(248 days)
The Health Check Kiosk is indicated for use by the general public so that a user can measure his/her own health parameters using devices cleared for use by the public. It is not a diagnostic device, and only furnishes data so that users can consult their personal physicians.
The Health Check Kiosk is a kiosk that is erected in public spaces, and provides a location where the general public can measure various health parameters. The Health Check kiosks are intended only to provide information, and are not for diagnostic use. No charge is made for use of the kiosk, but advertising may be posted inside of it. It is planned to locate the kiosk in non-medical settings such as gyms, corporate offices and retail stores.
The Xperex Inc. Health Check Kiosk 510(k) submission does not provide the detailed information requested regarding acceptance criteria and a study to prove the device meets these criteria in the typical format expected for a comprehensive medical device evaluation. Instead, it relies on a declaration of substantial equivalence to predicate devices.
Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is absent:
Analysis of Acceptance Criteria and Proving Study
The submission states:
- "Health Check Kiosk has been extensively validated by itself and in conjunction with the associated measurement devices."
- "Clinical tests are not necessary, since the Health Check Kiosk uses the same technology as the predicate devices."
- "The Health Check Kiosk is equivalent in safety and efficacy to the legally-marketed predicate devices."
This indicates that the primary "acceptance criterion" for this submission was substantial equivalence to predicate devices, rather than a specific set of performance metrics demonstrated through a novel study. The "study" proving this is implicitly the comparison to predicate devices and the assertion that the underlying technology is the same.
Therefore, many of your specific questions cannot be answered directly from the provided text, as the method of validation was comparison to existing devices, not a standalone performance study with established primary and secondary endpoints and corresponding acceptance criteria.
Response to Specific Questions:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The implicit acceptance criterion is "substantial equivalence in safety and efficacy to legally-marketed predicate devices," specifically those listed (Lifeclinic International, K040562; Advanced Monitoring Caregiving, K051544; Remote Nurse, K041308). There are no explicit quantitative performance acceptance criteria defined in this document for the new device itself (e.g., accuracy +/- X mmHg for blood pressure).
- Reported Device Performance: The document states that the "Health Check Kiosk has been extensively validated by itself and in conjunction with the associated measurement devices." However, it does not provide specific performance data (e.g., accuracy, precision, sensitivity, specificity) in a quantitative manner. The performance is inferred to be similar to the predicate devices due to shared technology.
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Sample size used for the test set and the data provenance: Not applicable. No specific "test set" (in terms of a patient cohort for performance evaluation) is described, as the validation relied on substantial equivalence and "non-clinical tests" not detailed here rather than a de novo clinical performance study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment by experts for a test set is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.
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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. This device is a kiosk for measuring health parameters, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "non-clinical tests" and "extensive validation by itself" could be interpreted as standalone performance assessment, but no details of such a study (methods, results, metrics) are provided. The explicit statement that "Clinical tests are not necessary" further indicates that rigorous human-in-the-loop or standalone clinical performance studies were not performed or required for this 510(k).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is established for the device's performance, as its equivalence to predicate devices (which presumably had established ground truth in their own filings) is the basis of clearance.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set in the typical sense.
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How the ground truth for the training set was established: Not applicable.
In summary, the 510(k) submission for the Xperex Health Check Kiosk indicates that its acceptance was based on its substantial equivalence to already cleared predicate devices, asserting that it uses the same technology and therefore does not require new clinical performance data to demonstrate safety and efficacy. Consequently, the detailed information about acceptance criteria, study design, sample sizes, and ground truth establishment (as typically applied to novel performance studies) is not present in this document.
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Xperex Inc .. 510(k) Submission Health Check Kiosk 510(k) Summary September 22, 2006
JUN - 7 2007
(1) Submitter Information
Name: Xperex Inc.
Address:
384 Oyster Point Blvd South San Francisco, CA 94080
Telephone Number: 650-266-2013
Contact Person:
Dr. George Myers Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708
Date Prepared: September 22, 2006
(2) Name of Device
Trade Name: Health Check Kiosk Common Name: Kiosk for Measurement of Health Parameters Classification name: System, measurement, blood-pressure, non-invasive
(3) Equivalent legally-marketed devices.
The Health Check Kiosk is a kiosk that is erected in public spaces, and provides a location where the general ~ublic can measure various health parameters. The Health Check kiosks are intended only to provide .formation, and are not for diagnostic use. No charge is made for use of the kiosk, but advertising may be
(4) Description
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Xperex Health Check Kiosk
ssted inside of it. It is planned to locate the kiosk in non-medical settings such as gyms, corporate offices and retail stores.
(5) Intended Use
The Health Check Kiosk is intended to be a multi-functional unit that provides tests for the general public to measure personal health parameters such as weight, body fat, blood pressure and pulse rate in public places and/or corporate environments.
(6) Performance Data
(a) Non-clinical tests
Health Check Kiosk has been extensively validated by itself and in conjunction with the associated measurement devices.
(b) Clinical tests
Clinical tests are not necessary, since the Health Check Kiosk uses the same technology as the predicate devices.
. ) Conclusions
The Health Check Kiosk is equivalent in safety and efficacy to the legally-marketed predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2007
Xperex Corporation c/o Medsys Inc. George Myers 377 Route 17 S Hasbrouck Heights, NJ 07604
Re: K063008
Trade/Device Name: Health Check Kiosk Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 18, 2007 Received: May 21, 2007
Dear Mr. Myers:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your your 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 for ass sured in the May 28, 1976, the enactment date of the Medical Device Amendments, or to commerco pror of riay 2011-12-11 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). and Costhere Frev (110) for the device, subject to the general controls provisions of the Act. The r ou may, cherefore, mainer of the Act include requirements for annual registration, listing of general controls pro reserving 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 If your device is clussined (600 as 10) als. Existing major regulations affecting your device can inay be subject to subli additions, 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 r lease oc acrised that I Dr. interest that your device complies with other requirements of the Act
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Page 2 -- Mr. George Myers
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. 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 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 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
B/himmer 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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Xperex Health Check Kiosk
Page 4-1
Indications for Use
510(k) Number (if known): Kod 3008
Health Check Kiosk Device Name: and the country of the country of the country of the county of the county of the county of the county of the county of the county of the county of the county of the county of
Indications for Use:
The Health Check Kiosk is indicated for use by the general public so that a user can measure his/her own health parameters using devices cleared for use by the public. It is not a diagnostic device, and only furnishes data so that users can consult their personal physicians.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhumima
Division of Cardiovascular Devices 510(k) Number_
§ 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).