INBODY

K110689 · Biospace Corporation Limited · MNW · Aug 19, 2011 · Cardiovascular

Device Facts

• Record ID: K110689
• Device Name: INBODY
• Applicant: Biospace Corporation Limited
• Product Code: MNW · Cardiovascular
• Decision Date: Aug 19, 2011
• 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, Visceral Fat Area (VFA). Actual : Weight [except for model S10, which requires the manual entry of weight], Body Mass Index (BMI), Impedance Values, height [only for model InBodyJ30, which has height-meter function].

Device Story

InBodyS10, InBody170, and InBodyJ30 are bioelectrical impedance analysis (BIA) devices. They measure body composition by applying electrical currents to the body and analyzing the resulting impedance (resistance and capacitance) of biological tissues. Lean tissue is highly conductive; fat and bone are poor conductors. The devices use 8-point tactile electrode systems (thumbs, palms, heels, fore-feet) to measure impedance across body segments (arms, legs, trunk). The InBodyS10 supports supine and sitting positions; InBody170 and J30 are upright. Inputs include electrical signals; outputs include estimated body composition metrics (e.g., skeletal muscle mass, body fat, visceral fat area) and actual measurements (weight, BMI, impedance). Used in clinical or health settings to assist providers in assessing body composition and metabolic status. Data helps inform nutritional or fitness-related clinical decision-making.

Clinical Evidence

Bench testing and software validation only. No clinical trial data presented. Substantial equivalence is based on technological similarity and performance testing.

Technological Characteristics

Bioelectrical impedance plethysmograph; 8-point tactile electrode system; multi-frequency impedance measurement (1, 5, 50, 250, 500, 1000 kHz depending on model); upright, supine, or sitting patient positioning; optional stand-alone application software (LB 110).

Indications for Use

Indicated for healthy subjects for the measurement of body composition parameters including skeletal muscle mass, body water compartments (ECW, ICW, TBW), body fat, lean mass, metabolic rates, and segmental body composition. No specific age or gender contraindications provided.

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 InBodyS20 (K052646)
• BioSpace InBody270 (K092786)

Reference Devices

• BSM370 scale (510(k) exempt)

Submission Summary (Full Text)

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## 510(k) Summary K110689

AUG 1 9 2011

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

> July 11, 2011 Contact: Kichul Cha, CEO

- l . Identification of the Device: Proprietary-Trade Name: Biospace Body Composition Analyzers, InBodyS10; InBody170; InBodyJ30: Classification Names: MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter
- Equivalent legally marketed devices: The BioSpace InBodyS20(K052646) and The BioSpace 2. InBody270(K092786)
- 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, Visceral Fat Area (VFA).

Actual : Weight [except for model S10, which requires the manual entry of weight], Body Mass Index (BMI), Impedance Values, height [only for model InBodyJ30, which has height-meter function].

- Description of the Device: InBodyS10, InBodyl70, and InBodyJ30 are impedance 4. 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 bighly 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.
- 6. Substantial Equivalence Chart, InBodyS10; InBody170; InBodyJ30; (Next page)

