INBODY by BIOSPACE CORPORATION LIMITED

Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental · Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Water, Body Shape Graph, Weight Control, Fat Control, Muscle Control

Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for InBody720], Reactance Values [only for InBody720], Phase Angle fonly for InBody720]

Device Description

These devices 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. Impedance plethysmographic devices are used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. Multi-frequency and segmental bioelectrical impedance analysis can estimate the distribution of body water (total body water; intra-cellular water), and can correlate with fluid compartmentalization. Assuming that body lean mass is hydrated in a constant and uniform manner; bioelectrical impedance analysis can be used to estimate body lean mass and fat mass. Body composition analysis results may be of value to health care professionals in their management of the relative balance and levels of fat and lean tissue

AI/ML Overview

The provided document describes the Biospace Body Composition Analyzers (Models InBody 120, InBody 370, InBody 720, InBody 520) which are impedance plethysmograph body composition analyzers. The study conducted for these devices aimed to prove their substantial equivalence to their predicate devices, rather than establishing specific quantitative acceptance criteria for their performance. The acceptance criteria for these devices, as implied by the FDA 510(k) summary, is that their clinical performance is comparable to that of legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that "proves" the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., accuracy percentages, standard deviations) that the device must achieve. Instead, the "acceptance criteria" appear to be based on demonstrating clinical performance comparable to predicate devices. The reported device performance is therefore framed in terms of this comparability.

Acceptance Criterion (Implied)	Reported Device Performance
Clinical performance comparable to legally marketed predicate devices.	For InBody 120: A comparison performance test was conducted against InBody 720 (predicate device). Results showed comparable performance.
	For InBody 370: A comparison performance test was conducted against InBody 720 (predicate device). Results showed comparable performance.
	For InBody 520: A comparison performance test was conducted against InBody J30 (predicate device). Results showed comparable performance.
	For InBody 720: A comparison performance test was conducted against InBody J30 (predicate device). Results showed comparable performance. (Note: InBody 720 is also listed as a predicate itself in other tests, indicating a complex predicate strategy. The document refers to the specific test for InBody 720 as comparing it to InBody J30).
Substantial equivalence in technological characteristics to predicate devices.	"These new models have very similar technological characteristics and performed comparably to our predicates. The same scientific principles are used to produce the measurements." (Section 9. Conclusion) This is supported by the detailed comparison table listing features, measurement methods, electrode types, and operational parameters which are largely consistent with the predicate devices.
Safety and effectiveness comparable to predicate devices.	"The results of bench, safety, and software testing indicates that the new devices are as safe and effective as the predicate device." (Section 6. Safety and Effectiveness, comparison to predicate device.) This implies the devices meet safety and effectiveness standards, likely through adherence to recognized standards like IEC 60601-1 and IEC 60601-1-2 for electromagnetic and safety testing and internal software validation. Specific performance data from these tests is not provided in this summary.

2. Sample Sizes used for the test set and data provenance

InBody 120: 39 examinees
InBody 370: 88 examinees
InBody 520: 75 examinees
InBody 720: 62 examinees
Data Provenance: The studies were conducted at unknown locations but by "Biospace Corporation Limited" (KOREA). The timeframe for the studies are indicated:
- InBody 120: August 19th - August 23rd, 2012
- InBody 370: September 3rd - September 5th, 2012
- InBody 520: July 2nd - July 4th, 2010
- InBody 720: July 2nd - July 4th, 2010
Retrospective/Prospective: The studies are described as "comparison performance tests" conducted with "groups of examinees" during specific dates. This suggests they were prospective studies where data was collected specifically for validation purposes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide information on the number or qualifications of experts used to establish ground truth.

4. Adjudication method for the test set

The document does not specify any adjudication method for the test set. Given that these are bioelectrical impedance analysis devices, the "ground truth" would likely come from other established body composition measurement methods (e.g., DEXA, hydrostatic weighing), not from expert consensus or adjudication of subjective interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The clinical studies were "comparison performance tests" between the new devices and predicate devices on groups of examinees. These are standalone device comparisons, not focused on human reader performance with or without AI assistance.

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

Yes, the studies described are, by nature, standalone performance evaluations. The devices are body composition analyzers, and their measurement outputs are compared to the predicate devices. There is no human-in-the-loop component described for the measurement process itself, other than the subject operating the device as intended. The "clinical performance" test directly evaluates the algorithm (and hardware) of the new device against the predicate.

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

The document does not explicitly state the method used for "ground truth" during the comparison studies. However, in the context of bioelectrical impedance analysis, the "ground truth" would typically come from a more established or reference method for body composition measurement (e.g., Dual-energy X-ray absorptiometry (DEXA), hydrostatic weighing, isotopic dilution). The comparison itself is made against a "predicate device" which is already legally marketed and presumed to provide accurate measurements. Therefore, the predicate device itself serves as a proxy for "ground truth" in these comparison studies.

