BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20

K052646 · Biospace Corporation Limited · MNW · Dec 16, 2005 · Cardiovascular

Device Facts

• Record ID: K052646
• Device Name: BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20
• Applicant: Biospace Corporation Limited
• Product Code: MNW · Cardiovascular
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

For use only in healthy subjects for Measurement Of: Estimated : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW),Total Body Water, (TBW), ECW to TBW ratio, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass Actual : Weight, (except for model S20, which requires the manual entry of weight) Body Mass Index (BMI),and Impedance Values

Device Story

InBody 520, 720, and S20 are body composition analyzers using bioelectrical impedance analysis (BIA). Devices apply electrical signals to body; measure resistance and capacitance of biological tissues. High water/electrolyte content in lean tissue makes it conductive; fat/bone are poor conductors. Device processes impedance/reactance data to estimate body composition parameters (water distribution, fat, lean mass, metabolic rates). Used in clinical or health settings; operated by healthcare providers or patients. Output provided to user/provider to assess body composition. S20 requires manual weight entry; others measure weight automatically. Benefits include non-invasive assessment of body composition metrics.

Clinical Evidence

Bench and clinical testing performed. Results indicate the devices are as safe and effective as the predicate. No specific sensitivity, specificity, or p-values provided in the summary.

Technological Characteristics

Bioelectrical impedance analysis (BIA) technology. Measures resistance and capacitance. Operating frequencies: 1, 5, 50, 250, 500, 1000 kHz (varies by model). Measures impedance and reactance values. Standalone body composition analyzer form factor.

Indications for Use

Indicated for healthy subjects to measure body composition parameters including ECW, ICW, TBW, ECW/TBW ratio, body fat, lean mass, metabolic rates, segmental lean mass, weight, BMI, and impedance values.

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

• Biospace Body Composition Analyzer Model InBody 3.0 (K042528)

Submission Summary (Full Text)

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K052646
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## DEC 16 2005

## EXHIBIT 2

510(k) Summary Biospace Corporation Limited 363 Yangjae-dong, Seocho-gu, Seoul 137-898, Korea Tel : [phone], Fax : [phone] Homepage : http:// www.biospace.co.kr September 20, 2005 Contact: Kichul Cha, CEO

- 1. Identification of the Device: Iuchintation of the Device Body Composition Analyzers, Models Inbody 520, Inbody 720, and Inbody S20 520, Inoody 720, and moody works on ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter
- 2. Equivalent legally marketed devices: Biospace Body Composition Analyzer Model InBody 3.0, K042528
- 3. Indications for Use (intended use) For use only in healthy subjects for measurcment of: Estimated : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW),Total Body 01: Estimatou : ECW to TBW ratio, Body Fat, Body Lean + Dry Lean, Mctabolic Rates, Segmental Lean Mass Actual : Weight, (except for model S20, which requires the manual entry of weight) Body Mass Index (BMI),and Impedance Values
- Description of the Device: Models Inbody 520, Inbody 720, and Inbody S20 are 4. Description of the or apposition analyzers. The devices determine body mipodation parameters based on bioclectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical on the unrently otharrerally highly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone arc relatively poor or ovallars. By analyzing the response to clectrical signals, BIA thereby permits differentiation of lean tissue, fat, and water and, in some instances, derivation of related body composition parameters. The total impedance resulting from BIA incorporates both resistance and capacitance components.
- Safety and Effectiveness, comparison to predicate device. The results of bench 5. and clinical testing indicates that the new device is as safe and effective as the predicate devices.

