TANITA BODY COMPOSITION ANALYZER, MODEL SC-331

K090479 · Tanita Corporation of America · MNW · Jul 7, 2009 · Cardiovascular

Device Facts

• Record ID: K090479
• Device Name: TANITA BODY COMPOSITION ANALYZER, MODEL SC-331
• Applicant: Tanita Corporation of America
• Product Code: MNW · Cardiovascular
• Decision Date: Jul 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TANITA Body Composition Analyzer is indicated for use in the measurement of weight and impedance, and the estimation of body mass index (BMI), total body fat percent, total body water percent and weight, muscle mass (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass, using BIA (Bioelectrical Impedance Analysis). The device is indicated for use for healthy children 5-17 years old and healthy adults with active, moderately active, to inactive lifestyles.

Device Story

The Tanita SC-331 is a body composition analyzer utilizing bioelectrical impedance analysis (BIA). The device uses a 4-electrode 'foot-to-foot' measurement system at a 50kHz frequency to measure weight and electrical impedance. Inputs include user age (5-99), height, activity level, and body type (standard/athlete). The device processes these inputs to estimate body composition parameters, including BMI, body fat percentage, total body water, muscle mass, bone mass, visceral fat rating, BMR, DCI, and metabolic age. It is intended for use by healthy individuals in clinical or consumer settings. Output is provided via a display and an integrated printer, with data transfer capabilities via RS-232C and USB. Healthcare providers or users utilize these outputs to monitor body composition trends and assess metabolic health, aiding in weight management and fitness tracking.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance comparisons to predicate devices using established BIA methodology.

Technological Characteristics

4-electrode bioelectrical impedance analysis (BIA) system; 50kHz measurement frequency; AC adapter/DC7V power; RS-232C and USB connectivity; integrated printer; weight capacity up to 600 lb/270 kg or 450 kg/1,000 lb; weight increments 0.1 lb/50g or 0.2 lb/100g.

Indications for Use

Indicated for healthy children 5-17 years old and healthy adults with active, moderately active, or inactive lifestyles for measurement of weight/impedance and estimation of body composition metrics including BMI, body fat, body water, muscle mass, bone mass, visceral fat, BMR, DCI, and metabolic age.

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)
• TANITA Body Composition Monitor (K040778)

Submission Summary (Full Text)

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### 510(k) SUMMARY

submitted in accordance with the requirements of SMDA 1990 and 21 CFR Section 807.92

Trade Name Common Name: Classification Name:

JUL - 7 2009

Description of Applicant Device:

The TANTA Body Corposition Analyzer SC-331 is a composition analyzer that tillizes BA (biolectical inqedance analysis) to deternine body mass inter (BM), tata body tat percent, todal body water per cont and veine and smooth, plysique rating, bone mass, visceral lat rathy rang, boss) meabolic race (BMF), day caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass for use by adults and children.

Indications For Use:

The TANTA Body Composition is indicated tor use in the measure, and the estmain of tody mass index (BM), total boty valent, todal body vater percent and weight, must (skeletal and smooth), the mass, visceral lat raing with healty rare (BMP), daily cale (BMP), daire intake (DC), metablic intake (CC), metablic age, and target body fat percent with predicted weight and fat mass, using BlA (Binelectrical Impedance Analysis).

The device is indicated for use for healthy children 5-17 years old and healthy active, moderately active, to inaclive lifestyles.

Predicate Devices:

BMI - Indicator

TANTA Body Fat Analyzer Professional and Consumer Models K014009 and K040778.

TANITA Bady Composition Analyzer: Model SC-331

ANALYZER, BODY COMPOSITION 21 CFR \$807.92

Body Composition Analyzer

Scientific Concepts and Significant Performance Characteristics:

| *Same as shown in SECTION 9. and APPENDIX 1. (Substantial Equivalence Matrix) | | | | | | |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------|--------------------------------------------------------------------------------------------------------|---------|--------------------------------------------------------------------------------------------------------|---------------|
| | Body Composition Analyzer<br>SC-331 Specification | | Body Composition Analyzer | | Body Composition Monitor | |
| | | | TBF-215/300/310/410, BF-35D | | BC-53X | |
| 510(k) number | | New<br>K014009 | | K040778 | | |
| Product Description | Body composition analyzer that utilizes a BIA<br>technology to determine internal body<br>composition. | | Body composition analyzer that utilizes a BIA<br>technology to determine internal body<br>composition. | | Body composition analyzer that utilizes a BIA<br>technology to determine internal body<br>composition. | |
| Analytical Method / Measurement | Patented "Foot-to-Foot" BIA, In house BIA and<br>DEXA reference | | Patented "Foot-to-Foot" BIA, In house BIA and<br>DEXA reference | | Patented "Foot-to-Foot" BIA, In house BIA and<br>DEXA reference | |
| Measurement Frequency | 50kHz | | 50kHz | | 50kHz | |
| Number of Electrodes | 4 | | 4 | | 4 | |
| Specifications | | | | | | |
| Weight Capacity | 600 lb / 270 kg or 450 kg / 1,000 lb | | 270 kg / 600 lb | | 150 kg / 330 lb | |
| Weight Increments | 0.2 lb / 100 g or 0.1 lb / 50 g | | 100 g / 0.2 lb | | 100 g / 0.2 lb | |
| Body Fat % Increments | 0.1% | | 0.1% | | 0.1% | |
| User Memory | 4 | | 4 | | 4 | |
| Input Age | 5 - 99<br>5-17: Child<br>18-99: Adult | | 7 - 99<br>7-17: Child<br>18-99: Adult | | 7 - 99<br>7-17: Child<br>18-99: Adult | |
| Input Height | 3' - 7' 11.5" / 90 - 249.9cm | | 3' - 7' 11.5" / 90 - 249.9cm | | 3' 4.0" - 7' 3.0" / 100-220cm | |
| Input Activity Level | | | | | 1 - 3 | |
| Input Body Type | Standard / Athlete | | Standard / Athlete | | Standard / Athlete | |
| Recall Function | | | | | | ✓ |
| Power Supply | AC Adapter / DC7V | | AC Adapter / DC5V | | AA Batteries | |
| Printer Function | ✓ | | ✓ | | | |
| Computer Interface | RS-232C & USB | | RS-232C | | | |
| Indicate for Use | | | | | | |
| | Print-Out | Display | Print-Out | Display | Print-Out | Display |
| Actual: | | | | | | |
| Weight | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Impedance | ✓ | - | ✓ | - | - | - |
| Estimated: | | | | | | |
| FAT % | ✓ | ✓ | ✓ | ✓ | - | ✓ |
| FAT Mass | ✓ | - | ✓ | - | - | - |
| FAT % - Indicator | ✓ | - | In the manual | - | - | - |
| Predicated Fat Mass | ✓ | - | ✓ | - | - | - |
| Predicated Weight | ✓ | - | ✓ | - | - | - |
| FFM | ✓ | - | ✓ | - | - | ✓ |
| Muscle Mass | ✓ | - | ✓ | - | - | ✓ |
| Muscle Mass - Indicator | ✓ | - | ✓ | - | - | In the manual |
| Physique Rating | ✓ | - | ✓ | - | - | ✓ |
| Total Body Water | ✓ | - | ✓ | - | - | ✓ |
| Total Body Water % | ✓ | - | ✓ | - | - | ✓ |
| BMR / DCI | ✓ | - | ✓ | - | - | ✓ |
| BMR - Indicator | ✓ | - | - | - | - | In the manual |
| Metabolic Age | ✓ | - | ✓ | - | - | ✓ |
| Visceral Fat Rating | ✓ | - | ✓ | - | - | ✓ |
| Visceral Fat Level - Indicator | ✓ | - | - | - | - | ✓ |
| Bone Mass | ✓ | - | ✓ | - | - | ✓ |
| BMI | ✓ | - | ✓ | - | - | - |

in the manual

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K090479
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#### 510(k) SUMMARY

submitted in accordance with the requirements of SMDA 1990 and 21 CFR Section 807.92

Suble by side compaison of the TANTA Body Compssition Analyzer SC-331 to the predical clements that the applicant trence are substantaly equivaler to those early marked devices.

eleased on the results of ission in the least of the II ANTA's whole body BA, the TANTA Body Composition Analyzer SC-331 performs equivaltity of the prelicate devicas and therefore is subtantially equivalent.

Toshihiko Ishikawa
TANITA Corporation of America Product Manager

Tel: [phone] Fax [phone]

Սսո 30th, 2009

্

. * .

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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wavy lines representing the department's commitment to health, services, and human well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL = 7 2009

Mr. Toshihiko Ishikawa Product Manager Tanita Corporation of America, Inc. 2625 South Clearbrook Drive ARLINGTON HEIGHTS IL 60005

Re: K090479

Trade/Device Name: TANITA Body Composition Analyzer Model SC-331 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Codes: MNW Dated: June 30, 2009 Received: July 1, 2009

Dear Mr. Ishikawa:

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); medical device reporting of medical

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device-related 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 electronic 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/ucm115809.htm for 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" (21CFR Part 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/cdrl/mdr/ 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 number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K 090479

Device Name:

TANITA Body Composition Analyzer Model SC-331

Indications For Use:

The TANITA Body Composition Analyzer is indicated for use in the measurement of weight and impedance, and the estimation of body mass index (BMI), total body fat percent, total body water percent and weight, muscle mass (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass, using BIA (Bioelectrical Impedance Analysis).

The device is indicated for use for healthy children 5-17 years old and healthy adults with active, moderately active, to inactive lifestyles.

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)

(vers 6/25/05)

Hebert Lerner

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

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