Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device that collects vital signs and facilitates remote consultations. It mentions software for managing the interface, collecting data, and enabling video conferencing, but there is no mention of AI or ML being used for analysis, interpretation, or any other function.

Therapeutic

No.

The device is intended for health checks and collecting vital signs, not for directly treating or preventing diseases or conditions. It explicitly states it is "not intended for diagnostic use" and only provides data for users to consult with their physicians.

Diagnostic

No

The document explicitly states multiple times that "The Consult Station TS is not intended for diagnostic use" and "The Consult Station TS is not a diagnostic device". It emphasizes that it only provides data for users to consult with their personal physician.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of a "health booth" which is an enclosed space containing "sensors and instruments" and "communication tools". It also mentions the use of physical devices like an otoscope, dermatoscope, stethoscope, and pulse oximeter, even if used remotely. While software is a critical component, the system relies on significant hardware for data acquisition and interaction.

IVD (In Vitro Diagnostic)

Based on the provided information, the Consult Station TS is not an IVD (In Vitro Diagnostic) device.

Here's why:

Explicit Statement: The document explicitly states multiple times: "The Consult Station TS is not intended for diagnostic use." and "The Consult Station TS is not a diagnostic device".
Intended Use: The primary intended use is for the general public to perform a health check and measure vital signs. While it facilitates remote interaction with a healthcare professional for additional examinations, the device itself is not performing diagnostic tests on biological samples in vitro.
Nature of Measurements: The measurements taken (weight, BMI, temperature, blood pressure, pulse rate, blood oxygen level, ENT/skin examinations, auscultation sounds) are primarily physiological measurements and visual inspections, not tests performed on biological specimens outside the body.
Role of Healthcare Professional: The document emphasizes that the healthcare professional's role in the "Supervised Mode" is to guide the lay user and interpret the data, not that the device itself is providing a diagnosis.
Lay User Responsibility: The document clearly states that lay users should consult their personal physician if they have concerns regarding the results, reinforcing that the device is a screening tool, not a diagnostic one.

While the device collects medical data and facilitates remote examinations, its core function and stated purpose do not align with the definition of an In Vitro Diagnostic device, which involves testing biological samples outside the body to provide information for diagnosis, monitoring, or screening.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

DXN, FLL, DQA

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:

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.
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.

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

fourteen (14) years old or older. The Consult Station TS is not intended for children under the age of fourteen (14).

Intended User / Care Setting

Intended user: general public (lay users), healthcare professional.
Care setting: indoor public areas, such as: pharmacies, senior living communities, shopping centers, corporations, etc.

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)

Usability Study:

Study type: Usability Study, human factors testing.
Sample size: 48 U.S. participants (distinct test subjects) in three (3) distinct user groups, conducting a total of ninety-six (96) Unsupervised sessions.
Data source: Conducted by a third party, Connected Healthcare Solutions.
Annotation protocol: Live, observed and documented testing over approximately two (2) weeks.
Key results:
- Primary objective: Evaluate the usability of the Consult Station TS.
  - System usability by patients was assessed using a quantitative usability instrument and semi-structured one-on-one interviews.
  - System functionality was assessed through semi-structured one-on-one interviews and Health Care Provider's feedback in terms of successful vital signs collections.
  - Patient compliance using the system was assessed through number of prescribed actions versus actual actions.
- Secondary objective: Evaluate the human factors utility of the Consult Station TS.
  - System human factors was assessed using a qualitative, subjective instrument and one-on-one interviews.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K101198, K903134, K160816

Reference Device(s)

K140785, K102893

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a human figure with three faces in profile.

March 17, 2017

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

H4D SAS % Esin Yesilalan Senior Regulatory Scientist Voisin Consulting Life Sciences 222 Third Street Suite 3121 Cambridge, Massachusetts 02142

Re: K153600

Trade/Device Name: Consult Station TS Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN, FLL, DQA Dated: February 27, 2017 Received: February 28, 2017

Dear Esin Yesilalan:

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.

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

1

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 devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Sincerely.

Muda Jellun
for

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

Enclosure

2

Indications for Use

510(k) Number (if known) K153600

Device Name Consult Station TS

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------

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SECTION 5 510 (k) SUMMARY

5	510(K) SUMMARY	5-2
5.1	Submitter Information	5-2
5.2	Device Identification	5-2
5.3	Identification of Predicate Devices	5-2
5.4	Device Description	5-3
5.5	Indications for Use	5-4
5.6	Comparison to Predicate Devices	5-5
	5.6.1 Summary of Technological Characteristics	5-6
	5.6.2 Electromagnetic Compatibility and Electrical Safety	5-7
	5.6.3 Performance and Clinical Testing	5-8
	5.6.4 Clinical Studies	5-9
	5.6.5 Biocompatibility Testing	5-10
	5.6.6 Comparison with the Predicates and Conclusion	5-10
5.7	Device Comparison Table	5-10
5.8	Conclusion	5-22

List of Tables

Table 5-1 Table Predicate Devices for Consult Station TS®	5-5
Table 5-2 Table Predicate Devices for the blood pressure module.	5-5
Table 5-3 Table Predicate Devices for the thermometer	5-6
Table 5-4 Device Comparison Table	5-11
Table 5-5 Comparison of the Blood Pressure Module with Omron Hem-705CP	5-19
Table 5-6 Comparison of the Thermometer IR with Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)	5-21

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Image /page/4/Picture/1 description: The image shows the logo for H4D Health for Development. The logo features a blue, stylized globe made of small squares on the left. To the right of the globe is the text "H4D" in a bold, blue font, followed by a vertical line. Next to the line is the text "HEALTH FOR DEVELOPMENT" in a smaller, gray font.

