(81 days)
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
Models Inbody 520, Inbody 720, and Inbody S20 are body composition analyzers. The 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.
The provided K052646 document for Biospace Corporation Limited's InBody Body Composition Analyzers (Models 520, 720, and S20) does not contain detailed acceptance criteria, specific study designs, or reported device performance metrics as requested. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Biospace Body Composition Analyzer Model InBody 3.0, K042528) to obtain 510(k) clearance from the FDA.
The document indicates that "bench and clinical testing indicates that the new device is as safe and effective as the predicate devices," but it does not provide the quantitative results or specific acceptance criteria for these tests. The comparison table primarily highlights the features and indications for use, including the different frequencies used for impedance measurements, between the new devices and the predicate.
Therefore, many of the requested details cannot be extracted directly from this document. Below is an attempt to address the points based on the available information and what can be inferred about a 510(k) submission for substantial equivalence.
Acceptance Criteria and Study for Biospace Body Composition Analyzers (Models InBody 520, InBody 720, and InBody S20)
The provided submission primarily focuses on demonstrating "substantial equivalence" to a predicate device, as opposed to establishing specific performance acceptance criteria and proving them through detailed studies with quantitative results. The core of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily that it meets pre-defined acceptance criteria for novel performance claims.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, explicit quantitative acceptance criteria and reported device performance metrics (e.g., accuracy, precision, correlation coefficients against a gold standard) are not detailed. The document generally states: "The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices."
The comparison table (Section 6) focuses on functional equivalence, listing the Indications for Use and Analysis Method as identical to the predicate device, but expands the Operating parameters (Frequency) for the new models (InBody 720 and S20) compared to the predicate and InBody 520. This suggests that the "acceptance criteria" were likely related to demonstrating similar measurements and safety profiles to the predicate, rather than meeting specific numerical performance targets against a true gold standard.
| Parameter/Characteristic | Acceptance Criteria (Inferred from Substantial Equivalence Goal) | Reported Device Performance (Inferred/Stated) |
|---|---|---|
| Safety | As safe as predicate device (Biospace Body Composition Analyzer Model InBody 3.0, K042528). | "Bench and clinical testing indicates that the new device is as safe... as the predicate devices." |
| Effectiveness | As effective as predicate device (Biospace Body Composition Analyzer Model InBody 3.0, K042528) in measuring listed body composition parameters. | "Bench and clinical testing indicates that the new device is as ...effective as the predicate devices." |
| Indications for Use | Identical to predicate device for healthy subjects. | All new models (520, 720, S20) share identical (or expanded for 720, S20 with additional frequencies for impedance/reactance) indications as the predicate. |
| Analysis Method | Identical Bioelectrical Impedance Analysis (BIA) method. | All new models use Bioelectrical Impedance Analysis (BIA). |
| Operating Parameters | Comparable or enhanced measurement frequencies. | InBody 520 uses 5, 50, 500kHz. InBody 720 and S20 use 1, 5, 50, 250, 500, 1,000kHz (and 5, 50, 250kHz for Reactance). The predicate used 5, 50, 250, 500kHz. |
Missing Information: The document does not provide actual numerical data for accuracy, precision, bias, correlation coefficients, or any other specific performance metrics from the bench or clinical testing mentioned.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. For a 510(k) submission based on substantial equivalence, clinical data might involve healthy volunteers to demonstrate comparable measurements to the predicate device, but specific sample sizes and data provenance (e.g., country of origin, retrospective/prospective nature) are not disclosed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. Body composition analysis, especially with BIA, usually relies on reference methods (e.g., DEXA, hydrodensitometry) or other validated BIA devices rather than expert consensus on images. The "ground truth" for the test set would likely be measurements from the predicate device or a clinical gold standard, if such a study was performed.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided. As the device measures quantitative physiological parameters rather than interpreting images or clinical signs, an adjudication method for "test set" interpretation is generally not applicable in the same way it would be for diagnostic imaging.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
This information is not provided. MRMC studies are typically used in diagnostic imaging to assess human reader performance with and without AI assistance. This device is a quantitative measurement tool (body composition analyzer), not an imaging interpretation aid, so an MRMC study is highly unlikely to have been performed or relevant for this type of submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone algorithm/device for body composition analysis. The "performance" described would inherently be the algorithm's performance in providing measurements. The document generally states "bench and clinical testing," which implies direct performance evaluation of the device in a standalone capacity. No human-in-the-loop component is mentioned or suggested for the primary function of body composition measurement.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The specific type of "ground truth" used for any clinical testing (if conducted beyond direct comparison to the predicate) is not explicitly stated. However, for body composition analyzers like the InBody series, the ground truth typically involves:
- Validated Reference Methods: Such as Dual-energy X-ray Absorptiometry (DEXA), hydrodensitometry (underwater weighing), or isotope dilution for water compartments.
