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 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/gateway systems communicate over a secure internet connection to a secure database on the host server running the icp triagemanager software.

AI/ML Overview

The provided document, K122095, is a 510(k) Summary for the Tunstall icp triagemanager system. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics of the device itself.

Therefore, the information required for a table of acceptance criteria and reported device performance (points 1-7) is not explicitly available in this summary. The 510(k) process for this device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device (K103276, Intel Health Guide Express) without necessarily reporting detailed performance studies against pre-defined acceptance criteria for the new device.

However, I can extract information related to the testing performed, ground truth, and training data based on the provided text, where available.

1. Table of Acceptance Criteria and Reported Device Performance

Not available in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not explicitly stated in this 510(k) summary for the icp triagemanager. The document mentions "extensive verification and validation testing" but does not detail the size or nature of the test sets used for these evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not explicitly stated. Given the nature of the device (a remote patient monitoring software system for reviewing patient vitals and questions, not for direct diagnosis or real-time monitoring), the concept of "ground truth" established by multiple experts in a diagnostic sense might not be directly applicable as it would be for an imaging device. The system relies on data from "standard commercially available medical devices designed for home use" and "clinical judgment and experience by a caregiver" for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not explicitly stated.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a software application for reviewing patient information, not an AI or diagnostic tool that directly assists human readers in interpreting medical images or making diagnoses. Its purpose is to facilitate remote monitoring and communication, alerting caregivers to out-of-range vital signs.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This concept is somewhat applicable, but not in the sense of a standalone diagnostic algorithm. The device itself is a software system that presents data and triggers alerts based on user-defined thresholds. The document states it "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." Therefore, its "standalone" performance would relate to its ability to accurately receive, store, display, and alert based on pre-defined vital sign parameters, which is implicitly covered by "software verification and validation tests."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As the device's function is data presentation and alerting based on pre-set thresholds, "ground truth" would likely involve:

Accuracy of data transmission and display: Verifying that data received from connected medical devices is accurately transmitted, stored, and displayed on the platform.
Accuracy of alert generation: Verifying that the system correctly triggers alerts (email/pages) when vital signs exceed user-defined upper or lower limits.
Software functionality: Verifying that all features (adding/removing patients, triaging, follow-up, user management, reporting) work as intended.

These "ground truths" would be established through software verification and validation testing, likely against specifications and known correct outputs/behaviors, rather than through clinical expert consensus on diagnostic interpretations.

8. The sample size for the training set

Not applicable. The icp triagemanager is a software application that processes and presents patient data based on pre-defined clinical rules (user-defined thresholds) and existing physiological data from external devices. It is not described as a machine learning or artificial intelligence system that requires a "training set" in the conventional sense for a diagnostic algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for a machine learning model.

Summary

{0}------------------------------------------------

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: (011) 45 72 100 163 Fax: (011) 45 72 100 164 e-mail: noa@tunstallhealthcare.com

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: (011) 31 070 345 8570 Fax: (011) 31 070 346 7299 e-mail: PMTeurope@emergogroup.com

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

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the word "Tunstall" in white letters on a black background. The word is in a sans-serif font and is centered in the image. The background is a rounded rectangle. The image is simple and clean, with a focus on the word "Tunstall".

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 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

{2}------------------------------------------------

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.

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.

{3}------------------------------------------------

unstall

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.

{4}------------------------------------------------

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1979
A------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Acres of the Art of Children American American American Comments of






LAND A LA LEA LEA LEA LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE1

1-4-4
1

Addressed

Predicate Device Comparison Table

Device Name	icp triagemanager	Intel Health Guide Express(K103276)	Significant Differences
Product Code	DRG	DRG	None
Regulation #	870.2910	870.2910	None
Class	II	II	None
Intended Use	The Tunstall icp triagemanagersoftware application allows thecaregiver to review patientinformation and to motivate andprovide educational information to thepatient.	The Intel Health Guide Express isintended to collect vital signmeasurements from physiologicalmeasurement devices intended for usein the home. Patients can review thestored vital sign measurementinformation and receive educationaland motivational content fromcaregivers. Patients can also engage invideo conferences with caregivers andanswer the caregivers' questions byparticipating in surveys. The IntelHealth Care Management Suite allowsthe caregiver to review patient dataand initiate video conferencing withpatients, or select and send educationaland motivational content to patients.	The icp triagemanager and theIntel Health Guide Express haveessentially identical IntendedUses, with the difference that icptriagemanager does not include avideo conferencing feature (pleasesee part in yellow).
Environmentof Use	Healthcare providers.	Home users and healthcare providers.	The icp triagemanager and theIntel Health Guide Express haveessentially identical Environmentof Use, with the difference thaticp triagemanager does notinclude home users (please seepart in yellow)

{5}------------------------------------------------

The first and the comments of the country of the country of the country of	1
	1




------------------------------------------------------------------------------------------------------------------------------------------------------------------------------comments of the property and program and first and the program and concession,


	-44
	1-




I

Device Name	icp triagemanager	Intel Health Guide Express(K103276)	Significant Differences
Limitations ofUse	The Tunstall icp triagemanager is notintended to provide automatedtreatment decisions, nor is it to be usedas a substitute for a professionalhealthcare judgment. Clinicaljudgment and experience by acaregiver are required to check andinterpret the patient informationdelivered.	The Intel Health Guide Express is notinterpretive, nor is it intended fordiagnosis or as a substitute for medicalcare, and it is not intended to providereal time data. It is made available topatients when time-critical care is notrequired.	The icp triagemanager and theIntel Health Guide Express haveessentially identical Limitations ofUses.
Principles ofOperation	The Tunstall icp triagemanager is notintended for real-time monitoring, isnot an alarm system and may not beused to receive real-time or time-critical data, is not intended forpatients requiring direct medicalsupervision or emergencyintervention, and is not intended fordirect diagnosis or monitoring.	The Intel Health Guide Express iscontraindicated for patients requiringdirect-medical supervision oremergency intervention. It is intendedfor patients who are willing andcapable of managing its use. Clinicaljudgment and experience by acaregiver are required to check andinterpret the information delivered.	The icp triagemanager and theIntel Health Guide Express haveessentially identical Principles ofOperation, with the difference thatthe Intel Health Guide Expressincludes a hub/gateway system
	To be used upon prescription of alicensed physician or authorizedhealthcare provider.	To be used upon prescription of alicensed physician or authorizedhealthcare provider.
	A software application running on ahost server that allows caregivers toreview (on a secure website) patientvital signs received fromcommercially available, compatiblehub/gateway systems	A software application that is workingas hub/gateway sending data measuredby patients to a data server whereanother software package is used forthe review (on a secure website) ofpatient vital signs
Device Name	icp triagemanager	Intel Health Guide Express(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).
TechnologicalCharacteristics	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:• Blood Pressure• Weight• Blood Glucose Level• Oxygen Saturation• FEV/PEV	Compatible patient data:• Blood Pressure• Weight• Blood Glucose Level• Oxygen Saturation• FEV/PEV

510(k) — icp triagemanage

Page 5-6

{6}------------------------------------------------

Tunsta

510(k) — icp triagemanag

K12 2095 P7/8

Page 5-7

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the word "Tunstall" in white letters against a black background. The word is in a bold, sans-serif font. The background is a rounded rectangle, with the word "Tunstall" centered inside.

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).

{8}------------------------------------------------

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.

{9}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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

{10}------------------------------------------------

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.

× 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
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K122095

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
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.(b)
Classification. Class II (performance standards).