5 510(K) SUMMARY

5.1 Submitter Information

Company Name:	H4D
Company Address:	92 avenue Kleber, 75016 Paris, FRANCE
Company Phone:	+33 (0) 1 46 24 20 64
Company Fax:	33 (0) 9 58 29 67 66
Contact Person:	Marta Rivas
Date of Summary:	February 24, 2017

5.2 Device Identification

Trade Name:	Consult Station TS ®
Common Name:	Health booth
Classification Name:	Non-invasive blood pressure measurement system
Product Code:	DXN, FLL, DQA
Regulation Number:	870.1130
Device Class:	Class II

5.3 Identification of Predicate Devices

H4D's Consult Station TS® is substantially equivalent to the following predicate device:

CSI Model 9K Managed Health System, manufactured by Computerized Screening, Inc. and cleared for commercial distribution under 510(k) K101198;
Among the FDA Class II device components of the Consult Station, the non-invasive blood pressure module and the thermometer carry a CE approval in the EU; however, they are not cleared in the US. Nevertheless, this blood pressure module is substantially equivalent to Omron Hem-705CP Automated Monitor System (510(k) K903134) and the temperature module is equivalent to Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-361T, BW-CX10) (510k number K160816).
. Omron Hem-705CP Automated Monitor System 510(k) K903134;
Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-. CX10) (510k number K160816).

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5.4 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:

A scenario where the lay user will autonomously self-perform the measurements of his/her vital 1. 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.
1. 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.

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Image /page/6/Picture/1 description: The image shows the logo for H4D, which stands for Health for Development. The logo features the letters "H4D" in a bold, sans-serif font, with the "H" and "4" in a darker shade of blue and the "D" in a lighter shade. To the left of the letters is a graphic of blue squares arranged in a grid-like pattern. To the right of the letters is the text "HEALTH FOR DEVELOPMENT" in a smaller, sans-serif font.

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.

ર.5 Indications for 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 (temperature, weight and BMI, 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 and Throat) and skin examinations, auscultation sounds and blood oxygen level. The lay user and the healthcare professional are able to see and to interact with each other.

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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 (14).

The Consult Station TS can be deployed in indoor public areas, such as: pharmacies, senior living communities, shopping centers, corporations, etc.

5.6 Comparison to Predicate Devices

H4D is claiming substantial equivalence for Consult Station TS with the CSI Model 9K Managed Health System, which is currently commercially available in the U.S. Relevant information on the predicate devices is shown in Table 5-1.

Table 5-1	Table Predicate Devices for Consult Station TS®
-----------	-------------------------------------------------

Device Name	CSI Model 9K Managed Health System
Manufacturer	Computerized Screening, Inc.
510(k) Number	K101198
Regulatory Class	Class II
Common Name	Automated Blood Pressure Monitor
Clearance Date	04 Aug 2010

H4D is claiming substantial equivalence for the blood pressure module with the Omron Hem-705CP, which is currently commercially available in the U.S. Relevant information on the predicate devices is shown in Table 5-1

| Table Predicate Devices for the blood pressure module

Table 5-2
--------------------------------------------------------------------

| Device Name | Omron Auto Oscillometric DIG BP
MONT/HEM-704C 705C |
|------------------|-------------------------------------------------------|
| Manufacturer | Omron Marshall Products, INC. |
| 510(k) Number | K903134 |
| Regulatory Class | Class II |
| Common Name | Noninvasive blood pressure
measurement system |
| Clearance Date | 01/08/1991 |

H4D is claiming substantial equivalence for the temperature with the Infrared thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) which are currently commercially available in the U.S. Relevant information on the predicate devices is shown in Table 5-3.

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| Device Name | Infrared Thermometer (Model: LX-26E,
LX-260TE, PRO LX-261E, LX-360,
LX-361T, BW-CX10) |
|------------------|---------------------------------------------------------------------------------------------|
| Manufacturer | Nexmed Technology Co., Ltd |
| 510(k) Number | K160816 |
| Regulatory Class | Class II |
| Regulation Name | Clinical Electronic Thermometer |
| Clearance Date | 09/21/2016 |

Table 5-3 Table Predicate Devices for the thermometer

5.6.1 Summary of Technological Characteristics

The physiological parameters measurements available in Unsupervised Mode (the scenario where the lay user autonomously self-performs all measurements of his/her vital signs) are :

The weight and BMI calculation,
The temperature,
. The blood pressure and pulse rate.

