(175 days)
ESCORT LINK Central Station Monitor Model 3200
No reference devices were found in the text.
No
The document describes a central station monitor for displaying and storing patient vital sign data and alarms. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No.
This device is a central station monitor used for surveillance and documentation of patient vital sign data and arrhythmia monitoring, not for direct therapeutic intervention.
No
The device is described as a "Central Station Monitor" intended for "centralized surveillance and documentation of patient vital sign data and arrhythmia monitoring and alarms." It displays, stores, and records data from other monitors, rather than actively diagnosing conditions itself.
No
The device description explicitly states it is comprised of a standard VGA Display, a standard Personal Computer Base, and an auxiliary base for network communications hardware, indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "centralized surveillance and documentation of patient vital sign data and arrhythmia monitoring and alarms." This involves monitoring physiological parameters directly from the patient, not analyzing samples taken from the patient (which is the core of IVD).
- Device Description: The description details a system for displaying, storing, and recording patient vital sign and waveform data from bedside monitors and telemetry receivers. This aligns with patient monitoring, not in vitro analysis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the ESCORT-LINK™ Central Station Monitor is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The ESCORT LINK Central Station Monitor Model 20500 is intended to be used to provide centralized surveillance and documentation of patient vital sign data for a variable number of ESCORT Series 100, 300, and 400 bedside monitors and a variable number of UHF telemetry transmitters in the hospital environment.
The ESCORT-LINK™ Central Station Monitor is intended to be used to provide, using a wireless LAN for communication, centralized surveillance and documentation of patient vital sign data and arrhythmia monitoring and alarms for a variable number of ESCORT II bedside monitors and a variable number of UHF telemetry transmitters in the hospital environment. It is intended for use by healthcare practitioners trained in the use of the equipment only.
Product codes
74 DSI
Device Description
The ESCORT LINK Central Station Monitor Model 20500 is a Central Station monitor comprised of a standard VGA Display, a standard Personal Computer Base, and an auxiliary base used to mount the Network communications hardware (i.e. Spread Spectrum transponders and UHF telements of the The ESCORT LINK Central Station Monitor Model 20500 can provide the centralized display, storage, and recording (or printing) of patient vital sign and waveform data that is being monitored at ESCORT II 100, 300, or 400 bedside monitors or UHF Telemetry Receivers.
Data accumulated at ESCORT II bedsides is sent via a proprietary Spread Spectrum Local Area Network to the Central Station for display and storage. Data accumulated from any of Medical Data Electronics' analog or digital telemetry transmitters is sent directly to the Central Station on standard UHF telemetry frequencies. The Central Station oversees all communications activity, allowing each system component to pass information without interruption to patient monitoring.
The Central Station can provide alarm detecting and reporting for all vital sign parameters that are available to the Central Station. This alarm response is in addition to alarms that are available at the ESCORT 100, 300, or 400 bedsides. Also, arrhythmia monitoring is available for up to 16 patients at the Central Station to provide the configurable ability to detect and report certain cardiac abnormalities.
The Central Station can provide storage of patient data for up to 24 hours. This includes waveform and vital sign information for all available waveforms and parameter values. The waveform and vital sign data that has been stored in a patient file at the Central Station can be retrieved and viewed on the display or printed out on a Thermal Array recorder or a LaserJet® Printer.
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
hospital environment.
healthcare practitioners trained in the use of the equipment only.
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)
The ESCORT LINK Central Station Monitor Model 20500 is designed to functional standards developed by independent and regulatory agencies.
The criteria for these standards are identified in the following FDA documents:
- Reviewer Guidance for Computer Controlled Medical Devices . Undergoing 510(k) Review; Office of Device Evaluation, August 1991.
- Reviewer Guidance for Premarket Notification Submissions, ● Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory and Neurological Devices; November 1993.
Tests demonstrating consideration of and mitigation of hazards identified to have potentially arisen as the result of the modifications in the new device were developed. Conformance to product development procedures and plans is assured by application of system tests, reviews, and product verification and validation studies.
