INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR

K062652 · Tanita Corporation of America · MNW · Dec 28, 2006 · Cardiovascular

Device Facts

• Record ID: K062652
• Device Name: INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR
• Applicant: Tanita Corporation of America
• Product Code: MNW · Cardiovascular
• Decision Date: Dec 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TANITA Ironman Innerscan Body Composition Monitor measures body weight, impedance and estimates total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate(BMR), daily caloric intake(DCI) and metabolic age using BIA (Bioelectrical Impedance Analysis). The device is intended to be used by generally healthy children 7-17 years old and generally healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. Actual measurements made by the BC-558 include weight and impedance. Based upon these measured values, values are calculated for: total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI) and metabolic age.

Device Story

Computer-operated body composition analyzer; utilizes 8-electrode segmental Bioelectrical Impedance Analysis (BIA) to measure weight and impedance. Device calculates total and segmental body fat percentage, body water, muscle mass, bone mass, visceral fat, BMR, DCI, and metabolic age. Used in home environment by patients for self-assessment. Output displayed to user to monitor body composition trends over time; aids in tracking health and fitness status.

Clinical Evidence

Bench testing only. Performance validated by comparing BIA methodology against internal BIA and DXA reference standards.

Technological Characteristics

Segmental BIA technology; 8 electrodes; 50kHz measurement frequency; max 500μA current. Measures weight and impedance. Battery-powered (AA). Dimensions: 150kg capacity, 100g/50g increments. Data memory for 31 days/52 weeks/36 months.

Indications for Use

Indicated for body composition assessment in generally healthy children (7-17 years) and adults with active to inactive lifestyles. Used in home environment.

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 (K040778)
• TANITA Body Fat Analyzer Professional and Consumer Models (K033157)

Submission Summary (Full Text)

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#### SUMMARY

This summary of 510(k) safety and effectiveness information is accordance with the requirements of SMDA 1990 and 21 CFR 8807.92

Trade Name: Common Name:

TANITA Ironman Innerscan Body Composition Monitor: Model BC-558 Segmental Body Composition Monitor Classification Name: ANALYZER, BODY COMPOSITION 21 CFR §807.92

DEC 2 8 2006

Description of Applicant Device:

The TANTA Ironman Innerscan Body Composition Monitor BC-558 are a computer-operated body composition analyzer that utilizes BlA (bigledrical impedance analysis) to determine body fat percent, muscle mass, bone weight, visceral fat rating, Basal Metabolic Rate (BMR), metabolism age, physique rating, daily calorie intake (DCI), body water percent and segmental fat percent.

Intended Uses of Applicant Device:

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#### Predicate Devices

TANITA Body Fat Analyzer Professional and Consumer Models K040778 and K033157

Scientific Concepts and Significant Performance Characteristics: wn in SECTION 9 and APPENDIX 1 1St പ്പി

