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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ESCORT LINK Central Station Monitor Model 20500, based on the provided text:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or a direct table comparing them to reported device performance. Instead, it indicates that the device was designed to "functional standards developed by independent and regulatory agencies" and its performance was evaluated against these.

However, based on the "Device Testing" and "Test Conclusions" sections, we can infer the key performance areas that were tested and deemed acceptable:

Acceptance Criteria Area (Inferred)	Reported Device Performance (Summary from text)
Alarm Detecting and Reporting	Confirmed to be safe and effective
Arrhythmia Detecting and Reporting	Confirmed to be safe and effective
Accuracy of Patient Vital Sign Data	Confirmed to be safe and effective
Accuracy of Waveform Data	Confirmed to be safe and effective

The document states that the device was shown to be "safe, effective Central Station Monitor" in these areas, and "substantially equivalent" to the predicate device (ESCORT LINK Central Station Monitor Model 3200).

Study Details

The provided document offers limited specific details about the study methodology in the typical research paper format. However, it does provide some insights into the testing conducted:

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "tests demonstrating consideration of and mitigation of hazards" and "application of system tests, reviews, and product verification and validation studies." This suggests comprehensive system-level testing rather than a specific patient-based test set with a defined sample size.
- Data Provenance: Not specified. The context implies internal testing by Medical Data Electronics, Inc.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not mention the use of external experts for establishing ground truth for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. This level of detail regarding adjudication methods is not present in the document.
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:
- No. The device described is a central station monitor for vital signs and arrhythmia, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers would not be applicable or expected for this type of device.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Yes, implicitly. The "Device Testing" and "Test Conclusions" sections refer to "performance testing" of the "ESCORT LINK Central Station Monitor Model 20500" itself. This suggests testing the device's inherent functionality (alarm detection, arrhythmia detection, data accuracy) as a standalone system. The central station's role is to display, store, and report data, and its own algorithms for arrhythmia detection are specifically mentioned (Provided by Zymed Inc.).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. Given the nature of the device (monitoring vital signs and arrhythmia), the "ground truth" would likely involve known, controlled physiological signals or simulated data representing various cardiac events and vital sign parameters, allowing for verification of the device's detection and reporting accuracy against these known states. This would likely be established through engineering and physiological standards.
The sample size for the training set:
- Not applicable. The document describes a central monitoring system with specific hardware and software, including a "Zymed Inc." arrhythmia algorithm. It does not indicate that the device's core functionality (especially arrhythmia detection) involved a machine learning model that required a specific "training set" in the modern sense. The "Zymed Inc." algorithm would have been developed and validated by its provider, and its integration into this system would have been tested for proper function.
How the ground truth for the training set was established:
- Not applicable, as a "training set" in the machine learning context is not mentioned or implied for this device.

Summary

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K970012

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

1. Date of Preparation: December 31, 1996
1. Device Name:

Trade Name:	ESCORT LINK Central Station MonitorModel 20500
Common Name:	Central Station Monitor
Classification Name:	Monitor, ElectrocardiographDetector 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

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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.

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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.

1. 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.
1. 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.

The primary differences between the two devices are summarized in the following table:

Medical Data Electronics, Inc. -

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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, 200MBHDD
Operating System	MS Windows	MS DOS
Configuration	External to the PC base	Internal to the PC base
Patient MonitoringCapacity	Up to 16	Up to 32
Viewable Waveforms perPatient	Up to 8 per patient	1 per patient
Viewable Vital Sign Valuesper Patient	Up to 20 per patient	Up to 6 per patient
Telemetry Communication	902 - 928 Mhz SpreadSpectrum communicationbetween the bedside andthe Central Station;450 - 470 Mhz UHFcommunication betweentelemetry receivers and theCentral Station	450 - 470 Mhz UHFcommunication betweenthe bedside and theCentral Station
Alarm Handling	Alarms are interactivelyenabled and disabled fromeither the bedside or theCentral Station	Alarms are enabled anddisabled from the bedsideonly
Full Disclosure	Up to 3 waveforms perpatient can be reviewed ata time.	1 Waveform per patientcan 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.

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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.

1. 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.

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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.

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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

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: ESCORT-LINK® CENTRAL STATION MONITOR

FDA/CORH / ODE / DMC Indications for Use:

MODEL 20500

(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)

Page 1 of 1

Regulation Number and Section

§ 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.