BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5

K053556 · Jawon Medical Co., Ltd. · MNW · Aug 31, 2006 · Cardiovascular

Device Facts

• Record ID: K053556
• Device Name: BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5
• Applicant: Jawon Medical Co., Ltd.
• Product Code: MNW · Cardiovascular
• Decision Date: Aug 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The ZEUS 9.9 and VENUS 5.5 body composition analyzers 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. The only difference between the ZEUS 9.9 and VENUS 5.5 is head part of main unit; that is, the head part of the ZEUS 9.9 has a key pad and touch screen while the head part of the VENUS 5.5 has only a touch screen.

Device Story

Compact, automatic impedance plethysmograph; measures body composition via BIA method. Inputs: user-provided personal data (height, weight, gender, age) and measured body impedance. Operation: tetra-polar electrodes contact hands and feet; device injects minute electric current (360 µA) to measure impedance across whole body and segments (arms, legs, trunk). Output: PBF, MBF, LBM, TBW, BMI, BMR, segmental LBM, ICW, ECW, ECW/TBW ratio, and WHR. Used in clinical or general settings; operated by user. ZEUS 9.9 features keypad and touch screen; VENUS 5.5 features touch screen only. Output provides quantitative body composition metrics to assist in health monitoring and assessment.

Clinical Evidence

Clinical comparison testing performed in healthy subjects (ages 7-89) comparing ZEUS 9.9 against BODYSTAT Quad Scan 4000 and TANITA BC-418. Results demonstrated no significant difference in performance between subject and predicate devices.

Technological Characteristics

Impedance plethysmograph; BIA method; tetra-polar electrode configuration (8 electrodes). AC line powered (110-120V, 50/60Hz). Compliance with IEC 60601-1, IEC 60601-1-2, and ISO 10993 standards.

Indications for Use

Indicated for healthy subjects aged 7-89 for estimation of body composition parameters including body fat, lean body mass, total body water, BMI, BMR, and segmental body water distribution using 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

• BODYSTAT Quad scan 4000 Body Composition Analyzer (K002835)
• TANITA Body Composition Analyzer BC-418 (K033157)

Submission Summary (Full Text)

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JAWON

1 OF PACE #1208-12, Sinsang, Jinryang, Kyungsan-City Kyungsangbukdo, 712-830 Korea TEL . [phone] FAX. [phone] e-mail : [e-mail] homepage : http://www.jawon.co.kr

# MEDICAL

## 510(k) Summary

## BODY COMPOSTION ANALYZER Models VENUS 9.9 and ZEUS 5.5

AUG 3 1 2006

3

K053556

## 1. COMPANY INFORMATION.

Name : Jawon Medical CO., LTD.

Address : 1208-12, Sinsang-Li, Jinryang-Eup, Kyungsan-City, Kyungsang-Bukdo, Korea.

Phone : [phone]

Contact : Mr. J.H. CHO , Senior Engineer, R&D center

#### 2. DEVICE IDENTIFICATION.

Trade Name : Model ZEUS 9.9/VENUS 5.5 BODY COMPOSITION ANALYZER

Common name and Classification name : BODY COMPOSITION ANALYZER . Impedance plethysmograph, MNW

#### 3. PREDICATE DEVICE.

BODYSTAT Quad scan 4000 Body Composition Analyzer, K002835, decision on 07/03/2001

TANITA Body Composition Analyzer BC-418, K033157, decision on 08/08/2004

#### 4. DEVICE DESCRIPTION.

- Model ZEUS 9.9/VENUS 5.5 of Jawon Medical is compact, automatic General: Impedance plethysmographer intended for estimating of body composition of user such as PBF(Percentage of Body Fat), MBF(Mass of Sody 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/Bioelectrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hin Ratio) of the user. These devices are intended for use only in healthy subjects between age of 7-89. The only difference between the ZEUS 9.9 and VENUS 5.5 is head part of main unit; that is, the head part of the ZEUS 9.9 has a key pad and touch screen while the head part of the VENUS 5.5 has only a touch screen.

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Image /page/1/Picture/0 description: The image shows the word "JAWON" in bold, black letters. The letters are large and fill most of the frame. A thick, black line underlines the entire word, emphasizing it. The background is plain white, making the text stand out.

## MEDICAL

PAGE 2 OF #1208-12, Sinsang, Jinryang, Kyungsan-City Kyungsangbukdo, 712-830 Korea TEL . [phone] FAX. [phone] e-mail : [e-mail] homepage : http://www.jawon.co.kr

14053556

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### Operation: The subject device employs a measurement algorithms which is called BIA method, to measure user's body composition.

ZEUS 9.9/VENUS 5.5 device's tetra-polar type electrode connect to human body and then send an minute electric current like 360 A human body and then ZEUS 9.9/VENUS 5.5 device can measure impedance of the human body.

ZEUS 9.9/VENUS 5.5 can measure body composition of user with personal data which already saved height, weight, gender, ages and new calculated body impedance.

