INBODY, MODEL 3.0

K042528 · Biospace Corporation Limited · MNW · Jan 11, 2005 · Cardiovascular

Device Facts

• Record ID: K042528
• Device Name: INBODY, MODEL 3.0
• Applicant: Biospace Corporation Limited
• Product Code: MNW · Cardiovascular
• Decision Date: Jan 11, 2005
• 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 : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW to TBW ratio, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass Actual : Weight, Body Mass Index (BMI),and Impedance Values

Device Story

InBody 3.0 is an impedance plethysmograph body composition analyzer. Device uses bioelectrical impedance analysis (BIA) to differentiate lean tissue, fat, and water. Input: electrical signals applied to body; device measures resistance and capacitance components of total impedance. Output: estimated body composition parameters (ECW, ICW, TBW, body fat, lean mass, metabolic rates, segmental lean mass) and actual measurements (weight, BMI, impedance values). Device features 8-electrode tactile system (thumbs, palms, heels, fore-feet) for upright measurement. Used in clinical or health-monitoring settings; operated by user or technician. Output provided to healthcare provider or user to assess body composition and metabolic status.

Clinical Evidence

Bench and clinical testing performed. Results indicate the device is as safe and effective as the predicate devices. No specific sensitivity, specificity, or p-values provided in the summary document.

Technological Characteristics

Impedance plethysmograph; bioelectrical impedance analysis (BIA). 8-electrode tactile system (thumbs, palms, heels, fore-feet). Operating frequencies: 5, 50, 250, 500 kHz. Measures resistance and capacitance. Upright measurement configuration.

Indications for Use

Indicated for healthy subjects to measure body composition parameters including ECW, ICW, TBW, body fat, lean mass, metabolic rates, segmental lean mass, weight, BMI, and impedance values.

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

• BodyStat QuadScan 4000 (K002835)
• RJL Systems BIA-101A (K830292)
• Biospace Body Composition Analyzer Model InBody AP1 (K023478)

Submission Summary (Full Text)

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K042528
PAGE 1 OF 2

JAN 1 1 2005

## EXHIBIT 2 510(k) Summary

Biospace Corporation Limited 363 Yangjae-dong, Seocho-gu, Seoul 137-898, Korea Tel : [phone], Fax : [phone] Homepage : http:// www.biospace.co.kr November 8, 2004 Contact: Kichul Cha, CEO

- 1. Identification of the Device: Proprietary-Trade Name: InBody AP1 BODY COMPOSITION ANALYZER Classification Names: 74 MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter
- 2. Equivalent legally marketed devices: K002835 BodyStat QuadScan 4000; K830292 RJL Systems BIA-101A; K023478 Biospace Body Composition Analyzer Model InBody AP1
- 3. Indications for Use (intended use) For use only in healthy subjects for Measurement Of: Estimated : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW to TBW ratio, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass Actual : Weight, Body Mass Index (BMI),and Impedance Values
- Description of the Device: InBody 3.0 is an impedance plethysmograph body 4. composition analyzer. The device determines 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.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices.

