(163 days)
Not Found
No
The description focuses on standard vital sign monitoring, data display, storage, and alarm functions. While it includes an ST algorithm, there is no mention of AI or ML techniques being used for this or any other function. The validation against a standard database (European ST-T) is typical for traditional algorithms, not necessarily indicative of ML.
No
The device is a central station monitor for surveillance and documentation of patient vital sign and arrhythmia/ST data, which supports healthcare practitioners in monitoring but does not directly treat or provide therapy to patients.
Yes
The device is described as providing "centralized surveillance and documentation of patient vital sign data and arrhythmia/ST monitoring," implying it collects and analyzes data to support diagnosis. It specifically mentions "arrhythmia monitoring, with ST reporting," and the ability to "detect and report certain cardiac abnormalities." The statement "The significance of the ST segment changes must be determined by a physician" further clarifies its role in providing data for a diagnosis.
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 physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ESCORT-LINK® Central Station Monitor is designed to monitor and display patient vital signs (like heart rate, blood pressure, etc.) and cardiac activity (arrhythmia/ST monitoring) using data collected from bedside monitors and telemetry transmitters. This is done externally to the patient's body, not by analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's for "centralized surveillance and documentation of patient vital sign data and arrhythmia/ST monitoring." This aligns with patient monitoring, not in vitro testing.
- Device Description: The description focuses on the hardware components and the process of receiving and displaying patient data from other devices. There is no mention of analyzing biological samples.
Therefore, the ESCORT-LINK® Central Station Monitor falls under the category of patient monitoring devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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, including ST analysis, 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
74MLD
Device Description
The modified 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. The modified ESCORT-LINK® Central Station Monitor Model 20500 can provide centralized display, storage and recording (or printing) of patient vital sign and waveform data that are being monitored at ESCORT® II, 100, 300 or 400 Series Bedside Monitors or UHF Telemetry Receivers. Data accumulated at ESCORT® II Bedside Monitors is sent via a proprietary Spread Spectrum Local Area Network to the modified ESCORT-LINK® Central Station Model 20500 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. Telemetry transmitter communication may include patient data similar to that described for the ESCORT® II Bedside Monitors. The modified ESCORT-LINK® Central Station Monitor Model 20500 oversees all communications activity, allowing each system component to pass information without interrupting patient monitoring. The modified ESCORT-LINK® Central Station Monitor Model 20500 can provide alarm detection and reporting for all vital sign parameters available to the central station. This alarm response is in addition to alarms available at the ESCORT® II 100. 300 or 400 Series Bedside Monitors. Also, arrhythmia monitoring, with ST reporting, is available for up to 16 patients at the Central Station to provide the configurable ability to detect and report certain cardiac abnormalities, including ST abnormalities. Parameter alarms, arrhythmia alarms and ST alarms are independently configurable to accommodate the wide range of patients encountered in the hospital environment. The Central Station provides storage of patient data. Stored patient data includes waveform and vital sign information. Stored waveform and vital sign data can be retrieved for viewing or printing.
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
healthcare practitioners trained in the use of the equipment only. / hospital environment
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
The algorithm comprising the modification was validated against the European ST-T (ESC) database. Validation of system, including the modification, performance was demonstrated by testing against the MDE Software Validation System Test Report, predicated on the performance of the unmodified device.
Summary of Performance Studies
The MDE ESCORT-LINK® Central Station Model 20500, modified by the addition of an ST analysis and alarm option, is shown by performance testing, stressing the areas of alarms detection and reporting, arrhythmia detecting and alarms, ST event detecting and alarms, and accuracy of patient vital sign and waveform data, to be a safe, effective Central Station Monitor. The modified ESCORT-LINK® Central Station Monitor Model 20500 is substantially equivalent to the unmodified ESCORT-LINK® Central Station Monitor Model 20500.
Key Metrics
Not Found
Predicate Device(s)
ESCORT-LINK® Central Station Monitor Model 20500
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.
0
510(k) SUMMARY K982104
ESCORT-LINK® CENTRAL STATION MONITOR MODEL 20500 WITH ST OPTION
-
- Submitter:
Medical Data Electronics 12720 Wentworth Street Arleta, California 91331
- Submitter:
| Telephone: | 818-768-6411 |
|---|---|
| Telefax: | 818-768-4197 |
David M. Trueblood Contact: Regulatory Affairs Manager
-
- Date of Preparation: June 12, 1998
- Device Name: 3.
| Trade Name: | ESCORT-LINK® Central Station Monitor
Model 20500 with ST Option |
|----------------------|--------------------------------------------------------------------|
| Common Name: | Central Station Monitor |
| Classification Name: | Monitor, Electrocardiographic
Detector and Alarm, Arrhythmia |
- Substantial Equivalence:
The ESCORT-LINK® Central Station Monitor Model 20500 with ST Option is substantially equivalent to the ESCORT-LINK® Central Station Monitor Model 20500.
