BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT

K082253 · Bodystat , Ltd. · MNW · Nov 25, 2008 · Cardiovascular

Device Facts

• Record ID: K082253
• Device Name: BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT
• Applicant: Bodystat , Ltd.
• Product Code: MNW · Cardiovascular
• Decision Date: Nov 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

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 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.

Device Story

Bodystat 1500 is an impedance plethysmograph using bio-electrical impedance analysis (BIA). Device applies 50 kHz electrical current via electrodes on subject; measures voltage drop to determine tissue impedance. Impedance correlates with fluid content; water low in fat tissue (high impedance), high in lean tissue (high impedance). Device uses proprietary regression equations to convert impedance and subject demographics (age, gender, weight, height, waist/hip circumference) into body composition estimates: fat%, fat weight, lean weight, total body water, basal metabolic rate, BMI, and waist/hip ratio. Used for health assessment; optional Body Manager and Wellness software programs track changes over time or provide educational graphical reports. Intended for use on healthy adults.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on hardware and software modifications to a previously cleared predicate device using the same operating principle.

Technological Characteristics

Impedance plethysmograph; BIA technology; 50 kHz signal source; electrodes for body contact; calculates body composition via proprietary regression equations; includes optional software for data management and reporting.

Indications for Use

Indicated for non-invasive bio-impedance analysis (BIA) to determine body composition status in normal healthy human adults.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Bodystat 1500 Body Composition Monitoring Unit (K951097)

Submission Summary (Full Text)

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# PAGE 1 OF 2

## NOV 2 5 2008

### 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.

510(k) Number : K082253

#### Submitter: A.

Bodystat Ltd P O Box 50 Douglas Isle of Man IM99 1DQ BRITISH ISLES

> Phone: [phone] Fax:

Contact: IJ Meeuwsen

Date Prepared: October 318 , 2008

## B. Device Names:

Classification name Impedance Plethysmograph Common/usual name Body Composition Monitor Proprietary name Bodystat 1500 Body Composition Monitoring Unit

#### C. Predicate Device:

The modified BODYSTAT®1500 Body Composition Monitoring Unit is substantially equivalent to previously cleared device, K951097, Bodystat 1500 Body Composition Monitoring Unit.

The BODYSTAT® 1500 Body Composition Monitoring Unit device is a hardware and software modification of the previously cleared device.

#### D. Device Description:

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

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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.

#### E. Intended Use:

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 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.

#### F. Comparison with the Predicate Device:

The modified BODYSTAT®1500 Body Composition Monitoring Unit is a hardware and software modification of the previously cleared Bodystat 1500. The modified Bodystat 1500 and the previously cleared Bodystat 1500 have the same intended use and use the same operating principle.

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.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, arranged in a cascading pattern.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 25 2008

Mr. I. J. Meeuwsen President BODYSTAT® LIMITED P.O. Box 50 Douglas, Isle of Man IM99 1DQ BRITISH ISLES

K082253 Re:

> Trade/Device Name: BODYSTAT® 1500 Body Composition Monitoring Unit Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: November 14, 2008 Received: November 19, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2

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); 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 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Joppu M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT 4

## Indications for Use

510(k) Number : K082253

## Device Name: BODYSTAT®1500 Body Composition Monitoring Unit

Indications for Use:

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.

Prescription Use (21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

Helent lemen
Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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