(457 days)
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.
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.
Here's a breakdown of the acceptance criteria and supporting studies for the Consult Station TS, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized standards. Direct "acceptance criteria" for metrics like sensitivity, specificity, or accuracy (beyond standard adherence) are not explicitly stated for the overall device, but rather for its individual components in relation to their respective standards.
| Component / Parameter | Acceptance Criteria (Standard Adherence) | Reported Device Performance |
|---|---|---|
| Blood Pressure Monitoring | 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) | Device meets requirements of compliance with ANSI AAMI ISO 80601-2-30:2009 & A1:2013. Clinical and Performance testing completed per EN 1060-4: 2004 (Procedures for determining the accuracy of the entire automated non-invasive blood pressure system) and ANSVAAMI/ISO 81060-2 per "Same arm sequential method". Measurement range: SYS: 25 to 280 mmHg; DIA: 10 to 220 mmHg. Accuracy/calibration: < +/-5 mmHg. |
| Infrared Thermometer | ASTM E1965-98 (Reapproved 2009) (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature) and ISO 80601-2-56:2009 (Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement). | Device is compliant with ASTM E1965-98 (Reapproved 2009) and ISO 80601-2-56:2009. Accuracy: ±0.2°C (±0.4°F) for the range of 32.0°C to 36.0°C and for 39.0 °C to 42.0°C. ±0.1°C from 36.1°C to 38.9°C. ± 32.54°F (± 0.3 °C) from 32 °C - 42 °C (89.6°F- 107.6 °F). |
| Pulse Oximeter | ISO 80601-2-61:2011-04-01 (Particular requirements for basic safety and essential performance of pulse oximeter equipment). | Device meets requirements for Clinical testing according to ISO 80601-2-61, according to its original 510(k) (K140785). |
| Software | "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) for a device of Moderate level of concern, and IEC 62304: 2006 (Medical device software - Lifecycle software process). | Software validation satisfactorily completed according to the mentioned guidance. 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 and IEC 62304: 2006. |
| Electrical Safety/EMC | IEC 60601-1:2005 + A1:2012 / AAMI ANSI ES60601-1:2005 and A1:2012 and A2:2010; IEC 60601-1-11 Edition 1.0 2010-04; IEC 60601-1-2 Edition 3: 2007-03; AAMI/ANSI/IEC 60601-1-2 Edition 4:2014-02. | Consult Station TS is compliant with IEC 60601-1:2005 + A1:2012 / AAMI ANSI ES60601-1:2005 and A1:2012 and A2:2010, IEC 60601-1-11, IEC 60601-1-2 Edition 3, and AAMI/ANSI/IEC 60601-1-2 Edition 4:2014-02. |
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10; FDA's 510(k) Memorandum G95-1. | The blood pressure cuff, pulse oximeter, and stethoscope are compliant with ISO 10993 (established through their original 510(k)s). Biocompatibility tests (Cytotoxicity, Sensitization, Skin Irritation) were performed on the thermometer and handle (PA 2200 material) according to ISO 10993-1, -5, -10 and GLP. |
2. Sample Size Used for the Test Set and Data Provenance
- Usability Study (Human Factors Testing):
- Sample Size: 48 U.S. participants.
- Data Provenance: Prospective, conducted by a third-party (Connected Healthcare Solutions) over approximately two weeks of live, observed, and documented testing in the U.S.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Usability Study: The document mentions "Expert Analysis of hazards and risks associated with use of the devices" but does not specify the number or qualifications of these experts. Healthcare professionals (HCPs) were one of the user groups in the usability study, providing feedback on "successful vital signs collections." However, these HCPs appear to be users of the system, not necessarily adjudicators of ground truth for measurements.
- For the integrated components (blood pressure monitor, thermometer, pulse oximeter), ground truth was established through adherence to recognized performance standards (e.g., clinical tests for accuracy) presumably by the original manufacturers or testing bodies, not detailed in this document in terms of expert numbers or qualifications for this specific submission.