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| | BodyStat<br>QuadScan 4000 | RJL Systems<br>BIA-101A | Biospace Body<br>Composition<br>Analyzer Model<br>InBody AP1 | Biospace Body<br>Composition<br>Analyzer Model<br>InBody 3.0 |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>number | K002835 | K830292 | K023478 | |
| Intended<br>Use | Body composition<br>analyzer | Body composition<br>analyzer | Body composition<br>analyzer | Body composition<br>analyzer |
| Indications<br>for Use<br>(Healthy<br>subjects) | Measurement Of:<br>Estimated :<br>Extra-Cellular Water,<br>Intra-Cellular Water,<br>Total Body Water,<br>Body Fat,<br>Body Lean + Dry<br>Lean,<br>Metabolic Rates,<br>Actual :<br>Waist/Hip Ratio,<br>Body Mass Index<br>(BMI),<br>and Impedance<br>Values:<br>5, 50, 100, 200kHz | Measurement Of:<br>Resistance and<br>Reactance Value:<br>50kHz | Measurement Of:<br>Estimated :<br>Extra-Cellular Water,<br>Intra-Cellular Water,<br>Total Body Water,<br>Body Fat,<br>Body Lean + Dry<br>Lean,<br>Metabolic Rates,<br>Actual :<br>Weight,<br>Body Mass Index<br>(BMI),<br>and Impedance<br>Values:<br>5, 50, 250kHz | Measurement Of:<br>Estimated :<br>Extra-Cellular<br>Water(ECW),<br>Intra-Cellular<br>Water(ICW),<br>Total Body Water<br>(TBW),<br>ECW to /TBW ratio<br>Body Fat,<br>Body Lean + Dry<br>Lean,<br>Metabolic Rates,<br>Segmental Lean<br>Mass<br>Actual :<br>Weight,<br>Body Mass Index<br>(BMI),<br>and Impedance<br>Values:<br>5, 50, 250, 500kHz |
| Analysis<br>Method | Bioelectrical<br>Impedance | Bioelectrical<br>Impedance | Bioelectrical<br>Impedance | Bioelectrical<br>Impedance |
| Operating<br>parameters | Frequency :<br>5, 50, 100, 200kHz | Frequency :<br>50kHz | Frequency :<br>5, 50, 250kHz | Frequency :<br>5, 50, 250, 500kHz |
| Electrode<br>Type | adhesive | adhesive | tactile | tactile |
| Number /<br>Placement<br>of Electrodes | 4 electrodes<br>placed on<br>hands and feet | 4 electrodes<br>placed on<br>hands and feet | 8 electrodes<br>placed on thumbs,<br>palms, heels, and<br>fore-feet | 8 electrodes<br>placed on thumbs,<br>palms, heels, and<br>fore-feet |
| Impedance<br>Measuring | Whole Body<br>( Right Arm to Right | Whole Body<br>( Right Arm to Right | Right Arm, Left Arm,<br>Trunk,<br>Right Leg, Left Leg | Right Arm, Left Arm,<br>Trunk,<br>Right Leg, Left Leg |

## 6. Substantial Equivalence Chart, InBody AP1 BODY COMPOSITION ANALYZER

## 7. Conclusion

Leg )

Supine

Site

Patient

Position

7. After analyzing both belief and clinical teams and effective as the producate
InBody 3.0 BODY COMPOSITION ANALYZER as safe and effective as the predicate Ifibody 3.0 BODT COMI OUTFORTITIVE - BEAT - Substantially equivalent to the predicate devices.

Leg )

Supine

Upright

Upright

2

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2005

Biospace Corporation Limited c/o Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

Re: K042528

Trade/Device Name: InBody 3.0 Body Composition Analyzer Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: November 8, 2004 Received: November 9, 2004

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of pror to ria) 2011-07-12, 11:25 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 r ou may, dictere, manner are a e act include requirements for annual registration, listing of general oonline provisioning practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 acc 10) ... Existing major regulations affecting your device can be it may of subjoct to adamestic segulations, 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 i Tease be advised that I Drivision that your device complies with other requirements of the Act that I Dri has made a active and regulations administered by other Federal agencies. You must of any I ederal statures and rougherents, including, but not limited to: registration and listing Comply with and No. 3 requirently Part 801); good manufacturing practice requirements as set (21 CFR Part 801), acceming (21 CFR Part 820); and if applicable, the electronic form in the quality by tickle (QB) -13
product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter whil anow you to obgin maining of substantial equivalence of your device to a legally premarked notheation: "The PDF maning station for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acvice for your as not of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation on your responsibilities under the Act from the 007.97). I Ou may obtain other gational and Consumer Assistance at its toll-free number (800) DIVISION of Shian Manufacturers, Internet address http://www.fda.gov/cdrb/dsmaldsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K042528 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:_Biospace InBody 3.0

Indications For Use:

For use only in healthy subjects for Measurement Of: For use only in nealthy Subjects for modelier Water (ICW),Total Body Water
Estimated : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW),Total Botas Estimated : Extra-Ochaldi Water (Eot. P) , Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass Segmental Eoun Mass Index (BMI),and Impedance Values

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (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)

David R. Syrom

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042528

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