Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on bioelectrical impedance analysis (BIA) and impedance plethysmography, which are established methods for body composition analysis. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The performance studies describe correlation with a predicate device, not validation of an AI/ML algorithm.

Therapeutic

No.
The device is used for measurement and estimation of various body composition parameters in healthy subjects, providing data that may be of value to healthcare professionals for management of the balance and levels of fat and lean tissue. It does not exert a therapeutic effect.

Diagnostic

No.

Explanation: The "Intended Use" section explicitly states "For use only in healthy subjects" and lists various metrics related to body composition (e.g., muscle mass, body fat, water distribution). While these measurements can be of value to healthcare professionals for managing the balance of fat and lean tissue, the device itself is not indicated for diagnosing specific diseases or medical conditions. It provides measurements, not diagnoses.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "impedance plethysmograph body composition analyzer" and describes the use of electrical signals and bioelectrical impedance analysis (BIA), which requires hardware to apply and measure these signals.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The description of this device clearly states it measures electrical impedance changes in a region of the body such as the arms and legs, and applies electrical currents to the body. It does not analyze samples like blood, urine, or tissue outside of the body.
The intended use is for measurement of body composition parameters in healthy subjects. While the results may be of value to healthcare professionals, the primary function is not to diagnose, monitor, or screen for diseases or conditions by analyzing biological specimens.

The device is a body composition analyzer that uses bioelectrical impedance analysis (BIA) to estimate various body composition parameters. This is a non-invasive method applied directly to the body, not an in vitro test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For use only in healthy subjects for Measurement of:

Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ICW), Total Body Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, 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 Shape Graph, Weight Control, Fat Control, Muscle Control, Segmental ECW/TBW, Segmental ICW, TBW/LBM, Leg Lean Mass, Fitness Score, AC (Arm Circumference)

Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for InBody S10], Reactance Values [only for InBody770, InBody S10], Phase Angle [only for InBody770, InBody S10]

Product codes (comma separated list FDA assigned to the subject device)

MNW

Device Description

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. 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; extra-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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

From age 3 ~ age 99

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Testing: We conducted clinical testing on each model and compared the results to a predicate. Approximately 80 patients aged 6 to mid 60's, both males and females, were tested. The correlation coefficients for all four new units were very nearly 1.00 showing excellent correlation.

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Correlation coefficients for all four new units were very nearly 1.00.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K110689

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K123228

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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

September 23, 2014

Biospace Corporation Limited % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, FL 34114

Re: K141483

Trade/Device Name: Biospace Body Composition Analyzers, Model InBody770, InBody570, InBody S10, InBody230 Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: August 19, 2014 Received: August 22, 2014

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, 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.

1

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

Sincerely yours,

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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

2

Indications for Use

510(k) Number (if known) K141483

Device Name

Biospace Body Composition Analyzers, Model InBody770, InBody570, InBody S10, InBody230

Indications for Use (Describe) For use only in healthy subjects for Measurement of:

Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ICW), Total Body Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, 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 Shape Graph, Weight Control, Fat Control, Muscle Control, Segmental ECW/TBW, Segmental ICW, TBW/LBM, Leg Lean Mass, Fitness Score, AC (Arm Circumference)

Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for InBody S10], Reactance Values [only for InBody770, InBody S10], Phase Angle [only for InBody770, InBody S10]

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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3

510(k) Summary K141483 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: May 22, 2014 Contact: Kichul Cha, CEO

1. Identification of the Devices: Proprietary-Trade Names: Biospace Body Composition Analyzer, Model InBody770 Biospace Body Composition Analyzer, Model InBody570 Biospace Body Composition Analyzer, Model InBody S10 Biospace Body Composition Analyzer, Model InBody230 Classification Names: ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter Requlation Description: Impedance plethysmograph. Classification Panel: Cardiovascular Product Code: MNW Regulation Number: 870. 2770 Classification: -
1. Equivalent legally marketed devices: (Predicate device Information) Biospace Body Composition Analyzer Model InBody 170, InBody J30 InBody S10, K110689 The Segmental Body Water indication was cleared in K123228, InBody 770, InBody570, InBodyS10, InBody H20.

3. 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 + 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, Segmental ECW/TBW, Segmental ICW, TBW/LBM, Leg Lean Mass, Fitness Score, AC (Arm Circumference)

Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for InBody770, InBody S10], Reactance Values [only for InBody770, InBody S10], Phase Angle [only for InBody770, InBody S10]

1. Description: 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.
  These devices are impedance plethysmograph body composition analyzers. These devices

4

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; extra-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

