(248 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on providing a location for users to measure parameters using cleared devices, not on advanced data processing or analysis.
No
The device is intended solely for measuring health parameters and furnishing data for users to consult their physicians, not for treating or preventing disease.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not a diagnostic device." The "Device Description" also reiterates that the kiosks "are not for diagnostic use."
No
The device description explicitly states it is a "kiosk that is erected in public spaces," indicating a physical hardware component beyond just software.
Based on the provided information, the Health Check Kiosk is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "It is not a diagnostic device, and only furnishes data so that users can consult their personal physicians."
- Purpose: The device description emphasizes that the kiosk is "intended only to provide information, and are not for diagnostic use."
- Lack of Diagnostic Function: The kiosk measures health parameters using cleared devices but does not perform any analysis or interpretation of biological samples (which is a key characteristic of IVDs). It simply presents the data from these other devices.
- Non-Medical Setting: The intended location in non-medical settings like gyms, corporate offices, and retail stores further supports its non-diagnostic nature.
Therefore, the Health Check Kiosk acts as a platform to gather and display health data from other devices, but it does not perform the diagnostic function itself.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
general public
Intended User / Care Setting
general public / public places and/or corporate environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
(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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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.
2
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
3
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
4
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_