INBODY AP1 BODY COMPOSITION ANALYZER

K023478 · Biospace Co.,Ltd · MNW · May 13, 2003 · Cardiovascular

Device Facts

• Record ID: K023478
• Device Name: INBODY AP1 BODY COMPOSITION ANALYZER
• Applicant: Biospace Co.,Ltd
• Product Code: MNW · Cardiovascular
• Decision Date: May 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

For Measurement Of: Estimated: Extra-Cellular Water, Intra-Cellular Water, Total Body Water, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Actual : Weight, Body Mass Index (BMI),and Impedance Values.

Device Story

InBody AP1 is an impedance plethysmograph body composition analyzer using bioelectrical impedance analysis (BIA). Device applies electrical currents at 5, 50, and 250 kHz to the body via 8 tactile electrodes placed on thumbs, palms, heels, and fore-feet. System measures impedance (resistance and capacitance) across five segments: right arm, left arm, trunk, right leg, and left leg. By analyzing tissue conductivity—where lean tissue is highly conductive due to water/electrolytes and fat/bone are poor conductors—the device derives body composition metrics. Operated in an upright position, the device provides quantitative outputs to healthcare providers to assist in assessing patient body composition and metabolic status.

Clinical Evidence

The submission relies on both bench and clinical testing to demonstrate substantial equivalence. No specific performance metrics (e.g., sensitivity, specificity, p-values) are provided in the summary document; however, the manufacturer concludes that testing confirms the device is as safe and effective as the predicate devices.

Technological Characteristics

Impedance plethysmograph using BIA. Employs 8 tactile electrodes for segmental analysis (arms, trunk, legs). Operating frequencies: 5, 50, 250 kHz. Measures resistance and capacitance. Upright patient positioning. Class II device.

Indications for Use

Indicated for the measurement of body composition parameters including extra-cellular water, intra-cellular water, total body water, body fat, body lean/dry lean, metabolic rates, weight, BMI, and impedance values in patients.

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)
• Tanita Corporation of America Body Fat Analyzer Model TBF-105 (K930599)
• Omron Healthcare Body Fat Analyzer Model HBF-306 (K011652)

Submission Summary (Full Text)

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## EXHIBIT 2 510(k) Summary of Safety and Effectiveness

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

> October 2, 2002 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 BodyStat QuadScan 4000, K002835, RJL Systems BIA-101A, K830292, Tanita Corporation of America Body Fat Analyzer Model TBF-105, K930599, and Omron Healthcare Body Fat Analyzer Model HBF-306, K011652.
- 3. Indications for Use (intended use) For Measurement Of: Estimated: Extra-Cellular Water, Intra-Cellular Water, Total Body Water, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Actual : Weight, Body Mass Index (BMI),and Impedance Values.
- 4. Description of the Device: InBody AP1 is an impedance plethysmograph body 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 | Biospace Body Composition<br>Analyzer Model InBody AP1 |
|-------------------------------------|------------------------------------------|--------------------------------------------------------|
| 510(k) number | K002835 | |
| Intended Use | Body composition analyzer | Body composition analyzer |
| Indications for Use | Measurement Of: | Measurement Of: |
| | Estimated : | Estimated : |
| | Extra-Cellular Water, | Extra-Cellular Water, |
| | Intra-Cellular Water, | Intra-Cellular Water, |
| | Total Body Water, | Total Body Water, |
| | Body Fat, | Body Fat, |
| | Body Lean + Dry Lean, | Body Lean + Dry Lean, |
| | Metabolic Rates, | Metabolic Rates, |
| | Actual : | Actual : |
| | Waist/Hip Ratio, | Weight, |
| | Body Mass Index (BMI), | Body Mass Index (BMI), |
| | and Impedance Values | and Impedance Values |
| Analysis Method | Bioelectrical Impedance | Bioelectrical Impedance |
| Operating parameters | Frequency : | Frequency : |
| | 5, 50, 100, 200kHz | 5, 50, 250kHz |
| Electrode Type | adhesive | tactile |
| Number /<br>Placement of Electrodes | 4 electrodes | 8 electrodes |
| | placed on | placed on thumbs, palms, heels, |
| | hands and feet | and fore-feet |
| Impedance Measuring Site | Whole Body<br>( Right Arm to Right Leg ) | Right Arm, Left Arm, Trunk,<br>Right Leg, Left Leg |
| | | |
| Patient Position | Supine | Upright |

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

## 7. Conclusion

After analyzing both bench and clinical testing data, it is the conclusion of Biospace that the InBody AP1 BODY COMPOSITION ANALYZER as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2003

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

Re: K023478

Trade/Device Name: Biospace InBody, Model AP1, Body Composition Analyzer Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: February 11, 2003 Received: February 12, 2003

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.

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); 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.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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j) Indications for Use

K023478 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Device Name: InBody AP1 BODY COMPOSITION ANALYZER

Indications for Use: For Measurement Of:

Estimated: Extra-Cellular Water, Intra-Cellular Water, Total Body Water, Body Fat, Body Lean + Dry Lean, Metabolic Rates,

Actual : Weight, Body Mass Index (BMI),and Impedance Values

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ OR Over the Counter Use_ (Per 21 CFR 801.109)

Nancy C Hogdon

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