(83 days)
The BC100 Body Composition Analysis System is a noninvasive bioimpedance analyzer for use in healthy subjects for measurement of actual height, actual weight and estimated body fat percentage. The applicable age range is 10 to 80 years old.
The proposed Athletic IQ, Inc. (AIQ) BC100 Body Composition Analysis System is a noninvasive bioimpedance analyzer for use in healthy subjects for measurement of actual height, actual weight and estimated body fat percentage. The applicable age range is 10 to 80 years old. The device determines estimated body fat percentage 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, whereas fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA permits differentiation of fat vs. lean tissue. When combined with the subject's height and weight parameters, age, and gender, an estimated body fat percentage may be calculated using an experimentally derived algorithm.
The provided text states that "Clinical testing was conducted to establish the algorithm used by the BC100 system for estimation of percent body fat using bioelectrical impedance data." However, it does not provide details on the acceptance criteria, the specific study design, or the results of this clinical testing. Therefore, I cannot construct the requested tables or provide detailed answers to many of your questions based only on the provided text.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the provided text.
- Reported Device Performance: Not specified in the provided text, beyond the general statement that "Clinical testing was conducted to establish the algorithm."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (country of origin, retrospective/prospective).
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)
- Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- Not applicable/Not specified. This device is a diagnostic tool, not an AI-assisted interpretation tool for human readers. It directly provides an estimated body fat percentage.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device "determines estimated body fat percentage based on bioelectrical impedance analysis (BIA)" and calculates it "using an experimentally derived algorithm." This indicates a standalone algorithm performance without human intervention in the result generation. However, the performance metrics for this standalone algorithm are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. For body fat analysis, a common ground truth method would be DEXA (Dual-energy X-ray absorptiometry) or hydrostatic weighing, but the text does not mention the method used.
8. The sample size for the training set
- Not specified. The text mentions "an experimentally derived algorithm," implying a training set was used, but no details are given.
9. How the ground truth for the training set was established
- Not specified.
Summary of what is known from the provided text:
- Device Name: BC100 Body Composition Analysis System
- Intended Use: Noninvasive bioimpedance analyzer for measurement of actual height, actual weight, and estimated body fat percentage in healthy subjects aged 10-80 years old.
- Technology: Bioelectrical Impedance Analysis (BIA) combined with subject's height, weight, age, and gender, using an experimentally derived algorithm.
- Performance Claim: "Clinical testing was conducted to establish the algorithm used by the BC100 system for estimation of percent body fat using bioelectrical impedance data."
- Regulatory Conclusion: Found "safe and effective for its intended use" based on this clinical testing and comparison to predicate devices.
Missing Information:
Crucially, the provided 510(k) summary and FDA letter do not contain the detailed clinical study results, acceptance criteria, or sample sizes that would allow for a comprehensive answer to your request. These details are typically found in the full 510(k) submission, not necessarily in the summary or clearance letter.
{0}------------------------------------------------
Athletic IQ, Inc. February 28, 2006
PAGE 1 OF 1
BC100 Body Composition Analysis System
510(k) Summary
General Company Information
Athletic IQ, Inc.
275 Turnpike Street Canton, MA 02021 Mark Butts, President 781-821-4114
MAY 2 4 2006
General Device Information
| Product Name: | BC100 Body Composition Analysis System |
|---|---|
| Common Name: | Body fat analyzer |
| Classification: | Impedance plethysmograph (body composition analyzer) / MNW |
| Predicate Devices | RJL Quantum II Bioelectrical Body Composition Analyzer (K830292) |
| Omron BodyLogic Body Fat Analyzer (K011652) | |
| Long-Well 6DS Body Fat Analyzer (K030203) |
Indications for Use:
The BC100 Body Composition Analysis System is a noninyasive bioimpedance analyzer for use in healthy subjects for measurement of actual height, actual weight and estimated body fat percentage. The applicable age range is 10 to 80 years old.
Product Description:
The proposed Athletic IQ, Inc. (AIQ) BC100 Body Composition Analysis System is a noninvasive bioimpedance analyzer for use in healthy subjects for measurement of actual height, actual weight and estimated body fat percentage. The applicable age range is 10 to 80 years old. The device determines estimated body fat percentage 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, whereas fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA permits differentiation of fat vs. lean tissue. When combined with the subject's height and weight parameters, age, and gender, an estimated body fat percentage may be calculated using an experimentally derived algorithm.
Safety and Performance:
Substantial equivalence for this device was based on a comparison of labeling and performance characteristics as compared to the predicate devices, as well as on the results of testing to establish compliance with international standards for electrical safety and electromagnetic compatibility (IEC 60601-1 & IEC 60601-1-2). Clinical testing was conducted to establish the algorithm used by the BC100 system for estimation of percent body fat using bioelectrical impedance data.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Athletic IQ BC100 Body Composition Analysis System has been shown to be safe and effective for its intended use.
Image /page/0/Picture/18 description: The image shows the number 2241 in a slightly distressed font. The numbers are black against a white background. The numbers are slightly uneven, with the 2's being slightly smaller than the 4 and 1.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows a logo or emblem on the left and the word "DEPARTMENT" on the right. The logo on the left appears to be a stylized representation of three vertical lines or strokes, possibly resembling a symbol or initial. The word "DEPARTMENT" is printed in a bold, sans-serif font, with a horizontal line underneath it, suggesting it is a heading or title.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 2 4 2006
Athletic IQ. Inc. c/o Pamela Papineau, R.A.C. Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue AYER MA 01432
Re: K060552
Trade/Device Name: BC100 Body Composition Analysis System Regulation Number: 21 CFR 8870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW . Dated: February 28, 2006 Received: March 2, 2006
Dear Ms. Papineau:
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/1/Picture/10 description: The image shows a logo with the text "FDA Centennial" and the years "1906-2006". Below the logo, the text "Protecting and Promoting Public Health" is displayed in a decorative font. The logo is circular and contains stars and additional text around the perimeter. The overall image appears to be a commemorative emblem or seal.
{2}------------------------------------------------
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 (OS) 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 premaince notification - 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 11 you don't upon 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
ﺤﺪ
Enclosure
{3}------------------------------------------------
Athletic IQ. Inc. February 28, 2006
510(k) Premarket Notification (Traditional) BC100 Body Composition Analysis System
Page
510(k) Number (if known): $040552
BC100 Body Composition Analysis System Device Name:
Indications for Use:
The BC100 Body Composition Analysis System is a noninvasive bioimpedance analyzer for use in healthy subjects for measurement of actual height, actual weight and estimated body fat percentage. The applicable age range is 10 to 80 years old.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-the -Counter Use _ X (21 CFR 807 Subpart D)
(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 Reproduct and Radiological Devic 510(k) Number
06.0009
§ 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.