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 Description

InBodyS10, InBodyl70, and InBodyJ30 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 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.

AI/ML Overview

This 510(k) summary (K110689) indicates that the Biospace Body Composition Analyzers (InBodyS10, InBody170, InBodyJ30) are substantially equivalent to predicate devices based on "bench and software testing." However, it does not provide details about specific acceptance criteria or the study that definitively proves the device meets those criteria. The document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed performance study with explicit acceptance criteria and results for the new devices.

Here's a breakdown of what is and isn't present in the provided text regarding your request:

1. A table of acceptance criteria and the reported device performance

Not provided. The document states, "The results of bench and software testing indicates that the new devices are as safe and effective as the predicate device," but it does not present a table of specific acceptance criteria (e.g., accuracy +/- X%, precision Y%) or the quantitative performance measurements of the new devices against those criteria. The comparative table primarily focuses on features and measured parameters rather than performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. Neither the sample size nor the data provenance (country, retrospective/prospective) for any test sets are mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided. There is no mention of experts or their qualifications for establishing ground truth. The document indicates that for "Visceral Fat Area (VFA)," evaluation was done "with CT," implying CT scans were used as a reference, but it doesn't describe the process of establishing ground truth from these CT scans or involving human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided. As no details of a test set or ground truth establishment by experts are given, no adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This device is a body composition analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Implied but not detailed. The device is an impedance plethysmograph body composition analyzer. It "determines body composition parameters based on bioelectrical impedance analysis (BIA)." This implies a standalone algorithm (the BIA analysis) calculates the parameters. However, no specific standalone performance study details (metrics, datasets) are provided beyond the general statement of "bench and software testing."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Implied for VFA, otherwise not specified. For "Visceral Fat Area (VFA)," the document states "Evaluation with CT." This suggests CT scans were used as a reference standard (ground truth) for VFA measurements. For other parameters (e.g., Skeletal Muscle Mass, Body Fat, Total Body Water), the type of ground truth used for validation is not specified.

8. The sample size for the training set

Not provided. There is no mention of a training set or its sample size. The document's purpose is a 510(k) summary for substantial equivalence, which often doesn't require detailed descriptions of training data for such devices unless significant machine learning or AI algorithm development is a core differentiating factor.

9. How the ground truth for the training set was established

Not provided. As no training set is mentioned, naturally, how its ground truth was established is also not provided.

In summary:

This 510(k) summary establishes substantial equivalence by comparing the new devices' features and measurement capabilities to previously cleared predicate devices. It states that "bench and software testing indicates that the new devices are as safe and effective as the predicate device," but it lacks detailed performance study information, including specific acceptance criteria, quantitative results, sample sizes, expert qualifications, or detailed ground truth methodologies that would typically be associated with a "study that proves the device meets the acceptance criteria." For devices like these, the substantial equivalence argument often relies on the proven safety and effectiveness of the existing predicate device and demonstrating that the new device operates on the same principles and provides comparable measurements.

Summary

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( N. 1 OF PAGE

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 : +82-2-501-3939, Fax : +82-2-501-3978 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)
1. 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.
1. 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.
1. Substantial Equivalence Chart, InBodyS10; InBody170; InBodyJ30; (Next page)

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K110689
PAGE 2 OF 3

Devices		InBody270	InBodyS20	InBodyS10	InBody170	InBodyJ30
510(k) number		K092786	K052646	New	New	New
Manufacturer		BioSpace	BioSpace	BioSpace	BioSpace	BioSpace
Measurement of Estimated :	Extra-CellularWater(ECW),	√	√	√	√	√
	Intra-CellularWater(ICW),	√	√	√	√	√
	Total Body Water,	√	√	√	√	√
	Skeletal MuscleMass	√	√	√	√	√
	Body Fat,	√	√	√	√	√
	Body Lean + DryLean,	√	√	√	√	√
	Basal MetabolicRates,	√	√	√	√	√
	Segmental LeanMass,	√	√	√	√	√
	ECW/TBW		√	√	√	√
	Segmental Body Fatmass,	√		√	√	√
	% Segmental BodyFat,	√		√	√	√
	Energy expenditureof activity,	√		√	√	√
	Visceral Fat Area(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(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	BioelectricalImpedance	√	√	√	√	√
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	√			√	√
ImpedanceMeasuring Site	Foot	√			√	√
	Right Arm	√	√	√	√	√
	Left Arm	√	√	√	√	√
	Trunk	√	√	√	√	√
	Right Leg	√	√	√	√	√
	Left Leg	√	√	√	√	√
Patient Position	Upright	√	√	√	√	√
	Supine		√	√

Devices		InBody270	InBodyS20	InBodyS10	InBody170	InBodyJ30
	Sitting			√
Applicationsoftware(Optional)	LB 110 (Stand-alonedevice)			√(510(k)Exempt)	√(510(k)Exempt)	√(510(k)Exempt)

.. -

· ·······

・・・・

: . . . . . . .

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K110689
PAGE 3 OF 3

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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Page 2

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 (800) 638-2041 or (301) 796-7100 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

Page 1 of 1

Regulation Number and Section

§ 870.2770 Impedance plethysmograph.

(a)
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.(b)
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.