ICP TRIAGEMANAGER

K122095 · Emergo Europe Consulting BV · DRG · Jul 26, 2012 · Cardiovascular

Device Facts

• Record ID: K122095
• Device Name: ICP TRIAGEMANAGER
• Applicant: Emergo Europe Consulting BV
• Product Code: DRG · Cardiovascular
• Decision Date: Jul 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Indications for Use

The Tunstall icp triagemanager software application allows the caregiver to review patient information and to motivate and provide educational information to the patient. The Tunstall icp triagemanager is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. Clinical judgment and experience by a caregiver are required to check and interpret the patient information delivered. The Tunstall icp triagemanager is not intended for real-time monitoring, is not an alarm system and may not be used to receive real-time or time-critical data, is not intended for patients requiring direct medical supervision or emergency intervention, and is not intended for direct diagnosis or monitoring.

Device Story

Web-based telehealth application for healthcare personnel to review patient vital signs and survey responses. Inputs: physiological data (blood pressure, weight, blood glucose, oxygen saturation, FEV/PEV) from compatible, commercially available home-use hub/gateway devices. Operation: data transmitted via secure internet to host server; software allows triage based on user-defined thresholds, patient list management, and report generation. Output: graphic overviews, patient reports, and educational/motivational content for patients. Used by trained medical professionals in clinical settings. Does not provide automated treatment decisions or diagnosis; requires clinical judgment for interpretation. Benefits: facilitates remote management of non-critical chronic patients.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation included risk assessment, software verification, and software validation testing to ensure system reliability and performance according to intended use.

Technological Characteristics

Web-based application running on standard off-the-shelf server. Connectivity: secure internet via compatible hub/gateways. Data types: blood pressure, weight, blood glucose, oxygen saturation, FEV/PEV. Features: role-based access, triage management, reporting. Software: web-based, non-real-time, threshold-based alerts.

Indications for Use

Indicated for remote monitoring of patients with chronic conditions such as diabetes, COPD, or coronary heart disease. Not for patients requiring direct medical supervision, emergency intervention, or real-time monitoring.

Regulatory Classification

Identification

A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Predicate Devices

• Intel Health Guide Express (K103276)

Submission Summary (Full Text)

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K122095 818

JUL 2 6 2012

# 510(k) Summary (in accordance with 21 CFR 807.92)

510(k) Number K

#### I. Applicant Information

Applicant:

TUNSTALL HEALTHCARE Stroemmen 6 DK-9400 Noerresundby Denmark

Niels Ole Andersen

Contact Person:

Tel: [phone] Fax: [phone] e-mail: [e-mail]

# Application Correspondent:

EMERGO EUROPE CONSULTING BV Prinsessegracht 20 2514 Den Haag The Netherlands

Director of QA & Regulatory Compliance

Contact Person:

Rachida Ziani Business Development & Project Manager Tel: [phone] Fax: [phone] e-mail: [e-mail]

## Date Prepared:

May 4, 2012

#### II. Device Name and Classification

Proprietary Name: Common/Usual Name: Classification Name:

Regulation Number: Product Codes: Classification: Classification Panel:

## icp triagemanager

Remote Patient Monitoring System Radiofrequency physiological signal transmitter and receiver 21 CFR 870.2910 DRG Class II Cardiovascular Devices

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#### III. Predicate Device

The icp triagemanager device is substantially equivalent to the following FDA cleared predicate device with regard to indications for use, performance and technological characteristics:

| 510(k) Number: | K103276 |
|----------------------|--------------------------------------------------------------|
| Trade Name: | Intel Health Guide Express |
| Manufacturer: | Intel Corporation |
| Classification Name: | Radiofrequency physiological signal transmitter and receiver |
| Common/Usual Name: | Remote Patient Monitoring System |
| Regulation Number: | 21 CFR 870.2910 |
| Product Codes: | DRG |
| Classification: | Class II |

#### IV. Device Description

The icp triagemanager is a web-based, telehealth remote patient monitoring system application used by trained healthcare personnel to access patient's vitals sign data and patient's answers to health related questions.

The icp triagemanager allows healthcare professionals to review patient's information and to provide educational or motivational information to the patients. The software also allows medical personnel to predefine upper and lower limits outside of which communication with caregivers is initiated.

The icp triagemanager is not intended for direct diagnosis or monitoring of patient's conditions, nor is it intended for providing automated treatment decisions or to be used as substitute for professional healthcare judgment. The system is not intended for real-time monitoring of time-critical data, nor is it intended for patients requiring direct medical supervision or emergency intervention.

