(83 days)
Not Found
No
The description focuses on basic recording and storage functionality, with no mention of automated analysis, pattern recognition, or learning algorithms. The interpretation is explicitly stated to be done by a physician.
No.
The device is an event recorder that captures and stores ECG data for diagnostic purposes, not for treating a condition.
Yes
The device is intended to record electrocardiogram data for interpretation by a physician to diagnose intermittent and unexpected cardiac events and arrhythmias.
No
The device description explicitly mentions hardware components such as an "activator" button, electrodes, and memory for storing ECG and voice recordings. It also describes physical placement of electrodes and transmission of data telephonically, all indicating a hardware component is integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The Heart Access Plus is an event recorder that records electrocardiogram (ECG) signals directly from the patient's body. It is worn by the patient and captures electrical activity of the heart in vivo.
- Intended Use: The intended use is to record cardiac events experienced by the patient, not to analyze samples taken from the patient.
- Input: The input is an electrical signal from the heart, not a biological sample.
Therefore, the Heart Access Plus falls under the category of a medical device that performs measurements on the patient, rather than an in vitro diagnostic device that analyzes samples from the patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
74 DXH
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 for all of the channels is limited by the total events 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.
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
patient's home, place of work, or when traveling
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Paceart Associates Heart Access Plus
ー
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:
-
- 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
1
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.
2
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 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.
(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)