Model ZEUS 9.9/VENUS 5.5 is AC line powered(AC 110~120V, 50/60Hz) Power:

- 5. INTENDED USES: The ZEUS 9.9 and VENUS 5.5 body composition analyzers 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. The only difference between the ZEUS 9.9 and VENUS 5.5 is head part of main unit; that is, the head part of the ZEUS 9.9 has a key pad and touch screen while the head part of the VENUS 5.5 has only a touch screen.
#### 6. COMPARISON WITH PREDICATE DEVICE.

Models ZEUS 9.9/VENUS 5.5 of Jawon devices have been compared with BODYSTAT Quad Scan 4000 of BODYSTAT LTD and TANITA Body Composition Analyzer BC-418. The intended uses of Jawon devices and predicate devices are the same. Both of Jawon devices and predicate devices use BIA(Bio-electrical Impedance Analysis) method to estimate body composition parameters,

The differences between Jawon devices and predicate devices are as follows Measurement frequency is 50, 5, 100, 200kHz for BODYSTAT Quad Scan 4000, and 50kHz for Tanita BC-418 instead of 50, 1, 5, 250, 550, 1000kHz for Jawon devices. 4 electrodes are placed on hands and feet for BODYSTAT Quad Scan 4000 and 8 electrodes on hands and feet for Tanita BC-418 instead of 8 electrodes on hands and feet(or ankle) for Jawon devices.

- Impedance measurement site is whole body for BODYSTAT Qaud Scan 4000 and right arm, right leg, left arm, left leg and trunk for Tanita BC-418 instead of whole body, right arm, right leg, left arm, left leg and trunk for Jawon devices.
- Therefore, there is no difference in intended use and no technologic differences that raise new questions concerning either safety or effectiveness.

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JAWON

## MEDICAL

PAGE 3 OF #1208-12, SInsang, Jinryang, Kyungsan-City Kyungsangbukdo, 712-830 Korea TEL . [phone] FAX. [phone] e-mail : [e-mail] homepage : http://www.jawon.co.kr

K C53556

್ತಿ

#### 7. Non-clinical tests

The ZEUS 9.9 and VENUS 5.5 body composition analyzers meet of the requirements of international standards IEC 60601-1, IEC 60601-1-2, and ISO 10993 series.

### 8. Clinical tests

Comparison testing was performed using the ZEUS 9.9 body composition analyzer and predicated devices-BODYSTAT Quad Scan 4000 and TANITA BC-418 in healthy subjects between the age of 7-89. Results of the testing showed that the ZEUS 9.9 body composition analyzer is equivalent in performance to the predicate devices-BODYSTAT Quad Scan 4000 and TANITA BC-418. There is no significant difference between the ZEUS 9.9 body composition analyzer and predicate devices-BODYSTAT Quad Scan 4000 and TANITA BC-418.

#### 9. Conclusions

Based on the indications for use, clinical data, non-clinical testing, and comparison to predicate devices, the ZEUS 9.9 and VENUS 5.5 body composition analyzers are as safe, as effective, and perform as well or better than the predicate devices-BODYSTAT Quad Scan 4000 Body Composition Analyzer and TANITA Body Composition Analyzer BC-418. Accordingly.

Confidential

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## AUG 3 1 2006

Jawon Medical Co., Ltd. c/o Mr. Heung Bong Lim MI Consulting Co., Ltd. Room 624, Life Officetel, 61-3 Yoido-Dong, Youngdeungpo-GU Seoul, Korea REPUBLIC OF KOREA 150-731

Re: K053556

Trade/Device Name: JAWON MEDICAL BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 Regulation Number: 21 CFR §870.2772 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: August 2, 2006 Received: August 2, 2006

Dear Mr. Lim:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Dector Pro() promation is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the enclosure) to regally man of the Medical Device Amendments, or to devices that provide to May 20, 1770, and chient asks the provisions of the Federal Food, Drug, and Cosmetic have bech recuired in accoranted of a premarket approval application (PMA). You may, ACC (Act) that do not require apple at on the general controls provisions of the Act. The general therefore, mailier the det include requirements for annual registration, listing of devices, good Controls provisions of alsbeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (Premarket IT your device is classified (see acore) historial controls. Existing major regulations affecting your Apploval), it thay be subject to sail aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA device ban be round in nouncements concerning your device in the Federal Register.

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Protecting and Promoting Public Health

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Page 2 -

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 Of It at 807), its end (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) I ms letter notification. The FDA finding of substantial equivalence of your device to a legally premated 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrl/industry/support/index.html.

Sincerely vours.

Nancy Chogdon

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

510(k) Number (if Known):

## Device Name: JAWON MEDICAL BODY COMPOSITION ANALYZER MODELS ZEUS 9.9 AND VENUS 5,5

Indications For Use:

The ZEUS 9.9 and VENUS 5,5 body composition analyzers 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.

The only difference between the ZEUS 9.9 and VENUS 5.5 is head part of main unit; that is, the head part of the ZEUS 9.9 has a key pad and touch screen while the head part of the VENUS 5.5 has only a touch screen

Prescription Use

AND/OR

Over-The-Counter Use *X*

(Per 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IN NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic 510(k) Numbe

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