← Product Code [MSX](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MSX) · K973640 # TS2000 MEDICAL DEVICE MONITOR (K973640) _Trincore Systems, Inc. · MSX · Mar 12, 1998 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MSX/K973640 ## Device Facts - **Applicant:** Trincore Systems, Inc. - **Product Code:** [MSX](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MSX.md) - **Decision Date:** Mar 12, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2300 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Software as a Medical Device ## Indications for Use 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 Story TS2000 is a PC-based central monitoring station; aggregates data from bedside pulse oximeters and infusion pumps; redisplays information on a single central monitor. Operates via RS-232 hardwired connection to bedside devices; provides secondary visual and audible alarm annunciation. Used in hospitals, clinics, and surgical centers by trained healthcare professionals. System allows remote viewing of multiple patients simultaneously; supports up to 40 patients; maintains 24-hour trends. Output assists clinicians in managing medical devices; supplements existing bedside monitoring procedures; does not replace primary monitoring or physician care. Benefits include improved management of medical devices and enhanced safety through centralized oversight. ## Clinical Evidence No clinical data. Evidence consists of bench and simulation testing conducted according to the TS2000 Software Life Cycle, complying with FDA guidance for computer-controlled medical devices. ## Technological Characteristics Pentium-class PC; MS Windows 95 OS; SVGA color monitor; RS-232 hardwired connectivity. Modular multi-parameter central station architecture. Software-based data aggregation and display. No specific material standards cited. ## Regulatory 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. ## Predicate Devices - Baxter Flo-Gard 6301 Volumetric Infusion Pump ([K915522](/device/K915522.md)) - Nellcor Puritan Bennett Oxinet II ([K942147](/device/K942147.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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: ұ 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 {1}------------------------------------------------ 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: 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. #### 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 | |-----------------|----------------------| |-----------------|----------------------| {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 Monitor
without Touchscreen | SVGA Color Monitor
With 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 | Modular
Multi Parameter | Modular
Multi Parameter | | Devices Monitored | Pulse Oximeters
Infusion Pumps | Nellcor Symphony Monitors
N-3000 Pulse Oximeter
N-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. {4}------------------------------------------------ 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. {5}------------------------------------------------ #### 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ 510(k) Number (if known): y Device name: TS2000 Medical Device Monitor Indications For Use: 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. Ka73640 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 (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) OR Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MSX/K973640](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MSX/K973640) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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