(913 days)
Not Found
No
The description details the use of bio-electrical impedance analysis (BIA) and proprietary regression equations to calculate body composition. There is no mention of AI or ML algorithms being used for data processing or analysis.
No
The device is used to measure and track body composition, not to treat any medical condition or disease.
No
Explanation: The device is described as "for the purposes of performing a non-invasive BIA measurement on normal healthy human adults and children to determine their Body Composition status." It measures body composition parameters like fat, lean mass, and water, and tracks changes over time, rather than diagnosing a medical condition or disease.
No
The device description explicitly states it is a "light weight, handheld, battery-operated device that uses bio-electrical impedance analysis (BIA)" and describes the hardware components and their function (passing electrical current, measuring voltage drop). While it includes software programs, it is fundamentally a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Bodystat 1500MDD uses bio-electrical impedance analysis (BIA) by passing a small electrical current through the body. It does not analyze samples taken from the body.
- Intended Use: The intended use is to perform a non-invasive measurement on the body to determine body composition status. This is a direct measurement on the living subject, not an analysis of a biological specimen.
Therefore, the Bodystat 1500MDD falls under the category of a non-invasive medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For the purposes of performing a non-invasive BIA measurement on normal healthy human adults and children to determine their Body Composition status.
These measurements include Body Mass Index (BMI), waist/hip ratio, tissue impedance. These measurements are used to calculate the estimated levels of body lean and dry lean, total body water, and metabolic rates.
Bodystat BODY MANAGER and WELLNESS SOFTWARE PROGRAMS are automatically included with this device.
The Body Manager Program is designed for 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 designed for first time assessments on subjects. The program's graphical presentations provide information on each of the specific measurements in an educational format.
Product codes
MNW
Device Description
The Bodystat 1500MDD Body Composition Monitoring Unit is a light weight, handheld, batteryoperated device 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 low impedance. The subject's age, sex, height, waist measurement, and hip measurement are also used to calculate various values.
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 TBW. 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. A body composition analysis report is comprised of Body Fat, Lean Body Mass, Dry Lean Mass, Total Body Water, and Optimal Ranges. Metabolic rates, Waist/Hip Ratio, and BMI are also reported. In addition, raw values are shown for Impedance at 5 kHz and at 50 kHz. The Bodystat 1500MDD contains separate equations for children aged 6 - 17 years and for adults aged 18 - 70 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
children aged 6 - 17 years and for adults aged 18 - 70 years
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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PAGE 1 OF 2
510(k) Summarv
FEB - 7 2011
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92,
510(k) Number : K082254
- Submitter: A.
Bodystat Ltd P O Box 50 Douglas Isle of Man IM99 1DQ British Isles
Phone: +44-1624-629571 Fax: +44-1624-611544
Contact: I J Meeuwsen
Date Prepared: January 24, 2011
- B. Device Names:
| Classification name | Body Composition Analyzer |
|---|---|
| Common/usual name | Body Composition Analyzer |
| Proprietary name | Bodystat 1500MDD Body Composition Monitoring Unit |
C. Predicate Device:
The BODYSTAT® 1500MDD Body Composition Monitoring Unit is substantially equivalent to the following previously cleared and legally marketed devices:
- . K994242, Bodystat 1500MDD Body Composition Monitoring Unit.
- . K002835, Bodystat Quadscan Ouad Frequency Monitoring Unit
D. Device Description:
The Bodystat 1500MDD Body Composition Monitoring Unit is a light weight, handheld, batteryoperated device 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 low impedance. The subject's age, sex, height, waist measurement, and hip measurement are also used to calculate various values.
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 TBW. 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
1
calculated as the difference between body weight and lean body mass. A body composition analysis report is comprised of Body Fat, Lean Body Mass, Dry Lean Mass, Total Body Water, and Optimal Ranges. Metabolic rates, Waist/Hip Ratio, and BMI are also reported. In addition, raw values are shown for Impedance at 5 kHz and at 50 kHz. The Bodystat 1500MDD contains separate equations for children aged 6 - 17 years and for adults aged 18 - 70 years.
PAGE 2 OF 2
E. Intended Use:
For the purposes of performing a non-invasive BIA measurement on normal healthy human adults and children to determine their Body Composition status.
These measurements include Body Mass Index (BMI), waist/hip ratio, tissue impedance. These measurements are used to calculate the estimated levels of body lean and dry lean, total body water, and metabolic rates.
Bodystat BODY MANAGER and WELLNESS SOFTWARE PROGRAMS are automatically included with this device.
The Body Manager Program is designed for 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 designed for first time assessments on subjects. The program's graphical presentations provide information on each of the specific measurements in an educational format.
F. Comparison with the Predicate Device:
The BODYSTAT® 1500MDD Body Composition Monitoring Unit is a hardware and software modification of the previously cleared Bodystat 1500MDD device, and measures at the additional frequency of 5 kHz like the Quadscan device.
Based on the data and information presented here, the BODYSTAT® 1500MDD Body Composition Monitoring Unit is substantially equivalent to the previously cleared predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. I. J. Mecuwsen President Bodystat® Ltd. P.O. Box 50 Douglas, Isle of Man, IM99 1DO BRITISH ISLES
FEB - 7 201
Re: K082254
Trade/Device Name: BODYSTAT ロ1500MDD Body Composition Monitoring Unit Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: September 27, 2010 Received: September 30, 2010
Dear Mr. Meeuwsen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Please be advised that FDA's issuance of a substantial equivalence determination does 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); medical device reporting of medical device-related
:
3
Page 2
adverse events) (21 CFR 803); 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 1,000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm117808991111 for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Production 807.97). For questions regarding the reporting of adverse events under the MDR regulation (2) CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default:htm.
Sincerely yours,
Hubert Lemire MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
4
Indications for Use
510(k) Number :
Device Name: BODYSTAT=1500MDD Body Composition Monitoring Unit
Indications for Use:
For the purposes of performing a non-invasive BIA measurement on normal healthy human adults and children to determine their Body Composition status.
The measurements include Body Mass Index (BMI), waist/hip ratio, tissue impedance at 5kHz and at 50kHz. These measurements are used to calculate the estimated levels of body fat, body lean and dry lean, total body water, and metabolic rates,
Bodystat BODY MANAGER and WELLNESS SOFTWARE PROGRAMS are automatically included with this device.
The Body Manager Program is designed for 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 designed for first time assessments on subjects. The program's graphical presentations provide information on each of the specific measurements in an educational format.
Prescription Use AND/OR (21 CFR 801 Subpart D)
Over-The-Counter Use X (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)
Division Sign Off