The associated instruments for physiological parameters measurement consist of the following:

. An electronic scale,
. An infrared non-contact forehead thermometer,
. An electronic sphygmomanometer.

The exams available in Supervised Mode (the scenario where the lay user remotely connected with a healthcare professional through the audio-video conferencing feature to perform additional examinations) are:

. ENT examinations (inspection of the external ear canal) using an otoscope,
Skin surface examinations using a dermatoscope,
. Auscultation of sounds associated with the heart and lungs using a stethoscope,
Blood oxygen level measurement using a pulse oximeter.

The Hardware computer components consist of the following:

. Height measuring device using ultrasonic;
. A touch screen which allows to enter data or to answer questions and the start and stop the measurements :
. An embedded computer with interface connections for sensors and instruments;
. Environmental sensors (temperature, humidity percentage) ;
A printer ensuring the editing of a ticket which summarizes the measurement results and the ● patient identifiers.

The Remote Monitoring components consist of the following:

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A camera and loudspeakers ;
A touch screen used as input device for the lay user. Measurements can be started and stopped bylay users using the controls displayed on the touch screen;
. A LCD 19" screen for man-machine interface. The LCD screen is used for displaying interactive screens, videos instructions and measurement results. The functionality to gain remote access to a qualified physician is available via a LCD screen. Once measurements are done (note: the proprietary software of the instruments take over the Consult Station TS during that time) the results are displayed on a LCD screen.

The Software solution consists of the following:

A software embedded in the Consult Station for starting, stopping and repeating measurements, management of the MMI used to give instructions to the patient, to collect patient data and to print them on the printer;
. An audio-video conference feature through which users are remotely connected with a healthcare professional:
. A website, on which users and physicians can consult the medical data collected, through the use of a secure user ID and password (found on the ticket printed inside the booth).

Software requires the following technologies/environments:

.NET C# Language (Visual Studio 2013, framework 4.5) with WPF, WCF, Entity framework and ASP.NET MVC 2
. MS SOL Server 2012 database server
. IIS 7.5 web server"

Hardware of the Consult Station TS includes a computer with Microsoft Windows 7 Operating system with a Single Board Industrial Computer PCM-9363 with Embedded Intel Atom N455 1.66 GHz/D525 1.8 GHz Processor.

5.6.2 Electromagnetic Compatibility and Electrical Safety

The Consult Station TS has been subject to electromagnetic compatibility and electrical safety and essential performance testing and is compliant with the standards as listed below:

IEC 60601-1 :2005 + A1 :2012 and AAMI ANSI ES60601-1:2005 and A1:2012 and A2:2010 Electrical equipment - Part 1: General requirements for basic safety and essential performance;
IEC 60601-1-11 Edition 1.0 2010-04 Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in homecare environment;

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Image /page/10/Picture/1 description: The image contains a logo for "H4D | HEALTH FOR DEVELOPMENT". The logo consists of the letters "H4D" in a bold, sans-serif font, with the "H" and "4" in a darker shade of blue and the "D" in a lighter shade. To the right of "H4D" is the text "HEALTH FOR DEVELOPMENT", with "HEALTH" in a smaller font size and "FOR DEVELOPMENT" in a larger font size. The text is also in a blue color, but slightly lighter than the "H4D" letters. To the left of the letters is a graphic of blue squares.

Consult Station TS meets requirements of compliance with the standard IEC 60601-1-2 Edition ● 3: 2007-03; Electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests and by equivalence with the standard IEC 60601-1-2 Edition 3: 2007
. Acceptance tests for the home environment and US deviations have been completed according to ANSVAAMI/IEC 60601-1-:2014 Electrical Safety Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetidisturbances -- Requirements and test.

Performance and Clinical Testing 5.6.3

The Consult Station TS has been subject to bench and clinical evaluation and meets requirements for the basic safety and essential performance of all its components as listed below:

Automated non-invasive sphygmomanometers

. The automated sphygmomanometer has been subject to bench tests and meets requirements of compliancewith the standard ANSI AAMI ISO 80601-2-30:2009 & A1:2013, Particular Requirements for Safety, including essential performance, of automatic cycling non-invasive blood pressure measuring equipment;
The automated sphygmomanometer has been also subject to clinical tests by their original manufacturer before their integration in the Consult Station TS and meets requirements for Clinical and Performance testing according to EN 1060-4: 2004 Non-invasive sphygmomanometers - Part 4 (Procedures for determining the accuracy of the entire automated non-invasive blood pressure system was completed by the supplier of the blood pressure module). The study was completed according to EN ISO 1060-4, as per procedure "Sequential blood pressure measurement" (N3). The methodology, criteria and results of the test meet the compliance with the standard ANSVAAMI/ISO 81060-2 as per procedure "Same arm sequential method".