8. The sample size for the training set

The document does not provide any information about a "training set" or its sample size. These devices use bioelectrical impedance analysis (BIA), which relies on established physiological models and algorithms, likely developed and validated over time. The submission focuses on demonstrating equivalence to predicates, implying the core algorithms are already established, rather than presenting a de novo AI development requiring a specific training set validation.

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

As no training set is mentioned, there is no information provided on how its ground truth might have been established.

Summary

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NOV 2 5 2013

K130777 Page 1 of 4

510(k) Summary K130777 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.inbody.com DATE PREPARED: February 15, 2013 Contact: Kichul Cha, CEO

Identification of the Devices:

Proprietary-Trade Names:

Biospace Body Composition Analyzer, Model InBody 120 .
. Biospace Body Composition Analyzer, Model InBody 370
� Biospace Body Composition Analyzer, Model InBody 720
. Biospace Body Composition Analyzer, Model InBody 520

Classification Names: ANALYZER, BODY COMPO5ITION Common/Usual Name: Body fat meter Regulation Description: Impedance plethysmograph. Classification Panel: Cardiovascular Product Code: MNW Regulation Number: 870. 2770 Classification: =

Equivalent legally marketed devices: (Predicate device Information) 2. Biospace Body Composition Analyzer Model InBody 170, InBody J30 InBody S10, K110689 The Segmental Body Water indication was cleared in K123228, InBody 770, InBody510, InBody$10, InBody H20.
1. 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), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Water, Body Shape Graph, Weight Control, Fat Control, Muscle Control

Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for In8ody720], Reactance Values [only for InBody720], Phase Angle [only for InBody720]

Page 20 of 2539

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Description: These devices are impedance plethysmograph body composition analyzers. These 4. 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. I Impedance plethysmographic devices are used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. Multi-frequency and segmental bioelectrical impedance analysis can estimate the distribution of body water (total body water; intra-cellular water), and can correlate with fluid compartmentalization. Assuming that body lean mass is hydrated in a constant and uniform manner; bioelectrical impedance analysis can be used to estimate body lean mass and fat mass. Body composition analysis results may be of value to health care professionals in their management of the relative balance and levels of fat and lean tissue

ഗ് Safety and Effectiveness, comparison to predicate device. The results of bench, safety, and software testing indicates that the new devices are as safe and effective as the predicate device.

Devices		InBody170	InBodyI30	InBody510	InBody120	InBody370	InBody720	InBody520
510(k)number		K110689	K110689	K110689	New	New	New	New
Manufacturer		Biospace	Biospace	Biospace	Biospace	Biospace	Biospace	Biospace
Measurementof Estimated :	Extra-CellularWater(ECW)	V	V	V	V	V	V	V
	Intra-CellularWater(ICW)	V	V	V	V	V	V	V
	Total BodyWater(TBW)	V	V	V	V	V	V	V
	SkeletalMuscleMass	V	V	V	V	V	V	V
	Body FatMass	V	V	V	V	V	V	V
	Lean BodyMass	V	V	V	V	V	V	V
	Dry LeanMass	V	V	V	V	V	V	V
	BasalMetabolicRates	V	V	V	V	V	V	V
	SegmentalLean Mass	V	V	V	V	V	V	V
	ECW/TBW	V	V	V	V	V	V	V
	SegmentalBody Fat	V	V	V	V	V	V	V
Devices		InBody170	InBody130	InBody510	InBody120	InBody370	InBody720	InBody520
	mass
	%SegmentalBody Fat	V	V	V
	Energyexpend-iture ofactivity	V	V	V
	VisceralFat Area	V	V	V
	SegmentalBodyWater	(Cleared inK123228)	(Cleared inK123228)	(Cleared inK123228)	V	V	V	V
Measure-ment ofActual :	Weight	V	V		V	V	V	V
	Height		V		V	V	V	V
	Body MassIndex(BMI)	V	V	V	V	V	V	V
	ImpedanceValues	20, 100kHz	5, 50,250kHz	1, 5, 50,250, 500,1,000kHz	20, 100kHz	5, 50,250kHz	1, 5, 50,250, 500,1,000kHz	5,50, 500kHz
	ReactanceValues			5, 50,250kHz			5, 50,250kHz
	PhaseAngle			5, 50,250kHz			5,50,250kHz
Measurementmethod		BioelectricalImpedance	BioelectricalImpedance	BioelectricalImpedance	BioelectricalImpedance	BioelectricalImpedance	BioelectricalImpedance	BioelectricalImpedance
Electrodetype		4 electric poles8 points Touchtype electrodemeasure-ment	4 electricpoles 8points Touchtypeelectrodemeasure-ment	4 electricpoles 8points Touchtypeelectrodemeasure-ment	4 electric poles8 points Touchtype electrodemeasurement	4 electricpoles 8points Touchtypeelectrodemeasure-ment	4 electricpoles 8points Touchtypeelectrodemeasure-ment	4 electricpoles 8points Touchtypeelectrodemeasure-ment
Power Source		Inputpower: AC100-120/200-240V, 50/60Hz, 1.2AOutputpower:DC12V, 3.4A	Inputpower: AC100-120/200-240V,50/60Hz,1.2AOutputpower:DC12V,3.4A	Inputpower: AC100-120/200-240V,50/60Hz,1.2AOutputpower:DC12V,3.4A	Inputpower: AC100-120/200-240V, 50/60Hz, 1.2AOutputpower:DC12V, 3.4A	Inputpower: AC100-120/200-240V,50/60Hz,1.2AOutputpower:DC12V,3.4A	100-240V~,50/60HzNoadapter	Inputpower: AC100-120/200-240V,50/60Hz,1.2AOutputpower:DC12V,3.5A
Equipment weight		14.3kg	29kg	2kg	5.7kg	20 kg	45kg	26kg
Equipment size		396(W)x608(L)x	360(W)x640(L)x	202(W)x322(L)x	393(W)x516(L)x	460(W)x677(L)x	520(W)x870(L)x	522 (W) x843(L)x
Devices	InBody170	InBodyJ30	InBodyS10	InBody120	InBody370	InBody720	InBody520
	mm	mm			mm	mm	mm
Measurementtime	30 seconds	30seconds	110seconds	Weightmeasure-ment 3~~5seconds,Impedancemeasure-ment 5~~7seconds.	45seconds	Less than1 minuteformedicalmode(Lessthan 2minutesforresearchpurposemode)	50seconds
Measurementage	From age 3~ age 99	From age3 ~ age 99	From age 3~ age 99	From age 3~ age 99	From age3 ~ age 99	From age 3~ age 99	From age3 ~ age 99
Measurement weight	10 ~ 250kg	10 ~ 250kg	10 ~ 250kg	5 ~ 250kg	10 ~ 250kg	10 ~ 250kg	10 ~ 250kg