The icp triagemanager runs on a standard "off-the-shelf" server hosted by the health care facility and allows caregivers to review patient vital signs on the secure website. The patient's physiological data are measured using standard commercially available medical devices designed for home use. These devices communicate via commercially available hub/gateways compatible with the icp triagemanager software installed on the host server. The hub/gateways are also medical devices already available for telehealth home use. The hub/gateway systems communicate over a secure internet

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# stall

connection to a secure database on the host server running the icp triagemanager software.

The main features of the icp triagemanager software are:

- Adding/removing patients to/from monitoring list .
- . Triaging patients based on user defined severity
- . Follow up on individual patient measurements and schedules
- Assigning 3rd party monitors to individual patients .
- Adding/removing/administering users ●
- Reviewing and print patient data reports .

The main users of the program are trained medical professionals needing telehealth remote monitoring of non-critical patients who do not require emergency intervention. Clinical judgment and experience by a caregiver are always required to interpret the patient information displayed by the icp triagemanager software.

#### V. Intended Use

The Tunstall icp triagemanager software application allows the caregiver to review patient information and to motivate and provide educational information to the patient.

The Tunstall icp triagemanager is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. Clinical judgment and experience by a caregiver are required to check and interpret the patient information delivered.

The Tunstall icp triagemanager is not intended for real-time monitoring, is not an alarm system and may not be used to receive real-time or time-critical data, is not intended for patients requiring direct medical supervision or emergency intervention, and is not intended for direct diagnosis or monitoring.

#### VI. Summary of the Technical Characteristics

The ico triagemanager is a web application that allows healthcare personnel to log into the system to perform triage of patients based on their vitals data and their answers to predefined questions. Patients' vitals data is received from commercially available remote patient monitoring devices and is stored in the system.

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The icp triagemanager application allows remote monitoring of patients with conditions like diabetes, chronic obstructive pulmonary disease, or coronary heart disease, etc.

The principle technical characteristics capabilities of the system are:

- . Handle several patients' data individually, where data is collected remotely via external patient monitors;
- . Send questionnaires, surveys, etc. from the host-server via a "Generic Patient Monitoring Interface" to external patients;
- . Receive patient data and answers from external patient via internet connection via a "Generic Patient Monitoring Interface";
- . Support icp triagemanager system login for users with role-based access rights and support an administrator role capable of controlling and maintaining the system;
- . Restrict access to patients' data;
- . Allow the grouping of triage staff into dedicated treatment teams, each with specific clinical specialties;
- . Present a graphic overview of patients' data to triage staff, which can be sorted according to customizable users' needs;
- Present patients' data in patient reports that can be displayed online . and can be stored as individual files and printed from the system.

The following Predicate Device Comparison Table provides a summary of the comparison between the icp triagemanager and the predicate device listed in Section III, with respect to intended use, environment of use, limitations of use, principles of operation and technological characteristics. More detailed information regarding the basis for the determination of substantial equivalence can be found at Section 12 of this 510(k) submission.

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# Predicate Device Comparison Table

| Device Name | icp triagemanager | Intel Health Guide Express<br>(K103276) | Significant Differences |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DRG | DRG | None |
| Regulation # | 870.2910 | 870.2910 | None |
| Class | II | II | None |
| Intended Use | The Tunstall icp triagemanager<br>software application allows the<br>caregiver to review patient<br>information and to motivate and<br>provide educational information to the<br>patient. | The Intel Health Guide Express is<br>intended to collect vital sign<br>measurements from physiological<br>measurement devices intended for use<br>in the home. Patients can review the<br>stored vital sign measurement<br>information and receive educational<br>and motivational content from<br>caregivers. Patients can also engage in<br>video conferences with caregivers and<br>answer the caregivers' questions by<br>participating in surveys. The Intel<br>Health Care Management Suite allows<br>the caregiver to review patient data<br>and initiate video conferencing with<br>patients, or select and send educational<br>and motivational content to patients. | The icp triagemanager and the<br>Intel Health Guide Express have<br>essentially identical Intended<br>Uses, with the difference that icp<br>triagemanager does not include a<br>video conferencing feature (please<br>see part in yellow). |
| Environment<br>of Use | Healthcare providers. | Home users and healthcare providers. | The icp triagemanager and the<br>Intel Health Guide Express have<br>essentially identical Environment<br>of Use, with the difference that<br>icp triagemanager does not<br>include home users (please see<br>part in yellow) |