Infrared thermometer

. The IR thermometer has been tested on bench and is compliant with the standard ASTM E1965-98 (Reapproved 2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature:
The IR thermometer has been subject to clinical investigation and is compliant with the standard ISO 80601-2-56 First Edition 2009-10-01 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.

11

Image /page/11/Picture/0 description: The image shows the logo for H4D, which stands for Health for Development. The logo features a stylized globe made of blue squares on the left side. To the right of the globe, the text "H4D" is written in a bold, sans-serif font, with a vertical line separating it from the words "HEALTH FOR DEVELOPMENT" written in a smaller, sans-serif font. The overall design is clean and modern, suggesting a focus on global health initiatives.

Pulse oximeter

The pulse oximeter has been subject to clinical tests by their original manufacturer before their . integration in the Consult Station TS and meets requirements for Clinical testing according to ISO 80601-2-61 First edition 2011-04-01 Medical electrical equipment - Part 2-61 (Particular requirements for basic safety and essential performance of pulse oximeter equipment was completed according to its original 510(k) (K140785)

Software

Software validation has been satisfactorily completed according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) for a device of Moderate level of concern. Software Requirements Specification, Architecture Design Chart, Software Design Specifications, Traceability Analysis, Software Development Environment Description, Verification and Validation and Revision Level History were completed in accordance with relevant FDA guidance documents and with the international standard IEC 62304: 2006 Medical device software - Lifecycle software process.

5.6.4 Clinical Studies

An Usability Study, containing 48 U.S. participants in the human factors testing, was conducted by a third part Connected Healthcare Solutions. The H4D Human Factors validation protocol considered and tested various Use Cases, Risks, Known Use Errors and Expert Analysis of hazards and risks associated with use of the devices on forty-eight (48) distinct test subjects in three (3) distinct User groups in a total of ninety-six (96) Unsupervised sessions over a period of approximately two (2) weeks of live, observed and documented testing.

The study poplation was allocated in 3 user groups:

. Lay user patients: Male and female ages > 14 - 21 years of age o Patients under the age of 18 had parental consent.
. Lay user patients: Male and female ages 21 years of age and older
Health Care Professionals ●

The primary study objective was to evaluate the usability of the Consult Station TS:

System usability by patients was assessed using a quantitative usability instrument and semi-● structured one-on-one interviews.
System functionality was assessed through semi-structured one-on-one interviews and ● Health Care Provider's feedback in terms of successful vital signs collections.
. Patient compliance using the system was assessed through number of prescribed actions versus actual actions.

The secondary study objective was to evaluate the human factors utility of the Consult Station TS:

. System human factors was assessed using a qualitative, subjective instrument and one-onone interviews.

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5.6.5 Biocompatibility Testing

The Consult Station TS has been evaluated in accordance with international and FDA recognized standard, ISO 10993-1 as well as FDA's 510(k) Memorandum G95-1. The Consult Station TS medical components are considered surface devices with skin contact and limited duration. Accordingly, the following biocompatibility tests have been conducted:

. Cytotoxicity according to ISO 10993-5
. Sensitization according to ISO 10993-10
Skin Irritation according to ISO 10993-10

All tests were performed on sterilized finished product in accordance with Good Laboratory Practices (GLP) with no deviations. These regulations set forth the minimum basic requirements for study conduct, personnel, facilities, equipment, written protocols, operating procedures, study reports, and a system of quality assurance oversight for each study to help assure the safety of FDA regulated products.

5.6.6 Comparison with the Predicates and Conclusion

This paragraph describes the substantial equivalence between the Consult Station TS and the predicates CSI Model 9K Managed Health System (K101198).

Among the FDA Class II device components of the Consult Station, the non-invasive blood pressure module is substantially equivalent to Omron Hem-705CP Automated Monitor System (510(k) K903134). The table 5-5 compares the module with Omron Hem-705CP.

Similarly, thermometer component of the Consult Station TS is manufactured by H4D is substantially equivalent to Infrared Thermometer (Model: LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) (510k number K160816). The table 5.6 compares the thermometer module with Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) (510k number K160816).

5.7 Device Comparison Table

Table 5-4 compares the similarities and differences between Consult Station TS device and the predicate CSI Model 9K Managed Health System (K101198).

