(209 days)
For Measurement Of: Estimated: Extra-Cellular Water, Intra-Cellular Water, Total Body Water, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Actual : Weight, Body Mass Index (BMI),and Impedance Values
InBody AP1 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 document is a 510(k) summary for the InBody AP1 Body Composition Analyzer. It aims to demonstrate substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria with defined numerical thresholds.
The document does not contain the following information:
- A table of acceptance criteria with reported device performance (in terms of specific metrics like accuracy, sensitivity, specificity, etc., with numerical targets).
- Details of a study proving the device meets acceptance criteria, as the focus is on substantial equivalence.
- Sample size for a test set, data provenance, number of experts for ground truth, adjudication methods, or details of MRMC or standalone studies.
- Training set sample size or how its ground truth was established.
Instead, the document focuses on comparing the InBody AP1 to a predicate device (BodyStat QuadScan 4000) based on their intended use, indications for use, analysis methods, and operating parameters.
Here's a summary of the available information, structured to address your request where possible, and noting where information is absent:
Acceptance Criteria and Study Details for InBody AP1 Body Composition Analyzer
The provided 510(k) summary establishes substantial equivalence to a predicate device rather than explicitly defining and demonstrating adherence to specific numerical acceptance criteria. The "acceptance criteria" can be inferred as meeting the functional and performance characteristics deemed equivalent to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria (e.g., "accuracy > 95%") are not defined in this document, the table below focuses on the comparison made to establish substantial equivalence. The "Acceptance Criteria" implicitly refer to the predicate device's established performance and characteristics, and the "Reported Device Performance" pertains to the InBody AP1 matching those characteristics.
| Feature / Criterion (as implied by predicate comparison) | Predicate Device (BodyStat QuadScan 4000) Performance/Characteristic | InBody AP1 Reported Device Performance/Characteristic |
|---|---|---|
| Intended Use | Body composition analyzer | Body composition analyzer |
| Indications for Use (Estimated) | Extra-Cellular Water, Intra-Cellular Water, Total Body Water, Body Fat, Body Lean + Dry Lean, Metabolic Rates | Extra-Cellular Water, Intra-Cellular Water, Total Body Water, Body Fat, Body Lean + Dry Lean, Metabolic Rates |
| Indications for Use (Actual) | Waist/Hip Ratio, Body Mass Index (BMI), and Impedance Values | Weight, Body Mass Index (BMI), and Impedance Values |
| Analysis Method | Bioelectrical Impedance | Bioelectrical Impedance |
| Operating Frequencies | 5, 50, 100, 200kHz | 5, 50, 250kHz |
| Electrode Type | adhesive | tactile |
| Number/Placement of Electrodes | 4 electrodes placed on hands and feet | 8 electrodes placed on thumbs, palms, heels, and fore-feet |
| Impedance Measuring Site | Whole Body (Right Arm to Right Leg) | Right Arm, Left Arm, Trunk, Right Leg, Left Leg |
| Patient Position | Supine | Upright |
Conclusion from the document: "After analyzing both bench and clinical testing data, it is the conclusion of Biospace that the InBody AP1 BODY COMPOSITION ANALYZER as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance:
- The document mentions "clinical testing data" but does not specify the sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe the establishment of a ground truth for a test set in the context of expert review.
4. Adjudication method for the test set:
- Not specified. No information is provided regarding adjudication methods.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- Not specified. The document does not mention an MRMC study or any comparison of human readers with or without AI assistance. The device itself is a body composition analyzer, not a diagnostic imaging AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is inherently a "standalone" algorithm in a sense, as it directly measures and calculates body composition parameters. It's not an assistive AI for human interpretation in the way an imaging algorithm would be. The document implies the device performs its function directly by analyzing bioelectrical impedance. No specific "standalone performance study" in the context of comparing with human performance is described.
7. The type of ground truth used:
- The document implies that the "ground truth" or reference for evaluating the InBody AP1's performance would be the established accuracy and clinical utility of its predicate devices, or other accepted methods for body composition analysis against which bioelectrical impedance analysis is typically validated. However, the specific methodology for establishing ground truth data in the "clinical testing data" mentioned is not detailed. It does not explicitly state pathology, outcomes data, or expert consensus as the ground truth.
8. The sample size for the training set:
- Not specified. The document does not provide any details about a training set. The device uses bioelectrical impedance analysis (BIA), which typically relies on established physiological models and algorithms, rather than being "trained" on a specific dataset in the way a modern machine learning algorithm would be.
9. How the ground truth for the training set was established:
- Not applicable/Not specified. As there's no mention of a traditional "training set" in the context of machine learning, there is no information on how its ground truth might have been established.
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EXHIBIT 2 510(k) Summary of Safety and Effectiveness
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
October 2, 2002 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
-
- Indications for Use (intended use) For Measurement Of: Estimated: Extra-Cellular Water, Intra-Cellular Water, Total Body Water, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Actual : Weight, Body Mass Index (BMI),and Impedance Values.
-
- Description of the Device: InBody AP1 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.
-
- 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 | Biospace Body CompositionAnalyzer Model InBody AP1 | |
|---|---|---|
| 510(k) number | K002835 | |
| Intended Use | Body composition analyzer | Body composition analyzer |
| Indications for Use | Measurement Of: | Measurement Of: |
| Estimated : | Estimated : | |
| Extra-Cellular Water, | Extra-Cellular Water, | |
| Intra-Cellular Water, | Intra-Cellular Water, | |
| Total Body Water, | Total Body Water, | |
| Body Fat, | Body Fat, | |
| Body Lean + Dry Lean, | Body Lean + Dry Lean, | |
| Metabolic Rates, | Metabolic Rates, | |
| Actual : | Actual : | |
| Waist/Hip Ratio, | Weight, | |
| Body Mass Index (BMI), | Body Mass Index (BMI), | |
| and Impedance Values | and Impedance Values | |
| Analysis Method | Bioelectrical Impedance | Bioelectrical Impedance |
| Operating parameters | Frequency : | Frequency : |
| 5, 50, 100, 200kHz | 5, 50, 250kHz | |
| Electrode Type | adhesive | tactile |
| Number /Placement of Electrodes | 4 electrodes | 8 electrodes |
| placed on | placed on thumbs, palms, heels, | |
| hands and feet | and fore-feet | |
| Impedance Measuring Site | Whole Body( Right Arm to Right Leg ) | Right Arm, Left Arm, Trunk,Right Leg, Left Leg |
| Patient Position | Supine | Upright |
6. Substantial Equivalence Chart, InBody AP1 BODY COMPOSITION ANALYZER
7. Conclusion
After analyzing both bench and clinical testing data, it is the conclusion of Biospace that the InBody AP1 BODY COMPOSITION ANALYZER as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping birds in flight, with flowing lines suggesting movement or energy. The entire logo is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2003
Biospace Corporation Limited c/o Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015
Re: K023478
Trade/Device Name: Biospace InBody, Model AP1, Body Composition Analyzer Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: February 11, 2003 Received: February 12, 2003
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 (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); 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 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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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j) Indications for Use
K023478 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Device Name: InBody AP1 BODY COMPOSITION ANALYZER
Indications for Use: For Measurement Of:
Estimated: Extra-Cellular Water, Intra-Cellular Water, Total Body Water, Body Fat, Body Lean + Dry Lean, Metabolic Rates,
Actual : Weight, Body Mass Index (BMI),and Impedance Values
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ OR Over the Counter Use_ (Per 21 CFR 801.109)
Nancy C Hogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .
§ 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.