TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418

K033157 · Tanita Corp. of America · MNW · Apr 8, 2004 · Cardiovascular

Device Facts

• Record ID: K033157
• Device Name: TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418
• Applicant: Tanita Corp. of America
• Product Code: MNW · Cardiovascular
• Decision Date: Apr 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

A body composition analyzer that measures body weight and impedance and estimates total and segmental body fat percent, body mass index (BMI), fat mass, fat-free mass, regional muscle mass, basal metabolic rate, and total body water using BIA (bioelectrical impedance analysis) in healthy children (7-17 years old) and healthy adults.

Device Story

Computer-operated body composition analyzer; utilizes segmental bioelectrical impedance analysis (BIA) to determine body weight, body fat percentage, and regional muscle mass. Inputs: electrical impedance measurements via scale electrodes. Transformation: BIA technology calculates body composition metrics. Outputs: body weight, body fat %, BMI, fat mass, fat-free mass, regional muscle mass, BMR, and total body water. Used in clinical settings; operated by healthcare professionals. Output provides quantitative data to assist in assessing patient body composition and metabolic status.

Clinical Evidence

No clinical data provided. Substantial equivalence based on comparison of BIA methodology and performance characteristics to predicate device.

Technological Characteristics

Segmental BIA technology; computer-operated scale form factor. Measures impedance to estimate body composition. No specific materials or software architecture details provided.

Indications for Use

Indicated for healthy children (7-17 years) and healthy adults to measure body weight and impedance to estimate body fat, BMI, fat mass, fat-free mass, regional muscle mass, BMR, and total body water.

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

• TANITA Body Fat Analyzer Professional Model TBF-410 (K014009)

Submission Summary (Full Text)

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APR = 8 2004

# 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

| Trade Name: | TANITA BC-418, Segmental Body Composition Analyzer |
|----------------------|----------------------------------------------------|
| Common Name: | Body Composition Analyzer / Body Fat Analyzer |
| Classification Name: | ANALYZER, BODY COMPOSITION<br>21 CFR § 870.2770 |

## Description of Applicant Device:

The TANITA BC-418, Segmental Body Composition Analyzer is a computer-operated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent and regional muscle mass.

#### Intended Uses of Applicant Device:

Intended to be used as a body fat analyzer that determines body weight and estimates body fat and skeletal muscle mass with the use of BIA (bioelectrical impedance analysis). Other outputs include BMR (basal metabolic rate), TBW (total body water), and BMI (body mass index).

## Predicate Device:

TANITA Body Fat Analyzer Professional Model TBF-410 K014009

#### Scientific Concepts and Significant Performance Characteristics:

| | Body Fat Analyzer<br>Model TBF-410<br>K014009 | Segmental Body Composition<br>Analyzer<br>Model BC-418 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE: | A combination non-invasive<br>device, which determines weight<br>and estimates body fat<br>composition using BIA<br>(bioelectrical impedance<br>analysis). | A combination non-invasive<br>device, which determines weight<br>and estimates body fat<br>composition and muscle mass<br>using BIA (bioelectrical<br>impedance analysis). |
| PRODUCT DESCRIPTION: | Body composition analyzer/scale<br>that utilizes a "foot-to-foot" BIA<br>(bio- electrical impedance)<br>technology to determine internal<br>body composition. | Body composition analyzer/scale<br>that utilizes segmental BIA (bio-<br>electrical impedance) technology<br>to determine internal body<br>composition. |
| ANALYTICAL<br>METHOD/MEASUREMENT | • Foot-to-Foot BIA<br>• In-house BIA and DEXA<br>reference methods | • Segmental BIA<br>• In-house BIA and DEXA<br>reference methods |

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# 510(k) SUMMARY, continued

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

Side by side comparisons of the TANITA BC-418, Segmental Body Composition Analyzer to the predicate device Body Fat Analyzer Professional Model TBF-410 clearly demonstrate that the applicant device is substantially equivalent to the legally marketed device.

Based on the results of using the previously approved BIA methodology with our whole body BIA, it was concluded that the TANITA BC-418, Segmental Body Composition Analyzer performs as well as the predicate device and therefore have proven its safety and efficacy.

Rhoda Lynn Valera TANITA Corporation of America Requlatory Affairs Specialist

Phone: [phone] [phone] Fax:

September 26, 2003

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Image /page/2/Picture/12 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 2004

Ms. Rhoda Lynn N. Valera Regulatory Affairs Specialist Tanita Corporation of America, Inc. 2625 South Clearbrook Drive ARLINGTON HEIGHTS IL 60005

Re: K033157

Trade/Device Name: Tanita Segmental Body Composition Analyzer BC-418 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: January 9, 2004 Received: January 12, 2004

Dear Ms. Valera:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatived of the enactment date of the Medical Device Amendments, or to comments provision to May 20, 1978, are cance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). allo Cosmette Her (110) that to novice, subject to the general controls provisions of the Act. The r ou may, dicrolore, mains of the Act include requirements for annual registration, listing of gencial controls provisions of ractice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 and 10) . 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 i that FDA has made a determination that your device complies with other requirements of the Act that I D.A has made a actuations administered by other Federal agencies. You must or any I ederal statutes and registements, including, but not limited to: registration and listing comply with and rice broquent (FR Part 801); good manufacturing practice requirements as set (21 CFR Part 007), assemis (QS) regulation (21 CFR Part 820); and if applicable, the clectronic forth in the quant) 05 sections (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin markering of substantial equivalence of your device to a legally prematication. The PDF maily to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desite specific advice for your control to the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Augulany, for questions on the personal prosse note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general by releasence to premarked notification (er the Act may be obtained from the Division of Small Information on your responsionaliss and Consumer Assistance at its toll-five number [phone] or Mandiacturers, Theemadonal ans Colless http://www.fda.gov/cdrl/dsmaldsmamain.html.

Sincercly yours,

Nancy C. Brogdon

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

Enclosure

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| 510(k) Number: | K033157 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | TANITA BC-418, Segmental Body Composition Analyzer |
| Indications for Use: | A body composition analyzer that measures body weight and<br>impedance and estimates total and segmental body fat<br>percent, body mass index (BMI), fat mass, fat-free mass,<br>regional muscle mass, basal metabolic rate, and total body<br>water using BIA (bioelectrical impedance analysis) in healthy<br>children (7-17 years old) and healthy adults. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

(Optional Format 1-2-96)

Nancy Hodgson
Division Sign Off

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