HEART ACCESS PLUS CARDIAC EVENT RECORDER by PACEART, INC.

The event recorder, called the "Heart Access Plus," 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 indicated to him by his physician. The unit is intended to be used in the patient's home, place of work, or when traveling. Recordings are then to be transmitted telephonically to a central receiver, where they are printed as received and then can be interpreted by a physician.

The unit also has a voice diary so that the patients can record notes of the circumstances when the event was recorded. The Heart Access Plus operates in the so-called "Looping" mode, in which it is always active, and in which it records an interval of one channel of cardiac activity before and an interval after the depression of the button; durations of the intervals are programmable. The intended patient population is patients experiencing intermittent and unexpected cardiac events and arrhythmias.

Device Description

The Paceart "Heart Access Plus"™ combines a "looping" cardiac event recorder and a voice diary. The feature permits the device to record a sample of the electrocardiogram both before and after the patient senses a symptom of a cardiac event and presses the "activator" button, unlike many other recorders which only record the ECG for a period after the sensing of the symptom. The voice diary permits a patient to record the circumstances which led to his making a recording.

The number and duration of events are programmable by the physician. The device can record up to 270 seconds of electrocardiogram. Each event can be programmed for 5 to 50 seconds of "pre-history" ECG (ECG before the activator button is pressed) and 5 to 95 seconds of "post-history" ECG (after the activator button is pressed). There can be one or two channels (two electrodes per channel, placed as desired) and up to six events: the total duration of all of the events for all of the channels is limited by the total record time of 270 seconds. The device will not permit programming more events than can be stored, and once the memory is full no more electrocardiograms can be recorded. The voice diary permits recording up to 90 seconds of notes.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details for the Paceart Heart Access Plus Event Recorder:

Based on the provided documentation, the Paceart Heart Access Plus received 510(k) clearance based on substantial equivalence to predicate devices and compliance with a relevant standard. The acceptance criteria are primarily defined by this equivalence and standard adherence, rather than specific performance metrics explicitly listed as "acceptance criteria."

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence	Device functionality, intended use, and technology should be substantially equivalent to identified predicate devices.	The Paceart Heart Access Plus was compared in tests to one of the predicate devices (specifically mentioning the Ralin Heart-Aide Event recorder and the Braemar ER700 Event Recorder, K923930). The documentation states, "the two devices are equivalent." This implies that its performance aspects were found to be comparable to the predicate.
Applicable Standard	Compliance with relevant industry standards for ambulatory electrocardiographs.	The Heart Access Plus has been tested according to AAMI EC38, Ambulatory Electrocardiographs, and meets the applicable requirements. This explicitly states compliance with the technical and performance specifications outlined in that standard.
Safety and Effectiveness	The device must be safe and effective for its intended use.	The overarching statement is, "These tests all show that the Paceart Heart Access Plus is safe and effective for its intended use." This is a conclusion drawn from the equivalence and standard compliance testing.

Study Information

The provided text describes the type of testing performed rather than a detailed standalone study report with specific statistical results.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The documentation mentions "tests" were conducted, but does not specify the number of devices tested, the number of events recorded, or the number of patients involved in any comparative or standard compliance testing.
- Data Provenance: Not explicitly stated. Given the nature of a 510(k) submission, the testing would typically be conducted by the manufacturer or a contracted lab. It's not specified if patient data (e.g., ECGs) from a specific country was used or if it was retrospective or prospective.
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable/Not mentioned. The testing primarily revolved around technical equivalence to a predicate device and adherence to a recognized standard (AAMI EC38). Expert consensus for specific diagnostic ground truth (e.g., classifying arrhythmias) is not described in this context. The interpretation of recordings is stated to be by "a physician" at a central receiver, but this is describing the intended use, not the ground truth establishment for the device validation.
Adjudication Method for the Test Set:
- Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used when comparing observer interpretations of data. Here, the "test set" appears to be the device itself being compared to a predicate or a standard, rather than a clinical dataset adjudicated by multiple readers.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study comparing human readers with and without AI assistance was not done. This device is a cardiac event recorder, a hardware device for capturing ECG data, and does not involve AI or human interpretation assistance in the sense of a diagnostic algorithm.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, in spirit. The "testing" against the predicate device and the AAMI EC38 standard is essentially a standalone performance evaluation of the device's ability to accurately record and function according to its design and industry benchmarks. It’s not an "algorithm" in the modern AI sense, but rather the device's inherent functional performance. The device's performance in recording ECG data is evaluated independently of human interpretation during the testing phase.
Type of Ground Truth Used:
- The ground truth for the equivalence testing would be the performance of the predicate device (Ralin Heart-Aide or Braemar ER700) and the specifications outlined in the AAMI EC38 standard. For example, if AAMI EC38 specifies frequency response or common mode rejection ratios, the device's measured performance in these areas would be compared against those specifications.
Sample Size for the Training Set:
- Not applicable. This device is a hardware event recorder, not an AI/machine learning algorithm that requires a "training set."
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.

