(167 days)
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
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.
The provided text describes the Biospace Body Composition Analyzer, Model InBody 230, and its substantial equivalence to predicate devices, but it does not contain a detailed study report with specific acceptance criteria and performance data in a format that lends itself to a direct table of acceptance criteria vs. device performance, nor does it explicitly detail the methodology of a study to prove it meets acceptance criteria.
However, based on the information provided, particularly the "Substantial Equivalence Chart" and the "Conclusion" section, we can infer the acceptance criteria are implicitly met by demonstrating substantial equivalence to the existing predicate devices. The document states that "After analyzing both bench and clinical testing data, it is the conclusion of Biospace that the Model [InBody 230] is as safe and effective as the predicate devices... and has been validated via human clinical trial."
Given the limitations of the provided text, I will construct a response that extracts the relevant information and indicates where detailed information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria (e.g., specific accuracy thresholds for body fat percentage). Instead, substantial equivalence is claimed based on comparable intended use, technology, and performance to predicate devices. The "reported device performance" is implied to be "as safe and effective as the predicate devices" and "validated via human clinical trial."
| Criterion Type | Predicate Device (InBody 3.0, K042528) | Predicate Device (InBody 520, K052646) | New Device (InBody 230, K062603) |
|---|---|---|---|
| Intended Use | Body composition analyzer, measurement of: Estimated ECW, ICW, TBW, ECW/TBW, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass. Actual: Weight, BMI, Impedance Values | Body composition analyzer, measurement of: Estimated ECW, ICW, TBW, ECW/TBW, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass. Actual: Weight, BMI, Impedance Values | Body composition analyzer, measurement of: Estimated Skeletal Muscle Mass, ECW, ICW, TBW, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass. Actual: Weight, BMI, Impedance Values |
| Analysis Method | Bioelectrical Impedance | Bioelectrical Impedance | Bioelectrical Impedance |
| Operating Frequencies | 5, 50, 250, 500kHz | 5, 50, 500kHz | 20, 100kHz |
| Electrode Type | Tactile (8 electrodes) | Tactile (8 electrodes) | Tactile (8 electrodes) |
| Measuring Sites | 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 |
| Performance | Implied to be safe and effective for its intended use | Implied to be safe and effective for its intended use | "As safe and effective as the predicate devices, validated via human clinical trial." (Specific performance metrics are not provided in the summary) |
Note: The primary "acceptance criterion" demonstrated here is "substantial equivalence" to the listed predicate devices, rather than meeting specific quantitative performance targets like sensitivity, specificity, or accuracy percentages. The document does not provide a study breakdown with numerical results against pre-defined thresholds.
2. Sample Size and Data Provenance for Test Set
The document mentions "human clinical trial" and "clinical testing data" but does not specify the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature) for any clinical data used.
3. Number of Experts and Qualifications for Ground Truth
The document does not provide information on the number of experts used to establish ground truth or their qualifications. The study methodology is not detailed in the provided text.
4. Adjudication Method for Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size for human readers improving with or without AI assistance. This device is a measurement tool, not an AI-assisted diagnostic imaging interpretation system.
6. Standalone Performance Study
The document states that the device was "validated via human clinical trial" and that "bench and clinical testing data" support its safety and effectiveness. This implies a standalone performance evaluation of the device's measurements. However, specific details of this standalone performance, such as metrics (e.g., accuracy, precision) or comparative data against a gold standard, are not provided. The claim is primarily about substantial equivalence to predicate devices, which also perform standalone measurements.
7. Type of Ground Truth Used
The document does not explicitly state the type of "ground truth" used in the human clinical trial. For body composition analyzers, gold standards usually involve methods like DEXA (Dual-energy X-ray Absorptiometry), hydrostatic weighing, or isotopic dilution, but this is not specified here. The absence of specific ground truth details suggests that the equivalence might primarily rely on comparison of outputs and operational characteristics with existing BIA devices deemed safe and effective.
8. Sample Size for Training Set
The document does not provide information on a separate "training set" or its sample size. This type of device (Bioelectrical Impedance Analysis) typically relies on established biophysical models rather than a machine learning training paradigm that would have a distinct training set in the AI sense.
9. How Ground Truth for Training Set Was Established
Since a distinct "training set" in the machine learning sense is not indicated, the document does not describe how ground truth for any such set was established. The device's operation is based on bioelectrical impedance principles, which leverage physiological constants and empirical equations derived from research, rather than a data-driven training process in the way an AI model would be trained.
{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 CompositionAnalyzer Model InBody 3.0 | Biospace Body CompositionAnalyzer Model InBody 520 | Biospace Body CompositionAnalyzer 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 forUse | Body Fat,Body Lean + Dry Lean,Metabolic Rates,Segmental Lean MassActual:Weight,Body Mass Index (BMI),and Impedance Values:5, 50, 250, 500kHz | Body Fat,Body Lean + Dry Lean,Metabolic Rates,Segmental Lean MassActual:Weight,Body Mass Index (BMI),and Impedance Values:5, 50, 500kHz | Skeletal Muscle MassBody Fat,Body Lean + Dry Lean,Metabolic Rates,Segmental Lean MassActual:Weight,Body Mass Index (BMI),and Impedance Values:20, 100kHz |
| Analysis Method | Bioelectrical Impedance | Bioelectrical Impedance | Bioelectrical Impedance |
| Operatingparameters | 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 ofElectrodes | placed on thumbs, palms,heels, and fore-feet | placed on thumbs, paims,heels, and fore-feet | placed on thumbs, palms,heels, and fore-feet |
| ImpedanceMeasuring 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
Page 1 of 1
§ 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.