TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)

K040778 · Tanita Corp. of America · MNW · Dec 23, 2004 · Cardiovascular

Device Facts

• Record ID: K040778
• Device Name: TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)
• Applicant: Tanita Corp. of America
• Product Code: MNW · Cardiovascular
• Decision Date: Dec 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TANITA family of InnerScan Body Composition Monitors measure body weight and impedance and estimate percentage of body fat and body water, visceral fat rating, bone mass, muscle mass, physique rating, daily calorie intake (DCI) and metabolic age using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 7-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.

Device Story

Device is a computer-operated body composition monitor/scale; utilizes foot-to-foot bioelectrical impedance analysis (BIA) to measure body weight and impedance. Inputs include user weight and electrical impedance; device transforms these via proprietary algorithms to estimate body fat %, total body water %, visceral fat rating, bone mass, muscle mass, physique rating, metabolic age, and daily calorie intake. Used in home environment by consumers for self-assessment. Output displayed on device screen; provides users with body composition metrics to monitor health and lifestyle. Benefits include non-invasive tracking of body composition parameters.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing and validation of BIA methodology against reference methods including DEXA, deuterium dilution, and MRI.

Technological Characteristics

Foot-to-foot bioelectrical impedance analysis (BIA) scale. Measures weight and impedance. Models BC-533, BC-534, BC-550. Standalone consumer device. No specific material standards or software architecture details provided.

Indications for Use

Indicated for healthy children 7-17 years old and healthy adults with active, moderately active, or inactive lifestyles for body composition assessment in home settings.

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 and Consumer Models (K014009)

Submission Summary (Full Text)

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TANITA InnerScan Body Composition Monitor 510(k) Submission

# DEC 2 3 2004

# 510(k) SUMMARY

This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92

| Trade Name: | TANITA InnerScan Body Composition Monitor<br>Models BC-533, BC-534 and BC-550 |
|-------------------------|-------------------------------------------------------------------------------|
| Common Name: | Body Composition Analyzer / Body Fat Analyzer / Body Fat Monitor |
| Classification<br>Name: | ANALYZER, BODY COMPOSITION<br>21 CFR \$ 870.2770 |

## Description of Applicant Device:

The TANITA InnerScan Body Composition Monitor is a computer-operated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent, body water percent, muscle mass, bone mass, visceral fat rating, metabolic age, physique rating and daily calorie intake.

| | Model Number | | |
|--------------------------------------------|--------------|--------|--------|
| Body Composition Capabilities | BC-533 | BC-534 | BC-550 |
| Total Body Water % (TBW %) | ✓ | ✓ | ✓ |
| Visceral Fat Rating | ✓ | ✓ | ✓ |
| Bone Mass | ✓ | ✓ | ✓ |
| Muscle Mass / Physique Rating | ✓ | ✓ | |
| Daily Calorie Intake (DCI) / Metabolic Age | ✓ | ✓ | |
| Daily Calorie Intake (DCI) | | | ✓ |

#### Intended Uses of Applicant Device:

Intended to be used as a body fat analyzer that determines body weight and estimates body fat with the use of BIA (bioelectrical impedance analysis). Other outputs include total body water, DCI (daily calorie intake), bone mass, visceral fat rating, metabolic age, physique rating and muscle mass.

## Predicate Devices:

TANITA Body Fat Analyzer Professional and Consumer Models K014009

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### 510(k) SUMMARY, continued

