BOD POD

K060848 · Life Measurement, Inc. · OAC · Jun 27, 2006 · Cardiovascular

Device Facts

• Record ID: K060848
• Device Name: BOD POD
• Applicant: Life Measurement, Inc.
• Product Code: OAC · Cardiovascular
• Decision Date: Jun 27, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

The BOD POD® is indicated for measuring the body mass and estimating the body composition (i.e. percent and absolute amounts of fat and lean body mass) of generally healthy individuals. The BOD POD is also indicated for estimating Resting Metabolic Rate (RMR) and Total Energy Expenditure (TEE) in generally healthy individuals aged 18 years or older.

Device Story

BOD POD measures body mass via integrated scale and body volume via air displacement plethysmography; calculates body density; uses scientific algorithms to estimate body composition (fat/lean mass), RMR, and TEE. Used in clinical/research settings; operated by trained personnel. Output provided to healthcare provider to assess metabolic and body composition status; aids in clinical decision-making regarding health and nutrition. Benefits include accurate, non-invasive body composition and metabolic rate assessment.

Clinical Evidence

Bench testing only. Verification testing compared RMR and TEE results generated by the device against expected results derived from published scientific research. No clinical trial data presented.

Technological Characteristics

Air displacement plethysmograph; includes weighing apparatus and volume measurement chamber. Uses densiometric principle. Software-based algorithms for body composition, RMR, and TEE estimation.

Indications for Use

Indicated for measuring body mass, body composition (fat/lean mass), and estimating Resting Metabolic Rate (RMR) and Total Energy Expenditure (TEE) in generally healthy individuals aged 18 years or older.

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

• Sonamet Body Composition Analyzer (K924972)
• TANITA Segmental Body Composition Analyzer Model BC-418 (K033157)

Submission Summary (Full Text)

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JUN 27 2006

# Section 5 – 510(k) Summary

The following is the 510(K) summary in accordance with 21CFR807.87(h)

### SUBMITTER INFORMATION

| Company Name: | Life Measurement, Inc. |
|------------------------------------|--------------------------------------------------|
| Establishment Registration Number: | 3003873943 |
| Company Address: | 1850 Bates Avenue<br>Concord, CA 94520 |
| Company Phone: | [phone] |
| Company Facsimile: | [phone] |
| Contact Person: | Michael Sullivan<br>Vice President of Operations |

### DEVICE IDENTIFICATION

| Device Trade Name: | Sonamet Body Composition Analyzer<br>Note : The trade name for the original Sonamet Body Composition<br>analyzer is currently the “BOD POD”. This will remain unchanged. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Generic Name: | Body Composition Analyzer |
| Device Classification: | Classification code: 21 CFR 870.2770<br>Code MNW |
| Classification Panel | Cardiovascular |

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#### IDENTIFICATION OF PREDICATE DEVICES

The Sonamet Body Composition System is substantially equivalent to the following devices, which have received FDA clearance:

| Device Name | Manufacturer | K Number |
|---------------------------------------------------------------|----------------------------------|----------|
| Sonamet Body<br>Composition Analyzer | Life Measurement,<br>Inc. | K924972 |
| TANITA Segmental<br>Body Composition<br>Analyzer Model BC-418 | TANITA Corporation<br>of America | K033157 |

The technological characteristics of the Sonamet Body Composition System have not been changed. The method of calculating RMR using values of Fat Free Mass is similar to the methods used by the TANITA Model BC-418 unit to calculate Basal Metabolic Rate.

#### DEVICE DESCRIPTION

The Sonamet Body Composition System is designed to measure the mass and estimate the body composition of individuals. Once an individual's body composition has been determined, the BOD POD is able to accurately estimate Resting Metabolic Rate (RMR) and total Energy Expenditure (TEE).

The BOD POD estimates body composition using a densiometric approach (i.e. by determining the density of the entire body). A weighing apparatus is used to measure the subject's mass. Air displacement plethysmography is used to measure the subject's volume. Using this data, the subject's density is calculated. The subject's body composition is then estimated using several algorithms derived from scientific research.

An individual's RMR and TEE can also be estimated accurately using values for Fat Mass and Fat Free Mass. Scientifically derived algorithms utilize the Fat Mass and Fat Free mass values determined by the BOD POD to calculate RMR and TEE.

#### INTENDED USE

The BOD POD® is indicated for measuring the body mass and estimating the body composition (i.e. percent and absolute amounts of fat and lean body mass) of generally healthy individuals. The BOD POD is also indicated for estimating Resting Metabolic Rate (RMR) and Total Energy Expenditure (TEE) in generally healthy individuals aged 18 years or older.

#### CONCLUSIONS DRAWN FROM STUDIES

The results of verification testing demonstrate that the RMR and TEE results generated by the BOD POD Body Composition Analyzer are accurate when compared with expected results based on published scientific research, and is substantially equivalent to the predicate devices. Test results indicate that the device satisfies functional performance requirements safely and accurately when used as indicated.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, conveying the department's mission and purpose.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alex Urlando Vice President, Operations Life Measurement, Inc. 1850 Bates Avenue CONCORD, CA 94520

MAY - 1 2007

Re: K060848 Trade/Device Name: BOD POD® Sonamet Body Composition Analyzer [modified indications] Regulation Number: 21 CFR§870.2770 Regulation Name: Air Displacement Plethysmograph for Body Composition Analysis Regulatory Class: Class II Product Code: OAC Dated: March 23, 2006 Received: March 31, 2006

Dear Mr. Urlando:

This letter corrects our substantially equivalent letter of June 27, 2006.

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 (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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21

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Page 2 - Mr. Alex Urlando

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 continue marketing your device as described in your Section Fins loter will and it your of the FDA finding of substantial equivalence of your device s rotty premazine ted 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 10 gatable of the may obtain other general information on your responsibilities under the Act 601.97). Touring 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/dsma/dsmamain.html

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): K060848

Device Name: Sonamet Body Composition Analyzer (BOD POD)

Indications For Use:

The BOD POD® is indicated for measuring the body mass and estimation the beste composition (i.e. percent and absolute amounts of fat and lean body on the more and any and Rate (RMR) and Total Energy Expenditure (TEE) in generally healthy individuals aged 18 years or older.

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

Over-The-Counter Have 1 (21 CFR 8: , . .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON FRIENDE ACCLE P NEEDED)

Concurrence of CDRH, Office of Device Evaluation = 140 €

Nancy C. Gordon
(Division Sign-Off)

Division of Reprodu live, Abdo and Radiological Devices 510(k) Number

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(vers 6/25/05)