INBODY, MODELS: 270, R20, R20B

K092786 · Biospace Corporation Limited · MNW · Mar 10, 2010 · Cardiovascular

Device Facts

• Record ID: K092786
• Device Name: INBODY, MODELS: 270, R20, R20B
• Applicant: Biospace Corporation Limited
• Product Code: MNW · Cardiovascular
• Decision Date: Mar 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

For use only in healthy subjects for Measurement of: Estimated: Skeletal muscle mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water, (TBW), Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass, Segmental Body Fat mass, % Segmental Body Fat, and Energy expenditure of activity. Actual : Weight, Body Mass Index (BMI),and Impedance Values

Device Story

Impedance plethysmograph body composition analyzer; uses bioelectrical impedance analysis (BIA) to measure body composition. Input: electrical current applied to body via 8 tactile electrodes (thumbs, palms, heels, fore-feet). Principle: lean tissue is highly conductive (water/electrolytes); fat/bone are poor conductors. Device measures resistance and capacitance components of total impedance. Output: estimated skeletal muscle mass, body water (ECW, ICW, TBW), body fat, lean mass, metabolic rates, segmental lean/fat mass, % segmental body fat, energy expenditure, weight, BMI, and impedance values. Used in healthy subjects; upright position. Models InBody 270 (pedestal stand), InBody R20/R20B (coiled cord). R20B includes Bluetooth connectivity. Power: AC line or 4-AA batteries (R20). Healthcare providers or users review output to assess body composition metrics.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and software validation.

Technological Characteristics

Impedance plethysmograph; BIA technology. 8-electrode tactile system (thumbs, palms, heels, fore-feet). Operating frequencies: 20, 100kHz. Power: AC line or 4-AA batteries (Model R20). Connectivity: Bluetooth (Model R20B). Form factors: pedestal stand (InBody 270) or coiled cord (InBody R20/R20B).

Indications for Use

Indicated for healthy subjects to measure body composition parameters including skeletal muscle mass, body water compartments (ECW, ICW, TBW), body fat, lean mass, metabolic rates, and segmental body composition. Also measures 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 230 (K062603)

Submission Summary (Full Text)

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K092786
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### 510(k) Summary K09

Biospace Corporation Limited Donghyun Building, 518-10 Dogok 2 - Dong Gangnam-Gu, Seoul, KOREA 135-854 Tel : [phone], Fax : [phone] Homepage : http:// www.biospace.co.kr

MAR 1 0 2010

August 27, 2009 Contact: Kichul Cha, CEO

- Identification of the Device: 1. Proprietary-Trade Name: Biospace Body Composition Analyzers, Models InBody 270, InBody R20, and InBody R20B Classification Names: 74 MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter
- 2. Equivalent legally marketed devices: Biospace Body Composition Analyzer Model InBody 230 K062603
- 3. Indications for Use (intended use) For use only in healthy subjects for Measurement of: Estimated: Skeletal muscle mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water, (TBW), Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass, Segmental Body Fat mass, % Segmental Body Fat, and Energy expenditure of activity. Actual : Weight, Body Mass Index (BMI),and Impedance Values
- 4. Description of the Device: Models InBody 270, InBody R20, and InBody R20B are impedance plethysmograph body composition analyzers. These devices determine body composition parameters based on bioelectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical current. Lean tissue is generally highly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone are relatively poor conductors. By analyzing the response to electrical 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.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench and software testing indicates that the new devices are as safe and effective as the predicate device.

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K092786
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| | Biospace Body Composition Analyzer | Models InBody 270, InBody R20, and |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Model InBody 230 | InBody R20B |
| 510(k) number | K062603 | (NEW) |
| Indications for Use | Measurement of Estimated<br>Extra-Cellular Water(ECW),<br>Intra-Cellular Water(ICW),<br>Total Body Water,<br>Skeletal Muscle Mass<br>Body Fat,<br>Body Lean + Dry Lean,<br>Basal Metabolic Rates,<br>Segmental Lean Mass | Measurement of Estimated<br>Extra-Cellular Water(ECW),<br>Intra-Cellular Water(ICW),<br>Total Body Water,<br>Skeletal Muscle Mass<br>Body Fat,<br>Body Lean + Dry Lean,<br>Basal Metabolic Rates,<br>Segmental Lean Mass<br>New:<br>Segmental Body Fat mass<br>% Segmental Body Fat- Energy<br>expenditure of activity |
| | Measurement of Actual :<br>Weight<br>Body Mass Index (BMI)<br>Impedance Values | Measurement of Actual :<br>Weight<br>Body Mass Index (BMI)<br>Impedance Values |
| Analysis Method | Bioelectrical Impedance | Bioelectrical Impedance |
| Operating parameters | Frequency :<br>20, 100kHz | Frequency :<br>20, 100kHz |
| Electrode Type | Tactile | Tactile . |
| Number / | 8 electrodes | 8 electrodes |
| Placement of | placed on thumbs, palms, heels, and | placed on thumbs, palms, heels, and |
| Electrodes | fore-feet | fore-feet |
| Impedance Measuring | Right Arm, Left Arm, Trunk, | Right Arm, Left Arm, Trunk, |
| Site | Right Leg, Left Leg | Right Leg, Left Leg |
| Patient Position | Upright | Upright |
| Patient population | Healthy individuals | SAME |
| Power Source | AC Line . | SAME, Except Model R20 operates<br>from 4-AA alkaline batteries. |

6. Substantial Equivalence Chart, Model InBody 270, InBody R20, and InBody R20B .

Differences between models InBody 270, InBody R20, and InBody R20B: InBody 270 has a pedestal stand for the hand contacts, and InBody R20/R20B use a coiled cord for the hand contacts. Model R20B has Bluetooth, whereas the other two models do not.

#### 7. Conclusion

After analyzing bench testing data, software validation, and the risk analysis, it is the conclusion of Biospace that the Models InBody 270, InBody R20, and InBody R20B, BODY COMPOSITION ANALYZERS are as safe and effective as the predicate devices, and have few technological differences, thus rendering them substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G61 Silver Spring, MD 20993-0002

# MAR ] 0 2010

Biospace Corporation Ltd. c/o Mr. Daniel Kamm Kamm & Associates 8726 Ferrara Court NAPLES FL 34114

Re: K092786

Trade/Device Name: Biospace Body Composition Analyzer, Models InBody 270, InBody R20, and InBody R20B

Regulation Number: 21 CFR 8870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW · Dated: January 26, 2010 Received: February 2, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

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): K09 2786

Device Name: Biospace Body, Composition Analyzer, Models InBody 270, InBody R20, and InBody R20B.

Indications For Use:

For use only in healthy subjects for Measurement Of:

Estimated:

Skeletal muscle mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water, (TBW), Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass, Segmental Body Fat mass, % Segmental Body Fat, and Energy expenditure of activity.

Actual : 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)

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

510(k) Number_

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