(102 days)
The EasyBody 202 and EasyBody 203 are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.
The EasyBody 205 is intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), Segmental LBM, recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.
The EasyBody 202, EasyBody 203 and EasyBody 205 measure the impedance and weight of the user, and are intended for use only in healthy subjects between the age of 5-89.
The EasyBody 202, EasyBody 203 and EasyBody 205 are non-invasive body composition analyzers intended for use only in healthy subjects between the age of 5-89. The devices employ BIA(Bio-electrical Impedance Analysis) method, 4 electrodes for EasyBody 202 and EasyBody 203, 8 electrodes for EasyBody 205, and then measure body composition using an experimentally derived algorithm. The devices are powered by four AA batteries (DC 6V) or AC adapter.
Here's a summary of the acceptance criteria and the study details for the Jawon Medical Body Composition Analyzer Models EasyBody 202, EasyBody 203, and EasyBody 205, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the demonstration of "no significant difference" and substantial equivalence to the predicate device, ZEUS 9.9 (K053556). The specific performance metrics for acceptance are not explicitly listed as numerical targets (e.g., "accuracy > 90%"). Instead, the performance is judged against the established performance of the predicate.
| Performance Metric/Characteristic (as compared to predicate device ZEUS 9.9) | Acceptance Criteria | Reported Device Performance (EasyBody 202, 203, 205) |
|---|---|---|
| Safety | No unsafe differences | Meets IEC 60601-1, EN 60601-1-2 and ISO 10993 series; |
| Effectiveness | No significant difference | Clinical comparison tests show no significant difference |
| Overall Performance | As well as predicate | Performs as well as the predicate device |
| Technological Characteristics | No new safety/effectiveness questions | Differences don't raise new questions |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "clinical comparison tests," but does not provide details on the number of subjects or cases used in these tests.
- Data Provenance: Not explicitly stated, but the submitter and contact person are from the Republic of Korea, suggesting the clinical tests were likely conducted there. It is described as "clinical comparison tests," implying prospective data collection for the purpose of the study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study relies on comparison to a predicate device, rather than a separate expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the manner typically associated with AI products where human readers improve with or without AI assistance. This device is a standalone body composition analyzer, not a diagnostic aid for human readers. The clinical tests were for comparing the device's performance to another device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was conducted. The "clinical comparison tests" evaluate the device's outputs (PBF, MBF, LBM, BMR, etc.) against the predicate device's outputs directly. The device operates independently to measure and estimate these parameters.
7. Type of Ground Truth Used
The "ground truth" for the test set was essentially the measurements and estimations provided by the predicate device (ZEUS 9.9). The study aimed to show that the new devices produced comparable results to an already legally marketed, substantially equivalent device. There is no mention of an independent, gold-standard reference ground truth (e.g., DEXA scan, hydrostatic weighing, pathology).
8. Sample Size for the Training Set
The document does not describe a "training set" in the context of an AI algorithm learning from data. The devices "measure body composition using an experimentally derived algorithm," which likely refers to a pre-defined algorithm based on physiological models and potentially some internal calibration data, rather than a machine learning model trained on a large dataset. Therefore, a sample size for a training set in the AI sense is not applicable/not provided.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" and its "ground truth" (in the AI/machine learning sense) is not applicable to the description of this device's algorithm development. The algorithm is described as "experimentally derived," which typically implies a scientific or engineering approach to formula derivation and calibration, rather than a data-driven machine learning training process with ground truth labels.
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K072325
Page 1 of 4
Section 5
510(k) Summary
NOV 3 0 2007
[As Required by 21 CFR 807.92]
| Date Prepared: | August 03, 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 EasyBody 202, EasyBody 203 and EasyBody 205 | |
| Common Name: | Body Fat Analyzer / Body Fat Monitor / Body Composition Monitor |
| Classification Name: | Body Composition Analyzer (Impedance plethysmograph) / MNW |
| Predicate Device: | Body Composition Analyzer Model ZEUS 9.9 (K053556) |
| Device Description: | The EasyBody 202, EasyBody 203 and EasyBody 205 are non-invasive bodycomposition analyzers intended for use only in healthy subjects between theage of 5-89. The devices employ BIA(Bio-electrical Impedance Analysis)method, 4 electrodes for EasyBody 202 and EasyBody 203, 8 electrodes forEasyBody 205, and then measure body composition using an experimentallyderived algorithm. The devices are powered by four AA batteries (DC 6V) orAC adapter. |
| Intended use: | Body Composition Analyzer Models EasyBody 202 and EasyBody 203 areintended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), |
| Jawon Medical | EasyBody |
Section 5: Page 1 of 4
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LBM(Lean Body Mass), BMR(Basic Metabolic Rate), recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.
Body Composition Analyzer Model EasyBody 205 is intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), Segmental LBM, recommended daily calorie intake. daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.
The EasyBody 202, EasyBody 203 and EasyBody 205 measure the impedance and weight of the user, and are intended for use only in healthy subjects between the age of 5-89.
- Technologic characteristics: The devices EasyBody 202, EasyBody 203 and EasyBody 205 have been compared to the predicate device ZEUS 9.9 such as a comparing table of technology characteristics. The differences in this submission don't raise new questions concerning either safety or effectiveness.
- Non-clinical and clinical tests: The subject devices EasyBody 203 and EasyBody 203 meet the requirements of IEC 60601-1, EN 60601-1-2 and ISO 10993 series. The results of clinical comparison tests with predicate device ZEUS 9.9 demonstrate that there is no significant difference between the subjected devises and the predicate device.
