(14 days)
Not Found
No
The summary describes a remote patient monitoring system that allows caregivers to review data and set thresholds, but there is no mention of AI or ML for data analysis, interpretation, or decision support.
No.
The device is a software application for reviewing patient information and providing educational content, and it explicitly states it is "not intended to provide automated treatment decisions" or "be used as a substitute for a professional healthcare judgment." This indicates it does not directly manage or treat a medical condition.
No
The device description explicitly states, "The Tunstall icp triagemanager is not intended for direct diagnosis or monitoring."
No
The device description explicitly states that the system utilizes "standard commercially available medical devices designed for home use" to measure physiological data, and these devices communicate with the software via "commercially available hub/gateways." This indicates the system includes hardware components beyond just the software itself.
Based on the provided information, the Tunstall icp triagemanager software application is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Tunstall icp triagemanager Function: The description clearly states that the software is a web-based telehealth remote patient monitoring system. It receives patient vital sign data and answers to health-related questions, which are collected using standard commercially available medical devices for home use. It does not process or analyze biological specimens.
- Intended Use: The intended use is for caregivers to review patient information, motivate, and provide educational information. It explicitly states it is not intended for direct diagnosis, monitoring, or providing automated treatment decisions.
Therefore, the Tunstall icp triagemanager falls under the category of a remote patient monitoring system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DRG
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professionals / healthcare facility (host server)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 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
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.
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.
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
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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 triagemanager
software application allows the
caregiver to review patient
information and to motivate and
provide educational information to the
patient. | The Intel Health Guide Express is
intended to collect vital sign
measurements from physiological
measurement devices intended for use
in the home. Patients can review the
stored vital sign measurement
information and receive educational
and motivational content from
caregivers. Patients can also engage in
video conferences with caregivers and
answer the caregivers' questions by
participating in surveys. The Intel
Health Care Management Suite allows
the caregiver to review patient data
and initiate video conferencing with
patients, or select and send educational
and motivational content to patients. | The icp triagemanager and the
Intel Health Guide Express have
essentially identical Intended
Uses, with the difference that icp
triagemanager does not include a
video conferencing feature (please
see part in yellow). |
| Environment
of Use | Healthcare providers. | Home users and healthcare providers. | The icp triagemanager and the
Intel Health Guide Express have
essentially identical Environment
of Use, with the difference that
icp triagemanager does not
include home users (please see
part 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 |
- |
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| I | |
| Device Name | icp triagemanager | Intel Health Guide Express
(K103276) | Significant Differences |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Limitations of
Use | 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 Intel Health Guide Express is not
interpretive, nor is it intended for
diagnosis or as a substitute for medical
care, and it is not intended to provide
real time data. It is made available to
patients when time-critical care is not
required. | The icp triagemanager and the
Intel Health Guide Express have
essentially identical Limitations of
Uses. |
| Principles of
Operation | 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. | The Intel Health Guide Express is
contraindicated for patients requiring
direct-medical supervision or
emergency intervention. It is intended
for patients who are willing and
capable of managing its use. Clinical
judgment and experience by a
caregiver are required to check and
interpret the information delivered. | The icp triagemanager and the
Intel Health Guide Express have
essentially identical Principles of
Operation, with the difference that
the Intel Health Guide Express
includes a hub/gateway system |
| | To be used upon prescription of a
licensed physician or authorized
healthcare provider. | To be used upon prescription of a
licensed physician or authorized
healthcare provider. | |
| | A software application running on a
host server that allows caregivers to
review (on a secure website) patient
vital signs received from
commercially available, compatible
hub/gateway systems | A software application that is working
as hub/gateway sending data measured
by patients to a data server where
another software package is used for
the review (on a secure website) of
patient 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). |
| Technological
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:
• 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.
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 |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K122095 |