The MDE ESCORT LINK Central Station Monitor Model 20500 is shown by performance testing, stressing the areas of alarm detecting and reporting, arrhythmia detecting and reporting, and accuracy of patient vital sign and waveform data, to be a safe, effective Central Station Monitor. The MDE ESCORT LINK Central Station Monitor Model 20500 is substantially equivalent to the ESCORT LINK Central Station Monitor Model 3200.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The ESCORT LINK Central Station Monitor Model 20500 is substantially equivalent to the ESCORT LINK Central Station Monitor Model 3200.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
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Image /page/0/Picture/1 description: The image shows a logo with the letters "MDE" in bold, stylized font. To the left of the letters is a graphic that resembles a mountain range or a waveform, enclosed within a rounded rectangle. Below the logo, the word "RELIABLE" is printed in a simple, sans-serif font, and below that, the word "Innovations" is written in a cursive font with a trademark symbol. The overall design is clean and professional, suggesting a company focused on technology or engineering.
510(k) Summary
Page 1
JUN 26 1997
ESCORT LINK Central Station Model 20500
1. Submitter:
Medical Data Electronics 12720 Wentworth Street Arleta, California 91331
Telephone: 818-768-6411 Telefax: 818-768-4197
Contact: David M. Trueblood Regulatory Affairs Manager
-
- Date of Preparation: December 31, 1996
-
- Device Name:
| Trade Name: | ESCORT LINK Central Station Monitor
Model 20500 |
|----------------------|---------------------------------------------------------------|
| Common Name: | Central Station Monitor |
| Classification Name: | Monitor, Electrocardiograph
Detector and Alarm, Arrhythmia |
4. Substantial Equivalence:
The ESCORT LINK Central Station Monitor Model 20500 is substantially equivalent to the ESCORT LINK Central Station Monitor Model 3200.
- ನ. Description of the Device:
The ESCORT LINK Central Station Monitor Model 20500 is a Central Station monitor comprised of a standard VGA Display, a standard Personal Computer Base, and an auxiliary base used to mount the Network communications hardware (i.e. Spread Spectrum transponders and UHF telements of the
The ESCORT LINK Central Station Monitor Model 20500 can provide the centralized display, storage, and recording (or printing) of patient vital sign and waveform data that is being monitored at ESCORT II 100, 300, or 400 bedside monitors or UHF Telemetry Receivers.
12720 Wentworth St. ▲ Arleta, CA 91331-4329 ▲ (818) 768-6411 ▲ Fax (818) 768-7602
1
Image /page/1/Picture/0 description: The image shows a logo with the letters "MDE" in bold, sans-serif font. To the left of the letters is a stylized graphic that resembles a mountain or a stylized letter "A". Below the logo, the words "RELIABLE Innovations" are printed in a smaller, italicized font. The logo has a simple, clean design, and the text suggests a focus on dependable and innovative solutions.
Page 2
Data accumulated at ESCORT II bedsides is sent via a proprietary Spread Spectrum Local Area Network to the Central Station for display and storage. Data accumulated from any of Medical Data Electronics' analog or digital telemetry transmitters is sent directly to the Central Station on standard UHF telemetry frequencies. The Central Station oversees all communications activity, allowing each system component to pass information without interruption to patient monitoring.
The Central Station can provide alarm detecting and reporting for all vital sign parameters that are available to the Central Station. This alarm response is in addition to alarms that are available at the ESCORT 100, 300, or 400 bedsides. Also, arrhythmia monitoring is available for up to 16 patients at the Central Station to provide the configurable ability to detect and report certain cardiac abnormalities.
The Central Station can provide storage of patient data for up to 24 hours. This includes waveform and vital sign information for all available waveforms and parameter values. The waveform and vital sign data that has been stored in a patient file at the Central Station can be retrieved and viewed on the display or printed out on a Thermal Array recorder or a LaserJet® Printer.
-
- Intended Use of the Device:
The ESCORT LINK Central Station Monitor Model 20500 is intended to be used to provide centralized surveillance and documentation of patient vital sign data for a variable number of ESCORT Series 100, 300, and 400 bedside monitors and a variable number of UHF telemetry transmitters in the hospital environment.
- Intended Use of the Device:
-
- Summary of the Technological Characteristics of the New Device Compared to the Predicate Device:
The MDE ESCORT LINK Central Station Monitor Model 20500 is a new Central Station monitor, however, its intended use and method of operation are substantially equivalent to the MDE ESCORT LINK Central Station Monitor Model 3200.
- Summary of the Technological Characteristics of the New Device Compared to the Predicate Device:
The primary differences between the two devices are summarized in the following table:
Medical Data Electronics, Inc. -
2
Image /page/2/Picture/0 description: The image shows a logo with the letters "MDE" in bold, sans-serif font. To the left of the letters is a stylized graphic that resembles a mountain range or a series of peaks. Below the letters, the word "RELIABLE" is printed in a smaller, sans-serif font, and below that, the word "Innovations" is written in a cursive font with a trademark symbol next to it. The logo has a simple, clean design, suggesting a company that values reliability and innovation.
