EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM

K991211 · Reynolds Medical , Ltd. · DXH · Jul 8, 1999 · Cardiovascular

Device Facts

• Record ID: K991211
• Device Name: EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM
• Applicant: Reynolds Medical , Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Jul 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Indications for Use

The EventStation is intended to be used as a central receiving station for electrocardiograms that are recorded by Patient-Activated cardiac event recorders and then transmitted by telephone to a central station. It can operate in either an automatic "Unattended Mode" or a manual "Attended Mode." It has no ECG analysis capability, and is not intended to be used for this purpose. The system can also download the contents of Reynolds event recorders directly by means of a cable. It is not intended to display pacemaker activity.

Device Story

EventStation functions as central receiving station for ECG data transmitted via telephone from patient-activated cardiac event recorders or via direct cable download. System comprises PC with voice modem running Windows 98 and proprietary software. Operates in automatic 'Unattended Mode' or manual 'Attended Mode'. Used by clinicians to receive and review ECG recordings. Device lacks ECG analysis capabilities and does not display pacemaker activity. PC hardware is modified to prevent OS changes or unauthorized software loading. Output allows healthcare providers to view transmitted ECGs for clinical decision-making.

Clinical Evidence

Clinical equivalence testing performed on patients to demonstrate performance parity with predicate devices. No further clinical data provided.

Technological Characteristics

PC-based system with voice modem; Windows 98 OS; modified hardware to restrict OS/software changes. Connectivity via telephone line or direct cable. Standards: EN60950 (non-patient contact equipment), EN55022, EN50082 (EMI/EMC). No ECG analysis or pacemaker display capability.

Indications for Use

Indicated for use as a central receiving station for ECGs recorded by patient-activated cardiac event recorders and transmitted via telephone or direct cable download. Not intended for ECG analysis or display of pacemaker activity.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Predicate Devices

• Reynolds Cardio-Connect (K972649)
• Paceart Cardio-Voice (K952065)

Submission Summary (Full Text)

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Reynolds EventStation 510(k) Submission Page A 4

.

JUL - 8 1999

## Reynolds Medical Ltd. 510(k) Submission EventStation ECG Trans-Telephonic Receiving System

991211

## 510(k) Summary

### (1) Submitter Information

Name: Reynolds Medical Ltd.

Address:

1-2 Hartforde Court John Tate Court Hertford, Herts SG137NW ENGLAND

Telephone Number: 44-1992-507700

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone [phone] Fax [phone]

Date Prepared: October 5, 1998

(2) Name of Device

Trade Name: EventStation ECG Trans-Telephonic Receiving System Common Name: ECG Central Station Trans-telephonic system. Classification name: Transmitters and Receivers, Electrocardiograph, Telephone, 74 DXH

(3) Equivalent legally-marketed devices.

1. Reynolds Cardio-Connect, K972649

- 2. Paceart Cardio-Voice, K952065.
(4) Description

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Reynolds EventStation 510(k) Submission Page A 5

The EventStation enables the physician to receive and review ECG recordings transmitted by the patient from a Reynolds CardioCall event recorder and other compatible event recorders.

The EventStation consists of a personal computer with voice modem, operating under Windows 98, and special software written by Reynolds Medical Ltd. The computer is assembled by Revnolds from standard components, and has been modified so that the operating system cannot be changed and unauthorized software cannot be loaded.

#### (5) Intended Use

The EventStation is intended to be used as a central receiving station for electrocardiograms that are recorded by Patient-Activated cardiac event recorders and then transmitted by telephone to a central station. It can operate in either an automatic "Unattended Mode" or a manual "Attended Mode." It has no ECG analysis capability, and is not intended to be used for this purpose.

(6) Performance Data

#### (a) Non-clinical tests

The EventStation software has been tested in accordance with EN60950, En 55022, and EN50082. EN 60950 is the standard required for non-patient contact equipment, and the other standards are for electromagnetic interference and immunity.

The EventStation software has undergone extensive validation testing.

(b) Clinical tests

An Equivalence test has been done on patients, to show that the EventStation is equivalent to a predicate device.

(c) Conclusions

The EventStation ECG Trans-Telephonic Receiving System is equivalent in safety and efficacy to the legally-marketed predicate devices.

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Image /page/2/Picture/0 description: The image contains the words "Reynolds MEDICAL" in bold, black font. The word "Reynolds" is on top of the word "MEDICAL". There is a line going through the middle of the words, and there is a heart rate line going through the middle of the word "Reynolds".

Reynolds Medical Limited, 1 Harforde Court, John Tate Road, Hertford SG13 7NW England Telephone: [phone] Fax: [phone] email: [e-mail] International Telephone: + 44 1992 507 700 Fax: + 44 1992 501 213

# Reynolds Medical Ltd

# Truthful and Accuracy Statement

EventStation Trans-Telephonic Receiving Station

The submitter believes that to the best of his knowledge that all data and information submitted in this premarket notification are truthful and accurate, and that no material fact has been omitted.

Signed Hf Maze

Title JOINT MANAGING DIRECTOR

Date 16 March 1999

Image /page/2/Picture/10 description: The image shows a circular seal with the letter 'R' in the center. The seal has text around the perimeter, but the text is not clear enough to read. The seal appears to be a mark of quality or certification.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 JUL

Mr. George C. Myers Medsys, Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604

Re : K991211 EventStation ECG TransTelephonic Receiving System Requlatory Class: II (two) Product Code: DXH Dated: April 9, 1999 Received: April 9, 1999

Dear Mr. Myers:

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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 Reqister. Please note: this

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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.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, 2 Misbranding by reference to premarket notification? (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

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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Reynolds EventStation 510(k) Submission Page 5

Page 1

510(k) Number (if known): K99/211

Indications for Use Form

## Device Name: EventStation Trans-Telephonic Receiving Station

### Indications for Use:

The EventStation is intended to be used as a central receiving station for electrocardiograms that are recorded by Patient-Activated cardiac event recorders and then transmitted by telephone to a central station. It can operate in either an automatic "Unattended Mode" or a manual "Attended Mode." It has no ECG analysis capability, and is not intended to be used for this purpose. The system can also download the contents of Reynolds event recorders directly by means of a cable. It is not intended to display pacemaker activity.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Stuar Robinson for DB1 7/8/99

Concurrence of CDRH. Office of Device Evaluation (ODE)

**Prescription Use**
Use
(Per 21 CFR 810.109) ✓

OR

Over-the-Counter

(Optional Format 1-2-96)