(90 days)
The Stayhealthy BC1 and the Stayhealthy/Fitness Expert BC2 devices are used solely to estimate the body fat and lean muscle components of the body using bioelectrical impedance technology.
The Stayhealthy Calorie tracker (CT1) and the Stayhealthy/Fitness Expert Calorie Tracker (CT2) are companion devices and are used solely to determine the calories used by a client when worn for a given period of time.
The BC1 and BC2 can output, via computer driven software the percent body fat of a person. The lean body mass can also be displayed. The devices are intended for use by both men and women who are 18 and older. The CT1 and the CT2 the companion devices can output, via computer driven software the number calories used by a person. The calories used can also be displayed. The BC1, BC2, CT1 and CT2 are not intended to be used to diagnose any known disease.
The Stayhealthy BC1 and Stayhealthy/ Fitness expert BC2, Body Composition Analyzer is a computer-operated and web enabled body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent and lean body mass percent. Both devices are about 10 inches across. The BC1 has an oval shape and is about 3 inches thick. The BC2 has an almost square shape with rounded corners. Both devices are made of slate grey plastics with polished metal inserts that are held by the hands to emit and receive signals to and from the body. The BC1 has an RS232 output socket and the BC2 has a USB output socket. Both devices have a dock where the calorie tracker is docked to upload its data. The CT1 and CT2 are both about 2 by 3 inches and made of slate gray plastics with a single display window and a docking port. They can be attached to clothes on the body via a clip on the back.
Here's an analysis based on the provided text, outlining the acceptance criteria and study details for the Stayhealthy BC1/BC2 Body Composition Analyzers:
The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner. Instead, it describes a clinical trial proving the device's accuracy and then concludes that the device is "safe, effective and perform as good as or better than the predicate device." Therefore, the reported device performance is aligned with the outcome of this study, aiming for a tight correlation and no significant difference from the "gold standard."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tight correlation between BC1 and hydrostatic immersion methods. | Result: "The results showed a tight correlation between the two methods of measurement over the age range and the weight range used." |
| Minimal variation in repeated BC1 measurements. | Result: "There was less than a 0.5% variation in three BC1 measurements made on each individual." |
| No significant difference between BC1 and hydrostatic methods for total body composition values. | Result: "There was no significant difference between the total body composition values for the hydrostatic method compared to the BC1 (BIA method) (P value 0.05)." |
| Device performance is as good as or better than the predicate device (Omron Body Fat Analyzer Model HBF-306 K011652). | Conclusion: "both devices are safe, effective and perform as good as or better than the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 72 subjects
- Data Provenance: The study was commissioned by Stayhealthy and performed by the University of East Tennessee. This suggests the data is likely from the United States.
- Retrospective or Prospective: Not explicitly stated, but clinical trials are typically prospective studies where data is collected for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable in the traditional sense of expert review for medical imaging or diagnosis.
- Qualifications of Experts: The "gold standard" for body fat estimation used was hydrostatic immersion. This is a scientific measurement method, not typically performed by "experts" in the sense of physicians or radiologists making diagnoses. The specialists performing and interpreting hydrostatic immersion would be trained in this specific anthropometric technique. The document does not specify their roles or qualifications.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The comparison was made between the device's measurements and the "gold standard" (hydrostatic immersion), which provides a direct quantitative measurement. There was no need for adjudication among multiple human reviewers for interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Was it done?: No, an MRMC comparative effectiveness study was not done. This study focuses on the accuracy of the device against a "gold standard" measurement, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Was it done?: Yes, the described study is a standalone performance study of the Stayhealthy BC1 device. It compares the device's output (body fat percent via BIA) directly to a "gold standard" measurement (hydrostatic immersion), without human interpretation as part of the primary outcome assessment.
7. The Type of Ground Truth Used
- Ground Truth Type: A "gold standard" scientific measurement: Hydrostatic Immersion for estimation of body fat percent.
8. The Sample Size for the Training Set
- Sample Size: The document does not provide information about a specific training set size. The study described is a clinical validation study, likely for the already developed algorithm. The development and training of the BIA algorithm would have occurred prior to this validation study, and those details are not included in this summary.
9. How the Ground Truth for the Training Set Was Established
- How Established: The document does not provide information on how the ground truth for any potential training set was established. Given the nature of BIA devices, the training of the algorithm typically involves comparing BIA readings against known body composition measurements (like DEXA, hydrostatic weighing, or other validated methods) in a diverse population to establish the predictive model. However, these details are absent from the provided text.
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K052522
PAGE 1 OF 3
DEC I 3 2005
SUMMARY
Stayhealthy Inc. 300 Elfwood Drive, Monrovia,
CA 91016
Phone # 626-599-8893
Fax # 626-357-7534
Contact Mr. John Collins
Summary prepared September 8th, 2005.
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Section 6.1 Stayhealthy BC1 and Stayhealthy/Fitness Expert BC2, Body composition analyzer 510K submission.
SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 21 Part 807.92
| Trade name: | Stayhealthy BC1 and Stayhealthy/Fitness Expert Fitness Expert BC2,Body Composition Analyzer. Stayhealthy CT1 and Stayhealthy/Fitness Expert CT2 |
|---|---|
| Common Name: | Body composition analyzer/body fat analyzer and calorie tracker. |
| Classification: | II |
| Name: | ANALYZER, BODY COMPOSITION. |
| 21 CFR part 870.2770 |
Description of applicant devices:
The Stayhealthy BC1 and Stayhealthy/ Fitness expert BC2, Body Composition Analyzer is a computer-operated and web enabled body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent and lean body mass percent. Both devices are about 10 inches across. The BC1 has an oval shape and is about 3 inches thick. The BC2 has an almost square shape with rounded corners. Both devices are made of slate grey plastics with polished metal inserts that are held by the hands to emit and receive signals to and from the body. The BC1 has an RS232 output socket and the BC2 has a USB output socket. Both devices have a dock where the calorie tracker is docked to upload its data. The CT1 and CT2 are both about 2 by 3 inches and made of slate gray plastics with a single display window and a docking port. They can be attached to clothes on the body via a clip on the back.
Intended Uses of the Applicant Device:
The BC1 and the BC2 are used as body fat analyzers that estimate the body fat and lean body mass with use of BIA (bioelectrical impedance analysis). The CT1 and the CT2 devices that are sold as companion devices with the BC1 and BC2 are used to track the number of calories used by the client. (Based on selected motion detection). Predicate device(s);
outputs percent fat on a computer
Body composition analyzer that
display
Omron Body Fat Analyzer Model HBF-306 K011652
Product Description:
Body fat analyzer Body composition Analyzer Model HBF-306 Model BC1 And BC2 Omron Healthcare. Stayhealthy and Stayhealthy/ Fitness Expert. Intended use: A handheld device that A handheld device connected to Estimates body fat a computer that estimates body Composition using BIA and fat composition using BIA and
outputs percent fat on a
Body composition analyzer
Digital display.
Scientific Concepts and Significant Performance Characteristics
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| that utilizes “hand to hand”BIA technology to determineinternal body composition | Utilizes “hand to hand” BIAtechnology to determine internalbody composition | |
|---|---|---|
| Analytical Method/Measurement: | Hand to Hand BIAIn House BIA and DEXAmethods | Hand to Hand BIAIn House and Third party BIAand Hydrostaticmethods |
Other technical data: The BC1/BC2 devices have been tested for conformity to industry standard safety tests for medical electrical equipment. These included EN 60601-1, EN 60601-1-1, En 60601-1-2, EN 61000-3-2, EN 61000-3-3, and CAN/ CSA C22.2 No 601.1-M90.
Clinical Data. Stayhealthy commissioned the University of East Tennessee to perform a clinical trial comparing the accuracy of the BC1 to the "gold Standard" of hydrostatic immersion for estimation of body fat percent. This study included 72 subjects, both men and women, ages 18 to 45, and lean to overweight. The results showed a tight correlation between the two methods of measurement over the age range and the weight range used. There was less than a 0.5% variation in three BC1 measurements made on each individual. There was no significant difference between the total body composition values for the hydrostatic method compared to the BC1 (BIA method) ( P value 0.05).
Conclusion. Since the core technology and the algorithms used in the BC1 model and the BC2 are the same and both have been tested for safety we can conclude that both devices are safe, effective and perform as good as or better than the predicate device.
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Image /page/3/Picture/1 description: The image shows a circular seal with text around the perimeter and a stylized bird-like figure in the center. The text around the seal appears to be the name of a department or organization, possibly related to health and human resources. The bird-like figure is abstract, with flowing lines suggesting movement or flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2005
Mr. John Collins CEO Stayhealthy, Inc. 300 Elfwood Drive MONROVIA CA 91016
Re: K052522
Trade/Device Name: Stayhealthy Body Composition Analyzer (BC1) Stayhealthy/Fitness Expert Body Composition Analyzer (BC2) Stayhealthy Calorie Tracker (CT1) Stayhealthy/Fitness Expert Calorie Tracker (CT2)
Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: September 13, 2005 Received: September 14, 2005
Dear Mr. Collins:
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 mis letter with anon yours of substantial equivalence of your device to a legally prematice notification: "The Play 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 001:37). " For may overnment 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. 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): K052522
Device Name: Stayhealthy Body Composition Analyzer (BC1) and Stayhealthy/Fitness Expert Body Composition Analyzer (BC2) The Stayhealthy Calorie Tracker (CT1) and the Stayhealthy/Fitness Expert Calorie Tracker (CT2)
Indications for Use:
The Stayhealthy BC1 and the Stayhealthy/Fitness Expert BC2 devices are used solely to estimate the body fat and lean muscle components of the body using bioelectrical impedance technology.
The Stayhealthy Calorie tracker (CT1) and the Stayhealthy/Fitness Expert Calorie Tracker (CT2) are companion devices and are used solely to determine the calories used by a client when worn for a given period of time.
The BC1 and BC2 can output, via computer driven software the percent body fat of a person. The lean body mass can also be displayed. The devices are intended for use by both men and women who are 18 and older. The CT1 and the CT2 the companion devices can output, via computer driven software the number calories used by a person. The calories used can also be displayed. The BC1, BC2, CT1 and CT2 are not intended to be used to diagnose any known disease.
(Part 21 CFR 801 Subpart D) AND/OR Prescription Use __ N/A_______________________________________________________________________________________________________________________________________________________ Over-The-Counter Use ___ YES____(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) x xx ヽ▽ ☆ x = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C hogdon
(Division Sign-Off)
Division of Reproductive. Al and Radiological Devic 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.