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| Device Name | icp triagemanager | Intel Health Guide Express<br>(K103276) | Significant Differences |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Limitations of<br>Use | The Tunstall icp triagemanager is not<br>intended to provide automated<br>treatment decisions, nor is it to be used<br>as a substitute for a professional<br>healthcare judgment. Clinical<br>judgment and experience by a<br>caregiver are required to check and<br>interpret the patient information<br>delivered. | The Intel Health Guide Express is not<br>interpretive, nor is it intended for<br>diagnosis or as a substitute for medical<br>care, and it is not intended to provide<br>real time data. It is made available to<br>patients when time-critical care is not<br>required. | The icp triagemanager and the<br>Intel Health Guide Express have<br>essentially identical Limitations of<br>Uses. |
| Principles of<br>Operation | The Tunstall icp triagemanager is not<br>intended for real-time monitoring, is<br>not an alarm system and may not be<br>used to receive real-time or time-<br>critical data, is not intended for<br>patients requiring direct medical<br>supervision or emergency<br>intervention, and is not intended for<br>direct diagnosis or monitoring. | The Intel Health Guide Express is<br>contraindicated for patients requiring<br>direct-medical supervision or<br>emergency intervention. It is intended<br>for patients who are willing and<br>capable of managing its use. Clinical<br>judgment and experience by a<br>caregiver are required to check and<br>interpret the information delivered. | The icp triagemanager and the<br>Intel Health Guide Express have<br>essentially identical Principles of<br>Operation, with the difference that<br>the Intel Health Guide Express<br>includes a hub/gateway system |
| | To be used upon prescription of a<br>licensed physician or authorized<br>healthcare provider. | To be used upon prescription of a<br>licensed physician or authorized<br>healthcare provider. | |
| | A software application running on a<br>host server that allows caregivers to<br>review (on a secure website) patient<br>vital signs received from<br>commercially available, compatible<br>hub/gateway systems | A software application that is working<br>as hub/gateway sending data measured<br>by patients to a data server where<br>another software package is used for<br>the review (on a secure website) of<br>patient vital signs | |
| Device Name | icp triagemanager | Intel Health Guide Express<br>(K103276) | Significant Differences |
| | The system allows user defined upper and lower limits and, when either limit is exceeded, the system email and/or pages the caregiver. | The system allows user defined upper and lower limits and, when either limit is exceeded, the system email and/or pages the caregiver. | whereas the icp triagemanager relies on commercially available, compatible hub/gateway systems (please see part in yellow). |
| Technological<br>Characteristics | Icp triagemanager runs on a standard web host server | Intel Health Guide Express Care Management runs on a standard web host server | The icp triagemanager and the Intel Health Guide Express Care Management Suite have essentially identical Technological Characteristics |
| | Support for standard internet browsers | Support for standard internet browsers | |
| | Compatible patient data:<br>• Blood Pressure<br>• Weight<br>• Blood Glucose Level<br>• Oxygen Saturation<br>• FEV/PEV | Compatible patient data:<br>• Blood Pressure<br>• Weight<br>• Blood Glucose Level<br>• Oxygen Saturation<br>• FEV/PEV | |

510(k) — icp triagemanage

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Tunsta

510(k) — icp triagemanag

K12 2095 P7/8

:

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#### VII. Summary of Testing

Tunstall Healthcare has conducted extensive verification and validation testing of the icp triagemanager system, as a remote patient monitoring system that is capable of providing reliable patient's vitals sign information to healthcare personnel.

All of the different components of the icp triagemanager software have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate in accordance with its intended use.

The analyses performed included:

- Risk Assessment .
- Software verification tests .
- Software validation tests .

# VIII. Conclusions

The icp triagemanager conforms to all applicable FDA recognized consensus standards and, based on the comparison of intended use and technological characteristics, is substantially equivalent to the Intel Health Guide Express software manufactured by Intel Corporation (K103276).

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

## Public Health Service

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

JUL 26 2012

Tunstall Healthcare c/o Mr. J.A. (Harry) van Vugt Responsible Third Party Official DEKRA Certification B.V. Utrechtseweg 310, NL-6812 AR Arnhem The Netherlands

Re: K122095

Trade Name: Tunstall Healthcare icp triagemanager Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II (two) Product Codes: DRG Dated: July 6, 2012 Received: July 12, 2012

Dear Mr. van Vugt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed four becaused in ed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stared in the enactment date of the enactment date of the Medical Device Amendments, or to conniner of the 1125 20, 1978) 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 I ou may, therefore, maint of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 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.

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Page 2 – Mr. J.A. (Harry) van Vugt

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 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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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# 4. Indication for Use Statement

510(k) Number (if known): Kl22095

icp triagemanager Device Name:

Indications for Use:

The Tunstall icp triagemanager software application allows the caregiver to review patient information and to motivate and provide educational information to the patient.

The Tunstall icp triagemanager is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. Clinical judgment and experience by a caregiver are required to check and interpret the patient information delivered.

The Tunstall icp triagemanager is not intended for real-time monitoring, is not an alarm system and may not be used to receive real-time or time-critical data, is not intended for patients requiring direct medical supervision or emergency intervention, and is not intended for direct diagnosis or monitoring.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | Page 1 of 1 |
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| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K122095 |