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Description of the Modified Device: 5.
The modified 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.
The modified ESCORT-LINK® Central Station Monitor Model 20500 can provide centralized display, storage and recording (or printing) of patient vital sign and waveform data that are being monitored at ESCORT® II, 100, 300 or 400 Series Bedside Monitors or UHF Telemetry Receivers.
Data accumulated at ESCORT® II Bedside Monitors is sent via a proprietary Spread Spectrum Local Area Network to the modified ESCORT-LINK® Central Station Model 20500 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. Telemetry transmitter communication may include patient data similar to that described for the ESCORT® II Bedside Monitors. The modified ESCORT-LINK® Central Station Monitor Model 20500 oversees all communications activity, allowing each system component to pass information without interrupting patient monitoring.
The modified ESCORT-LINK® Central Station Monitor Model 20500 can provide alarm detection and reporting for all vital sign parameters available to the central station. This alarm response is in addition to alarms available at the ESCORT® II 100. 300 or 400 Series Bedside Monitors. Also, arrhythmia monitoring, with ST reporting, is available for up to 16 patients at the Central Station to provide the configurable ability to detect and report certain cardiac abnormalities, including ST abnormalities. Parameter alarms, arrhythmia alarms and ST alarms are independently configurable to accommodate the wide range of patients encountered in the hospital environment.
The Central Station provides storage of patient data. Stored patient data includes waveform and vital sign information. Stored waveform and vital sign data can be retrieved for viewing or printing.
6. Intended Use of the Device:
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, including ST analysis, 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.
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- Summary of the Technological Characteristics of the Modified Device Compared 7. to the Unmodified Device:
The modification which is the subject of this premarket notification regarding the ESCORT-LINK® Central Station Monitor Model 20500 consists of adding an ST analysis with alarms option. The primary differences between the modified and the unmodified devices are summarized in the following table.
| SPECIFICATION | UNMODIFIED
MODEL 20500 | MODIFIED
MODEL 20500 |
|----------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| ST Measurement | None | Automatic |
| ST Alarms | None | ST Deviation |
| Annotation | Time, date, parameter values, ID
source, speed, abnormal events
with arrhythmia option | Time, date, parameter values, ID
source, speed, abnormal events
with arrhythmia option, ST
deviation with ST option |
8. Device Testing
The modified ESCORT-LINK® Central Station Monitor Model 20500 is designed and tested to functional standards developed by independent and regulatory agencies. 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, 1991.
The algorithm comprising the modification was validated against the European ST-T (ESC) database. Validation of system, including the modification, performance was demonstrated by testing against the MDE Software Validation System Test Report, predicated on the performance of the unmodified device.
Tests demonstrating consideration of and mitigation of hazards identified to have potentially arisen as the result of the modifications to the ESCORT-LINK® Central Station Monitor Model 20500 were developed. Conformance to design control procedures were assured by application of design reviews, system tests and device verification and validation studies.
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9. Test Conclusions:
The MDE ESCORT-LINK® Central Station Model 20500, modified by the addition of an ST analysis and alarm option, is shown by performance testing, stressing the areas of alarms detection and reporting, arrhythmia detecting and alarms, ST event detecting and alarms, and accuracy of patient vital sign and waveform data, to be a safe, effective Central Station Monitor. The modified ESCORT-LINK® Central Station Monitor Model 20500 is substantially equivalent to the unmodified ESCORT-LINK® Central Station Monitor Model 20500.
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Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 1998
Mr. David M. Trueblood Medical Data Electronics, Inc. 12720 Wentworth Street Arleta, CA 91331-4329
Re: K982104 ESCORT-LINK® Central Station Monitor Model 20500 Regulatory Class: III (three) Product Code: 74 MLD Dated: October 30, 1998 Received: November 2, 1998
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 legally marketed predicate 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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 requlatory 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/dsma/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): K 982104
Device Name:ESCORT-LINK® CENTRAL STATION MONITOR
Indications for Use:
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/ST monitoring 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.
The ST algorithm has been tested for accuracy of the ST segment measurement data. The significance of the ST segment changes must be determined by a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _ Prescription Use OR Over-the-Counter Use (Per 2.1 CFR 801.109)