BIOSPACE BODY COMPOSITION ANALYZER

K141483 · Biospace Corporation Limited · MNW · Sep 23, 2014 · Cardiovascular

Device Facts

• Record ID: K141483
• Device Name: BIOSPACE BODY COMPOSITION ANALYZER
• Applicant: Biospace Corporation Limited
• Product Code: MNW · Cardiovascular
• Decision Date: Sep 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended 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]

Device Story

Biospace Body Composition Analyzers (InBody770, 570, S10, 230) are impedance plethysmographs used to estimate body composition. Device applies multi-frequency electrical currents to body via 8-point tactile electrodes; measures impedance, resistance, and reactance. Lean tissue (high water/electrolyte content) conducts current better than fat/bone. Device transforms electrical response data into estimates of body water (ICW, ECW, TBW), skeletal muscle mass, body fat, and metabolic rates. Used in clinical settings by healthcare professionals to manage fat/lean tissue balance. Output provided as numerical values and graphs; assists clinicians in assessing patient body composition and fluid compartmentalization. Benefits include non-invasive, rapid assessment of body composition parameters.

Clinical Evidence

Clinical testing conducted on approximately 80 patients, aged 6 to mid-60s, both genders. Study compared new models (InBody 770, 570, S10, 230) against predicate devices. Results demonstrated excellent correlation with coefficients nearly 1.00 for all four units. Bench testing included electromagnetic safety (IEC 60601-1, IEC 60601-1-2) and software validation.

Technological Characteristics

Impedance plethysmograph using multi-frequency bioelectrical impedance analysis (BIA). Employs 4-pole, 8-point tactile electrode measurement system. Operates at various frequencies (1kHz to 1000kHz depending on model). Measures resistance, reactance, and phase angle. Connectivity and software details not specified beyond general software validation. Power source: AC 100-240V, 50/60Hz. Dimensions and weight vary by model.

Indications for Use

Indicated for healthy subjects, ages 3 to 99, for body composition analysis including measurement of body water, muscle mass, fat mass, and metabolic rates via bioelectrical impedance analysis.

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

• InBody 170 (K110689)
• InBody J30 (K110689)
• InBody S10 (K110689)

Reference Devices

• InBody 770 (K123228)
• InBody 570 (K123228)
• InBody S10 (K123228)
• InBody H20 (K123228)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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

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# 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)

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510(k) Summary K141483 Biospace Corporation Limited Donghyun Building, 518-10 Dogok 2 - Dong Gangnam-Gu, Seoul, KOREA 135-854 Tel : [phone], Fax : [phone] 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: -
- 2. 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]

- 4. 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

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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

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

#### 6. Comparison table

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- 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.
- 8. 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.
- 9. 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.