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Table 5-4	Device Comparison Table
	Consult Station TS®
(subject 510(k))	CSI Model 9K
Managed Health
System (K101198)	Comparison
FDA Product
Code	DXN, FLL, DQA	DXN	Same (unchanged) CSI Model
9K
Regulation
No.	21 CFR 870.1130
(Non-invasive blood pressure
measurement system)	21 CFR 870.1130
(Non-invasive blood
pressure measurement
system)	Same regulation number
(unchanged) CSI Model 9K
Device Class	Class II	Class II	Same device class (unchanged)
CSI Model 9K
Intended Use	Consult Station TS is an automated
non-invasive screening device
intended to be used by the general
public.
It is not a diagnostic device and
only furnishes data so users can
consult their personal physician.
User should consult their personal
physician if they have concerns
regarding their measurement.
The Consult Station TS covers two
primary functions:
• It allows a lay user to
autonomously self-perform the
measurement of his/her vital
signs (temperature, weight and
BMI calculation, blood pressure,
pulse rate).
• It offers a lay user the possibility
to connect via an audio-video
conferencing feature with a
healthcare professional remotely
connected, the lay user and the
healthcare professional being
able to see and to interact with
each other. The healthcare
professional will then be able to
conduct additional examinations:
ENT (Ear, Nose and Throat) and
skin examinations, auscultation
of heart and lungs sounds and
measurement of blood oxygen
level and guide the lay user to
use the instruments for his/her
examination. The healthcare
professional will also be able to
analyze the readings from these	Unsupervised means for
measuring and tracking
an individual's blood
pressure, pulse rate, and
if optionally equipped,
weight and temperature.
Users may manually
enter or download blood
glucose level.	Unsupervised Mode:
The Consult Station TS has the
same intended use (i.e. furnishes
medical data so lay users can
consult their personal physician)
and follows the same principle
of operation (i.e. self-operation).
performing health check-ups via
an automated non-invasive
device in the form of a health
booth with panels, windows,
door and seat) as the predicates.
Both the Consult Station TS and
CSI Model 9K measure systolic
and diastolic blood pressure,
pulse rate and (if optionally equipped for CSI Model 9K)
weight and temperature.
Lay
users may also manually enter
or download blood glucose level
with both devices.
Supervised Mode:
When using the audio-video conferencing feature, the
Consult Station TS integrates
additional instruments (pulse oximeter, stethoscope, otoscope and dermatoscope) to perform
specific examinations (ENT and
skin examinations, auscultation sounds and blood oxygen level)
Consult Station TS®
(subject 510(k))	CSI Model 9K
Managed Health
System (K101198)	Comparison
examinations.
Lay users may also download blood
glucose level provided by an
external glucometer (not integrated
in the booth, (if such device is FDA
cleared).). Upon completion, data
may be stored and accessed by the
user via a website.
Consult Station is intended for
users fourteen years or older. The
Consult Station TS is not intended
for children under the age of
fourteen.
The use of the pulse oximeter,
dermatoscope, otoscope and the
stethoscope are restricted on the
order of a licensed practitioner.
Users may manually enter or
download blood glucose level.		predicates. Use of these
supplementary functionalities
requires guidance of a physician
via audio-conferencing to ensure
that medical devices are
properly placed on the lay user
and data is appropriately
collected for interpretation by
the physician.
The selected pulse oximeter
(K140785) and stethoscope
(K102893) are FDA cleared for
"remote use by a physician
using a computer" as they are
intended to be used when
integrated into the Consult
Station TS.
Addition of the oximeter does
not affect the safety and
effectiveness of the Consult
Station TS.
The stethoscope is FDA cleared,
510(k), K102893. The otoscope/
dermatoscope are MD class I,
FDA exempt. The addition of
the stethoscope electronic
otoscope/dermatoscope does not
raise new questions in terms of
safety /effectiveness of the
Consult Station TS.
Consult Station TS has
additional (non-MD regulated)
functionality of remote
consultation with a professional
health.
The data in the Consult Station
is HIPAA compliant; therefore
this function does not raise new
questions in terms of
safety/effectiveness in
comparison to predicates.
	Consult Station TS®
(subject 510(k))	CSI Model 9K
Managed Health
System (K101198)	Comparison
Indications
for 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 (temperature, weight and
BMI, 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 and
