The event recorder, called the "CardioCall," is intended to be worn by the patient and to record a short period of electrocardiogram when the patient depresses a button upon sensing symptoms described to him by his physician. The CardioCall can either operate in the so-called "Looping" mode, in which it is always active, and in which it records a minute of one channel of cardiac activity before and a minute after the depression of the button; or in the "Post-Activation" mode, in which the device records two channels of cardiac activity for one minute after the depression of the record button. The PC computer program, called the "CardioConnect," is indicated when it is desired to transfer the memory of the event recorder into a computer by direct connection, instead of using transtelephonic means. The CardioCall recorder is indicated if it is desired to record the electrocardiogram at the time when a patient experiences intermittent or transient symptoms such as dizziness, palpitations, or shortness of breath, and the patient is capable of activating the recorder at these times.

Device Description

CardioCall Event Recorder offers the user the choice of a looping cardiac event recorder (records the electrocardiogram both before and after the event) or a post-activation recorder (records the electrocardiogram only after the event). Inserting the patient cable automatically changes the system from post-activation to looping. Embedded electrodes in the case are used for post-activation recording. The unit records one channel in looping mode and two channels in post-activation mode, and has a maximum recording time of 20 minutes. In looping, the unit records ten events with one minute before and one minute after the event. Recordings can either be transmitted transtelephonically to a central station equipped with a standard transtelephonic receiver, or downloaded directly into a PC with the CardioConnect software, available as an option. The unit features a special battery conservation mode, to conserve battery power. While the device is compatible with a number of transtelephonic systems (the requirements are in the instruction book), all transtelephonic testing was done with the PaceArt receiving station.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Reynolds Medical CardioCall Event Recorder, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety Standards (Medical Device)	CardioCall has been tested to meet medical device safety standards EN60601-1 and UL2601-1 (equivalent to IEC 601-1). It is CE marked for European EMC directive compliance.
Electromagnetic Compatibility (EMC)	EMC testing was performed by approved agencies.
Equivalent Performance to Predicate Devices	The CardioCall and predicate devices gave equivalent performance in tests on human volunteers.
No Adverse Events	No adverse events were reported in clinical tests on human volunteers.
Cytotoxicity of Embedded Electrodes	The embedded electrodes were tested for cytotoxicity. The steel specifications for the electrodes meet the British equivalent of ASTM Standard F899-95.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated, described as "a series of tests on human volunteers." The exact number of volunteers is not provided.
Data Provenance: Clinical tests were conducted on "human volunteers." It's implied this was prospective as it describes the device being compared in new tests. The country of origin is not explicitly stated for the volunteers, but the submission is from a UK company, making it likely the tests were conducted there or in a setting associated with their operations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The study focuses on comparing the CardioCall's performance to predicate devices and demonstrating equivalency, rather than establishing ground truth against an external diagnostic standard as might be done for an AI-driven diagnostic device.

4. Adjudication method for the test set

This information is not provided in the document. The study design centers on demonstrating equivalent performance between devices, not on resolving discrepancies in interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study design was a comparison of the device's performance to predicate devices, not an assessment of human reader improvement with or without AI assistance. The CardioCall is an event recorder that captures ECG data, not an AI-assisted diagnostic tool for human interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance assessment was effectively performed for the device itself in comparison to the predicate devices. The "tests are included comparing the CardioCall to the predicate devices using an ECG simulator" and "the CardioCall was compared to the predicate devices in a series of tests on human volunteers," implying an evaluation of the device's ability to record and, if applicable, transmit ECG data accurately, independent of direct human interpretive assistance during the recording process.

7. The type of ground truth used

The "ground truth" in this context is the performance of the legally-marketed predicate devices (Ralin Heart-Aide Event recorder and Braemar ER700 Event Recorder, K923930). The study aimed to demonstrate that the CardioCall's performance was "equivalent" to these established devices, both in terms of data acquisition and transmission, and the absence of adverse events.

8. The sample size for the training set

This information is not applicable as the CardioCall Event Recorder is not an AI-based device that would require a "training set" in the machine learning sense. It's a hardware device for recording ECGs.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above (not an AI-based device requiring a training set).

Summary

{0}------------------------------------------------

Reynolds Medical CardioCall Event Recorder

Page A 3 (rev)

K972649

DEC - 4 1997

Reynolds Medical Ltd. CardioCall Event Recorder 510(k) Submission

510(k) Summary

(1) Submitter Information

Name: Reynolds Medical Ltd.

