(913 days)
For the purposes of performing non-invasive bio-electrical impedance analysis (BIA) measurements on healthy human adults and children to determine their Body Composition status. Such measurements include Body Mass Index (BMI), waist/hip ratio, and tissue Impedance at 5, 50, 100 and 200 kHz. These measurements are used to calculate the estimated levels of extra-cellular water, intracellular water, total body water, body fat, body lean and dry lean, and metabolic rates. QuadScan 4000 for Windows Software Program is automatically included with the device.
The OuadScan 4000 Body Composition & Fluid Monitoring Unit is a light weight, handheld, battery operated device that uses bio-electrical impedance analysis (BIA) to measure the impedance of the flow of an electrical current through the body; impedance is measured at four frequencies: 5, 50, 100, and 200 kHz. 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 lean tissue is high in water, thus lean tissue has a low impedance. The subject's age, sex, height, weight, 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) and ECW (extra-cellular water), may be used subsequently to convert measured impedances to corresponding estimates of TBW and ECW. By deduction, ICW is estimated. By applying the unique Bodystat® equation, Body Fat, Lean Mass and Dry Lean Mass can be assessed. The QuadScan 4000 contains separate body composition equations for children 6 years to 17 years, and adults 18 - 70 years.
The provided text is a 510(k) summary for the Bodystat QuadScan 4000 Body Composition & Fluid Monitoring Unit. This document states that the device is substantially equivalent to a previously cleared predicate device (OuadScan Ouad Frequency Monitoring Unit & OuadScan Wellness and Hydration Software Program cleared under K002835). As such, it primarily focuses on comparing the new device to the predicate rather than presenting a de novo study with specific acceptance criteria and performance data for the new device.
Therefore, the text does not contain detailed information regarding:
- Specific acceptance criteria (e.g., performance thresholds for accuracy, precision of body composition measurements).
- A dedicated study proving the device meets acceptance criteria, beyond the demonstration of substantial equivalence to a predicate device.
- Sample sizes for test or training sets.
- Data provenance, expert qualifications, adjudication methods, or MRMC studies.
- Standalone algorithm performance or the type of ground truth used in a new study.
The document emphasizes that the new device is a "hardware and software modification" of the predicate, implying that its performance is expected to be similar to the established performance of the predicate.
Given this, I can only extract limited information related to the device's intended use and the nature of its operation.
Here's a summary of what the document provides, and what it explicitly does not provide:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly list quantitative acceptance criteria (e.g., specific accuracy ranges for body fat percentage, water content) or present a table of reported device performance metrics against such criteria for the new device. The basis for clearance is substantial equivalence to a predicate device (K002835).
2. Sample size used for the test set and the data provenance:
Not provided. The document relies on substantial equivalence to a predicate device, not new clinical study data with test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not provided. There is no mention of a new test set requiring expert ground truth establishment for this 510(k) submission.
4. Adjudication method for the test set:
Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable and not provided. The device is a Body Composition Analyzer, not an imaging device requiring human reader interpretation or AI assistance in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is essentially a standalone algorithm with a hardware interface (Bio-electrical Impedance Analysis). However, no new performance study metrics for this device are provided, as substantial equivalence is the basis. The performance is implied to be similar to the predicate.
7. The type of ground truth used:
Not explicitly stated for a new study. The predicate device's prediction equations were "previously generated by correlating impedance measures against an independent estimate of TBW (total body water) and ECW (extra-cellular water)." This suggests independent quantitative measures (e.g., DEXA, isotope dilution, or other reference methods for body composition) were used as ground truth for developing the equations for the predicate device.
8. The sample size for the training set:
Not provided for this submission. The "prediction equations" for the predicate device were developed using an unspecified training set size.
9. How the ground truth for the training set was established:
For the predicate device's equations, ground truth was established by "correlating impedance measures against an independent estimate of TBW (total body water) and ECW (extra-cellular water)." This indicates the use of reference methods for measuring these body composition parameters.
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510(k) Summary
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.
K082255 510(k) Number :
A. Submitter:
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 QuadScan 4000 Body Composition & Fluid |
| Monitoring | Unit |
C. Predicate Device:
The BODYSTAT® OuadScan 4000 Body Composition & Fluid Monitoring Unit is substantially equivalent to the OuadScan Ouad Frequency Monitoring Unit & OuadScan Wellness and Hydration Software Program cleared under K002835.
D. Device Description:
The OuadScan 4000 Body Composition & Fluid Monitoring Unit is a light weight, handheld, battery operated device that uses bio-electrical impedance analysis (BIA) to measure the impedance of the flow of an electrical current through the body; impedance is measured at four frequencies: 5, 50, 100, and 200 kHz. 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 lean tissue is high in water, thus lean tissue has a low impedance. The subject's age, sex, height, weight, 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) and ECW (extra-cellular water), may be used subsequently to convert measured impedances to corresponding estimates of TBW and ECW. By deduction, ICW is estimated. By applying the unique Bodystat® equation, Body Fat, Lean Mass and
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Dry Lean Mass can be assessed. The QuadScan 4000 contains separate body composition equations for children 6 years to 17 years, and adults 18 - 70 years.
E. Intended Use:
For the purposes of performing non-invasive bio-electrical impedance analysis (BIA) measurements on healthy human adults and children to determine their Body Composition status.
Such measurements include Body Mass Index (BMI), waist/hip ratio, and tissue Impedance at 5, 50, 100 and 200 kHz. These measurements are used to calculate the estimated levels of extra-cellular water, intracellular water, total body water, body fat, body lean and dry lean, and metabolic rates.
QuadScan 4000 for Windows Software Program is automatically included with the device.
F. Comparison with the Predicate Device:
The BODYSTAT® QuadScan 4000 Body Composition and Fluid Monitoring Unit is a hardware and software modification of the previously cleared Bodystat QuadScan device.
Based on the data and information presented here, the BODYSTAT® QuadScan 4000 Body Composition Unit is substantially equivalent to the previously cleared predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of several curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. I. J. Meeuwsen President Bodystat® Ltd. P.O. Box 50 Douglas, Isle of Man, IM99 1DQ BRITISH ISLES
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K082255 Re:
Trade/Device Name: Bodystat QuadScan 4000 Body Composition & Fluid 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
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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 electric product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/ucm111780017, pr.as 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" (21 CFR Production 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 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 nomber (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default:htm.
Sincerely yours.
Hubert Humphrey
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
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Indications for Use
510(k) Number :
Device Name: Bodystat QuadScan 4000 Body Composition & Fluid Monitoring Unit
Indications for Use:
For the purposes of performing non-invasive bio-electrical impedance analysis (BIA) measurements on healthy human adults and children to determine their Body Composition & Hydration status.
The measurements include Body Mass Index (BMI), waist/hip ratio, tissue impedance at 5, 50, 100, and 200 kHz. These measurements are used to calculate the estimated levels of extra-cellular water, intracellular water, total body water, body fat, body lean and dry lean, metabolic rates.
QuadScan 4000 for Windows Software Program is automatically included with the device.
Prescription Use (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)
Huld Sum
AND/OR
§ 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.