Throat) and skin examinations,
auscultation sounds and blood
oxygen level. The lay user and the
healthcare professional are able to
see and to interact with 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 (14).
The Consult Station TS can be
deployed in indoor public areas,
such as: pharmacies, senior living
communities, shopping centers,
corporations, etc.	CSI Model 9K Managed
Health System Kiosk is
an automated non-
invasive screening device
intended for voluntary
use by the general public.
The device measures
systolic and diastolic
blood pressure, pulse and
if optionally equipped,
weight and temperature.
Users may also manually
enter or download blood
glucose level. Data from
the Model 9K may be
stored by the user for
tracking purposes.
It is not a diagnostic
device, and only
furnishes data so users
can consult their personal
physicians.
The device is intended
for users fourteen years
or older. Children under
the age of fourteen must
be accompanied by an
adult.	Similar general intended use as
CSI Model 9K.
The addition of new exams in
audio-video conferencing
feature: inspection of the
external ear canal, body surface
examination and auscultation of
sounds associated with internal
organs and blood oxygen level
measurement does not change
the general intended use of the
Consult Station TS compared
with the CSI Model 9K.
Intended
Population	General Public (≥ 14 years age).
The Consult Station TS is not
intended for children under the age
of fourteen.	General Public (≥ 14
years age). Children
under the age of fourteen
must be accompanied by
an adult.	The intended population of the
Consult Station TS is the same
as for the CSI Model 9K.
Hardware
design	Serial port using a RS-232
Interface. The touch screen is used
as input device for the user.
Measurements can be started and
stopped using the controls
displayed on the touch screen.	Serial port using a RS-
232 Interface. The device
has a touch screen for
user interface. The lay
user may select from a
menu of items. The lay	The hardware design of the
Consult Station TS is similar to
the CSI Model 9K.
	Consult Station TS®
(subject 510(k))	CSI Model 9K
Managed Health
System (K101198)	Comparison
	Once measurements are complete,
the results are displayed on a LCD
screen.
The lay user has to insert the arm in
the cuff mechanism before pressing
the "Start" button on the touch
screen.
An "Abort" button would result in
the immediate deflation of the cuff
and the aborting of the test.
This is meant for use in the event of
an emergency. Other buttons on the
main menu of the touch screen
display would result in the user
receiving the blood pressure
(systolic and diastolic) and heart
rate.
Interactive screens and videos
instructions are displayed on a LCD
screen.
Additionally, the functionality to
gain remote access to a professional
healthcare is available via a LCD
screen.
The Consult Station is equipped
with a printer.	user has to insert the arm
in the cuff mechanism
before pressing the
"Start" button on the
touch screen.
LCD touch screen user
interface to control and
receive blood pressure,
pulse rate, weight and
temperature readings.
A "Start" and "Release"
button is provided to
control the blood
pressure monitoring.
The 9K model may also
be equipped with a
scanner, printer, finger
print reader and signature
pad.
Display /Technology:
LCD computer monitor.
Software
design	The Consult Station TS uses a
software as an automated system
for measuring blood pressure, blood oxygen level, pulse rate,
temperature, weight, & height.
The system measures systolic and
diastolic arterial blood pressure
using an inflatable cuff mechanism
that is placed around the user's arm.
The cuff is then inflated before it is
gradually deflated using the
Oscillometric method.
The software is responsible for
starting and stopping
measurements.
The user is guided by a series of
interactive screens and voice
instructions. The software controls
user credentials (username and
password or sex, data of birth for	The CSI Model 9K
Managed Health System
Kiosk measures systolic
and diastolic arterial
blood pressure using an
inflatable cuff
mechanism that is placed
around the user's arm
(Oscillometric method).
While the user interface
is provided by a remote
server, the blood pressure
testing is totally
controlled by the BPM
controller with only the
hardware "Release"
button having override
authority.
The software and
graphics are held on the
server and sent to the unit	The software design of the
Consult Station TS is similar to
the CSI Model 9K.
	Consult Station TS®
(subject 510(k))	CSI Model 9K
Managed Health System (K101198)		Comparison
	user authentication), voice
instructions, presentation movies
and the video conference with a
remote physician.	based on the user input.