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| | Biospace Body<br>Composition<br>Analyzer Model<br>InBody 3.0,<br>Predicate | Biospace Body<br>Composition<br>Analyzer Model<br>InBody 720 | Biospace Body<br>Composition<br>Analyzer Model<br>InBody S20 | Biospace Body<br>Composition<br>Analyzer Model<br>InBody 520 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>number | K042528 | New | New | New |
| Intended<br>Use | Body<br>composition<br>analyzer | Body<br>composition<br>analyzer | Body<br>composition<br>analyzer | Body<br>composition<br>analyzer |
| Indications<br>for Use | (Healthy<br>Subjects)<br>Measurement<br>Of:<br>Estimated :<br>Extra-Cellular<br>Water(ECW),<br>Intra-Cellular<br>Water(ICW),<br>Total Body<br>Water,<br>ECW/TBW<br>Body Fat,<br>Body Lean +<br>Dry Lean,<br>Metabolic<br>Rates,<br>Segmental<br>Lean Mass<br>Actual :<br>Weight,<br>Body Mass<br>Index (BMI),<br>and<br>Impedance<br>Values:<br>5, 50, 250,<br>500kHz | (Healthy<br>Subjects)<br>Measurement<br>Of:<br>Estimated :<br>Extra-Cellular<br>Water(ECW),<br>Intra-Cellular<br>Water(ICW),<br>Total Body<br>Water,<br>ECW/TBW<br>Body Fat,<br>Body Lean +<br>Dry Lean,<br>Metabolic<br>Rates,<br>Segmental<br>Lean Mass<br>Actual :<br>Weight,<br>Body Mass<br>Index (BMI),<br>Impedance<br>Values:<br>1, 5, 50, 250,<br>500, 1,000kHz,<br>and<br>Reactance<br>Values:<br>5,50,250kHz | (Healthy<br>Subjects)<br>Measurement<br>Of:<br>Estimated :<br>Extra-Cellular<br>Water(ECW),<br>Intra-Cellular<br>Water(ICW),<br>Total Body<br>Water,<br>ECW/TBW<br>Body Fat,<br>Body Lean +<br>Dry Lean,<br>Metabolic<br>Rates,<br>Segmental<br>Lean Mass<br>Actual :<br>Weight,<br>Body Mass<br>Index (BMI),<br>Impedance<br>Values:<br>1, 5, 50, 250,<br>500, 1,000kHz,<br>and<br>Reactance<br>Values:<br>5,50,250kHz | (Healthy<br>Subjects)<br>Measurement<br>Of:<br>Estimated :<br>Extra-Cellular<br>Water(ECW),<br>Intra-Cellular<br>Water(ICW),<br>Total Body<br>Water,<br>ECW/TBW<br>Body Fat,<br>Body Lean +<br>Dry Lean,<br>Metabolic<br>Rates,<br>Segmental<br>Lean Mass<br>Actual :<br>Weight,<br>Body Mass<br>Index (BMI),<br>and<br>Impedance<br>Values:<br>5, 50, 500kHz |
| Analysis<br>Method | Bioelectrical<br>Impedance | Bioelectrical<br>Impedance | Bioelectrical<br>Impedance | Bioelectrical<br>Impedance |
| Operating<br>parameters | Frequency:<br>5, 50, 250, | Frequency: | Frequency: | Frequency: |
| | | 1, 5, 50, 250, | 1, 5, 50, 250, | 5, 50, 500kHz |

## 6. Substantial Equivalence Chart, Models Inbody 520, Inbody 720, and Inbody S20
Substantial Equivalence Chart, Models VITED C BODY COMPOSITION ANALYZERS

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 16 2005

Biospace Corporation Limited c/o Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

Re: K052646

Trade/Device Name: InBody Body Composition Analyzers, Models 520, 720 and S20 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: November 16, 2005 Received: November 17, 2005

Dear Mr. Kamm:

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.

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 Section 510(k) I ms letter will anow you to begin manoting of substantial equivalence of your device to a legally premarket notification. THC I DA miding of bactuallian 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 desire specific advice tor your corres on 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 Also, please note the regulation entitled, "Albertation on your responsibilities under the Act from the 807.97). Tou may obtain outch general michel. 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,

Nancy C. Hogdon

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): ____K052646

Device Name: Biospace Body Composition Analyzers, Models Inbody 520, Inbody 720, and Inbody S20

Indications For Use:

For use only in healthy subjects for Measurement Of: Estimated : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW),Total Body Water, (TBW), ECW to TBW ratio, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass Actual : Weight, (except for model S20, which requires the manual entry of weight) Body Mass Index (BMI),and Impedance Values

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

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C broadon

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

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