(62 days)
This device is 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.
This device is intended for use only in healthy subjects between the age of 7-89.
The ioi 353 is body composition analyzer is intended for use only in healthy subjects between the age of 7-89. The device employs BIA(Bio-electrical Impedance Analysis) method and 8 electrodes placed on hands and feet, and then measure body composition using an experimentally derived algorithm. The device is powered by AC adapter.
The Jawon Medical Body Composition Analyzer Model ioi 353 did not undergo clinical testing to establish its performance against specific acceptance criteria. Instead, substantial equivalence was claimed based on compliance with electrical safety and electromagnetic compatibility standards and the device's technological similarity to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | Meets IEC 60601-1 requirements |
| Electromagnetic Compatibility (EMC) | Compliance with EN 60601-1-2 | Meets EN 60601-1-2 requirements |
| Device Functionality | Measures/outputs/determines the same quantities as predicate device GAIA 359 PLUS (PBF, MBF, LBM, TBW, BMI, BMR, Segmental LBM, ICW, ECW, ECW/TBW, impedance, weight, WHR). | Same functionality as GAIA 359 PLUS. |
| Measurement Frequencies | Uses the same frequencies as predicate device GAIA 359 PLUS. | Uses the same frequencies as GAIA 359 PLUS. |
| Electrode Pattern and Number | Uses the same electrode pattern and number of electrodes as predicate device GAIA 359 PLUS. | Uses the same electrode pattern and number of electrodes as GAIA 359 PLUS. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical data is provided for the ioi 353 device, as it was not clinically tested. The evaluation relies on non-clinical tests (electrical safety and EMC) and comparison to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as no clinical test set was used for the ioi 353.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used for the ioi 353.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or referenced. The submission explicitly states the device was "not clinically tested."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone performance study for the algorithm was conducted or referenced in this document. The device's performance is inferred by its similarity to predicate devices.
7. Type of Ground Truth Used
The ground truth for the device's safety and effectiveness relies on compliance with international standards (IEC 60601-1, EN 60601-1-2) and the established performance of its predicate device (GAIA 359 PLUS and XBIA 500), rather than direct comparison to a clinical ground truth.
8. Sample Size for the Training Set
Not applicable. This device is not described as having an AI algorithm requiring a training set in the context of this 510(k) summary. Its algorithm is "experimentally derived," implying a fixed, pre-determined calculation based on BIA, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no AI training set is mentioned for this device. The "experimentally derived algorithm" for the Body Composition Analyzer (using BIA) would typically be based on established physiological models and correlations between impedance measurements and body composition, often developed through various research studies, but not specifically described as a machine learning training set in this submission.
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K092431
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Attachment 4
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
510(k) Summary
[As Required by 21 CFR 807.92]
OCT - 8 2009
| Date Prepared: | September 08, 2009 |
|---|---|
| Submitter: | Jawon Medical Co., Ltd. |
| #1208-12, Sinsang-Li, Jinryang-Eup, 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 431, Life Officetel, 61-3, Yoido-dong, Youngdeungpo-gu, Seoul, 150-731, | |
| Republic of Korea | |
| Tel: 82-2-6264-9001 | |
| Fax: 82-2-6269-9001 | |
| Trade Name: | Body Composition Analyzer Model ioi 353 |
| 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 GAIA 359 PLUS and XBIA 500 |
| (K071884) | |
| Device Description: | The ioi 353 is body composition analyzer is intended for use only in healthy |
| subjects between the age of 7-89. The device employs BIA(Bio-electrical | |
| Impédance Analysis) method and 8 electrodes placed on hands and feet, and | |
| then measure body composition using an experimentally derived algorithm. | |
| The device is powered by AC adapter. | |
| Intended use: | This device is 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 |
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K092431
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Hip Ratio) of the user.
This device is intended for use only in healthy subjects between the age of 7-89.
Technologic characteristics: Modified device ioi 353 has the same intended use and technology characteristics as predicate device GAIA 359 PLUS or XBIA 500. The differences in this submission don't raise new questions concerning either safety or effectiveness.
Non-clinical and clinical tests: Modified device ioi 353 meets the requirements of IEC 60601-1, EN 60601-1-2 and in-house test criteria. The ioi 353 was not clinically tested because the ioi 353 measures/outputs/determines the same quantities, uses the same frequencies, and uses the same electrode pattern and number of electrodes as the GAIA 359 PLUS.
Conclusions: Based on non-clinical tests, the modified device ioi 353 is as safe, as effective, and perform as well as the predicate device GAIA 359 PLUS or XBIA 500. Accordingly the modified devices are substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Jawon Medical Co., Ltd. c/o Mr. H. L. Jung Mi Consulting Co., Ltd. Room 431, Life Officetel. 61-3 Yoido-dong, Youngdeungpo-gu Seoul, 150-731 REPUBLIC OF KOREA
OCT - 8 2009
Re: K092431
Trade/Device Name: Jawon Medical Body Composition Analyzer Model ioi 353 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: September 8, 2009 Received: September 14, 2009
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 (PMA), i 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); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR. Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting 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):
KO92431
Device Name: Jawon Medical Body Composition Analyzer Model ioi 353
Indications for Use:
This device is 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 BlA(Bioelectrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hip Ratio) of the user.
This devices is 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)
Ayym Wh
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(Divisid Division of Reproductive, Abdomin and Radiological Devi 510(k) Number
1 - 1
§ 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.