1. 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		InBody 170	InBody J30	InBody S10	InBody 770 (new)	InBody 570 (new)	InBody S10 (new)	InBody 230 (new)
510(k) number		K110689	K110689	K110689	New	New	New	New
Manufact-urer		Biospace	Biospace	Biospace	Biospace	Biospace	Biospace	Biospace
Measurement of Estimated	Extra-Cellular Water (ECW)	√	√	√	√	√	√	√
	Intra-Cellular Water(ICW)	√	√	√	√	√	√	√
	Total Body Water (TBW)	√	√	√	√	√	√	√
	Skeletal Muscle Mass	√	√	√	√	√	√	√
	Body Fat Mass	√	√	√	√	√	√	√
	Lean Body Mass	√	√	√	√	√	√	√
	Dry Lean Mass	√	√	√	√	√	√	√
	Basal Metabolic Rates	√	√	√	√	√	√	√
Devices		InBody
170	InBody
J30	InBody
S10	InBody
770
(new)	InBody
570
(new)	InBody
S10
(new)	InBody
230 (new)
	Segmental Lean
Mass	√	√	√	√	√	√	√
	ECW/
TBW	√	√	√	√	√	√	√
	Segmental Body
Fat
mass %	√	√	√	√	√	√	√
	Segmental Body
Fat	√	√	√	√	√	√	√
	Energy
expenditure of
activity	√	√	√	√	√	√	√
	Visceral
Fat Area	√	√	√	√	√	√	√
	Segmental Body
Water			√	√	√	√
Measurement of
Actual :	Weight	√	√		√	√		√
	Height		√
	Body
Mass
Index
(BMI)	√	√	√	√	√	√	√
	Impedance
Values	20,
100kHz	5, 50,
250kHz	1, 5, 50,
250, 500,
1,000kHz	1, 5, 50,
250, 500,
1,000kHz	5, 50,
500kHz	1, 5, 50,
250, 500,
1,000kHz	20,
100kHz
	Reactance
Values			5,50,250k
Hz	5,50,250k
Hz		5,50,250k
Hz
	Phase
Angle			5,50,250k
Hz	5,50,250k
Hz		5,50,250k
Hz
	Measurement
method	Bioelectric
al
Impedance	Bioelectric
al
Impedance	Bioelectric
al
Impedance	Bioelectric
al
Impedance	Bioelectric
al
Impedance	Bioelectric
al
Impedance	Bioelectric
al
Impedance
	Electrode
type	4 electric
poles 8
points
Touch
type
electrode
measure
ment	4 electric
poles 8
points
Touch
type
electrode
measure
ment	4 electric
poles 8
points
Touch
type
electrode
measure
ment	4 electric
poles 8
points
Touch
type
electrode
measure
ment	4 electric
poles 8
points
Touch
type
electrode
measure
ment	4 electric
poles 8
points
Touch
type
electrode
measure
ment	4 electric
poles 8
points
Touch
type
electrode
measure
ment
Devices	InBody
170	InBody
J30	InBody
S10	InBody
770
(new)	InBody
570
(new)	InBody
S10
(new)	InBody
230 (new)
	Input
power: AC
100-
120/200-
240V,	Input
power: AC
100-
120/200-
240V,	Input
power: AC
100-
120/200-
240V,	Input
power: AC
100-
120/200-
240V,	Input
power: AC
100-
120/200-
240V,	100-
240V~,
50/60Hz	Input
power: AC
100-
120/200-
240V,
Power Source	50/60Hz,
1.2A
Output
power:
DC12V,
3.4A	50/60Hz,
1.2A
Output
power:
DC12V,
3.4A	50/60Hz,
1.2A
Output
power:
DC12V,
3.4A	50/60Hz,
1.2A
Output
power:
DC12V,
3.4A	50/60Hz,
1.2A
Output
power:
DC12V,
3.4A	No
adapter	50/60Hz,
1.2A
Output
power:
DC12V.
3.5A
Equipment weight	14.3kg	29kg	2kg	5.7kg	20 kg	45kg	26kg
Equipment size	396(W)
×
608(L)
×
955(H)
mm	360(W)
×
640(L)
×
2235(H)
mm	202(W)
×
322(L)
×
53(H):
mm	393(W)
×
516(L)
×
732(H)
mm	460(W)
×
677(L)
×
1020(H):
mm	520(W)
×
870(L)
×
1200(H):
mm	522 (W) ×
843(L) ×
1015(H)
:
mm
Measurement
time	30
seconds	30
seconds	110
seconds	Weight
measure
ment 3~5
seconds,
Impedanc
e
measure
ment 5~7
seconds.	45
seconds	Less than
1 minute
for
medical
mode(Les
s than 2
minutes
for
research
purpose
mode)	50
seconds
Measurement
age	From age
3 ~ age 99	From age
3 ~ age 99	From age
3 ~ age 99	From age
3 ~ age 99	From age
3 ~ age 99	From age
3 ~ age 99	From age
3 ~ age 99
Measurement weight	10
~
250kg	10
~
250kg	10
~
250kg	5 ~ 250kg	10
~
250kg	10
~
250kg	10
~
250kg

6. Comparison table

5

6

Discussion of Non-Clinical Testing: Electromagnetic and Safety Testing was conducted 7. to IEC 60601-1 and IEC 60601-1-2. Software validation was conducted. Literature was compiled and reviewed.
1. Discussion of Clinical Testing: We conducted clinical testing on each model and compared the results to a predicate. Approximately 80 patients aged 6 to mid 60's, both males and females, were tested. The correlation coefficients for all four new units were very nearly 1.00 showing excellent correlation.
1. Conclusion: As compared to our predicate devices (our own brand) these new models have 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 predicate previously cleared. The new devices are therefore substantially equivalent to our predicates.