MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500

K012336 · Medical Data Electronics · DSI · Oct 3, 2001 · Cardiovascular

Device Facts

• Record ID: K012336
• Device Name: MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
• Applicant: Medical Data Electronics
• Product Code: DSI · Cardiovascular
• Decision Date: Oct 3, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended 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.

Device Story

The ESCORT Vision Central Station is a central monitoring system comprising a standard PC, VGA display, and receiver hub. It receives patient vital sign and waveform data from ESCORT II bedside monitors and UHF telemetry transmitters (including the Stickman transmitter) via wireless LAN. The system provides centralized display, storage, and recording of patient data. It includes an ST segment monitoring algorithm; the significance of ST changes must be interpreted by a physician. Used in hospital settings by trained healthcare practitioners to facilitate patient surveillance and clinical decision-making regarding cardiac status.

Clinical Evidence

Bench testing only. The ST algorithm was tested for accuracy of ST segment measurement data. No clinical data provided.

Technological Characteristics

System consists of a standard PC, VGA display, and receiver hub. Communicates via wireless LAN and supports the WMTS band. Includes ECG measurement system and UHF transmitter. Software added for channel/identifier programming. Sterilization not applicable.

Indications for Use

Indicated for centralized surveillance and documentation of vital signs, arrhythmia, and ST segment monitoring in hospital environments for patients monitored via ESCORT II Bedside Monitors or UHF telemetry transmitters. Intended for use by trained healthcare practitioners.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ESCORT Vision Central Station (K982104)
• ESCORT Guardian, Model 20601 (K961138)

Submission Summary (Full Text)

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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: [e-mail] 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<br>Number | Class |
|---------------------------------------|--------------------------|-------|
| Arrhythmia Detector and Alarm | 870.1025 | III |
| Cardiac Monitor | 870.2300 | II |
| RF Physiological Transmitter/Receiver | 870.2910 | II |

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K012336 p. 2/3

| Predicate<br>Device | ESCORT Vision Central Station, 510(k) K982104, clearance date:<br>November 25, 1998 and the ESCORT Guardian, Model 20601, 510(k)<br>K961138, clearance date: July 14, 1997 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The modified ESCORT Vision Central Station is a central station monitor<br>comprised of a standard VGA display, a standard personal computer base<br>and an auxiliary base or receiver hub used to mount the network<br>communications hardware. The modified Stickman telemetry transmitter<br>is an RF physiological signal transmitter comprised of an ECG<br>measurement system packaged with a UHF transmitter. |
| | The modified ESCORT Vision Central Station provides centralized<br>display, storage and recording (or printing) of patient vital sign and<br>waveform data that are being monitored at ESCORT II, 100, 300 or 400<br>Series Bedside Monitors or UHF telemetry receivers. The modified<br>Stickman telemetry transmitter provides ECG signal monitoring and RF<br>signal transmission. |
| | The modified ESCORT Vision Central Station with Stickman Telemetry<br>Transmitters communicates in the new WMTS band, providing protection<br>against interference. |
| Indications<br>For Use | The ESCORT Vision Central Station is intended to be used to<br>provide, using a wireless LAN for communication, centralized<br>surveillance and documentation of patient vital sign data and<br>arrhythmia/ST monitoring for a variable number of ESCORT II Bedside<br>Monitors and a variable number of UHF telemetry transmitters in the<br>hospital environment. It is intended for use by healthcare practitioners<br>trained in the use of the equipment only. |
| | The ST algorithm has been tested for accuracy of the ST segment<br>measurement data. The significance of the ST segment changes must be<br>determined by a physician. |
| Technological<br>Characteristics | The modified ESCORT Vision Central Station with Stickman Telemetry<br>Transmitter has the same technological characteristics as the predicate<br>device. Additional software is added to facilitate the channel and |

identifier programming capability for Stickman telemetry transmitters
configured for WMTS.

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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.

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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.

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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 [phone]. Tiber of Compliance at [phone]. 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 [phone] or [phone] 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

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## 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)