(181 days)
No
The description focuses on Bioelectrical Impedance Analysis (BIA) and does not mention AI or ML.
No
The device is used for measurement and analysis of body composition parameters, not for treating or managing a disease or condition.
No
The device is described as a body composition analyzer that measures various body parameters in healthy subjects. It does not mention diagnosing diseases or conditions. The intended use is for measurement and analysis of body composition, not for diagnostic purposes.
No
The device description explicitly states that the devices are "impedance plethysmograph body composition analyzers" and "determine body composition parameters based on bioelectrical impedance analysis (BIA)". This 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 description clearly states that this device is an "impedance plethysmograph body composition analyzer" that uses "bioelectrical impedance analysis (BIA)". This involves applying electrical currents to the body and measuring the response.
- Intended Use: The intended use is 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. Actual : Weight, Body Mass Index (BMI),and Impedance Values". These are all measurements taken directly from the living subject, not from a sample taken from the subject.
Therefore, since the device operates by interacting directly with the body and does not analyze samples taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
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. Actual : Weight, Body Mass Index (BMI),and Impedance Values
Product codes
MNW
Device Description
Models InBody 270, InBody R20, and InBody R20B 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
Right Arm, Left Arm, Trunk, Right Leg, Left Leg
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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K092786
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510(k) Summary K09
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
MAR 1 0 2010
August 27, 2009 Contact: Kichul Cha, CEO
- Identification of the Device: 1. Proprietary-Trade Name: Biospace Body Composition Analyzers, Models InBody 270, InBody R20, and InBody R20B Classification Names: 74 MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter
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- Equivalent legally marketed devices: Biospace Body Composition Analyzer Model InBody 230 K062603
-
- 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. Actual : Weight, Body Mass Index (BMI),and Impedance Values
-
- Description of the Device: Models InBody 270, InBody R20, and InBody R20B 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.
-
- 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.
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K092786
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| Biospace Body Composition Analyzer | Models InBody 270, InBody R20, and | |
|---|---|---|
| Model InBody 230 | InBody R20B | |
| 510(k) number | K062603 | (NEW) |
| Indications for Use | 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 | 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 | ||
| New: | ||
| Segmental Body Fat mass | ||
| % Segmental Body Fat- Energy | ||
| expenditure of activity | ||
| Measurement of Actual : | ||
| Weight | ||
| Body Mass Index (BMI) | ||
| Impedance Values | Measurement of Actual : | |
| Weight | ||
| Body Mass Index (BMI) | ||
| Impedance Values | ||
| Analysis Method | Bioelectrical Impedance | Bioelectrical Impedance |
| Operating parameters | Frequency : | |
| 20, 100kHz | Frequency : | |
| 20, 100kHz | ||
| Electrode Type | Tactile | Tactile . |
| Number / | 8 electrodes | 8 electrodes |
| Placement of | placed on thumbs, palms, heels, and | placed on thumbs, palms, heels, and |
| Electrodes | fore-feet | fore-feet |
| Impedance Measuring | Right Arm, Left Arm, Trunk, | Right Arm, Left Arm, Trunk, |
| Site | Right Leg, Left Leg | Right Leg, Left Leg |
| Patient Position | Upright | Upright |
| Patient population | Healthy individuals | SAME |
| Power Source | AC Line . | SAME, Except Model R20 operates |
| from 4-AA alkaline batteries. |
- Substantial Equivalence Chart, Model InBody 270, InBody R20, and InBody R20B .
Differences between models InBody 270, InBody R20, and InBody R20B: InBody 270 has a pedestal stand for the hand contacts, and InBody R20/R20B use a coiled cord for the hand contacts. Model R20B has Bluetooth, whereas the other two models do not.
7. Conclusion
After analyzing bench testing data, software validation, and the risk analysis, it is the conclusion of Biospace that the Models InBody 270, InBody R20, and InBody R20B, BODY COMPOSITION ANALYZERS are as safe and effective as the predicate devices, and have few technological differences, thus rendering them substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G61 Silver Spring, MD 20993-0002
MAR ] 0 2010
Biospace Corporation Ltd. c/o Mr. Daniel Kamm Kamm & Associates 8726 Ferrara Court NAPLES FL 34114
Re: K092786
Trade/Device Name: Biospace Body Composition Analyzer, Models InBody 270, InBody R20, and InBody R20B
Regulation Number: 21 CFR 8870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW · Dated: January 26, 2010 Received: February 2, 2010
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
3
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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
4
Indications for Use
510(k) Number (if known): K09 2786
Device Name: Biospace Body, Composition Analyzer, Models InBody 270, InBody R20, and InBody R20B.
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.
Actual : 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)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number_
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