(157 days)
No
The description focuses on Bioelectrical Impedance Analysis (BIA) and does not mention AI or ML.
No.
The device is described as a body composition analyzer for measurement and analysis purposes, not for treating or rehabilitating health conditions.
No
The "Intended Use / Indications for Use" section states that the device is for "Measurement of" various body composition parameters and does not mention diagnosis of any disease or condition. It is used in "healthy subjects".
No
The device description explicitly states that the devices are "impedance plethysmograph body composition analyzers" and determine body composition based on "bioelectrical impedance analysis (BIA)". This involves applying an electrical current to the body, which requires hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Measurement of" various body composition parameters in "healthy subjects." This involves measuring physical characteristics of the body directly, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The device uses "bioelectrical impedance analysis (BIA)" to determine body composition. This is a non-invasive method that applies electrical currents to the body, not a method that analyzes biological samples in vitro (in a lab setting).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside of the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device measures physical attributes of the body itself.
N/A
Intended Use / Indications for Use
For use only in healthy subjects for Measurement of: Estimated: Skeletal muscle mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass, Segmental Body Fat mass, % Segmental Body Fat, and Energy expenditure of activity, Visceral Fat Area (VFA).
Actual : Weight [except for model S10, which requires the manual entry of weight], Body Mass Index (BMI), Impedance Values, height [only for model InBodyJ30, which has height-meter function].
Product codes
MNW
Device Description
InBodyS10, InBodyl70, and InBodyJ30 are impedance plethysmograph body composition analyzers. These devices determine body composition parameters based on bioelectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical current. Lean tissue is generally highly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA thereby permits differentiation of lean tissue, fat, and water and, in some instances, derivation of related body composition parameters. The total impedance resulting from BIA incorporates both resistance and capacitance components.
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
Not Found
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)
The results of bench and software testing indicates that the new devices are as safe and effective as 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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510(k) Summary K110689
AUG 1 9 2011
Biospace Corporation Limited Donghyun Building, 518-10 Dogok 2 - Dong Gangnam-Gu, Seoul, KOREA 135-854 Tel : +82-2-501-3939, Fax : +82-2-501-3978 Homepage : http:// www.biospace.co.kr
July 11, 2011 Contact: Kichul Cha, CEO
- l . Identification of the Device: Proprietary-Trade Name: Biospace Body Composition Analyzers, InBodyS10; InBody170; InBodyJ30: Classification Names: MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter
- Equivalent legally marketed devices: The BioSpace InBodyS20(K052646) and The BioSpace 2. InBody270(K092786)
-
- Indications for Use (intended use) For use only in healthy subjects for Measurement of: Estimated: Skeletal muscle mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass, Segmental Body Fat mass, % Segmental Body Fat, and Energy expenditure of activity, Visceral Fat Area (VFA).
Actual : Weight [except for model S10, which requires the manual entry of weight], Body Mass Index (BMI), Impedance Values, height [only for model InBodyJ30, which has height-meter function].
- Description of the Device: InBodyS10, InBodyl70, and InBodyJ30 are impedance 4. plethysmograph body composition analyzers. These devices determine body composition parameters based on bioelectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical current. Lean tissue is generally bighly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA thereby permits differentiation of lean tissue, fat, and water and, in some instances, derivation of related body composition parameters. The total impedance resulting from BIA incorporates both resistance and capacitance components.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and software testing indicates that the new devices are as safe and effective as the predicate device.