This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92

## Scientific Concepts and Significant Performance Characteristics:

| | Tanita Body Composition<br>Analyzer<br>Professional Models<br>K014009 | Tanita Body Composition<br>Analyzer<br>Consumer Models<br>K014009 | Tanita InnerScan Body<br>Composition Monitor<br>Models BC-533, BC-534 &<br>BC-550 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE: | A combination non-invasive<br>device, which determines<br>weight and estimates body<br>fat and<br>total body water using BIA<br>(bioelectrical impedance<br>analysis). | A combination non-<br>invasive device, which<br>determines weight and<br>estimates body fat using<br>BIA (bioelectrical<br>impedance analysis). | A combination non-<br>invasive device, which<br>determines weight and<br>estimates total body fat,<br>visceral fat rating, bone<br>mass, total body water,<br>muscle mass, metabolic<br>age, physique rating and<br>daily calorie intake with<br>the use of BIA<br>(bioelectrical impedance<br>analysis). |
| PRODUCT<br>DESCRIPTION: | Body composition<br>analyzer/scale that utilizes<br>a "foot-to-foot" BIA<br>(bioelectrical impedance)<br>technology to determine<br>internal body composition. | Body composition<br>analyzer/scale that utilizes<br>a "foot-to-foot" BIA<br>(bioelectrical impedance)<br>technology to determine<br>internal body composition. | Body composition<br>monitor/scale that utilizes<br>a "foot-to-foot" BIA<br>(bioelectrical impedance)<br>technology to determine<br>internal body composition. |
| ANALYTICAL<br>METHOD/<br>MEASUREMENT | - Foot-to-Foot BIA<br>- In-house BIA and<br>- DEXA reference<br>methods | - Foot-to-Foot BIA<br>- In-house BIA and<br>- DEXA reference<br>methods | - Foot-to-Foot BIA<br>- In-house BIA, DEXA,<br>- Deuterium Dilution<br>and MRI reference<br>methods |

Side by side comparison of the TANITA InnerScan Body Composition Monitor to the predicate devices clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices.

Based on the results of using the previously approved "Foot-to-Foot" BlA methodology with our patented inhouse BIA, it was concluded that the TANITA InnerScan Body Composition Monitor performs as well as the predicate devices and therefore have proven its safety and efficacy.

Rhoda Lynn Valera, RAC TANITA Corporation of America Regulatory Affairs Specialist

2625 S. Clearbrook Dr. Arlington Heights, IL 60005 Phone: [phone] [phone] Fax:

December 20, 2004

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight, stacked vertically. The emblem is rendered in black, contrasting with the white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2004

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

Re: K040778

Trade/Device Name: TANITA InnerScan Body Composition Monitor BC-533, BC-534 and BC-550 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: November 10, 2004 Received: November 12, 2004

Dear Ms. Valera:

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 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 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 Scetion 510(k) I ms letter will anow you to organism
premarket notification. The FDA finding of substantial equivalence of your device to a legally premaired predicated on: "The PDF maxing sification 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 11 you dosire specific act 100 of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Anot, production other general information on your responsibilities under the Act from the 601:27). " Ou may octurers, International and Consumer Assistance at its toll-free number (800) DIVISION of Unian Hallacturers 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

Enclosure

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TANITA InnerScan Body Composition Monitor 510(k) Submission

## INDICATIONS FOR USE

| 510(k) Number: | K040778 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | TANITA InnerScan BC-533, BC-534 and BC-550 Body Composition Monitor |
| Indications for Use: | The TANITA family of InnerScan Body Composition Monitors measure body weight and impedance and estimate percentage of body fat and body water, visceral fat rating, bone mass, muscle mass, physique rating, daily calorie intake (DCI) and metabolic age using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 7-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. |

### Model Number

| Body Composition Capabilities | BC-533 | BC-534 | BC-550 |
|--------------------------------------------|--------|--------|--------|
| Total Body Water % (TBW %) | ✓ | ✓ | ✓ |
| Visceral Fat Rating | ✓ | ✓ | ✓ |
| Bone Mass | ✓ | ✓ | ✓ |
| Muscle Mass / Physique Rating | ✓ | | |
| Daily Calorie Intake (DCI) / Metabolic Age | ✓ | ✓ | |
| Daily Calorie Intake (DCI) | | | ✓ |

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

> Over-the-Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Lyman

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

510(k) Number _

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