When the user requests a
blood pressure test, using
the touch screen, the
server sends a request
and cedes control to the
BPM controller and waits
for the readings to be
returned.

A similar process occurs
with the weight and
temperature
measurement. | | |
| Materials | Resin and glass fiber covered by
gelcoat. Not made with natural
rubber latex, polyester thread for
cuff. | Not available | Materials for CSI Model 9K are
not available for comparison. | |
| Components | The physiological parameters
measurements available in
Unsupervised Mode are:the weight
and BMI calculation, the
temperature, the blood pressure and
the pulse rate.

The exams available in Supervised
Mode are: ENT examinations
(inspection of the external ear
canal) using an otoscope, skin
surface examinations using a
dermatoscope, auscultation of
sounds associated with the heart
and lungs using a stethoscope and
blood oxygen level measurement
using a pulse oximeter. | Blood Pressure and Pulse
Rate, Weight and
Temperature | Unsupervised Mode:
Both the Consult Station TS and
CSI Model 9K measure systolic
and diastolic blood pressure,
pulse rate and (if optionally
equipped for CSI Model 9K)
weight and temperature. Lay
users may also manually enter
or download blood glucose level
with both devices.

Supervised Mode:
When using the audio-video
conferencing feature, the
Consult Station TS integrates
additional instruments (pulse
oximeter, stethoscope, otoscope
and dermatoscope) to perform
specific examinations (ENT and
skin examinations, auscultation
sounds and blood oxygen level)
not made available with the
predicates. Use of these
supplementary functionalities
requires guidance of a physician
via audio-conferencing to ensure
that medical devices are
properly placed on the lay user
and data is appropriately
collected for interpretation by
the physician.
The selected pulse oximeter
(K140785) and otoscope | |
| | Consult Station TS®
(subject 510(k)) | CSI Model 9K
Managed Health
System (K101198) | Comparison | |
| | | | (K102893) are FDA cleared for
"remote use by a physician
using a computer" as they are
intended to be used when
integrated into the Consult
Station TS.
No new questions of safety or
effectiveness arise from the
inclusion of pulse oximeter,
stethoscope, otoscope and
dermatoscope measuring
devices and associated the
audio-video conferencing
feature. | |
| Dimensions
and Weight | 6 feet length x 4 feet wide x 7,5 feet
tall | Not available | The dimensions for CSI Model
9K Station are not available for
comparison. | |
| User
Interaction | Interactive screens and voice
instructions | Interactive screens | Same (unchanged) as CSI
Model 9K. | |
| | Consult Station TS®
(subject 510(k)) | CSI Model 9K
Managed Health
System (K101198) | Comparison | |
| Electromagnetic Compatibility and Electrical Safety | EN 60601-1:2006 and AAMI /
ANSI ES60601-1:2005 and
AAMI/ANSI ES60601-1:2005 and
A1:2012 and A2:2010
IEC 60601-1-11 Edition 1.0 2010-
04 Part 1-11: General requirements
for basic safety and essential
performance - Collateral standard:
Requirements for medical electrical
equipment and medical electrical
systems used in homecare
environment. Consult Station TS
meets requirements of compliance
with the standard IEC 60601-1-2
Edition 3: 2007-03; Electrical
equipment - Part 1-2: General
requirements for basic safety and
essential performance - Collateral
standard: Electromagnetic
compatibility - Requirements and
tests and, by equivalence with the
standard IEC 60601-1-2 Edition 3:
2007
Deviations US and acceptance tests
for the home environment and US
deviations have been completed
according to AAMI/ANSI/IEC
60601-1-2 Edition 4:2014-02
Electrical Safety Medical electrical
equipment Part 1-2: General
requirements for basic safety and
essential performance - Collateral
Standard:
Electromagnetidisturbances --
Requirements and test. | Electromagnetic
compatibility – IEC
60601-1-2
Electrical Safety - IEC
60601-1-1 | Same (unchanged) as CSI
Model 9K, the Consult Station
TS is tested to meet electrical
safety and electromagnetic
compatibility requirements. | |
| | Performance testing –
Automated sphygmomanometers: | Performance testing –
according to
AAMI/ANSI SP10:2002 | ANSI AAMI ISO 80601-2-
30_2009 & A1 2013 cancels
and replaces the second edition | |
| Performance
Standards | ANSI AAMI ISO 80601-2-30
:2009& A1 2013 Medical electrical
equipment — Part 2-30: Particular
requirements for the basic safety
and essential performance of
automated non-invasive
The automated sphygmomanometer
has been also subject to clinical
tests by their original manufacturer
before their integration in the
Consult Station TS and meets | Manual, electronic, or
automated
sphygmomanometers
IEC 60601-2-30
Particular requirements
for the basic safety and
essential performance of
automated non-invasive
sphygmomanometers
No information available
on conformance to FDA | of IEC 60601-2-30, published
in 1999. This edition constitutes
a major technical revision as
well as an alignment with the
third edition of IEC 60601-1.
Same (unchanged) as CSI
Model 9K kiosk. | |

14

Image /page/14/Picture/1 description: The image shows the logo for H4D, which stands for Health for Development. The logo features a stylized globe made of small squares on the left, followed by the text "H4D" in a bold, sans-serif font. To the right of "H4D" is the text "HEALTH FOR DEVELOPMENT" in a smaller, sans-serif font. The overall design is clean and modern, with a focus on the organization's name and mission.

15

16

Image /page/16/Picture/1 description: The image shows the logo for H4D | HEALTH FOR DEVELOPMENT. The logo is blue and white. The H4D is in a bold, sans-serif font. To the left of the H4D is a graphic of small squares arranged in a grid pattern. The words "HEALTH FOR DEVELOPMENT" are in a smaller, sans-serif font and are located to the right of the H4D.

17

Image /page/17/Picture/1 description: The image shows the logo for H4D | HEALTH FOR DEVELOPMENT. The logo is in blue and white. The H4D is in large, bold letters. The words "HEALTH FOR DEVELOPMENT" are in smaller letters to the right of the H4D. There is a graphic to the left of the H4D that looks like a globe made of small squares.

18

Image /page/18/Picture/1 description: The image shows the logo for H4D, which stands for Health for Development. The logo features the letters H4D in a bold, sans-serif font, with the "H" and "4" connected. To the right of the letters, the words "HEALTH FOR DEVELOPMENT" are written in a smaller, sans-serif font. The logo also includes a graphic of a grid of blue squares, which are arranged in a circular pattern.

19

Image /page/19/Picture/1 description: The image contains the logo for H4D, which stands for Health for Development. The logo features a stylized globe made of small squares on the left side. To the right of the globe are the letters H4D in a bold, sans-serif font. To the right of the letters is the text "HEALTH FOR DEVELOPMENT" in a smaller, sans-serif font. The text is stacked vertically, with "HEALTH" on top and "FOR DEVELOPMENT" on the bottom.