Page 3
| SPECIFICATION | MODEL 20500 | MODEL 3200 |
|---|---|---|
| PC Specifications | Pentium PC, 16MB RAM, | |
| 2GB HDD | 386 PC, 8MB RAM, 200MB | |
| HDD | ||
| Operating System | MS Windows | MS DOS |
| Configuration | External to the PC base | Internal to the PC base |
| Patient Monitoring | ||
| Capacity | Up to 16 | Up to 32 |
| Viewable Waveforms per | ||
| Patient | Up to 8 per patient | 1 per patient |
| Viewable Vital Sign Values | ||
| per Patient | Up to 20 per patient | Up to 6 per patient |
| Telemetry Communication | 902 - 928 Mhz Spread | |
| Spectrum communication | ||
| between the bedside and | ||
| the Central Station; | ||
| 450 - 470 Mhz UHF | ||
| communication between | ||
| telemetry receivers and the | ||
| Central Station | 450 - 470 Mhz UHF | |
| communication between | ||
| the bedside and the | ||
| Central Station | ||
| Alarm Handling | Alarms are interactively | |
| enabled and disabled from | ||
| either the bedside or the | ||
| Central Station | Alarms are enabled and | |
| disabled from the bedside | ||
| only | ||
| Full Disclosure | Up to 3 waveforms per | |
| patient can be reviewed at | ||
| a time. | 1 Waveform per patient | |
| can be reviewed at a time. | ||
| Arrhythmia Algorithm | Provided by Zymed Inc. | Provided by PCLine |
8. Device Testing:
The ESCORT LINK Central Station Monitor Model 20500 is designed to functional standards developed by independent and regulatory agencies.
The criteria for these standards are identified in the following FDA documents:
- Reviewer Guidance for Computer Controlled Medical Devices . Undergoing 510(k) Review; Office of Device Evaluation, August 1991.
- Reviewer Guidance for Premarket Notification Submissions, ● Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory and Neurological Devices; November 1993.
Medical Data Electronics, Inc.
3
Image /page/3/Picture/0 description: The image shows a logo with the letters "MDE" in bold, sans-serif font. Above the letters are a series of vertical lines that form a mountain-like shape. Below the letters, the words "RELIABLE" and "Innovations" are written in a smaller font. The word "RELIABLE" is in a simple, sans-serif font, while the word "Innovations" is in a cursive font.
Page 4
Tests demonstrating consideration of and mitigation of hazards identified to have potentially arisen as the result of the modifications in the new device were developed. Conformance to product development procedures and plans is assured by application of system tests, reviews, and product verification and validation studies.
-
- Test Conclusions:
The MDE ESCORT LINK Central Station Monitor Model 20500 is shown by performance testing, stressing the areas of alarm detecting and reporting, arrhythmia detecting and reporting, and accuracy of patient vital sign and waveform data, to be a safe, effective Central Station Monitor. The MDE ESCORT LINK Central Station Monitor Model 20500 is substantially equivalent to the ESCORT LINK Central Station Monitor Model 3200.
- Test Conclusions:
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 26 1097
2017 11:4
Mr. David M. Trueblood Medical Data Electronics, Inc. 12720 Wentworth Street .... ...... Arleta, California ~91331-4329 ~1201
Re : K970012 ESCORT Link Central Station Monitor Model 20500 Regulatory Class: III (three) Product Code: 74 DSI Dated: April 11, 1997 Received: April 14, 1997
Dear Mr. Trueblood:
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 requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (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.
5
Page 2 - Mr. David M. Trueblood
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" (21 CFR 807.97). Other general information on your 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
6
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: ESCORT-LINK® CENTRAL STATION MONITOR
FDA/CORH / ODE / DMC Indications for Use:
MODEL 20500
The ESCORT-LINK™ Central Station Monitor is intended to be used to provide, using a wireless LAN for communication, centralized surveillance and documentation of patient vital sign data and arrhythmia monitoring and alarms for a variable number of ESCORT II bedside monitors and a variable number of UHF telemetry transmitters in the hospital environment. It is intended for use by healthcare practitioners trained in the use of the equipment only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
E. Ocnimo
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurologica! Devices
510(k) Number .
Prescription Use (Per 2.1 CFR 801.109)
Over-the-Counter Use_
(Optional Format 1-2-96)
OR
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