BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900

K071884 · Jawon Medical Co., Ltd. · MNW · Aug 9, 2007 · Cardiovascular

Device Facts

• Record ID: K071884
• Device Name: BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900
• Applicant: Jawon Medical Co., Ltd.
• Product Code: MNW · Cardiovascular
• Decision Date: Aug 9, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

These devices are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), TBW(Total Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hip Ratio) of the user. These devices are intended for use only in healthy subjects between the age of 7-89.

Device Story

Body composition analyzers (X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900) utilize bio-electrical impedance analysis (BIA) via 8 electrodes placed on hands and feet (or ankles) to measure body impedance. Devices process impedance data, weight, and user inputs through an experimentally derived algorithm to calculate body composition parameters (PBF, MBF, LBM, TBW, BMI, BMR, segmental LBM, ICW, ECW, ECW/TBW ratio, WHR). Operated in clinical settings, devices provide digital output on integrated LCD screens. Results assist healthcare providers in assessing patient body composition and metabolic status. XBIA 500/900 and others include optional blood pressure port integration. Data connectivity includes USB, RS-232C, or Bluetooth (XBIA 900) for PC/printer output.

Clinical Evidence

Clinical comparison tests performed against predicate device ZEUS 9.9. Results demonstrate no significant difference in performance between modified devices and predicate. Bench testing confirmed compliance with IEC 60601-1 and EN 60601-1-2 standards.

Technological Characteristics

Tetra-polar BIA method using 8 electrodes; AC power (100-230V); operating frequencies 1-1000kHz (varies by model); maximum applied current 180-500uA; digital LCD displays (various sizes/resolutions); connectivity via USB, RS-232C, or Bluetooth; integrated blood pressure port on most models.

Indications for Use

Indicated for healthy subjects aged 7-89 to estimate body composition metrics including PBF, MBF, LBM, TBW, BMI, BMR, segmental LBM, ICW, ECW, ECW/TBW ratio, and WHR using BIA.

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

• VENUS 5.5 (K053556)
• ZEUS 9.9 (K053556)

Submission Summary (Full Text)

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# 长071884 PAGE 1 OF 3

## Attachment 4

AUG - 9 2007

## 510(k) Summary

[As Required by 21 CFR 807.92]

| Date Prepared: | July 05, 2007 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Jawon Medical Co., Ltd. |
| | #1208-12, Sinsang-Li, Jinryang-Myun, Kyungsan-city, Kyungsang-Bukdo, |
| | 712-830, Republic of Korea |
| | Tel: [phone] |
| | Establishment Registration Number: 9616164 |
| Contact Person: | MI Consulting Co., Ltd. (Mr. HL Jung) |
| | RM 624, Life Officetel, 61-3, Yoido-dong, Youngdeungpo-gu, Seoul, 150-731, |
| | Republic of Korea |
| | Tel: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Trade Name: | Body Composition Analyzer |
| | Models X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 |
| Common Name: | Body Fat Analyzer / Body Fat Monitor / Body Composition Monitor |
| Classification Name: | Body Composition Analyzer (Impedance plethysmograph) / MNW |
| Predicate Device: | Body Composition Analyzer Models VENUS 5.5 and ZEUS 9.9 (K053556) |
| Device Description: | The X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 are body composition analyzers intended for use only in healthy subjects between the age of 7-89. The devices employ BIA(Bio-electrical Impedance Analysis) method and 8 electrodes placed on hands and feet (or ankles), and then measure body composition using an experimentally derived algorithm. For only XBIA 500, optional ankle electrode is not supplied. The devices are powered by AC100~230V 50/60Hz. |
| Intended use: | These devices are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), TBW(Total Body Water), |

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BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hip Ratio) of the user.

These devices are intended for use only in healthy subjects between the age of 7-89.

Technologic characteristics: Modified devices X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 have the same intended use and technology characteristics as predicate devices VENUS 5.5 and ZEUS 9.9. The differences in this submission don't raise new questions concerning either safety or effectiveness.

Non-clinical and clinical tests: Modified devices X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 meet the requirements of IEC 60601-1, EN 60601-1-2 and in-house test criteria. The results of clinical comparison tests with predicate device ZEUS 9.9 demonstrate that there is no significant difference between the modified devise and the predicate device.