| *Same as shown in SECTION 9. and APPENDIX 1. (Substantial Equivalence Matrix) | | | | |
|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---|
| | New | Predicate Device#: K040778 | Predicate Device#: K033157 | |
| | BC-558 Specification | BC-53X Specification | BC-418 Specification | |
| Product Description | Body composition monitor/scale that<br>utilizes a segmental BIA technology to<br>determine internal body composition. | Body composition monitor/scale that<br>utilizes a "foot-to-foot" BIA technology<br>to determine internal body composition. | Body composition monitor/scale that<br>utilizes a segmental BIA technology to<br>determine internal body composition | |
| Analytical Method /<br>Measurement | Segmental BIA In house BIA and<br>DXEA reference | Foot-to Foot BIA In house BIA and<br>DXEA/Deuterium Dilution reference | Segmental BIA In house BIA and<br>DXEA reference | |
| Measurement Frequency | 50kHz | 50kHz | 50kHz | |
| Measurement Current | Max. 500μA | Max. 500μA | Max. 90 μ A | |
| Number of Electrodes | 8 | 4 | 8 | |
| Specifications | | | | |
| Capacity | 150 kg / 330 lb | 150 kg / 330 lb | 200 kg / 440 lb | |
| Increments | 100 g / 0.2 lb or 50 g / 0.1 lb | 100 g / 0.2 lb | 100 g / 0.2 lb | |
| Body Fat % | 0.1% | 0.1% | 0.1% | |
| User Memory | 4 | 4 | | |
| Input Age | 7-99<br>7-17: 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 | 90cm~220cm | 100 cm - 220 cm | 90 cm - 249 cm | |
| Input Activity Level | 1 - 3 | 1 - 3 | | |
| Input Body Type | Standard / Athlete | Standard / Athlete | Standard / Athlete | |
| Data Memory | 31days / 1day average<br>52weeks / 1week average<br>36months / 1month average | 4weeks / 1week average<br>2months / 1month average | | |
| Power Supply | AA Batteries | AA Batteries | AC Adapter / DC5V 3.5A | |
| Printer Function | | | ✓ | |
| Computer Interface | - | | RS-232 | |
| Functions | | | | |
| Weight | ✓ | ✓ | ✓ | |
| | Full body | ✓ | ✓ | ✓ |
| | Right arm | ✓ | - | ✓ |
| Body Fat % | Left arm | ✓ | - | ✓ |
| | Right feet | ✓ | - | ✓ |
| | Left feet | ✓ | - | ✓ |
| | Trunk | ✓ | | ✓ |
| % Fat Judge<br>Body Water% | | ✓ | ✓ | ✓ |
| | Full body | ✓ | ✓ | ✓ |
| | Right arm | ✓ | | ✓ |
| Muscle Mass | Left arm | ✓ | | ✓ |
| | Right feet | ✓ | | ✓ |
| | Left feet | ✓ | - | ✓ |
| | Trunk | ✓ | - | ✓ |
| Physique Rating | | ✓ | ✓ | - |
| Bone mass | | ✓ | ✓ | - |
| Visceral Fat | | ✓ | ✓ | ✓ |
| Visceral Fat Judge | | ✓ | ✓ | - |
| BMR | | ✓ | ✓ | ✓ |
| DCI | | ✓ | ✓ | ✓ |
| Metabolic Age | | ✓ | ✓ | - |

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### 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92

Side by side comparison of the TANITA Ironman Innerscan Body Composition Monitor BC-558 to the predicate that the applicant devices are substantially equivalent to those legally marketed devices.

Based on the results of using the previously approved BlA methodobogy with our whole body BlA, it was concluded that the TANITA i ronman Innerstan Body Composition Moritor BC-558 performs as well as the predicate devices and therefore have proven its safety and efficacy.

Beth Mackey
TANITA Corporation of America Marketing Director

Tel: [phone]
Fax: [phone]

July 7, 2006 Revised in red. December 14. 2006

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## DEC 2 8 2006

Ms. Beth Mackey Marketing Director TANITA Corporation of America, Inc. 2625 South Clearbrook Drive ARLINGTON HEIGHTS IL 60005

Re: K062652

> Trade/Device Name: TANITA Ironman Innerscan Body Composition Monitor Model BC-558 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: December 14, 2006 Received: December 15, 2006

Dear Ms. Mackey:

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 (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image is a circular logo or emblem. The central element is the letters "FDA" in a stylized font, with the word "Centennial" written below it in a cursive font. Above the letters "FDA" are the numbers "1906 - 2006". The entire design is surrounded by a circular border with text, and there are three stars below the word "Centennial".

ing and Promoting Public

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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). 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/cdrlv/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

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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# Indications for Use

510(k) Number (if known): K 062652

Device Name: TANITA Ironman Innerscan Body Composition Monitor Model BC-558 Indications For Use: The TANITA Ironman Innerscan Body Composition Monitor measures body weight, impedance and estimates total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate(BMR), daily caloric intake(DCI) and metabolic age using BIA (Bioelectrical Impedance Analysis). The device is intended to be used by generally healthy children 7-17 years old and generally healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. Actual measurements made by the BC-558 include weight and impedance. Based upon these measured values, values are calculated for: total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI) and metabolic age.

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

Over-The-Counter Use X (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)

Nancyc Brogdon
(vers 6/25/05)(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K062652

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