Address: 1 Harforde Court John Tate Road Hertford SG13 7NW United Kingdom

Telephone Number: 44-1992-507700

(Official George Myers Person: Dr. Contact Correspondent) Medsys Inc. 377 Rt 17 S Hasbrouck Heights, NJ 07604 201-727-1703

Date Prepared: July 2, 1997, revised October 30, 1997

(2) Name of Device: Trade Name: CardioCall Event Recorder Common Name: Cardiac Event Recorder Classification Name: Transmitters and a Receivers, Electrocardiograph, Telephone (74DXH)
(3) Equivalent legally-marketed devices:

Ralin Heart-Aide Event recorder
Braemar ER700 Event Recorder, K923930

(4) Description

CardioCall Event Recorder offers the user the The choice of a looping cardiac event recorder (records the electrocardiogram both before and after the event) or a recorder the (records post-activation event electrocardiogram only after the event). Inserting the patient cable automatically changes the system from postto looping. Embedded electrodes in the case are activation post-activation recording. The unit records one used for channel in looping mode and two channels in post-activation mode, and has a maximum recording time of 20 minutes. In looping, the unit records ten events with one minute before

{1}------------------------------------------------

Reynolds Medical CardioCall Event Recorder Page A 4 (rev)

and one minute after the event. Recordings can either be transmitted transtelephonically to a central station equipped with a standard transtelephonic receiver, or downloaded directly into a PC with the CardioConnect software, available as an option. The unit features a special battery conservation mode, to conserve battery power. While the device is compatible with a number of transtelephonic systems (the requirements are in the instruction book), all transtelephonic testing was done with the PaceArt receiving station.

(5) Intended Use

"CardioCall," recorder, the is called The event intended to be worn by the patient and to record a short period of electrocardiogram when the patient depresses a button upon sensing symptoms described to him by his physician. The CardioCall can either operate in the socalled "Looping" mode, in which it is always active, and in which it records a minute of one channel of cardiac activity before and a minute after the depression of the button; or in the "Post-Activation" mode, in which the device records two channels of cardiac activity for one minute after the depression of the record button. The PC computer program, called the "CardioConnect," is indicated when it is desired to transfer the memory of the event recorder into a by direct connection, instead of using computer transtelephonic means. The CardioCall recorder is indicated if it is desired to record the electrocardiogram at the time when a patient experiences intermittent or transient symptoms such as dizziness, palpitations, or shortness of and the patient is capable of activating the breath, recorder at these times.

(6) Technological characteristics

The device has the same technological characteristics predicate devices. All the devices have as the microcontroller control with solid-state storage for the electrocardiograms. They all use patient-operated buttons to activate the various functions.

for The embedded electrodes have been tested cytotoxicity. The specifications of the steel for the embedded electrodes will require the metal to meet the British equivalent of ASTM Standard F899-95, "Stainless Steel Billet, Bar, and Wire for Surgical Instruments".

{2}------------------------------------------------

(b) Performance data

(1) Non-clinical tests

Tests are included comparing the CardioCall to the predicate devices using an ECG simulator. The CardioCall and predioConnect isolating cable have been tested to meet medical device safety standards EN60601-1 and UL2601-1 (these are equivalent to to IEC 601-1). Tests included electromagnetic compatibility testing and were performed by The device is CE marked to approved testing agencies. certify compliance with the European EMC directive.

(2) Clinical tests

The CardioCall was compared to the predicate devices in a series of tests on human volunteers. The devices gave equivalent performance, and there were no adverse events. When transtelephonic transmission was required, the tests were all performed with the PaceArt transtelephonic system.

(3) Conclusions

The CardioCall is equivalent in safety and efficacy to the legally-marketed predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 4. 1997

Mr. George Myers Reynolds Medical Ltd. c/o Medsys Inc. 377 Route 17 South Hasbrouck Heights, New Jersey 07604

Re: K972649 CardioCall Cardiac Event Recorder Regulatory Class: II (two) Product Code: 74 DXH Dated: November 17, 1997 Received: November 18, 1997

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 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 requlation may result in regulatory 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.

{4}------------------------------------------------

Page 2 - Mr. George Myers

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, "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/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Čallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number (if known): K972649

Device Name: CardioCall Cardiac Event Recorder

Indications for Use:

[Revised 30 October 1997]

The event recorder, called the "CardioCall," is intended to be worn by the patient and to record a short period of electrocardiogram when the patient depresses a button upon sensing symptoms described to him by his physician. The CardioCall can either operate in the so-called "Looping" mode, in which it is always active, and in which it records a minute of one channel of cardiac activity before and a minute after the depression of the button; or in the "Post-Activation" mode, in which the device records two channels of cardiac activity for one minute after the depression of The PC computer program, called the the record button. "CardioConnect," is indicated when it is desired to transfer the memory of the event recorder into a computer by direct The instead of using transtelephonic means. connection, CardioCall recorder is indicated if it is desired to record the electrocardiogram at the time when a patient experiences intermittent or transient symptoms such as dizziness, palpitations, or shortness of breath, and the patient is capable of activating the recorder at these times.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 810.109)

N.S.parshu

(Division Sign-Off) (Division Sign-Olt)
Division of Cardiovascular, Respiratory, Over-the-Counter Use Division of Neurological Devices

510(k) Number

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).