(31 days)
Not Found
No
The description explicitly states the device uses an "experimentally derived algorithm" and does not mention AI or ML.
No.
The device is intended to estimate various body composition metrics and is for use in healthy subjects, not for treating any specific disease or condition.
No
The device is intended to estimate various body composition parameters and is explicitly stated for "use only in healthy subjects." This indicates it's for general health assessment or tracking, not for diagnosing diseases or conditions.
No
The device description explicitly states that the devices employ BIA method and 8 electrodes placed on hands and feet (or ankles), and are powered by AC. This indicates the presence of hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: This device uses Bio-electrical Impedance Analysis (BIA) by placing electrodes on the hands and feet to measure body composition parameters like body fat, lean mass, and water content. It does not analyze samples taken from the body.
- Intended Use: The intended use is to estimate body composition parameters in healthy subjects, not to diagnose diseases or conditions based on analysis of biological samples.
Therefore, the device described falls under the category of a body composition analyzer, which is not considered an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
MNW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
healthy subjects between the age of 7-89.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2770 Impedance plethysmograph.
(a)
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.(b)
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.
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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: 82-53-856-0993 | |
| 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: 82-2-6264-9001 | |
| Fax: 82-2-6269-9001 | |
| Email: jung_halyong@yahoo.com | |
| 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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Image /page/1/Picture/0 description: The image shows the text "K671884 PAGE 2 OF 3". The text appears to be handwritten. The numbers are slightly distorted, and the text is not perfectly aligned.
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.
2
| Item | 510(k) # | Number/
Placement of
Electrodes | Operating
Parameters | Electrical
Current
applied during
measurement | Power
consumption | Power supply | Input height | Display LCD | Protocol
connecting to
PC | Protocol
connecting to
printer | Blood
Pressure' port | Dimensions
W x D x H;
Unit: mm) | Weight(main
unit) |
|----------------------------------------------------------------|-------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------|----------------------|-----------------------|--------------|----------------------------------------------------|------------------------------------------|---------------------------------------------------------------------------------|-------------------------|---------------------------------------|----------------------|
| | VENUS 5.5/ZEUS 9.9
K053556 | 8 electrodes placed on
hands and feet (or ankle)
(Tetra-polar electrode
method) | Frequency:
1, 5, 50, 250,550, 1000kHz | Maximum current
360uA | 50VA | AC120V 50/60Hz | 110200 cm | Digital LCD (640 x 480230V
pixel) - black | RS-232C (9 pin serial
port), USB port | IEEE 1284(25pin parallel)
port printer or PCB 3
protocol supplied printer | None | 470 x 655 x 1220 | 45kg |
| | X-SCAN PLUS II | Modified device | Same | Maximum current
180uA | 70VA | AC100
50/60Hz | 110200 cm | Digital LCD (6.4",230V
800 x 600 pixel) -
color | USB port | IEEE 1284(25pin
parallel) port | Yes | 496 x 836 x 1150 | 45kg |
| | GAIA 359 PLUS | Modified device | Same | Maximum current
500uA | 40VA | AC100
50/60Hz | 100200 cm | Digital LCD (6.4",230V
640 x 480 pixel) -
color | USB port | None | Yes | 460 x 660 x 1000 | 24kg |
| | PLUSAVIS 333 | Modified device | Same | Maximum current
500uA | 40VA | AC100
50/60Hz | 100200 cm | Digital LCD (6.4",230V
480 x 320 pixel) -
black | USB port | USB port,
Thermal printer | Yes | 460 x 660 x 1000 | 24kg |
| | XBIA 500 | Modified device
8 electrodes
placed on hands
and feet
(Tetra-polar
electrode method) | Frequency:
5, 50, 250kHz | Maximum current
280uA | 40VA | AC100
50/60Hz | 100200 cm | Digital LCD (6.4",230V
640 x 480 pixel) -
color | USB port | USB port | Yes | 400 x 673 x 972 | 24kg |
| | XBIA 900 | Modified device | Same | Maximum current
280uA | 70VA | AC100
50/60Hz | 80~200 cm | Digital LCD (12.1",
800 x 600 pixel) -
color | USB port | Bluetooth Function | Yes | 476 x 848 x 1062 | 45kg |
UNDER DIAGNOSTIC DEVICES AND IN VITRO DIAGNOSTIC DEVICES
4 - 3
KOT 1884
PAGE 3 OF 3
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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.
Image /page/3/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "FDA Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. The logo is surrounded by a dotted border and stars.
4
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 (800) 638-2041 or (301) 443-6597 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
5
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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