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| Devices | | InBody270 | InBodyS20 | InBodyS10 | InBody170 | InBodyJ30 |
|---------------------------------------|------------------------------------|------------|------------------------------|------------------------------|-------------------------|---------------------------------------------------------------|
| 510(k) number | | K092786 | K052646 | New | New | New |
| Manufacturer | | BioSpace | BioSpace | BioSpace | BioSpace | BioSpace |
| Measurement of Estimated : | Extra-Cellular<br>Water(ECW), | √ | √ | √ | √ | √ |
| | Intra-Cellular<br>Water(ICW), | √ | √ | √ | √ | √ |
| | Total Body Water, | √ | √ | √ | √ | √ |
| | Skeletal Muscle<br>Mass | √ | √ | √ | √ | √ |
| | Body Fat, | √ | √ | √ | √ | √ |
| | Body Lean + Dry<br>Lean, | √ | √ | √ | √ | √ |
| | Basal Metabolic<br>Rates, | √ | √ | √ | √ | √ |
| | Segmental Lean<br>Mass, | √ | √ | √ | √ | √ |
| | ECW/TBW | | √ | √ | √ | √ |
| | Segmental Body Fat<br>mass, | √ | | √ | √ | √ |
| | % Segmental Body<br>Fat, | √ | | √ | √ | √ |
| | Energy expenditure<br>of activity, | √ | | √ | √ | √ |
| | Visceral Fat Area<br>(VFA) | | | (Evaluation with CT) | (Evaluation with CT) | (Evaluation with CT) |
| | Weight | √ | | | √ | √ (Predicate BSM370_ scale, stand-on, patient, 510(k) exempt) |
| Measurement of Actual : | height | | | | | |
| | Body Mass Index<br>(BMI), | √ | √ | √ | √ | √ |
| | Impedance Values: | 20, 100kHz | 1, 5, 50, 250, 500, 1,000kHz | 1, 5, 50, 250, 500, 1,000kHz | 20, 100kHz | 5, 50, 250kHz |
| | Reactance Values: | | 5,50,250kHz | 5,50,250kHz | | |
| Analysis Method | Bioelectrical<br>Impedance | √ | √ | √ | √ | √ |
| Electrode Type | Tactile | √ | | | √ | √ |
| | Tactile / Adhesive | | √ | √ | | |
| Number of Electrodes | 8 electrodes | √ | √ | √ | √ | √ |
| Placement of Electrodes | placed on thumbs | √ | √ | √ | √ | √ |
| | placed on palms, | √ | √ | √ | √ | √ |
| | placed on heels | √ | √ | √ | √ | √ |
| | placed on fore-feet | √ | √ | √ | √ | √ |
| Electrode | First and third finger | | √ | √ | | |
| connection | ankle | | √ | √ | | |
| geometry | Hand | √ | | | √ | √ |
| Impedance<br>Measuring Site | Foot | √ | | | √ | √ |
| | Right Arm | √ | √ | √ | √ | √ |
| | Left Arm | √ | √ | √ | √ | √ |
| | Trunk | √ | √ | √ | √ | √ |
| | Right Leg | √ | √ | √ | √ | √ |
| | Left Leg | √ | √ | √ | √ | √ |
| Patient Position | Upright | √ | √ | √ | √ | √ |
| | Supine | | √ | √ | | |
| | | | | | | |
| Devices | | InBody270 | InBodyS20 | InBodyS10 | InBody170 | InBodyJ30 |
| | Sitting | | | √ | | |
| Application<br>software<br>(Optional) | LB 110 (Stand-alone<br>device) | | | √<br>(510(k)<br>Exempt) | √<br>(510(k)<br>Exempt) | √<br>(510(k)<br>Exempt) |

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#### 7. Conclusion

After analyzing bench testing data, software validation, and the risk analysis, and based upon the intended use, and upon the similarity of product configuration and administration, it can be concluded that Model InBodyS10, InBody170, InBodyJ30 are substantially equivalent to the identified predicate devices in terms of intended use, safety and effectiveness. The safety characteristics are identical.co the predicates.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Biospace Corporation Limited % Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

AUG 1 9 2011

Re: K110689

.

Trade/Device Name: InBodyS10, InBody170, InBodyJ30 Regulation Number: 21 CFR& 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: August 12. 2011 Received: August 17, 2011

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 (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.html 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,

Hubert Lehman MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

### Enclosure

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# Indications for use

510(k) Number (if Known) : K110689

Device Name : InBodyS10, InBody170, InBodyJ30

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, Visceral Fat Area (VFA).

Actual : Weight [except for model S10, which requires the manual entry of weight], Body Mass Index (BMI), Impedance Values, height [only for model InBodyJ30, which has height-meter function]

| Prescription Use | AND/OR | Over-The-Counter Use X |
|-----------------------------|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | (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
Badiologial Dovina

Radiological Devices 510(k) Number

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