Summary of Key Findings from the Document:

The 510(k) clearance for the Paceart Heart Access Plus was primarily based on a demonstration of substantial equivalence to existing predicate devices (Ralin Heart-Aide Event recorder and Braemar ER700 Event Recorder) and compliance with the AAMI EC38 standard for ambulatory electrocardiographs. The document confirms that "the two devices are equivalent" and that the Heart Access Plus "meets the applicable requirements" of AAMI EC38, leading to the conclusion of safety and effectiveness. The testing described is focused on the hardware device's functional performance against established benchmarks and predicate device performance, rather than complex clinical studies involving human interpretation or AI algorithms.

Summary

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Paceart Associates Heart Access Plus

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NOV 1 2 1997

Paceart Associates LP 510 (k) Submission Paceart Heart Access Plus Event Recorder 510 (K) Summary

(1) Submitter Information:

Name: Paceart Associates LP. Jersev Address: 22 Riverview Drive, Wayne New 07470 Telephone Number: 973-696-1122 Contact Person: Dr. George Myers, 201-727-1703

(2) Names: Trade: Paceart Heart Access Plus Event Recorder Common Usual Name: Looping Cardiac Event Recorder Classification Name: Transmitters and Receivers, Electrocardiograph, Telephone (74DXH)

(3) Classification, Panel Class II, 74DRX

(4) Predicate Devices:

1. Ralin Heart-Aide Event recorder

Braemar ER700 Event Recorder, K923930

(5) Description

The Paceart "Heart Access Plus"™ combines a "looping" "looping" cardiac event recorder and a voice diary. The feature permits the device to record a sample of the electrocardiogram both before and after the patient senses a symptom of a cardiac event and presses the "activator" button, unlike many other recorders which only record the ECG for a period after the sensing of the symptom. The voice diary permits a patient to record the circumstances which led to his making a recording.

The number and duration of events are programmable by the physician. The device can record up to 270 seconds of electrocardiogram. Each event can be programmed for 5 to 50 of "pre-history" ECG (ECG before the activator seconds button is pressed) and 5 to 95 seconds of "post-history" ECG (after the activator button is pressed). There can be one or two channels (two electrodes per channel, placed as desired) and up to six events: the total duration of all of the for all of the channels is limited by the total events record time of 270 seconds. The device will not permit

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programming more events than can be stored, and once the memory is full no more electrocardiograms can be recorded. The voice diary permits recording up to 90 seconds of notes.

(6) Intended Use

The event recorder, called the "Heart Access Plus," is intended to be worn by the patient and to record a short period of electrocardiogram before and after the instant when the patient depresses a button upon sensing symptoms indicated to him by his physician. The unit also includes a voice diary by which the patient may record the symptoms at the time of recording.

(7a) Predicate Devices

The predicate devices for the Paceart Heart Access Plus the Ralin Heart-Aide Event recorder and the Braemar are ER700 Event Recorder, cleared under K923930 by TZ Medical, also known as the Heartaid Series TZ.

(7b) Testing

Paceart Heart Access Plus has been compared in The tests to one of the predicate device, and the two devices are equivalent. The Heart Access Plus has been tested according to AAMI EC38, Ambulatory Electrocardiographs, and meets the applicable requirements.

These tests all show that the Paceart Heart Access Plus is safe and effective for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 1997

Dr. George Myers Medsys Inc. 377 Route 17 South Hasbrouck Heights, New Jersey 07604

Re: K973141 Heart Access Plus Cardiac Event Recorder Regulatory Class: II (two) Product Code: 74 DXH Dated: August 18, 1997 Received: August 21, 1997

Dear Dr. 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, Druq, 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 requlations 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 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.

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Page 2 - Dr. 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 requlation 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 . 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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Page _ l __ of __ of _________________________________________________________________________________________________________________________________________________________ I

ALL BE : S > .. HE

510(k) Number (if known):

Device Name: Heart Access Plus Cardiac Event Recorder

Indications for Use:

The unit also has a voice diary so that the patients can record notes of the circumstances when the event was recorded. The Heart Access Plus operates in the so-called "Looping" mode, in which it is always active, and in which it records an interval of one channel of cardiac activity before and an interval after the depression of the button; durations of the intervals are programmable. The The intended patient population is patients experiencing intermittent and unexpected cardiac events and arrhythmias.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arl A. Ciarlowski

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

Prescription Use (Per 21 CFR 810.109) OR

Over-the-Counter Use

P. GO

(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).