(81 days)
No
The description focuses on Bioelectrical Impedance Analysis (BIA) and does not mention AI or ML.
No.
The device is a body composition analyzer used for measurement and analysis of body parameters, not for treating any medical condition.
No
The device measures body composition parameters in healthy subjects, which is a measurement function rather than diagnosing a disease or condition.
No
The device description explicitly states that the devices are "body composition analyzers" that "determine body composition parameters based on bioelectrical impedance analysis (BIA)". This process involves applying an electrical current and analyzing the response, which requires hardware components beyond just software.
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: The device described is a body composition analyzer that uses bioelectrical impedance analysis (BIA) to measure parameters like body water, fat, and lean mass. This is done by applying electrical currents to the body's surface, not by analyzing samples taken from the body.
- Intended Use: The intended use is for "Measurement Of" various body composition parameters in "healthy subjects." This is a direct measurement of the body itself, not an analysis of a biological sample.
Therefore, the device falls under the category of a non-invasive medical device used for body composition analysis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use only in healthy subjects for measurcment of: Estimated : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW),Total Body 01: Estimatou : ECW to TBW ratio, Body Fat, Body Lean + Dry Lean, Mctabolic Rates, Segmental Lean Mass Actual : Weight, (except for model S20, which requires the manual entry of weight) Body Mass Index (BMI),and Impedance Values
Product codes
MNW
Device Description
Models Inbody 520, Inbody 720, and Inbody S20 are 4. Description of the or apposition analyzers. The devices determine body mipodation parameters based on bioclectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical on the unrently otharrerally highly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone arc relatively poor or ovallars. By analyzing the response to clectrical 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 clinical testing indicates that the new device is as safe and effective as the predicate devices.
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.
0
K052646
PAGE 1 OF 2
DEC 16 2005
EXHIBIT 2
510(k) Summary Biospace Corporation Limited 363 Yangjae-dong, Seocho-gu, Seoul 137-898, Korea Tel : +82-2-501-3939, Fax : +82-2-501-3978 Homepage : http:// www.biospace.co.kr September 20, 2005 Contact: Kichul Cha, CEO
-
- Identification of the Device: Iuchintation of the Device Body Composition Analyzers, Models Inbody 520, Inbody 720, and Inbody S20 520, Inoody 720, and moody works on ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter
-
- Equivalent legally marketed devices: Biospace Body Composition Analyzer Model InBody 3.0, K042528
-
- Indications for Use (intended use) For use only in healthy subjects for measurcment of: Estimated : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW),Total Body 01: Estimatou : ECW to TBW ratio, Body Fat, Body Lean + Dry Lean, Mctabolic Rates, Segmental Lean Mass Actual : Weight, (except for model S20, which requires the manual entry of weight) Body Mass Index (BMI),and Impedance Values
- Description of the Device: Models Inbody 520, Inbody 720, and Inbody S20 are 4. Description of the or apposition analyzers. The devices determine body mipodation parameters based on bioclectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical on the unrently otharrerally highly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone arc relatively poor or ovallars. By analyzing the response to clectrical 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 5. and clinical testing indicates that the new device is as safe and effective as the predicate devices.
1
| | Biospace Body
Composition
Analyzer Model
InBody 3.0,
Predicate | Biospace Body
Composition
Analyzer Model
InBody 720 | Biospace Body
Composition
Analyzer Model
InBody S20 | Biospace Body
Composition
Analyzer Model
InBody 520 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
number | K042528 | New | New | New |
| Intended
Use | Body
composition
analyzer | Body
composition
analyzer | Body
composition
analyzer | Body
composition
analyzer |
| Indications
for Use | (Healthy
Subjects)
Measurement
Of:
Estimated :
Extra-Cellular
Water(ECW),
Intra-Cellular
Water(ICW),
Total Body
Water,
ECW/TBW
Body Fat,
Body Lean +
Dry Lean,
Metabolic
Rates,
Segmental
Lean Mass
Actual :
Weight,
Body Mass
Index (BMI),
and
Impedance
Values:
5, 50, 250,
500kHz | (Healthy
Subjects)
Measurement
Of:
Estimated :
Extra-Cellular
Water(ECW),
Intra-Cellular
Water(ICW),
Total Body
Water,
ECW/TBW
Body Fat,
Body Lean +
Dry Lean,
Metabolic
Rates,
Segmental
Lean Mass
Actual :
Weight,
Body Mass
Index (BMI),
Impedance
Values:
1, 5, 50, 250,
500, 1,000kHz,
and
Reactance
Values:
5,50,250kHz | (Healthy
Subjects)
Measurement
Of:
Estimated :
Extra-Cellular
Water(ECW),
Intra-Cellular
Water(ICW),
Total Body
Water,
ECW/TBW
Body Fat,
Body Lean +
Dry Lean,
Metabolic
Rates,
Segmental
Lean Mass
Actual :
Weight,
Body Mass
Index (BMI),
Impedance
Values:
1, 5, 50, 250,
500, 1,000kHz,
and
Reactance
Values:
5,50,250kHz | (Healthy
Subjects)
Measurement
Of:
Estimated :
Extra-Cellular
Water(ECW),
Intra-Cellular
Water(ICW),
Total Body
Water,
ECW/TBW
Body Fat,
Body Lean +
Dry Lean,
Metabolic
Rates,
Segmental
Lean Mass
Actual :
Weight,
Body Mass
Index (BMI),
and
Impedance
Values:
5, 50, 500kHz |
| Analysis
Method | Bioelectrical
Impedance | Bioelectrical
Impedance | Bioelectrical
Impedance | Bioelectrical
Impedance |
| Operating
parameters | Frequency:
5, 50, 250, | Frequency: | Frequency: | Frequency: |
| | | 1, 5, 50, 250, | 1, 5, 50, 250, | 5, 50, 500kHz |
6. Substantial Equivalence Chart, Models Inbody 520, Inbody 720, and Inbody S20
Substantial Equivalence Chart, Models VITED C BODY COMPOSITION ANALYZERS
2
Image /page/2/Picture/1 description: The image shows a logo with a stylized bird-like figure composed of three curved lines, suggesting movement or flight. To the left of the bird, there's a curved text element, possibly the name of an organization or brand. The overall design is simple and abstract, with a focus on conveying a sense of dynamism and connection to nature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 2005
Biospace Corporation Limited c/o Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015
Re: K052646
Trade/Device Name: InBody Body Composition Analyzers, Models 520, 720 and S20 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: November 16, 2005 Received: November 17, 2005
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.
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.
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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin manoting of substantial equivalence of your device to a legally premarket notification. THC I DA miding of bactuallian 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 11 you desire specific advice tor your corres on 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 Also, please note the regulation entitled, "Albertation on your responsibilities under the Act from the 807.97). Tou may obtain outch general michel. 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. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____K052646
Device Name: Biospace Body Composition Analyzers, Models Inbody 520, Inbody 720, and Inbody S20
Indications For Use:
For use only in healthy subjects for Measurement Of: Estimated : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW),Total Body Water, (TBW), ECW to TBW ratio, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass Actual : Weight, (except for model S20, which requires the manual entry of weight) Body Mass Index (BMI),and Impedance Values
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
Nancy C broadon
(Division Sign-Off Division of Reproductive. and Radiological Devices 510(k) Number.
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