4. Adjudication Method for the Test Set
- Usability Study: No explicit "adjudication method" in the sense of resolving discrepancies in expert opinions on ground truth for medical conditions is mentioned. The study assessed "system usability," "system functionality" (via HCP feedback on successful vital signs collection), and "patient compliance." It was focused on human factors and usability, not diagnostic accuracy where an adjudication process would typically be needed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No MRMC comparative effectiveness study is described for the Consult Station TS itself. The device is for self-measurement or remote assistance, not for interpretation by multiple independent readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- The Consult Station TS is presented as an integrated system, with some components operating autonomously (Unsupervised Mode) and others with remote human assistance (Supervised Mode). The performance of individual measurement components (blood pressure, thermometer, pulse oximeter) in "standalone" mode (before integration) is referenced by their adherence to specific performance standards and sometimes their original 510(k) clearances. For example, the blood pressure module was subject to clinical tests by its "original manufacturer before their integration" and met EN 1060-4. The thermometer was tested on bench and clinically. The pulse oximeter also had clinical tests by its original manufacturer. So, the performance of these sub-components was assessed without the full Consult Station TS human-in-the-loop system, but the Consult Station TS itself is not an "algorithm-only" device for diagnostic purposes.
7. The Type of Ground Truth Used
- For vital signs measurements (BP, Temp, Pulse Ox): Ground truth was based on established clinical performance standards for medical devices (e.g., ANSI AAMI ISO 80601-2-30 for BP, ASTM E1965-98/ISO 80601-2-56 for Temp, ISO 80601-2-61 for Pulse Oximeter). These standards define procedures for accuracy testing against reference measurements, implying comparison to highly accurate clinical measurement standards.
- For Usability: Ground truth related to usability was derived from quantitative usability instruments, semi-structured interviews with patients and healthcare providers, and observation of prescribed vs. actual actions.
8. The Sample Size for the Training Set
- The document does not specify a distinct "training set" sample size for the Consult Station TS as a whole. The device is a collection of validated hardware components and software. Software validation adhered to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304, which outlines processes for software development and testing, but doesn't typically refer to a "training set" in the context of statistical machine learning. The usability study involved 48 U.S. participants, but this was a test set for human factors, not a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- As a traditional medical device assembling pre-cleared or standard-compliant components, the concept of a "training set" for an algorithm often associated with AI/machine learning is not explicitly detailed. The "ground truth" for the performance of its vital signs measurement components was established through rigorous adherence to internationally recognized and FDA-listed performance standards for those specific types of devices, which involve comparisons against highly accurate, commonly accepted measurement methods in controlled clinical settings. The software development followed standard lifecycle processes (IEC 62304) and FDA guidance for software in medical devices, which focus on requirements, design, verification, and validation rather than a data-driven "training set" approach for ground truth.
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Public Health Service
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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
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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
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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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Image /page/3/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 blue and the "D" in gray. To the left of the letters is a blue graphic of a grid of squares. To the right of the letters are the words "HEALTH FOR DEVELOPMENT" in a smaller, sans-serif font, with "HEALTH" in gray and "FOR DEVELOPMENT" in blue.
SECTION 5 510 (k) SUMMARY
CONTENTS
| 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. -
- 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.
- 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").
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 moduleTable 5-2 |
|---|
| -------------------------------------------------------------------- |
| Device Name | Omron Auto Oscillometric DIG BPMONT/HEM-704C 705C |
|---|---|
| Manufacturer | Omron Marshall Products, INC. |
| 510(k) Number | K903134 |
| Regulatory Class | Class II |
| Common Name | Noninvasive blood pressuremeasurement 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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Image /page/9/Picture/1 description: The image contains a logo for an organization called H4D, which stands for Health for Development. The logo consists of two parts: a graphic element on the left and the text "H4D | HEALTH FOR DEVELOPMENT" on the right. The graphic element is a stylized representation of interconnected squares, forming a spherical shape. The text is arranged in two lines, with "H4D" in a larger font size and "HEALTH FOR DEVELOPMENT" in a smaller font size.
- 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.
