The TS2000 Medical Device Monitor is intended to be used as a central monitoring station on those patients being monitored by pulse oximeter and infusion pump medical devices. It is used to provide a secondary display of the data from the medical devices to the centrally located TS2000 System display. It is intended for use by healthcare professionals trained in the use of the equipment only.

The TS2000 is intended for use by healthcare professionals thoroughly familiar with the features and operations of the TS2000. The TS2000 is intended to supplement and not to replace any part of the current device monitoring procedures.

The TS2000 is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care

Device Description

The TS2000 Medical Device Monitor is a PC based Central Monitoring Station that takes the information from different medical devices and redisplays them on a single monitor in a central location. It allows the remote monitoring of multiple medical devices simultaneously at the central station. The TS2000 provides secondary annunciation of the alarms from the medical devices at the central station as well.

AI/ML Overview

The provided 510(k) Premarket Notification for the TS2000 Medical Device Monitor does not contain information regarding acceptance criteria, device performance, or a study that directly proves the device meets specific acceptance criteria in the way a modern AI/ML device submission would.

This submission is from 1998, and the device is a "Central Monitoring Station Software" that essentially redisplays information from other medical devices. This type of device's "performance" is primarily assessed on its ability to accurately and reliably transmit and display data and alarms, validate its software, and demonstrate substantial equivalence to predicate devices, rather than clinical performance metrics like sensitivity or specificity for a diagnostic algorithm.

Here's a breakdown of what is available in the document and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided document in the format of specific acceptance criteria (e.g., minimum accuracy, sensitivity, etc.) and corresponding performance numbers.

The document discusses "thorough validation for safety and effectiveness" by complying with guidance documents for computer-controlled medical devices and software validation (pages 4 and 5). This suggests that the "performance" was assessed against software validation standards rather than clinical endpoints.

The "performance" described is functional:

Allows remote monitoring of multiple medical devices simultaneously.
Provides secondary annunciation of alarms.
"Provides additional assistance to the healthcare professional and makes the current local monitoring process safer and more effective." (Page 2)

2. Sample Size Used for the Test Set and Data Provenance

This information is not available in the provided document. The submission mentions "Non-clinical tests were conducted using both bench and simulation testing according to the test phase defined by the TS2000 Software Life Cycle" (Page 4). This refers to software testing, not a clinical study with a "test set" in the context of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable/available. Since there isn't a clinical test set with patient data being evaluated for a diagnostic or predictive outcome, there is no mention of experts establishing ground truth for such a purpose. The "ground truth" for this device would be the accurate and timely display of data and alarms from connected medical devices as confirmed by software validation.

4. Adjudication Method for the Test Set

This information is not applicable/available as there is no clinical test set requiring adjudication in the context of this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

This information is not applicable/available. An MRMC study is typically for evaluating human performance (e.g., radiologists interpreting images) with and without AI assistance. The TS2000 is a monitoring display system, not a diagnostic AI algorithm that directly assists human interpretation of complex medical cases.

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

The TS2000 is essentially a standalone software system in the sense that it processes and displays data automatically. Its "performance" would be assessed on its functional reliability and accuracy in replicating source device data and alarms. However, this is not a standalone "algorithm" in the modern AI sense, where a diagnostic or predictive output is generated. Its intended use explicitly states it "is intended to supplement and not to replace any part of the current device monitoring procedures" and "is not considered in and of itself to be diagnostic without skilled interpretation" (Page 7).

7. The Type of Ground Truth Used

For the software validation testing described, the "ground truth" would be the expected outputs from the simulated or bench-tested medical devices. For example, if a pulse oximeter was set to display a SpO2 of 98% and an alarm condition was simulated, the TS2000's "ground truth" would be to accurately display 98% and annunciate the alarm. This is a functional ground truth, not a clinical ground truth like pathology for a disease diagnosis.

8. The Sample Size for the Training Set

This information is not applicable/available. The TS2000 is not described as an AI/ML device that undergoes a "training" process with a dataset. It is a software system designed to perform specific functions.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/available for the same reasons as point 8.

Summary of Device and Approval Context:

The TS2000 Medical Device Monitor, as described in this 1998 510(k) submission (K973640), is a Central Monitoring Station Software. Its primary function is to consolidate and redisplay data and alarms from existing medical devices (pulse oximeters and infusion pumps) to a central location.

The approval for this device was based on a demonstration of substantial equivalence to predicate devices (Baxter Flo-Gard 6301 Volumetric Infusion Pump (K915522) for its monitoring aspects and Nellcor Puritan Bennett Oxinet II (K942147) as a central monitoring station). The software was validated for "safety and effectiveness" by complying with then-current FDA guidance documents for computer-controlled medical devices and software development.

The "study" that proves the device meets criteria is primarily the software validation and non-clinical bench/simulation testing (Page 4) which confirmed its functional accuracy and reliability in transmitting and displaying data and alarms as expected, in comparison to the existing predicate technologies. It was not a clinical trial with patient outcomes or expert reads of diagnostic data, as the device's role is purely for secondary display and annunciation.

Summary

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K4736040

TS2000 MEDICAL DEVICE MONITOR

Premarket Notification 510(k)

510 (K) SUMMARY

MAR 1 2 1998

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.929(c).