- Conclusions: Based on non-clinical and clinical tests, the subject devices EasyBody 202, EasyBody 203 and EasyBody 205 are as safe, as effective, and perform as well as the predicate device ZEUS 9.9. Accordingly, the subject devices are substantially equivalent to the predicate device.
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| ltems | Zeus 9.9 | EasyBody 202 | EasyBody 203 | EasyBody 205 |
|---|---|---|---|---|
| 510(k) # | K053556 | New | New | New |
| Intended Use | Body compositionAnalyzer | Same | Same | Same |
| Indicationsfor use | Estimated of:PBF(Percentage ofBody Fat), MBF(Massof Body Fat),LBM(Lean BodyMass), TBW(TotalBody Water,BMI(Body MassIndex), BMR(BasicMetabolic Rate),Segmental LBM,ICW(Intra-CellularWater), ECW(Extra-Cellular Water), andRatio of ECW/TBWActual :Impedance,BMI(Body MassIndex), weight,WHR(Waist to HipRatio)Healthy subjects ofthe age of 7-89 | Estimated of:PBF(Percentage ofBody Fat),MBF(Mass of BodyFat), LBM(LeanBody Mass),BMR(BasicMetabolic Rate),recommendeddaily calorie intake,daily exercise time,sort and term ofexerciseActual:Impedance, weightHealthy subjects ofthe age of 5-89 | Estimated of:PBF(Percentage ofBody Fat),MBF(Mass of BodyFat), LBM(LeanBody Mass),BMR(BasicMetabolic Rate),recommendeddaily calorie intake,daily exercise time,sort and term ofexerciseActual:Impedance, weightHealthy subjects ofthe age of 5-89 | Estimated of:PBF(Percentage ofBody Fat),MBF(Mass of BodyFat), LBM(Lean BodyMass), BMR(BasicMetabolic Rate),Segmental LBM,recommendeddaily calorie intake,daily exercise time,sort and term ofexerciseActual:Impedance, weightHealthy subjects ofthe age of 5-89 |
| AnalysisMethod | Bio-electricalImpedanceAnalysis (BIA) | Same | Same | Same |
| Operatingparameters | Frequency:1,5,50,250,550,1000kHz | Frequency:50kHz | Frequency:50kHz | Frequency:50kHz |
| Electrodetype | Tactile | Same | Same | Same |
| Number/Placement ofElectrodes | 8 electrodesPlaced on Hands andfeet(or ankle)(Tetra-polar Electrodemethod) | 4 electrodesPlaced on feet(Tetra-polarElectrode method) | 4 electrodesPlaced on feet(Tetra-polarElectrode method) | 8 electrodesPlaced on Handsand feet(Tetra-polarElectrode method) |
| Items | Zeus 9.9 | EasyBody 202 | EasyBody 203 | EasyBody 205 |
| PatientPosition | Upright | Same | Same | Same |
| ImpedanceMeasuringSite | Whole body,Right Arm, Right Leg,Left Arm, Left LegTrunk | Foot to Foot | Foot to Foot | Whole body,Right Arm, Right Leg,Left Arm, Left Leg,Trunk |
| ImpedanceMeasurementRange | 100 ~ 950 ohms | Same | Same | Same |
| Measuringheight | 110 ~ 200 cm | 100 ~ 200 cm | 100 ~ 200 cm | 100 ~ 200 cm |
| Measuringweight | 10 ~ 250 kg | 1~150 kg | 1~150 kg | 1~150 kg |
| MeasuringPBF | 3 ~ 50% | Same | Same | Same |
| MeasuringTime | Within 1 minute | About 15sec | About 15sec | About 15sec |
| Electricalcurrentappliedduringmeasurement | Maximum current360uA | Maximum current180uA | Maximum current180uA | Maximum current180uA |
| Powerconsumption | 50VA | 0.36VA | 0.36VA | 0.36VA |
| PowerSupply | AC120V 50/60Hz | AA Battery DC6Vor AC Adapter | AA Battery DC6Vor AC Adapter | AA Battery DC6Vor AC Adapter |
| Operatingambient | Temp: 10 ~ 40 ℃RH: 30 ~ 75% | Same | Same | Same |
| Storageambient | Temp: -20 ~ 60 ℃RH: lower than 95% | Same | Same | Same |
| Dimensions(W x L x H) | 470 x 655 x 1220mm | 310 x 311 x 38.5mm | 300 x 356 x 79mm | 300 x 300 x 369mm |
| Weight | 45Kg | 1.7kg | 2.2kg | 2.7kg |
< Comparison Table of technical characteristics >
Jawon Medical
EasyBody
Section 5: Page 3 of 4
ે છે. રે
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2007
Jawon Medical Co., Ltd. c/o H. L. Jung MI Consulting Co., Ltd. Room 624, Life Officetel, 61-3 Yoido-dong, Youngdeungpo-gu Seoul. 150-731 REPUBLIC OF KOREA
K072325 Re:
Trade/Device Name: JAWON MEDICAL BODY COMPOSITION ANALYZER MODELS EasyBody 202, EasyBody 203, and EasyBody 205 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: November 19, 2007 Received: November 21, 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 (PMA), 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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy 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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Section 4
Indications for Use
510(k) Number (if known): _ KO72325
Device Name: JAWON MEDICAL BODY COMPOSITION ANALYZER MODELS EasyBody 202, EasyBody 203 and EasyBody 205
Indications For Use:
The EasyBody 202 and EasyBody 203 are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.
The EasyBody 205 is intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), Segmental LBM, recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.
The EasyBody 202, EasyBody 203 and EasyBody 205 measure the impedance and weight of the user, and are intended for use only in healthy subjects between the age of 5-89.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(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)
Herbert Lewin
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
EasyBody 202/203/205
Section 4: Page 1 of 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.