(406 days)
Not Found
No
The description focuses on calculations and estimations based on measured and entered parameters, without mentioning AI/ML algorithms or training/test data.
No
The device is used for calculating and estimating body composition parameters for generally healthy individuals and does not mention any therapeutic claims or functions.
No
The "Intended Use / Indications for Use" states that the device "calculates and estimates body composition parameters" and explicitly mentions that "These devices are only for use with generally healthy individuals." This indicates it's for general health monitoring and not for diagnosing diseases or conditions.
No
The device description explicitly states that it uses "measured weight and impedance" as inputs, which implies the use of hardware components (like a scale and impedance measurement electrodes) to obtain these measurements. The software then processes these hardware-derived inputs.
Based on the provided information, 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 measures body composition parameters using physical measurements (weight, impedance) and entered data (height, age, gender). It does not analyze biological samples taken from the body.
- Intended Use: The intended use is to estimate body composition in generally healthy individuals, not to diagnose or detect diseases or conditions through the analysis of biological samples.
Therefore, while it is a medical device that provides health-related information, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
These devices calculates and estimates body composition parameters by using measured weight and impedance and entered height, age and gender. It shows body composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat, Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control, Goal setter.
In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).
These devices can only estimate the body composition parameters with the exception of Weight, BMI, and impedance. These devices are only for use with generally healthy individuals of a specified age range.
Product codes
MNW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Whole Body, Upper Body, Lower Body (implied from segmental analysis and specific models X-Contact 350, X-Contact 350M, X-Contact 350S)
Indicated Patient Age Range
"generally healthy individuals of a specified age range."
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: "These subject devices X-CONTACT 350, X-CONTACT 350M, and X-CONTACT 350S meets the requirements of IEC 60601-1, IEC 60601-1-2 and in-house test criteria. The results of performance tests using X-Contact 350 demonstrated that there is no significant difference in measurements. See the enclosed document number 15 (Performance Test-Clinical)"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ioi 353{K092431), EasyBody 202(K072325)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 18, 2015
Jawon Medical Co., Ltd. Won Hee Park President 1208-12, Sinsang-ri, Jinryang-eup Kyungsan-city Kyungsang-Bukdo 712-830 Republic of Korea
Re: K140045
Trade/Device Name: Jawon Body Composition Analyzers, Model X-CONTACT 350; X-CONTACT 350M; X-CONTACT 350S Regulation Number: 21 CFR 870.2770 Regulation Name: Analyzer, body composition Regulatory Class: II Product Code: MNW Dated: November 7, 2014 Received: November 20, 2014
Dear Won Hee Park,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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.
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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); medical device reporting (reporting of medical 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K140045
Device Name: Jawon Body Composition Analyzers Model X-CONTACT 350; X-CONTACT 350M; X-CONTACT 350S
Indications For Use:
These devices calculates and estimates body composition parameters by using measured weight and impedance and entered height, age and gender. It shows body composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat, Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control, Goal setter.
In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).
These devices can only estimate the body composition parameters with the exception of Weight, BMI, and impedance. These devices are only for use with generally healthy individuals of a specified age range.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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#1208-12 Sinsang-ri Jinryang-eup Kyungsan-City. Kyungsan-Bukdo712-830 Republic of Korea Tel-82-53-856—0993 Fax 82-53-856-0995
Doc. No. 4 510(K) Summary [K140045]
[As required by 21 CFR 807.92]
Date Prepared: 02/18/15
| Submitter: | Jawon Medical Co. LTD.
#1208-12 Sinsang-ri Jinryang-eup Kyungsan-City.
Kyungsan-Bukdo712-830 Republic of Korea
Tel-82-53-856-0993 Fax 82-53-856-0995
Establishment Registration Number 9616164 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | MEDMONTS Co. Ltd. (W.S. Park)
Life-officetel 320, 40 63 ro, Youngdeungpo-gu, Seoul 150-731, |
| Trade Name: | Body Composition Analyzer
Model X-Contact 350, X-Contact 350M, X-Contact 350S |
| 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 ioi 353{K092431) and EasyBody
202(K072325) |
X-Contact 350, X-Contact 350M, X-Contact 350S A list of 510(k) Devices To Be Cleared
| No. | Model Name | Indication for Use |
|---|---|---|
| 1 | X-Contact 350 | Whole Body Composition Analyzer |
| These devices calculates and estimates body composition parameters by using | ||
| measured weight and impedance and entered height, age and gender. It shows body | ||
| composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra | ||
| Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat, | ||
| Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control, | ||
| Goal setter. |
In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of
E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).
These devices can only estimate the body composition parameters with the exception
of Weight, BMI, and impedance. These devices are only for use with generally healthy
individuals of a specified age range. |
| 2 | X-Contact 350M | Upper Body Composition Analyzer
These devices calculates and estimates body composition parameters by using |
5
| 3 | X-Contact 350S | Lower Body Composition Analyzer
These devices calculates and estimates body composition parameters by using
measured weight and impedance and entered height, age and gender. It shows body
composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra
Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat,
Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control,
Goal setter.
In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of
E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).
These devices can only estimate the body composition parameters with the exception
of Weight, BMI, and impedance. These devices are only for use with generally healthy
individuals of a specified age range. |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technologic
Characteristics | These subject devices X-CONTACT 350, X-CONTACT 350M, X-CONTACT
350S have same intended use and technology characteristics as predicate
devices. See enclosed document number 9 (Substantial Equivalence
Discussion). The differences in this submission do not raise new questions
concerning either their safety or effectiveness. | |
| Non-Clinical and
Clinical Tests | These subject devices X-CONTACT 350, X-CONTACT 350M, and X-CONTACT
350S meets the requirements of IEC 60601-1, IEC 60601-1-2 and in-house test
criteria. The results of performance tests using X-Contact 350 demonstrated that
there is no significant difference in measurements. See the enclosed document
number 15 (Performance Test-Clinical) | |
| Conclusion: | Based on non-clinical and clinical tests, the modified devices X-CONTACT 350,
X-CONTACT 350M, and X-CONTACT 350S, are as safe, as effective, and
perform as predicate devices perform. (See document number 9-Substantial
Equivalents Discussion). Accordingly the subject devices X-CONTACT 350, X-
CONTACT 350M, and X-CONTACT 350S, are substantially equivalent to the
predicate devices | |