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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 9KManaged HealthSystem (K101198) | Comparison | ||
| FDA ProductCode | DXN, FLL, DQA | DXN | Same (unchanged) CSI Model9K | |
| RegulationNo. | 21 CFR 870.1130(Non-invasive blood pressuremeasurement system) | 21 CFR 870.1130(Non-invasive bloodpressure measurementsystem) | 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 automatednon-invasive screening deviceintended to be used by the generalpublic.It is not a diagnostic device andonly furnishes data so users canconsult their personal physician.User should consult their personalphysician if they have concernsregarding their measurement.The Consult Station TS covers twoprimary functions:• It allows a lay user toautonomously self-perform themeasurement of his/her vitalsigns (temperature, weight andBMI calculation, blood pressure,pulse rate).• It offers a lay user the possibilityto connect via an audio-videoconferencing feature with ahealthcare professional remotelyconnected, the lay user and thehealthcare professional beingable to see and to interact witheach other. The healthcareprofessional will then be able toconduct additional examinations:ENT (Ear, Nose and Throat) andskin examinations, auscultationof heart and lungs sounds andmeasurement of blood oxygenlevel and guide the lay user touse the instruments for his/herexamination. The healthcareprofessional will also be able toanalyze the readings from these | Unsupervised means formeasuring and trackingan individual's bloodpressure, pulse rate, andif optionally equipped,weight and temperature.Users may manuallyenter or download bloodglucose level. | Unsupervised Mode:The Consult Station TS has thesame intended use (i.e. furnishesmedical data so lay users canconsult their personal physician)and follows the same principleof operation (i.e. self-operation).performing health check-ups viaan automated non-invasivedevice in the form of a healthbooth with panels, windows,door and seat) as the predicates.Both the Consult Station TS andCSI Model 9K measure systolicand diastolic blood pressure,pulse rate and (if optionally equipped for CSI Model 9K)weight and temperature.Layusers may also manually enteror download blood glucose levelwith both devices.Supervised Mode:When using the audio-video conferencing feature, theConsult Station TS integratesadditional instruments (pulse oximeter, stethoscope, otoscope and dermatoscope) to performspecific examinations (ENT andskin examinations, auscultation sounds and blood oxygen level) | |
| Consult Station TS®(subject 510(k)) | CSI Model 9KManaged HealthSystem (K101198) | Comparison | ||
| examinations.Lay users may also download bloodglucose level provided by anexternal glucometer (not integratedin the booth, (if such device is FDAcleared).). Upon completion, datamay be stored and accessed by theuser via a website.Consult Station is intended forusers fourteen years or older. TheConsult Station TS is not intendedfor children under the age offourteen.The use of the pulse oximeter,dermatoscope, otoscope and thestethoscope are restricted on theorder of a licensed practitioner.Users may manually enter ordownload blood glucose level. | predicates. Use of thesesupplementary functionalitiesrequires guidance of a physicianvia audio-conferencing to ensurethat medical devices areproperly placed on the lay userand data is appropriatelycollected for interpretation bythe physician.The selected pulse oximeter(K140785) and stethoscope(K102893) are FDA cleared for"remote use by a physicianusing a computer" as they areintended to be used whenintegrated into the ConsultStation TS.Addition of the oximeter doesnot affect the safety andeffectiveness of the ConsultStation TS.The stethoscope is FDA cleared,510(k), K102893. The otoscope/dermatoscope are MD class I,FDA exempt. The addition ofthe stethoscope electronicotoscope/dermatoscope does notraise new questions in terms ofsafety /effectiveness of theConsult Station TS.Consult Station TS hasadditional (non-MD regulated)functionality of remoteconsultation with a professionalhealth.The data in the Consult Stationis HIPAA compliant; thereforethis function does not raise newquestions in terms ofsafety/effectiveness incomparison to predicates. | |||
| Consult Station TS®(subject 510(k)) | CSI Model 9KManaged HealthSystem (K101198) | Comparison | ||