ર. Comparison table

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Discussion of Non-Clinical Testing; Electromagnetic and Safety Testing was conducted to IEC 7. Software validation was conducted. Literature was compiled and 60601-1 and IEC 60601-1-2. reviewed.

8. Discussion of Clinical Testing:

In order to verify InBody120's clinical performance, we conducted comparison performance test between InBody120 and InBody720 that obtained FDA premarket notification under FDA law. The test was conducted from August 19rd, 2012 to August 23th, 2012 with a group of 39 examinees. In order to verify InBody370's clinical performance, we conducted comparison performance test between InBody370 and InBody720 that obtained FDA premarket notification under FDA law. The test was conducted from September 3rd, 2012 to September 5th, 2012 with a group of 88 examinees. In order to verify InBody520's clinical performance, we conducted comparison performance test between InBody520 and InBody J30 that obtained FDA premarket notification under FDA law. The test was conducted from July 2nd, 2010 to July 4th, 2010 with a group of 75 examinees. In order to verify InBody 720's clinical performance, we conducted comparison performance test between InBody J30 and InBody720 that obtained FDA premarket notification under FDA law. The test was conducted from July 2nd, 2010 to July 4th, 2010 with a group of 62 examinees

As compared to our predicate devices (our own brand) these new models have 9. Conclusion: very similar technological characteristics and performed comparably to our predicates. The same scientific principles are used to produce the measurements. We therefore conclude that our new models are substantially equivalent to our predicates cleared in 2011.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or extensions reaching upwards. The figure is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.

Public Health Service

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

November 25, 2013

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

K130777 Re:

Trade/Device Name: Biospace Body Composition Analyzer, Model InBody120 Biospace Body Composition Analyzer, Model InBody 370 Biospace Body Composition Analyzer, Model InBody 720 Biospace Body Composition Analyzer, Model InBody 520 Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: October 28, 2013 Received: October 30, 2013

Dear Daniel 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. Ilisting 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.

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Page 2 - Daniel Kamm, P.E.

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 (reporting of medical device-related 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/ucm1115809.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P.Lerner -S

for Benjamin R. Fisher, Ph.D. Director 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): K130777

Device Names:

1. Biospace Body Composition Analyzer, Model InBody120

Biospace Body Composition Analyzer, Model InBody370
Biospace Body Composition Analyzer, Model InBody720
Biospace Body Composition Analyzer, Model InBody520

Indications for use:

For use only in healthy subjects for Measurement of:

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)

Page 1 of 1

Herbert P 2013.11.25 15:0

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.