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510(k) Data Aggregation
K Number
K153600Device Name
Consult Station TS
Manufacturer
Date Cleared
2017-03-17
(457 days)
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
H4D SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Consult Station TS is intended to be used by the general public to perform a health check including the measurement of certain vital signs (weight, BMI, temperature, blood pressure and pulse rate). The lay user autonomously self-performs all the measurements listed above.
Using an audio-video conferencing feature incorporated in the Consult Station TS to connect with a healthcare professional remotely. it is possible to perform additional examinations: ENT (Ear. Nose. Throat) and skin examinations. auscultations sounds and blood oxygen level. The lay user and the healthcare professional are able to see and to interact each other.
The Consult Station TS is not intended for diagnostic use. Lay users should consult their personal physician if they have concerns regarding the results of their health check.
The Consult Station TS is intended for lay users of fourteen (14) years old or older. The Consult Station TS is not intended for children under the age of fourteen.
The Consult Station can be deployed in indoor public areas, such as: pharmacies, senior living communities, shopping centers, corporations, etc.
Device Description
The Consult Station TS is an automated non-invasive screening device intended to be used by the general public (lay users). Equipped with sensors and instruments, the Consult Station TS presents itself in the shape of a health booth and allows to perform health check-ups in order to collect reliable medical data.
The Consult Station TS is not a diagnostic device and only provides data in order for lay users to consult with their personal physician. Lay users should consult with their physician if they have concerns regarding the results of their health check-up.
Two scenarios for the use of the Consult Station TS are available:
1. A scenario where the lay user will autonomously self-perform the measurements of his/her vital signs ("Unsupervised Mode");
This use does not require assistance of a healthcare professional. The lay user autonomously self-performs a health check allowing him/her to collect a number of his/her vital signs: weight and BMI, systolic and diastolic blood pressure, pulse rate and temperature. An user interface guides the lay user with video tutorials, a series of interactive screens and voice instructions through the various steps of the health check cycle.
2. An alternative scenario where, at first, the lay user will autonomously self-perform measurements of his/her vital signs ("Unsupervised Mode"), and then be remotely connected with a healthcare professional through the audio-video conferencing feature to perform additional examinations ("Supervised Mode").
This use that requires assistance of a healthcare professional to ensure that data is appropriately collected and interpreted. After performing a health check (see scenario above), the lay user is connected through the audio-video conferencing feature with a healthcare professional, the lay user and the healthcare professional being able to see and to interact with each other.
The healthcare professional can then remotely guide the lay user to use as needed:
- · an otoscope for ENT examinations (inspection of the external ear canal),
- · a dermatoscope for skin surface examinations,
- · a stethoscope for auscultation of sounds associated with the heart and lungs,
- · a pulse oximeter for the measurement of the blood oxygen level.
The otoscope (ENT examination), the dermatoscope (skin examination), the stethoscope (auscultations sounds) and the pulse oximeter (blood oxygen level) are only used in the Supervised Mode. The use of the pulse oximeter, dermatoscope, otoscope and the stethoscope are restricted on the order of a licensed practitioner.
In both scenarios, at the end of cycle, a ticket is printed inside the booth which summarizes the results of the measurement as well as user access codes for subsequent online access.
Lay users may manually enter blood glucose level measurements. The Consult Station TS may accept loaded data from an external blood glucometer (if such device is FDA cleared).
Consult Station is intended for users of 14 years old or older. The Consult Station TS is not intended for children under the age of fourteen (14).
Consult Station TS system consists of:
- A health booth,
- A software embedded in the health booth,
- . A Consult Access software containing an audio-video conferencing feature,
- . A web application which provides secure access by patients and health professionals to their anonymized data.
The health booth is an enclosed space, accessible through a door and containing a seat, sensors and instruments as well as communication tools (i.e. screens, camera, speakers, printer).
The software embedded in the health booth is responsible for the management of the man-machine interface (MMI) used to provide instructions to the patient, to collect patient data and to print them via the printer on a ticket. The software is also responsible for starting, stopping and repeating measurements. These functionalities are implemented by communicating via the serial or USB interfaces of the connected devices involved (sending commands followed by receiving of results).
The Consult Access is a software that allows through an audio-video conferencing connecting a healthcare professional with a patient seated inside the Consult Station. The patient and the healthcare professional will be able to see and to interact with each other. The healthcare professional can remotely guide the patient throughout all the measurements and examinations performed. The otoscope, the dermatoscope and the oximeter are only available while the video conferencing feature is in use.
The web application provides secure access by patients and healthcare professionals (only with the patient's agreement) to the measurements performed via the Consult Station TS.
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