| Indicationsfor Use | The Consult Station TS is intendedto be used by the general public toperform a health check, includingthe measurement of certain vitalsigns (temperature, weight andBMI, blood pressure and pulserate). The lay user autonomouslyself-performs all the measurementslisted above.Using an audio-video conferencingfeature incorporated in the ConsultStation TS to connect with ahealthcare professional remotely, itis possible to perform additionalexaminations: ENT (Ear, Nose andThroat) and skin examinations,auscultation sounds and bloodoxygen level. The lay user and thehealthcare professional are able tosee and to interact with each other.The Consult Station TS is notintended for diagnostic use. Layusers should consult their personalphysician if they have concernsregarding the results of their healthcheck.The Consult Station TS is intendedfor lay users of fourteen (14) yearsold or older. The Consult StationTS is not intended for childrenunder the age of fourteen (14).The Consult Station TS can bedeployed in indoor public areas,such as: pharmacies, senior livingcommunities, shopping centers,corporations, etc. | CSI Model 9K ManagedHealth System Kiosk isan automated non-invasive screening deviceintended for voluntaryuse by the general public.The device measuressystolic and diastolicblood pressure, pulse andif optionally equipped,weight and temperature.Users may also manuallyenter or download bloodglucose level. Data fromthe Model 9K may bestored by the user fortracking purposes.It is not a diagnosticdevice, and onlyfurnishes data so userscan consult their personalphysicians.The device is intendedfor users fourteen yearsor older. Children underthe age of fourteen mustbe accompanied by anadult. | Similar general intended use asCSI Model 9K.The addition of new exams inaudio-video conferencingfeature: inspection of theexternal ear canal, body surfaceexamination and auscultation ofsounds associated with internalorgans and blood oxygen levelmeasurement does not changethe general intended use of theConsult Station TS comparedwith the CSI Model 9K. | |
| IntendedPopulation | General Public (≥ 14 years age).The Consult Station TS is notintended for children under the ageof fourteen. | General Public (≥ 14years age). Childrenunder the age of fourteenmust be accompanied byan adult. | The intended population of theConsult Station TS is the sameas for the CSI Model 9K. | |
| Hardwaredesign | Serial port using a RS-232Interface. The touch screen is usedas input device for the user.Measurements can be started andstopped using the controlsdisplayed on the touch screen. | Serial port using a RS-232 Interface. The devicehas a touch screen foruser interface. The layuser may select from amenu of items. The lay | The hardware design of theConsult Station TS is similar tothe CSI Model 9K. | |
| Consult Station TS®(subject 510(k)) | CSI Model 9KManaged HealthSystem (K101198) | Comparison | ||
| Once measurements are complete,the results are displayed on a LCDscreen.The lay user has to insert the arm inthe cuff mechanism before pressingthe "Start" button on the touchscreen.An "Abort" button would result inthe immediate deflation of the cuffand the aborting of the test.This is meant for use in the event ofan emergency. Other buttons on themain menu of the touch screendisplay would result in the userreceiving the blood pressure(systolic and diastolic) and heartrate.Interactive screens and videosinstructions are displayed on a LCDscreen.Additionally, the functionality togain remote access to a professionalhealthcare is available via a LCDscreen.The Consult Station is equippedwith a printer. | user has to insert the armin the cuff mechanismbefore pressing the"Start" button on thetouch screen.LCD touch screen userinterface to control andreceive blood pressure,pulse rate, weight andtemperature readings.A "Start" and "Release"button is provided tocontrol the bloodpressure monitoring.The 9K model may alsobe equipped with ascanner, printer, fingerprint reader and signaturepad.Display /Technology:LCD computer monitor. | |||
| Softwaredesign | The Consult Station TS uses asoftware as an automated systemfor measuring blood pressure, blood oxygen level, pulse rate,temperature, weight, & height.The system measures systolic anddiastolic arterial blood pressureusing an inflatable cuff mechanismthat is placed around the user's arm.The cuff is then inflated before it isgradually deflated using theOscillometric method.The software is responsible forstarting and stoppingmeasurements.The user is guided by a series ofinteractive screens and voiceinstructions. The software controlsuser credentials (username andpassword or sex, data of birth for | The CSI Model 9KManaged Health SystemKiosk measures systolicand diastolic arterialblood pressure using aninflatable cuffmechanism that is placedaround the user's arm(Oscillometric method).While the user interfaceis provided by a remoteserver, the blood pressuretesting is totallycontrolled by the BPMcontroller with only thehardware "Release"button having overrideauthority.The software andgraphics are held on theserver and sent to the unit | The software design of theConsult Station TS is similar tothe CSI Model 9K. | |
| Consult Station TS®(subject 510(k)) | CSI Model 9KManaged Health System (K101198) | Comparison | ||
| user authentication), voiceinstructions, presentation moviesand the video conference with aremote physician. | based on the user input.When the user requests ablood pressure test, usingthe touch screen, theserver sends a requestand cedes control to theBPM controller and waitsfor the readings to bereturned.A similar process occurswith the weight andtemperaturemeasurement. | |||
| Materials | Resin and glass fiber covered bygelcoat. Not made with naturalrubber latex, polyester thread forcuff. | Not available | Materials for CSI Model 9K arenot available for comparison. | |
