time.
The Wellness Program is ideal for first time assessments on subjects. The program's graphical presentations provide information on each of the specific measurements in an educational format.
The Bodystat 1500 Body Composition Monitoring Unit is an impedance plethysmograph that uses bio-electrical impedance analysis (BIA) to measure the impedance of the flow of an electrical current through the body. The impedance of tissue is proportional to the amount of fluid in the tissue; water is low in fat tissues, thus fat tissue has a high impedance, and high in lean tissues, thus lean tissue has a high impedance.
In practice, a small constant current is passed between electrodes spanning the body and the voltage drop between electrodes provides a measure of impedance. Prediction equations, previously generated by correlating impedance measures against an independent estimate of TBW (total body water), may be used subsequently to convert a measured impedance to a corresponding estimate of TB W. Lean body mass is then calculated from this estimate using an assumed hydration fraction for lean tissue; Bodystat uses a proprietary regression equation for this calculation. Fat mass is calculated as the difference between body weight and lean body mass.
The provided text is a 510(k) summary for the Bodystat 1500 Body Composition Monitoring Unit. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain information on acceptance criteria, specific study details (like sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies), or actual device performance metrics against acceptance criteria.
The document primarily focuses on establishing substantial equivalence to a previously cleared device (K951097) through hardware and software modification, sharing the same intended use and operating principle. The FDA letter confirms the 510(k) clearance based on this review.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and study details from the provided text. The document states that "Based on the data and information presented here, the modified BODYSTAT® 1500 Body Composition Monitoring Unit is substantially equivalent to the previously cleared Bodystat 1500 device," implying that the data was used to demonstrate this equivalence, but it does not describe the specific study parameters or results.
§ 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.