20

Image /page/20/Picture/1 description: The image shows the logo for H4D | Health for Development. The logo is in blue and gray. The H4D is in a bold, sans-serif font. To the left of the H4D is a graphic of blue squares. The words "Health for Development" are in a smaller, sans-serif font to the right of the H4D.

| Consult Station TS®
(subject 510(k)) | CSI Model 9K
Managed Health
System (K101198) | Comparison | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------|
| requirements for Clinical and
Performance testing according to
EN 1060-4: 2004 Non-invasive
sphygmomanometers - Part 4
(Procedures for determining the
accuracy of the entire automated
non-invasive blood pressure system
was completed by the supplier of
the blood pressure module) and
meets requirement for the
standardANSI/AAMI/ISO 81060-2-
2013 | software guidance | | |
| Thermometer:
E1965-98 (Reapproved 2009)
Standard Specification for
Infrared Thermometers for
Intermittent Determination of
Patient Temperature | | | |
| ISO 80601-2-56 First Edition
2009-10-01 Part 2-56: Particular
requirements for basic safety and
essential performance of clinical
thermometers for body
temperature measurement | | | |
| Pulse Oximeter: | | | |
| ISO 80601-2-61 First edition 2011-
04-01 Medical electrical equipment

Part 2-61: Particular requirements
for basic safety and essential
performance of pulse oximeter | | | |
| Software validation: | | | |
| Software validation has been
satisfactorily completed according
to "Guidance for the Content of
Premarket Submissions for
Software Contained in Medical
Devices" (May 11, 2005) for a
device of moderate level of
concern. | | | |
| IEC 62304: 2006 Medical device
software - Lifecycle software
process | | | |
| | Consult Station TS®
(subject 510(k)) | CSI Model 9K
Managed Health
System (K101198) | Comparison |
| Biocompatibility | The blood pressure cuff, the pulse
oximeter and the stethoscope are
certified to be compliant with ISO

Biocompatibility is
established utilizing their original
510k (already FDA cleared).

The thermometer and the handle of
the of the thermometer, otoscope
and dermatoscope are designed by
H4D and consists of the PA 2200
(nylon 12) powder manufactured by
a sintering process.
Biocompatibility tests were
performed according to the
standard ISO 10993-1. | The blood pressure cuff
and thermometer are
certified to be compliant
with ISO 10993. | Same (unchanged) as CSI
Model 9K. |
| Sterilization | Non-Sterile cleaning and
disinfecting instructions are
provided. | Non-Sterile | Same (unchanged) as CSI
Model 9K. |

21

Table 5-5 compares the similarities and differences between blood pressure monitor module and the predicate Omron Hem-705CP (K903134).

Table 5-5 Comparison of the Blood Pressure Module with Omron Hem-705CP

| | Non-invasive blood pressure monitor
in the Consult Station® | Omron Hem-705CP automated
monitor | Comparison |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Class | Class II | Class II | Same |
| FDA code
product | DXN | DXN (510k number K903134) | Same |
| Indications for
Use | To measure systolic and diastolic blood
pressure. It is not a diagnostic device
and only furnishes data so users can
consult their personal physician. | To sense the systolic and diastolic
blood pressure values. | Same |
| Intended Use | The Consult Station is intended to be
used by the general public. | The Omron blood pressure
monitor is intended to be used by
the adults | |
| Intended
Population | General Public (≥ 14 years age) | General Public (except infants) | Same |
| Hardware
design | The touch screen user interface is used
to control blood pressure. A start, stop
and redo buttons start, stop or redo the
measurements. The Consult Station is
equipped with a printer intended to print
the results. | The display panel is used to
control blood pressure. The Omron
Hem-705CP automated monitor is
equipped with a printer. | Same design |

22

Image /page/22/Picture/1 description: The image shows the logo for H4D, which stands for Health for Development. The logo features a stylized globe made of small squares on the left side. To the right of the globe is the text "H4D" in a bold, sans-serif font, followed by a vertical line and the words "HEALTH FOR DEVELOPMENT" in a smaller, sans-serif font. The text is in blue.

| | Non-invasive blood pressure monitor
in the Consult Station® | Omron Hem-705CP automated
monitor | Comparison |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Technical
Specifications | Measurement range: SYS: 25 to 280
mmHg; DIA: 10 to 220 mmHg
Accuracy/calibration:

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Predicate Device(s)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 870.1130 Noninvasive blood pressure measurement system.

Indications for Use

Indications for Use (Describe)

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

SECTION 5 510 (k) SUMMARY

CONTENTS

List of Tables

5 510(K) SUMMARY

5.1 Submitter Information

5.2 Device Identification

5.3 Identification of Predicate Devices

5.4 Device Description

ર.5 Indications for Use

5.6 Comparison to Predicate Devices

Table 5-3 Table Predicate Devices for the thermometer

5.6.1 Summary of Technological Characteristics

The Software solution consists of the following:

5.6.2 Electromagnetic Compatibility and Electrical Safety

Performance and Clinical Testing 5.6.3

Automated non-invasive sphygmomanometers

Infrared thermometer

Pulse oximeter

Software

5.6.4 Clinical Studies

5.6.5 Biocompatibility Testing

5.6.6 Comparison with the Predicates and Conclusion

5.7 Device Comparison Table

Table 5-5 Comparison of the Blood Pressure Module with Omron Hem-705CP

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