| Components | The physiological parametersmeasurements available inUnsupervised Mode are:the weightand BMI calculation, thetemperature, the blood pressure andthe pulse rate.The exams available in SupervisedMode are: ENT examinations(inspection of the external earcanal) using an otoscope, skinsurface examinations using adermatoscope, auscultation ofsounds associated with the heartand lungs using a stethoscope andblood oxygen level measurementusing a pulse oximeter. | Blood Pressure and PulseRate, Weight andTemperature | Unsupervised Mode:Both the Consult Station TS andCSI Model 9K measure systolicand diastolic blood pressure,pulse rate and (if optionallyequipped for CSI Model 9K)weight and temperature. Layusers may also manually enteror download blood glucose levelwith both devices.Supervised Mode:When using the audio-videoconferencing feature, theConsult Station TS integratesadditional instruments (pulseoximeter, stethoscope, otoscopeand dermatoscope) to performspecific examinations (ENT andskin examinations, auscultationsounds and blood oxygen level)not made available with thepredicates. Use of thesesupplementary functionalitiesrequires guidance of a physicianvia audio-conferencing to ensurethat medical devices areproperly placed on the lay userand data is appropriatelycollected for interpretation bythe physician.The selected pulse oximeter(K140785) and otoscope | |
| Consult Station TS®(subject 510(k)) | CSI Model 9KManaged HealthSystem (K101198) | Comparison | ||
| (K102893) are FDA cleared for"remote use by a physicianusing a computer" as they areintended to be used whenintegrated into the ConsultStation TS.No new questions of safety oreffectiveness arise from theinclusion of pulse oximeter,stethoscope, otoscope anddermatoscope measuringdevices and associated theaudio-video conferencingfeature. | ||||
| Dimensionsand Weight | 6 feet length x 4 feet wide x 7,5 feettall | Not available | The dimensions for CSI Model9K Station are not available forcomparison. | |
| UserInteraction | Interactive screens and voiceinstructions | Interactive screens | Same (unchanged) as CSIModel 9K. | |
| Consult Station TS®(subject 510(k)) | CSI Model 9KManaged HealthSystem (K101198) | Comparison | ||
| Electromagnetic Compatibility and Electrical Safety | EN 60601-1:2006 and AAMI /ANSI ES60601-1:2005 andAAMI/ANSI ES60601-1:2005 andA1:2012 and A2:2010IEC 60601-1-11 Edition 1.0 2010-04 Part 1-11: General requirementsfor basic safety and essentialperformance - Collateral standard:Requirements for medical electricalequipment and medical electricalsystems used in homecareenvironment. Consult Station TSmeets requirements of compliancewith the standard IEC 60601-1-2Edition 3: 2007-03; Electricalequipment - Part 1-2: Generalrequirements for basic safety andessential performance - Collateralstandard: Electromagneticcompatibility - Requirements andtests and, by equivalence with thestandard IEC 60601-1-2 Edition 3:2007Deviations US and acceptance testsfor the home environment and USdeviations have been completedaccording to AAMI/ANSI/IEC60601-1-2 Edition 4:2014-02Electrical Safety Medical electricalequipment Part 1-2: Generalrequirements for basic safety andessential performance - CollateralStandard:Electromagnetidisturbances --Requirements and test. | Electromagneticcompatibility – IEC60601-1-2Electrical Safety - IEC60601-1-1 | Same (unchanged) as CSIModel 9K, the Consult StationTS is tested to meet electricalsafety and electromagneticcompatibility requirements. | |
| Performance testing –Automated sphygmomanometers: | Performance testing –according toAAMI/ANSI SP10:2002 | ANSI AAMI ISO 80601-2-30_2009 & A1 2013 cancelsand replaces the second edition | ||
| PerformanceStandards | ANSI AAMI ISO 80601-2-30:2009& A1 2013 Medical electricalequipment — Part 2-30: Particularrequirements for the basic safetyand essential performance ofautomated non-invasiveThe automated sphygmomanometerhas been also subject to clinicaltests by their original manufacturerbefore their integration in theConsult Station TS and meets | Manual, electronic, orautomatedsphygmomanometersIEC 60601-2-30Particular requirementsfor the basic safety andessential performance ofautomated non-invasivesphygmomanometersNo information availableon conformance to FDA | of IEC 60601-2-30, publishedin 1999. This edition constitutesa major technical revision aswell as an alignment with thethird edition of IEC 60601-1.Same (unchanged) as CSIModel 9K kiosk. |
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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.
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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.
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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.
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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.
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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.