- Based on non-clinical and clinical tests, the modified devices X-SCAN PLUS Conclusions: II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 are as safe, as effective, and perform as well as the predicate devices VENUS 5.5 and ZEUS 9.9. Accordingly the modified devices are substantially equivalent to the predicate devices.

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| Item | 510(k) # | Number/<br>Placement of<br>Electrodes | Operating<br>Parameters | Electrical<br>Current<br>applied during<br>measurement | Power<br>consumption | Power supply | Input height | Display LCD | Protocol<br>connecting to<br>PC | Protocol<br>connecting to<br>printer | Blood<br>Pressure' port | Dimensions<br>W x D x H;<br>Unit: mm) | Weight(main<br>unit) |
|----------------------------------------------------------------|-------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------|----------------------|-----------------------|--------------|----------------------------------------------------|------------------------------------------|---------------------------------------------------------------------------------|-------------------------|---------------------------------------|----------------------|
| < Differences between predicate devices and modified devices > | VENUS 5.5/ZEUS 9.9<br>K053556 | 8 electrodes placed on<br>hands and feet (or ankle)<br>(Tetra-polar electrode<br>method) | Frequency:<br>1, 5, 50, 250,550, 1000kHz | Maximum current<br>360uA | 50VA | AC120V 50/60Hz | 110~200 cm | Digital LCD (640 x 480<br>pixel) - black | RS-232C (9 pin serial<br>port), USB port | IEEE 1284(25pin parallel)<br>port printer or PCB 3<br>protocol supplied printer | None | 470 x 655 x 1220 | 45kg |
| | X-SCAN PLUS II | Modified device | Same | Maximum current<br>180uA | 70VA | AC100~230V<br>50/60Hz | 110~200 cm | Digital LCD (6.4",<br>800 x 600 pixel) -<br>color | USB port | IEEE 1284(25pin<br>parallel) port | Yes | 496 x 836 x 1150 | 45kg |
| | GAIA 359 PLUS | Modified device | Same | Maximum current<br>500uA | 40VA | AC100~230V<br>50/60Hz | 100~200 cm | Digital LCD (6.4",<br>640 x 480 pixel) -<br>color | USB port | None | Yes | 460 x 660 x 1000 | 24kg |
| | PLUSAVIS 333 | Modified device | Same | Maximum current<br>500uA | 40VA | AC100~230V<br>50/60Hz | 100~200 cm | Digital LCD (6.4",<br>480 x 320 pixel) -<br>black | USB port | USB port,<br>Thermal printer | Yes | 460 x 660 x 1000 | 24kg |
| | XBIA 500 | Modified device<br>8 electrodes<br>placed on hands<br>and feet<br>(Tetra-polar<br>electrode method) | Frequency:<br>5, 50, 250kHz | Maximum current<br>280uA | 40VA | AC100~230V<br>50/60Hz | 100~200 cm | Digital LCD (6.4",<br>640 x 480 pixel) -<br>color | USB port | USB port | Yes | 400 x 673 x 972 | 24kg |
| | XBIA 900 | Modified device | Same | Maximum current<br>280uA | 70VA | AC100~230V<br>50/60Hz | 80~200 cm | Digital LCD (12.1",<br>800 x 600 pixel) -<br>color | USB port | Bluetooth Function | Yes | 476 x 848 x 1062 | 45kg |

UNDER DIAGNOSTIC DEVICES AND IN VITRO DIAGNOSTIC DEVICES

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

#### AUG - 9 2007

Jawon Medical Co., Ltd. c/o Mr. HL Jung, Manager MI Consulting Co., Ltd. Room 624, LifeOfficetel 61-3 Yoido-dong, Youngdeungpo-gu, Seoul 150-731 REPUBLIC OF KOREA

Re: K071884

Trade/Device Name: Body Composition Analyzers - Models X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, & XBIA 900 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: July 5, 2007 Received: July 10, 2007

Dear Mr. Jung:

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 (Premarket Approval), it may be subject to such 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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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.

This letter will allow you to begin marketing your device as described in your Section 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:

| 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 807.97). 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/cdrh/industry/support/index.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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#### Attachment 1

### Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Jawon Medical Body Composition Analyzer Device Name: Models X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900

Indications for Use:

These devices are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), TBW(Total Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hip Ratio) of the user.

These devices are intended for use only in healthy subjects between the age of 7-89.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hebert Leun

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

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