(90 days)
Not Found
No
The document explicitly states the device "has no ECG analysis capability" and does not mention any AI or ML terms.
No
The device is a central receiving station for electrocardiograms, functioning primarily as a data receiver and reviewer rather than directly treating or diagnosing physiological conditions.
No
The device is a central receiving station for electrocardiograms (ECGs) and acts as a data repository and review system. It explicitly states, "It has no ECG analysis capability, and is not intended to be used for this purpose." This indicates it does not interpret or diagnose conditions based on the ECG data it receives, which is a core function of a diagnostic device.
No
The device description explicitly states that the EventStation consists of a personal computer with a voice modem and special software. While the software is a key component, the system includes hardware (personal computer, voice modem) that is assembled and modified by the manufacturer. Therefore, it is not a software-only medical device.
Based on the provided information, the EventStation is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- EventStation's Function: The EventStation's primary function is to receive and manage electrocardiograms (ECG), which are recordings of electrical activity of the heart. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's a "central receiving station for electrocardiograms" and "has no ECG analysis capability."
- Device Description: The description reinforces its role in receiving and reviewing ECG recordings.
Therefore, the EventStation falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DXH
Device Description
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.
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
central receiving station for electrocardiograms
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
(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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 201-727-1703 Fax 201-727-1708
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.
- Reynolds Cardio-Connect, K972649
-
- Paceart Cardio-Voice, K952065.
(4) Description
- Paceart Cardio-Voice, K952065.
1
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.
2
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: (01992) 507 700 Fax: (01992) 501 213 email: rml@reymed.com 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.
3
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
4
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 (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, 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 (800) 638-2041 or (301) 443-6597 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
5
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)