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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 9KManaged HealthSystem (K101198) | Comparison | |
|---|---|---|---|
| requirements for Clinical andPerformance testing according toEN 1060-4: 2004 Non-invasivesphygmomanometers - Part 4(Procedures for determining theaccuracy of the entire automatednon-invasive blood pressure systemwas completed by the supplier ofthe blood pressure module) andmeets requirement for thestandardANSI/AAMI/ISO 81060-2-2013 | software guidance | ||
| Thermometer:E1965-98 (Reapproved 2009)Standard Specification forInfrared Thermometers forIntermittent Determination ofPatient Temperature | |||
| ISO 80601-2-56 First Edition2009-10-01 Part 2-56: Particularrequirements for basic safety andessential performance of clinicalthermometers for bodytemperature measurement | |||
| Pulse Oximeter: | |||
| ISO 80601-2-61 First edition 2011-04-01 Medical electrical equipment- Part 2-61: Particular requirementsfor basic safety and essentialperformance of pulse oximeter | |||
| Software validation: | |||
| Software validation has beensatisfactorily completed accordingto "Guidance for the Content ofPremarket Submissions forSoftware Contained in MedicalDevices" (May 11, 2005) for adevice of moderate level ofconcern. | |||
| IEC 62304: 2006 Medical devicesoftware - Lifecycle softwareprocess | |||
| Consult Station TS®(subject 510(k)) | CSI Model 9KManaged HealthSystem (K101198) | Comparison | |
| Biocompatibility | The blood pressure cuff, the pulseoximeter and the stethoscope arecertified to be compliant with ISO10993. Biocompatibility isestablished utilizing their original510k (already FDA cleared).The thermometer and the handle ofthe of the thermometer, otoscopeand dermatoscope are designed byH4D and consists of the PA 2200(nylon 12) powder manufactured bya sintering process.Biocompatibility tests wereperformed according to thestandard ISO 10993-1. | The blood pressure cuffand thermometer arecertified to be compliantwith ISO 10993. | Same (unchanged) as CSIModel 9K. |
| Sterilization | Non-Sterile cleaning anddisinfecting instructions areprovided. | Non-Sterile | Same (unchanged) as CSIModel 9K. |
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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 monitorin the Consult Station® | Omron Hem-705CP automatedmonitor | Comparison | |
|---|---|---|---|
| Device Class | Class II | Class II | Same |
| FDA codeproduct | DXN | DXN (510k number K903134) | Same |
| Indications forUse | To measure systolic and diastolic bloodpressure. It is not a diagnostic deviceand only furnishes data so users canconsult their personal physician. | To sense the systolic and diastolicblood pressure values. | Same |
| Intended Use | The Consult Station is intended to beused by the general public. | The Omron blood pressuremonitor is intended to be used bythe adults | |
| IntendedPopulation | General Public (≥ 14 years age) | General Public (except infants) | Same |
| Hardwaredesign | The touch screen user interface is usedto control blood pressure. A start, stopand redo buttons start, stop or redo themeasurements. The Consult Station isequipped with a printer intended to printthe results. | The display panel is used tocontrol blood pressure. The OmronHem-705CP automated monitor isequipped with a printer. | Same design |
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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 monitorin the Consult Station® | Omron Hem-705CP automatedmonitor | Comparison | |
|---|---|---|---|
| TechnicalSpecifications | Measurement range: SYS: 25 to 280mmHg; DIA: 10 to 220 mmHgAccuracy/calibration: < +/-5 mmHgMeasurement method: oscillometricmethodOperating temperatures: 50°F to 95 °F(10 °C to 35 °C)Storage temperatures : -4°F to 120°F (-20°C to 50°C) | Measurement range : 0 to 299mmHg Accuracy/calibration: ± 4mmHg Measurement method:oscillometric methodOperating temperatures: 50°F to104°F (10°C to 40°C)Storage temperatures : -4°F to140°F (-20°C to 60°C) | Similarcharacteristics |
| User Interaction | Interactive screen | Interactive screen | Same |
| ElectromagneticCompatibilityand ElectricalSafety | Electromagnetic compatibility –ANSI/AAMI/IEC 60601-1-2 Edition4:2014-02 Electrical SafetyEN 60601-1:2006 and AAMI / ANSIES60601-1:2005 | Not available, the 510(k) summaryisn't on the FDA database website. | Not available |
| PerformanceStandards | Recognized Consensus StandardsANSI AAMI ISO 80601-2-30_2009 &A1 2013 Medical electrical equipmentPart 2-30: Particular requirements forthe basic safety and essentialperformance of automated non-invasivesphygmomanometersBy equivalence, the blood pressuremonitor is compliant with the standardAAMI ANSI ISO 81060-2-2013 Non-invasive sphygmomanometers - Part 2:Clinical investigation of automatedmeasurement type | Not available, the 510(k) summaryisn't on the FDA database website. | Not available |
| Biocompatibility | The blood pressure cuff is compliantwith ISO 10993. | Not available | Not available |
| Sterilization | Non-Sterile | Non-Sterile | Same |
Table 5-6 compares the similarities and differences between IR thermometer module and the predicate Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) (K).
