(167 days)
No
The description focuses on Bioelectrical Impedance Analysis (BIA) and does not mention any AI or ML techniques for data processing or analysis.
No
The device measures body composition parameters in healthy subjects and is not intended for the diagnosis, cure, mitigation, treatment, or prevention of disease.
No
The device is designed for the measurement of body composition parameters in healthy subjects, not for the diagnosis of diseases or medical conditions.
No
The device description explicitly states "Model Inbody 230 is an impedance plethysmograph body composition analyzer. This device determines body composition parameters based on bioelectrical impedance analysis (BIA)." This indicates the device is a hardware-based system that applies electrical currents and measures impedance, which is not a software-only function.
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, the InBody 230, is a body composition analyzer that uses bioelectrical impedance analysis (BIA). It measures parameters like body fat, muscle mass, and water content by applying electrical currents to the body.
- Lack of Sample Analysis: The description clearly states that the device measures parameters directly from the healthy subject's body. There is no mention of analyzing samples taken from the body.
Therefore, the InBody 230 falls under the category of a medical device that interacts directly with the patient, rather than an in vitro diagnostic device that analyzes samples.
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.
Actual : Weight, Body Mass Index (BMI),and Impedance Values
Product codes
MNW
Device Description
Model Inbody 230 is an impedance plethysmograph body composition analyzer. This device determines 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 clinical testing indicates that the new device is as safe and effective as the predicate devices.
After analyzing both bench and clinical testing data, it is the conclusion of Biospace that the Model After analyzing both benefi and chilled tooling data, it is as safe and effective as the predicate devices, model 250, DODT COMI OUTFORT ANTESTERS to to substantially equivalent to the predicate allu has lew technological urrerences, thas been validated via human clinical trial.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
167603 OF 2
510(k) Summary Biospace Corporation Limited 363 Yangjae-dong, Seocho-qu, Seoul 137-898, Korea Tel : +82-2-501-3939, Fax : +82-2-501-3978 Homepage : http:// www.biospace.co.kr January 15, 2006
Contact: Kichul Cha, CEO
FEB ] 5 2007
l . Identification of the Device: Proprietary-Trade Name: Biospace Body Composition Analyzers, Model Inbody 230 Classification Names: 74 MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter
-
- Equivalent legally marketed devices: Biospace Body Composition Analyzer Model InBody 3.0, K042528, Model InBody 520, K052646. Predicates for skeletal muscle mass are: Tanita Ironman Innerscan Body Composition Monitor Model BC-558 (K062652 and Omron Body Composition Monitor and Scale Model HBF-500 (K062043)
-
- 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.
Actual : Weight, Body Mass Index (BMI),and Impedance Values
-
- Description of the Device: Model Inbody 230 is an impedance plethysmograph body composition analyzer. This device determines 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 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 | Biospace Body Composition
Analyzer Model InBody 520 | Biospace Body Composition
Analyzer Model InBody 230
(NEW) |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K042528 | K052646 | |
| Intended Use | Body composition analyzer | Body composition analyzer | Body composition analyzer |
| | Measurement Of: | Measurement Of: | Measurement Of: |
| | Estimated : | Estimated : | Estimated : |
| | Extra-Cellular Water(ECW),
Intra-Cellular Water(ICW),
Total Body Water,
ECW/TBW | Extra-Cellular Water(ECW),
Intra-Cellular Water(ICW),
Total Body Water,
ECW/TBW | Extra-Cellular Water(ECW),
Intra-Cellular Water(ICW),
Total Body Water, |
| Indications for
Use | Body Fat,
Body Lean + Dry Lean,
Metabolic Rates,
Segmental Lean Mass
Actual:
Weight,
Body Mass Index (BMI),
and Impedance Values:
5, 50, 250, 500kHz | Body Fat,
Body Lean + Dry Lean,
Metabolic Rates,
Segmental Lean Mass
Actual:
Weight,
Body Mass Index (BMI),
and Impedance Values:
5, 50, 500kHz | Skeletal Muscle Mass
Body Fat,
Body Lean + Dry Lean,
Metabolic Rates,
Segmental Lean Mass
Actual:
Weight,
Body Mass Index (BMI),
and Impedance Values:
20, 100kHz |
| Analysis Method | Bioelectrical Impedance | Bioelectrical Impedance | Bioelectrical Impedance |
| Operating
parameters | Frequency :
5, 50, 250, 500kHz | Frequency :
5, 50, 500kHz | Frequency :
20, 100kHz |
| Electrode Type | tactile | tactile | Tactile |
| Number / | 8 electrodes | 8 electrodes | 8 electrodes |
| Placement of
Electrodes | placed on thumbs, palms,
heels, and fore-feet | placed on thumbs, paims,
heels, and fore-feet | placed on thumbs, palms,
heels, and fore-feet |
| Impedance
Measuring Site | Right Arm, Left Arm, Trunk,
Right Leg, Left Leg | Right Arm, Left Arm, Trunk,
Right Leg, Left Leg | Right Arm. Left Arm, Trunk,
Right Leg, Left Leg |
| Patient Position | Upright | Upright | Upright |
| Power Source | AC line | SAME | SAME |
6. Substantial Equivalence Chart, Model Inbody 230 BODY COMPOSITION ANALYZER
PAGE 2. OF 2
7. Conclusion
After analyzing both bench and clinical testing data, it is the conclusion of Biospace that the Model After analyzing both benefi and chilled tooling data, it is as safe and effective as the predicate devices, model 250, DODT COMI OUTFORT ANTESTERS to to substantially equivalent to the predicate allu has lew technological urrerences, thas been validated via human clinical trial.
2
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 stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Biospace Corporation Ltd. c/o Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015
Re: K062603
Trade/Device Name: Biospace Body Composition Analyzer, Model InBody 230 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: January 28, 2007 Received: January 31, 2007
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.
Image /page/2/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 1906-2006. The central design features the FDA acronym in bold, stylized letters above the word "Centennial". Three stars are aligned beneath the word "Centennial". The logo is encircled by text, which is partially obscured due to the image quality.
Protecting and Promoting Public Health
3
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 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" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
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): K062603
Device Name: Biospace Body Composition Analyzer, Model Inbody 230
Indications For Use:
For use only in healthy subjects for Measurement Of: Estimated : Estimatou :
Skeletal muscle mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Okeiolar massio mass, -------------------------------------------------------------------------------------------------------------------------------------------------------
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)
David A. Syverson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K062603
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