Trincore Systems, Inc. Submitter: 7409 Butternut Court Fort Worth, TX 76137-1413
Voice: (817) 919-6789 Fax: (817) 847-8273 Email: trincore@juno.com

Vincent Occhipinti Contact Name:

Date Prepared: 15 September 1997

Commonly Known as Central Monitoring Station Software. Common Name:

Proprietary Name: TS2000 Medical Device Monitor (TS2000)

Fort Worth, TX 76108

Classification:

The TS2000 is Considered an Accessory to Type II Devices.

P.O. Box 150072

Trincore Systems, Inc.

Page 13

K973640

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TS2000 MEDICAL DEVICE MONITOR

Premarket Notification 510(k)

Performance Standard: Performance standards (section 514 of the Act) have not vet been established for the device that is the subject of this premarket notification submission.

Device Description:

Intended Use:

The TS2000 is intended for use as an accessory to Type II medical devices, specifically pulse oximeters and infusion pumps.

It is intended for use by healthcare professionals trained in the use of the medical devices that are being monitored.

The TS2000 is intended for use with patient populations, being monitored by healthcare professionals, undergoing the use of these Type II medical devices.

The TS2000 is intended for use in locations, such as hospitals, outpatient clinics, free standing surgical centers or other locations that monitor these Type II medical devices.

Trincore Systems, Inc.

P.O. Box 150072	Fort Worth, TX 76108
-----------------	----------------------

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Premarket Notification 510(k)

Predicate Devices:

Baxter Flo-Gard 6301 Volumetric Infusion Pump (K915522) Nellcor Puritan Bennett Oxinet II (K942147)

Comparison to Baxter Flo-Gard 6301 Volumetric Infusion Pump (K915522)

Local monitoring of this medical device is then available by viewing the display panel on the medical device and if desired, recording of the parameters. The TS2000 extends this concept by extending the display panel to a more centralized location.

By providing this remote viewing capability, the TS2000 provides additional assistance to the healthcare professional and makes the current local monitoring process safer and more effective in the following ways:

Provides additional assistance in the monitoring process

Safe and Effective

Reporting"

Better management of medical devices

Image /page/2/Picture/11 description: The image shows the logo and address of Trincore Systems, Inc. The address is P.O. Box 150072, Fort Worth, TX 76108. The logo is a geometric shape with lines and angles. The text is in a simple, sans-serif font.

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Premarket Notification 510(k)

Comparison to Nellcor Puritan Bennett Oxinet II (K942147)

Characteristic	TS2000	Oxinet II
Computer	Pentium Class PC	Pentium Class PC
Display	SVGA Color Monitorwithout Touchscreen	SVGA Color MonitorWith Touchscreen
Software Operating System	MS Windows 95	Unknown
Patient Capability	over 40 Patients	up to 30 Patients
Communications	RS-232(Hardwire)	Wireless 903-928 Mhz(Spread Spectrum Radio)
Central Station	ModularMulti Parameter	ModularMulti Parameter
Devices Monitored	Pulse OximetersInfusion Pumps	Nellcor Symphony MonitorsN-3000 Pulse OximeterN-3100 Blood Pressure
Data	Continuous	Continuous
Alarms	Visual and Audible	Visual and Audible
Reporting Capabilities	Multiple Available	Multiple Available
Calculations	Provided by the Device	Provided by the Device
Trends	24 hours	24 hours
Graphical User Interface	Yes	Yes

Image /page/3/Picture/4 description: The image shows the logo and address of Trincore Systems, Inc. The address is P.O. Box 150072, Fort Worth, TX 76108. The logo is a simple geometric design with three lines forming a triangle.

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Premarket Notification 510(k)

Statement of Substantial Equivalence:

The TS2000 monitors bedside medical devices at a more central location and provides enhancements to the normal bedside monitoring procedure. Any differences between the predicate devices do not increase any risk to the patient or change the overall concept of a central monitoring station.

The TS2000 software has thoroughly been validated for safety or effectiveness bv complying with the requirements of the Reviewer's Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review. Other guides that were referenced were the Software Development Activities and the General Principles of Software Validation. Non-clinical tests were conducted using both bench and simulation testing according to the test phase defined by the TS2000 Software Life Cycle.

Trincore Systems feels that the TS2000 is substantially equivalent to the predicate devices and other legally marketed central monitoring stations.

Image /page/4/Picture/6 description: The image shows the logo and address of Trincore Systems, Inc. The address is P.O. Box 150072, Fort Worth, TX 76108. The logo is a geometric shape with lines.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Vincent Occhipinti President Trincore System, Inc. 7409 Butternut Court Fort Worth, TX 76137-1413

MAR 1 2 1998

Re: K973640 TS2000 Medical Device Monitor Regulatory Class: Unclassified Product Code: 74 MSX Dated: February 12, 1998 Received: February 17, 1998

Dear Mr. Occhipinti:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Occhipint

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Other general information on your (21 CFR 807.97). responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph. D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device name: TS2000 Medical Device Monitor

Indications For Use:

Ka73640

The TS2000 is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

N. Denta Telle

(Division Sign-Off) Division of Cardiovascular, Respiratory. and Neurological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).