STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK by STAYHEALTHY, INC.

The Stayhealthy SH650 is intended to be used by the general public so that the user can measure his/her own blood pressure, heart rate, percent lean body mass, percent body fat, percent total body water, body weight, and if the user may have color blindness. It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. The user can also choose to print the data or send the data to a personal physician or a healthcare professional.

Device Description

Not Found

AI/ML Overview

The provided text from the FDA 510(k) clearance letter for the Stayhealthy Kiosk SH650 and SH650-C does not contain the specific details about the acceptance criteria and the study used to prove the device meets those criteria.

The letter acknowledges the substantial equivalence (SE) determination, which means the device is considered as safe and effective as a legally marketed predicate device. This determination is based on information provided in the 510(k) submission, which typically includes performance testing data. However, the clearance letter itself is a summary of the FDA's decision, not the detailed technical documentation of the device's performance study.

To answer your request, I would need access to the actual 510(k) submission (Tradition 510(k) or Special 510(k) - K123539) which would contain the study reports and acceptance criteria.

Based only on the provided text, I can infer the general type of device and its intended use, but not the specifics of its performance study.

Here's what I can extract/infer from the provided text, and what is missing:

Device Name: Stayhealthy Kiosk SH650 and SH650-C
Regulatory Number: 21 CFR 870.1130 (Noninvasive Blood Pressure Measurement System)
Primary Function (based on Indications for Use): Measures blood pressure, heart rate, percent lean body mass, percent body fat, percent total body water, body weight, and color blindness.

Information NOT available in the provided text:

Table of acceptance criteria and reported device performance: This would typically be a table showing specific metrics (e.g., accuracy, precision) for each measurement the device performs (blood pressure, body composition, etc.) and the target values (acceptance criteria) vs. the actual measured values.
Sample size used for the test set and the data provenance: The number of subjects or samples used in the performance study, and whether the data was collected prospectively, retrospectively, or from a specific region/country.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For blood pressure, this might involve human observers using a reference device. For body composition, it might involve DEXA scans or other gold standard methods read by qualified professionals.
Adjudication method: If a consensus was needed for ground truth, how disagreements were resolved.
Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study focuses on how AI assists human readers. Given the nature of a self-service kiosk measuring vital signs and body composition, an MRMC study is unlikely to be relevant, as it's not an AI-assisted diagnostic imaging interpretation device.
Standalone (algorithm only) performance: While the kiosk operates in a standalone manner for data collection, the term "standalone performance" often refers to an AI algorithm's performance without human intervention in a diagnostic context. Here, the device itself is the standalone measurement system. The performance would be assessed against a gold standard.
Type of ground truth used: For blood pressure, the ground truth is often established by simultaneous measurements with a validated reference device (e.g., mercury sphygmomanometer with trained observers). For body composition, it might be DEXA (Dual-energy X-ray Absorptiometry).
Sample size for the training set: Not applicable for a device like this unless it uses a machine learning model for certain measurements, and even then, this specific detail would be in the submission, not the clearance letter.
How the ground truth for the training set was established: Same as above.

Conclusion:

The provided FDA clearance letter is a regulatory document confirming substantial equivalence and does not detail the technical performance studies and acceptance criteria that were part of the 510(k) submission. To answer your specific questions, access to the full 510(k) submission for K123539 would be necessary.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 22, 2013

Stayhealthy, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K123539

Trade/Device Name: Stayhealthy Kiosk SH650 and SH650-C Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN, MNW and HIT Dated: March 22, 2013 Received: March 25, 2013

Dear Mr. Job:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Mr. Mark Job

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Owen-PFaris -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name: Stayhealthy SH650 Health Kiosk

Indications for Use:

Prescription Use	OR	Over-the-Counter Use_X_
(Per 21 CFR 810.subpart D)		(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Owen P. Faris -S
2013.04.22 15:53:30
-04'00'

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Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).