(116 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, Body Mass Index (BMI),and Impedance Values
InBody 3.0 is an impedance plethysmograph body composition analyzer. The 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 does not contain specific acceptance criteria or a study that directly proves the device meets such criteria in a quantitative sense (e.g., sensitivity, specificity, accuracy targets). Instead, it's a 510(k) summary for a medical device (InBody 3.0 Body Composition Analyzer) seeking substantial equivalence to existing legally marketed devices.
The "study" referenced in the document is a comparison to predicate devices, where the new device is deemed "as safe and effective as the predicate devices" based on "bench and clinical testing." However, the details of these tests, including specific performance metrics and acceptance criteria, are not provided.
Here's an attempt to answer the questions based on the available information, noting where information is missing:
1. A table of acceptance criteria and the reported device performance
No explicit quantitative acceptance criteria (e.g., specific accuracy ranges, correlation coefficients, or sensitivity/specificity thresholds) and corresponding reported performance values for the InBody 3.0 are provided in the document. The document states that "The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices," implying that its performance is comparable to the predicate devices, but without specifying how that "safety and effectiveness" was measured or what values constitute "safe and effective."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing mentions "clinical testing" but does not detail the sample size, study design (retrospective/prospective), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. Given that the device measures body composition parameters, the "ground truth" would likely involve reference methods for body composition (e.g., DEXA, hydrostatic weighing), rather than expert interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This type of study is not applicable to the InBody 3.0 Body Composition Analyzer. This device is an automated measurement tool for body composition, not an AI-assisted diagnostic imaging tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The InBody 3.0 is a standalone device that performs measurements directly. Its performance would inherently be "standalone." However, specific quantitative performance metrics (e.g., accuracy against a gold standard) are not reported in this summary. The assessment of "safety and effectiveness" against predicate devices implies standalone comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used for "clinical testing." For body composition analyzers, common ground truth methods include:
- Dual-energy X-ray absorptiometry (DEXA)
- Hydrostatic weighing (underwater weighing)
- Isotope dilution
- Air displacement plethysmography (Bod Pod)
It is highly probable that one or more of these established methods were used, but the document does not specify.
8. The sample size for the training set
This information is not provided in the document. The device uses Bioelectrical Impedance Analysis (BIA), which relies on established physiological models and algorithms. While these models are developed and potentially trained on various populations, the specific training set size for this particular device's algorithms is not disclosed in the 510(k) summary.
9. How the ground truth for the training set was established
This information is not provided in the document. Similar to the test set, any "training" (model development) for the BIA algorithms would have utilized established bodily composition measurement techniques, but the specifics are not detailed.
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K042528
PAGE 1 OF 2
JAN 1 1 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 November 8, 2004 Contact: Kichul Cha, CEO
-
- Identification of the Device: Proprietary-Trade Name: InBody AP1 BODY COMPOSITION ANALYZER Classification Names: 74 MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter
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- Indications for Use (intended 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, Body Mass Index (BMI),and Impedance Values
- Description of the Device: InBody 3.0 is an impedance plethysmograph body 4. composition analyzer. The 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.
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| BodyStatQuadScan 4000 | RJL SystemsBIA-101A | Biospace BodyCompositionAnalyzer ModelInBody AP1 | Biospace BodyCompositionAnalyzer ModelInBody 3.0 | |
|---|---|---|---|---|
| 510(k)number | K002835 | K830292 | K023478 | |
| IntendedUse | Body compositionanalyzer | Body compositionanalyzer | Body compositionanalyzer | Body compositionanalyzer |
| Indicationsfor Use(Healthysubjects) | Measurement Of:Estimated :Extra-Cellular Water,Intra-Cellular Water,Total Body Water,Body Fat,Body Lean + DryLean,Metabolic Rates,Actual :Waist/Hip Ratio,Body Mass Index(BMI),and ImpedanceValues:5, 50, 100, 200kHz | Measurement Of:Resistance andReactance Value:50kHz | Measurement Of:Estimated :Extra-Cellular Water,Intra-Cellular Water,Total Body Water,Body Fat,Body Lean + DryLean,Metabolic Rates,Actual :Weight,Body Mass Index(BMI),and ImpedanceValues:5, 50, 250kHz | Measurement Of:Estimated :Extra-CellularWater(ECW),Intra-CellularWater(ICW),Total Body Water(TBW),ECW to /TBW ratioBody Fat,Body Lean + DryLean,Metabolic Rates,Segmental LeanMassActual :Weight,Body Mass Index(BMI),and ImpedanceValues:5, 50, 250, 500kHz |
| AnalysisMethod | BioelectricalImpedance | BioelectricalImpedance | BioelectricalImpedance | BioelectricalImpedance |
| Operatingparameters | Frequency :5, 50, 100, 200kHz | Frequency :50kHz | Frequency :5, 50, 250kHz | Frequency :5, 50, 250, 500kHz |
| ElectrodeType | adhesive | adhesive | tactile | tactile |
| Number /Placementof Electrodes | 4 electrodesplaced onhands and feet | 4 electrodesplaced onhands and feet | 8 electrodesplaced on thumbs,palms, heels, andfore-feet | 8 electrodesplaced on thumbs,palms, heels, andfore-feet |
| ImpedanceMeasuring | Whole Body( Right Arm to Right | Whole Body( Right Arm to Right | Right Arm, Left Arm,Trunk,Right Leg, Left Leg | Right Arm, Left Arm,Trunk,Right Leg, Left Leg |
6. Substantial Equivalence Chart, InBody AP1 BODY COMPOSITION ANALYZER
7. Conclusion
Leg )
Supine
Site
Patient
Position
- After analyzing both belief and clinical teams and effective as the producate
InBody 3.0 BODY COMPOSITION ANALYZER as safe and effective as the predicate Ifibody 3.0 BODT COMI OUTFORTITIVE - BEAT - Substantially equivalent to the predicate devices.
Leg )
Supine
Upright
Upright
2
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2005
Biospace Corporation Limited c/o Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015
Re: K042528
Trade/Device Name: InBody 3.0 Body Composition Analyzer Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: November 8, 2004 Received: November 9, 2004
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of pror to ria) 2011-07-12, 11:25 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 r ou may, dictere, manner are a e act include requirements for annual registration, listing of general oonline provisioning practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 acc 10) ... Existing major regulations affecting your device can be it may of subjoct to adamestic segulations, 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 i Tease be advised that I Drivision that your device complies with other requirements of the Act that I Dri has made a active and regulations administered by other Federal agencies. You must of any I ederal statures and rougherents, including, but not limited to: registration and listing Comply with and No. 3 requirently Part 801); good manufacturing practice requirements as set (21 CFR Part 801), acceming (21 CFR Part 820); and if applicable, the electronic form in the quality by tickle (QB) -13
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) This letter whil anow you to obgin maining of substantial equivalence of your device to a legally premarked notheation: "The PDF maning station 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 If you desire specific acvice for your as not 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, prease note the regulation on your responsibilities under the Act from the 007.97). I Ou may obtain other gational and Consumer Assistance at its toll-free number (800) DIVISION of Shian Manufacturers, Internet address http://www.fda.gov/cdrb/dsmaldsmamain.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
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Indications for Use
K042528 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:_Biospace InBody 3.0
Indications For Use:
For use only in healthy subjects for Measurement Of: For use only in nealthy Subjects for modelier Water (ICW),Total Body Water
Estimated : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW),Total Botas Estimated : Extra-Ochaldi Water (Eot. P) , Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass Segmental Eoun 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 R. Syrom
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042528
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.