-
- Substantial Equivalence Chart, InBodyS10; InBody170; InBodyJ30; (Next page)
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| Devices | InBody270 | InBodyS20 | InBodyS10 | InBody170 | InBodyJ30 | |
|---|---|---|---|---|---|---|
| 510(k) number | K092786 | K052646 | New | New | New | |
| Manufacturer | BioSpace | BioSpace | BioSpace | BioSpace | BioSpace | |
| Measurement of Estimated : | Extra-Cellular | |||||
| Water(ECW), | √ | √ | √ | √ | √ | |
| Intra-Cellular | ||||||
| Water(ICW), | √ | √ | √ | √ | √ | |
| Total Body Water, | √ | √ | √ | √ | √ | |
| Skeletal Muscle | ||||||
| Mass | √ | √ | √ | √ | √ | |
| Body Fat, | √ | √ | √ | √ | √ | |
| Body Lean + Dry | ||||||
| Lean, | √ | √ | √ | √ | √ | |
| Basal Metabolic | ||||||
| Rates, | √ | √ | √ | √ | √ | |
| Segmental Lean | ||||||
| Mass, | √ | √ | √ | √ | √ | |
| ECW/TBW | √ | √ | √ | √ | ||
| Segmental Body Fat | ||||||
| mass, | √ | √ | √ | √ | ||
| % Segmental Body | ||||||
| Fat, | √ | √ | √ | √ | ||
| Energy expenditure | ||||||
| of activity, | √ | √ | √ | √ | ||
| Visceral Fat Area | ||||||
| (VFA) | (Evaluation with CT) | (Evaluation with CT) | (Evaluation with CT) | |||
| Weight | √ | √ | √ (Predicate BSM370_ scale, stand-on, patient, 510(k) exempt) | |||
| Measurement of Actual : | height | |||||
| Body Mass Index | ||||||
| (BMI), | √ | √ | √ | √ | √ | |
| Impedance Values: | 20, 100kHz | 1, 5, 50, 250, 500, 1,000kHz | 1, 5, 50, 250, 500, 1,000kHz | 20, 100kHz | 5, 50, 250kHz | |
| Reactance Values: | 5,50,250kHz | 5,50,250kHz | ||||
| Analysis Method | Bioelectrical | |||||
| Impedance | √ | √ | √ | √ | √ | |
| Electrode Type | Tactile | √ | √ | √ | ||
| Tactile / Adhesive | √ | √ | ||||
| Number of Electrodes | 8 electrodes | √ | √ | √ | √ | √ |
| Placement of Electrodes | placed on thumbs | √ | √ | √ | √ | √ |
| placed on palms, | √ | √ | √ | √ | √ | |
| placed on heels | √ | √ | √ | √ | √ | |
| placed on fore-feet | √ | √ | √ | √ | √ | |
| Electrode | First and third finger | √ | √ | |||
| connection | ankle | √ | √ | |||
| geometry | Hand | √ | √ | √ | ||
| Impedance | ||||||
| Measuring Site | Foot | √ | √ | √ | ||
| Right Arm | √ | √ | √ | √ | √ | |
| Left Arm | √ | √ | √ | √ | √ | |
| Trunk | √ | √ | √ | √ | √ | |
| Right Leg | √ | √ | √ | √ | √ | |
| Left Leg | √ | √ | √ | √ | √ | |
| Patient Position | Upright | √ | √ | √ | √ | √ |
| Supine | √ | √ | ||||
| Devices | InBody270 | InBodyS20 | InBodyS10 | InBody170 | InBodyJ30 | |
| Sitting | √ | |||||
| Application | ||||||
| software | ||||||
| (Optional) | LB 110 (Stand-alone | |||||
| device) | √ | |||||
| (510(k) | ||||||
| Exempt) | √ | |||||
| (510(k) | ||||||
| Exempt) | √ | |||||
| (510(k) | ||||||
| Exempt) |
.. -
:
· ·······
:
・・・・
·
: . . . . . . .
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K110689
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7. Conclusion
After analyzing bench testing data, software validation, and the risk analysis, and based upon the intended use, and upon the similarity of product configuration and administration, it can be concluded that Model InBodyS10, InBody170, InBodyJ30 are substantially equivalent to the identified predicate devices in terms of intended use, safety and effectiveness. The safety characteristics are identical.co the predicates.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Biospace Corporation Limited % Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
AUG 1 9 2011
Re: K110689
.
Trade/Device Name: InBodyS10, InBody170, InBodyJ30 Regulation Number: 21 CFR& 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: August 12. 2011 Received: August 17, 2011
Dear Mr. Kamm:
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.
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 of medical device-related
4
Page 2
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.html 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,
Hubert Lehman MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
5
Indications for use
510(k) Number (if Known) : K110689
Device Name : InBodyS10, InBody170, InBodyJ30
Indications for use :
For use only in healthy subjects for Measurement of :
Estimated: Skeletal muscle mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW),Total Body Water (TBW), Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass, Segmental Body Fat mass, % Segmental Body Fat, and Energy expenditure of activity, Visceral Fat Area (VFA).
Actual : Weight [except for model S10, which requires the manual entry of weight], Body Mass Index (BMI), Impedance Values, height [only for model InBodyJ30, which has height-meter function]
| Prescription Use | AND/OR | Over-The-Counter Use X |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Badiologial Dovina
Radiological Devices 510(k) Number
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