- Comparison to a Predicate Device: In a 510(k) context, a common approach is to demonstrate agreement with the legally marketed predicate device (Biospace Body Composition Analyzer Model InBody 3.0, K042528) through correlation studies or Bland-Altman analysis.
Given the 510(k) pathway, it is most probable that comparability to the predicate device was the primary "ground truth" for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
This information is not provided. BIA devices typically use mathematical models and equations to convert impedance values into body composition parameters. While these models might be "trained" or derived from large population datasets, the details of such training sets (size, characteristics, data provenance) are not part of this 510(k) summary. This submission focuses on the performance of the device (applying its algorithms) rather than the development of the algorithms themselves.
9. How the Ground Truth for the Training Set was Established
This information is not provided. If mathematical models within the device's software were derived from population data, the ground truth for establishing those models would typically come from a combination of gold-standard body composition methods (e.g., DEXA, hydrodensitometry) applied to a diverse cohort. However, this level of detail is beyond the scope of this 510(k) submission, which assumes the underlying BIA principles and algorithms are already established or sufficiently similar to a predicate.
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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
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- 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
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- Equivalent legally marketed devices: Biospace Body Composition Analyzer Model InBody 3.0, K042528
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- 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.
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| Biospace BodyCompositionAnalyzer ModelInBody 3.0,Predicate | Biospace BodyCompositionAnalyzer ModelInBody 720 | Biospace BodyCompositionAnalyzer ModelInBody S20 | Biospace BodyCompositionAnalyzer ModelInBody 520 | |
|---|---|---|---|---|
| 510(k)number | K042528 | New | New | New |
| IntendedUse | Bodycompositionanalyzer | Bodycompositionanalyzer | Bodycompositionanalyzer | Bodycompositionanalyzer |
| Indicationsfor Use | (HealthySubjects)MeasurementOf:Estimated :Extra-CellularWater(ECW),Intra-CellularWater(ICW),Total BodyWater,ECW/TBWBody Fat,Body Lean +Dry Lean,MetabolicRates,SegmentalLean MassActual :Weight,Body MassIndex (BMI),andImpedanceValues:5, 50, 250,500kHz | (HealthySubjects)MeasurementOf:Estimated :Extra-CellularWater(ECW),Intra-CellularWater(ICW),Total BodyWater,ECW/TBWBody Fat,Body Lean +Dry Lean,MetabolicRates,SegmentalLean MassActual :Weight,Body MassIndex (BMI),ImpedanceValues:1, 5, 50, 250,500, 1,000kHz,andReactanceValues:5,50,250kHz | (HealthySubjects)MeasurementOf:Estimated :Extra-CellularWater(ECW),Intra-CellularWater(ICW),Total BodyWater,ECW/TBWBody Fat,Body Lean +Dry Lean,MetabolicRates,SegmentalLean MassActual :Weight,Body MassIndex (BMI),ImpedanceValues:1, 5, 50, 250,500, 1,000kHz,andReactanceValues:5,50,250kHz | (HealthySubjects)MeasurementOf:Estimated :Extra-CellularWater(ECW),Intra-CellularWater(ICW),Total BodyWater,ECW/TBWBody Fat,Body Lean +Dry Lean,MetabolicRates,SegmentalLean MassActual :Weight,Body MassIndex (BMI),andImpedanceValues:5, 50, 500kHz |
| AnalysisMethod | BioelectricalImpedance | BioelectricalImpedance | BioelectricalImpedance | BioelectricalImpedance |
| Operatingparameters | 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
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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.
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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
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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.
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.