HEART ACCESS PLUS CARDIAC EVENT RECORDER

K973141 · Paceart, Inc. · DXH · Nov 12, 1997 · Cardiovascular

Device Facts

• Record ID: K973141
• Device Name: HEART ACCESS PLUS CARDIAC EVENT RECORDER
• Applicant: Paceart, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Nov 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

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 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.

Device Story

Heart Access Plus is a wearable looping cardiac event recorder with an integrated voice diary. Device continuously monitors ECG signals; upon patient activation via button press, it captures a programmable window of pre-event and post-event ECG data (up to 270 seconds total). Patient records symptoms via voice diary. Device is used by patients in home, work, or travel settings. Recorded data is transmitted telephonically to a central receiver, printed, and interpreted by a physician. Enables capture of transient cardiac events for clinical diagnosis and management.

Clinical Evidence

Bench testing only. The device was tested according to AAMI EC38, Ambulatory Electrocardiographs, and met all applicable requirements. No clinical trial data was provided.

Technological Characteristics

Looping cardiac event recorder; 1-2 channel ECG input; programmable memory (up to 270 seconds); voice diary (up to 90 seconds); telephonic transmission capability. Meets AAMI EC38 standards.

Indications for Use

Indicated for patients experiencing intermittent and unexpected cardiac events and arrhythmias.

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

• Ralin Heart-Aide Event recorder
• Braemar ER700 Event Recorder (K923930)

Submission Summary (Full Text)

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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
2. 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 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 The intended patient population is patients experiencing intermittent and unexpected cardiac events and arrhythmias.

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## 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)