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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)
| IR thermometer in the Consult Station® | Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) | Comparison | |
|---|---|---|---|
| Device Class | Class II | Class II | Same |
| FDA code product | FLL | FLL (510k number K160816) | Same |
| Indications for Use | The thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from human skin (temple) | Infrared Thermometer is intended for body temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference. | Same |
| Intended Use | The Consult Station is intended to be used by the general public. | The device can be used by consumers in household environment and doctor in clinic as reference. | Same |
| Intended Population | General Public (≥ 14 years age) | General Public of all ages | Similar |
| Hardware design | The thermometer measures the infrared heat generated by the surface of the skin over the temporal artery. The thermometer then converts it into a temperature value shown on LCD. The touch screen user interface is used to control the temperature A start, stop and redo buttons start, stop or redo the measurement. Results in memory can be transmitted to the physician's computer by cable. | The device uses infrared probe to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object. The infrared probe can recognize it and transfer to the proper electronic signal. The electronic signal can be processed in the Infrared Thermometer to convert to the temperature reading, which is displayed on the LCD. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The body mode is also forehead measurement mode. | Same design |
| Technical Specifications | Accuracy: ±0.2°C (±0.4°C) for the range of 32.0°C to 36.0°C and for 39.0 °C to 42.0°C±0.1°C from 36,1°C to 38,9°C± 32.54°F (± 0.3 °C) from 32 °C - 42 °C (89.6°F- 107.6 °F), | Accuracy: ±0.2°C (±0.4°C) for the range of 30°to 43°C (86.0°F to 109.4°F) (body mode)Display resolution: 0.1°C/0.1°F | Similar characteristics |
| IR thermometer in theConsult Station® | Infrared Thermometer(Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) | Comparison | |
| User Interaction | Interactive screen | Interactive screen | Same |
| ElectromagneticCompatibilityand ElectricalSafety | Electromagnetic compatibility –ANSI/AAMI/IEC 60601-1-2 Edition4:2014-02 Electrical SafetyIEC 60601-1-2 Edition 3: 2007-03 | IEC 60601-1: 2005+CORR.1(2006)+CORR.2 (2007), IEC60601-1-2: 2007, IEC60601-1-11: 2010, ISO80601-2-56: 2009 | Same |
| PerformanceStandards | E1965-98 (Reapproved 2009)Standard Specification for InfraredThermometers for IntermittentDetermination of PatientTemperatureISO 80601-2-56 First Edition 2009-10-01 Part 2-56: Particularrequirements for basic safety andessential performance of clinicalthermometers for body temperaturemeasurement | Meet the accuracy requirementspecified in ASTM E1965-98(2009) and ISO 80601-2-56:2009. | Same |
| Biocompatibility | The thermometer is compliant with ISO10993. | Comply with ISO 10993-1:2009,ISO 10993-5: 2009, ISO 10993-10: 2010 | Same |
| Sterilization | Non-Sterile | Non-Sterile | Same |
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Image /page/24/Picture/1 description: The image contains a logo for an organization called H4D, which stands for Health for Development. The logo features a stylized globe made up of small squares on the left side. To the right of the globe, the text "H4D" is displayed in a bold, sans-serif font, followed by a vertical line. Next to the line, the words "HEALTH FOR DEVELOPMENT" are written in a smaller, sans-serif font, with "HEALTH" stacked above "FOR DEVELOPMENT".
5.8 Conclusion
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 principles of operation (i.e. self-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) not made available with the predicates. Use of these supplementary functionalities requires guidance of a
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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.
Under the intended use described above, 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.
Even though a "Supervised Mode" poses a technical difference compared to the predicate device, as they have similar intended use and as this technical difference does not pose further associated safety risks, H4D believes that Consult Station TS is Substantially Equivalent to the predicate device, CSI Model 9K.
§ 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).