(71 days)
Not Found
No
The summary describes a central station for monitoring vital signs and ECG data, focusing on communication protocols and hardware. There is no mention of AI, ML, or any algorithms beyond a standard ST algorithm.
No
The device is described as a central station monitor intended for surveillance and documentation of patient vital sign data and arrhythmia/ST monitoring, which are diagnostic and monitoring functions, not therapeutic.
No
The device is described as a central station for "centralized surveillance and documentation of patient vital sign data and arrhythmia/ST monitoring." It provides "display, storage and recording (or printing) of patient vital sign and waveform data." While it processes ST segment measurement data, the document states, "The significance of the ST segment changes must be determined by a physician," indicating it does not make a diagnosis itself, but displays data for physician interpretation.
No
The device description explicitly states it is comprised of a standard personal computer base, a VGA display, an auxiliary base/receiver hub, and a telemetry transmitter, all of which are hardware components.
Based on the provided text, 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 description clearly states the device is a "Central Station" and "telemetry transmitter" used for "centralized surveillance and documentation of patient vital sign data and arrhythmia/ST monitoring." It receives data from bedside monitors and telemetry transmitters.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient. It is monitoring and displaying physiological signals and vital signs directly from the patient or through other monitoring devices.
Therefore, the function of this device falls under patient monitoring and data management, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ESCORT Vision Central Station 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.
Product codes
870.1025, 870.2300, 870.2910
Device Description
The modified ESCORT Vision Central Station is a central station monitor comprised of a standard VGA display, a standard personal computer base and an auxiliary base or receiver hub used to mount the network communications hardware. The modified Stickman telemetry transmitter is an RF physiological signal transmitter comprised of an ECG measurement system packaged with a UHF transmitter.
The modified ESCORT Vision Central Station provides 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. The modified Stickman telemetry transmitter provides ECG signal monitoring and RF signal transmission.
The modified ESCORT Vision Central Station with Stickman Telemetry Transmitters communicates in the new WMTS band, providing protection against interference.
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
Not Found
Summary of Performance Studies
Testing of the modified ESCORT Vision Central Station with Stickman Testing Telemetry Transmitter is being conducted by MDE to ensure mitigation of hazards. V&V testing and testing of the modified device to safety standards include the same ones as performed on the predicate devices with tests added to address issues raised as a result of the new hazard analysis.
Key Metrics
Not Found
Predicate Device(s)
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
OCT - 3 2001
ATTACHMENT 4
510(k) Summary
Date July 23, 2001
- Greg Alkire Contact Director, Regulatory Affairs Medical Data Electronics 12723 Wentworth Street Arleta, California 91331 818-768-6411 Ext 2157 Telephone: Or: Robert Bejgrowicz Ext 2821 Telefax: 818-768-7602 Email: galkire@emailmde.com ESCORT® Vision Central Station with Stickman Telemetry Transmitter Device Name Central Station Monitor Common Name Detector and Alarm, Arrhythmia Cardiac Monitor RF Physiological Transmitter/Receiver Classification The classification names and classifications of the ESCORT® Vision Central Station with Stickman Telemetry Transmitter are as follows:
| Device | Classification
Number | Class |
|---------------------------------------|--------------------------|-------|
| Arrhythmia Detector and Alarm | 870.1025 | III |
| Cardiac Monitor | 870.2300 | II |
| RF Physiological Transmitter/Receiver | 870.2910 | II |
1
K012336 p. 2/3
| Predicate
Device | ESCORT Vision Central Station, 510(k) K982104, clearance date:
November 25, 1998 and the ESCORT Guardian, Model 20601, 510(k)
K961138, clearance date: July 14, 1997 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | The modified ESCORT Vision Central Station is a central station monitor
comprised of a standard VGA display, a standard personal computer base
and an auxiliary base or receiver hub used to mount the network
communications hardware. The modified Stickman telemetry transmitter
is an RF physiological signal transmitter comprised of an ECG
measurement system packaged with a UHF transmitter. |
| | The modified ESCORT Vision Central Station provides 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. The modified
Stickman telemetry transmitter provides ECG signal monitoring and RF
signal transmission. |
| | The modified ESCORT Vision Central Station with Stickman Telemetry
Transmitters communicates in the new WMTS band, providing protection
against interference. |
| Indications
For Use | The ESCORT Vision Central Station 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. |
| Technological
Characteristics | The modified ESCORT Vision Central Station with Stickman Telemetry
Transmitter has the same technological characteristics as the predicate
device. Additional software is added to facilitate the channel and |
identifier programming capability for Stickman telemetry transmitters
configured for WMTS.
2
K012336 p. 3/3
- Testing of the modified ESCORT Vision Central Station with Stickman Testing Telemetry Transmitter is being conducted by MDE to ensure mitigation of hazards. V&V testing and testing of the modified device to safety standards include the same ones as performed on the predicate devices with tests added to address issues raised as a result of the new hazard analysis.
- Medical Data Electronics, in accordance with the FFDCA and 21 CFR Conclusions Part 807 and data included in this premarket notification, concludes that the modified ESCORT Vision Central Station with Stickman Telemetry Transmitter is safe, effective and substantially equivalent to the predicate device.
3
Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services (HHS). The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
OCT - 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Greg R. Alkire Director of Regulatory Affairs Medical Data Electronics 12723 Wentworth St. Arleta, CA 91331
Re: K012336
Trade Name: ESCORT Guardian Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: 74 DSI Dated: September 21, 2001 Received: September 24, 2001
Dear Mr. Alkire:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 -- Mr. Greg R. Alkire
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that 1 DA s issumited of a vederice complies with other requirements of the Act or that FDA had a decemination and your contraster by other Federal agencies. You must comply with CER Box 1907 all rederal statutes and regulations and limited to: registration and listing (21 CFR Part 807); all the Act s requirements, morading, backevring practice requirements as set forth in the quality labeling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter will anow you've 500 finding of substantial equivalence of your device to a legally prematicated predicated on "The PDF intention 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 IT you desire specific acrise for you in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 007.10 for questions on the promotion and advertising of Compliance at (301) 591 1815. Tiber of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation citince, "Wisolulaing of responsibilities under the Act may be obtained from the Division Other general information on your rel rel and Consumer 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,
V. Dealla Tell
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
ATTACHMENT 2
Indications for Use Statement
Page of 1
510(k) Number (if known): KO1233 L
Device Name: ESCORT Vision Central Station
Indications for Use:
The ESCORT Vision Central Station 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 of Cardiovascular & Respiratory Devices
510(k) Number K012336
Prescription Use \ (Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)