(152 days)
The HeartView P12/8 is a 12/8-lead Transtelephonic electrocardiographic recorder and transmitter which is intended to be used to record and transmit a patient's electrocardiogram (ECG) via the telephone to a diagnostic/emergency center. The HeartView P 12/8 can record either an eight lead or a twelve lead electrocardiogram, and has been designed so that the patient can attach the electrodes him/herself.
The HeartView P12/8 is a 12/8-lead Transtelephonic electrocardiographic recorder and transmitter which is intended to be used to record and transmit a patient's electrocardiogram (ECG) via the telephone to a diagnostic/emergency center. It is a modification to the Aerotel HeartView event recorder, K950004. For the original HeartView, the patient had 10 standard disposable electrodes attached to his chest by a physician, and the unit always recorded and over and electrocardiogram. The HeartView P 12/8 can record either an eight lead or a 12 clead electrocardiogram, and has been designed so that the patient can attach the electredes him/le rself.
To record an 8-lead electrocardiogram, three standard disposable electrodes are attached to the patient's chest, and in addition the patient places the recorder in a specific place on his chest and makes recordings using "button" electrodes embedded in the case. To record a 12-lead electrocardiogram, the disposable electrodes are in the same locations but the patient makes three recordings using the embedded "button" electrodes, each with the recorder in a different location on the chest (also explained later). The system is designed so that the patient can attach the electrodes and place the embedded electrodes him/herself with the recorder in the proper locations. Clinical tests have been done which show that the electrocardiograms produced when the patient attaches the electrodes and manipulates the recorder are of the same quality as in the original HeartView, K950004, in which disposable electrodes are attached by the physician.
Heart View P12/8 has internal memory, which enables it to record and store the ECG of a cardiac event when the Record Transmit button is pressed. The stored ECG can then be transmitted to the center by telephone at a later time. Transmitting the ECG does not erase it, so that an inadvertent or faulty transmission does not affect the recording.
The system is designed so that the patient can record an episode on the recorder and then transmit it in a simple, non-confusing way.
The provided text describes the HeartView P 12/8 Event Recorder and its clinical testing. However, it does not explicitly state "acceptance criteria" in the format of specific quantitative thresholds. Instead, the study's goal was to demonstrate equivalence in quality between ECGs recorded by the new device (patient-attached electrodes) and the predicate device (professionally-attached electrodes).
Here's an interpretation of the information based on the provided text, structured to answer your questions:
Acceptance Criteria and Device Performance Study
The primary acceptance criterion for the HeartView P12/8 was the equivalence of electrocardiogram (ECG) quality when electrodes were attached by the patient, compared to the predicate device where electrodes were professionally attached.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| ECGs produced with patient-attached electrodes are of equivalent quality to ECGs produced with professionally-attached electrodes (from the original HeartView, K950004). | "Clinical tests have been done which show that the electrocardiograms produced when the patient attaches the electrodes and manipulates the recorder are of the same quality as in the original HeartView, K950004, in which disposable electrodes are attached by the physician." "The electrodes were given to a cardiologist for comparison, who determined that the quality of the electrocardiograms from the two devices was equivalent." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The text mentions "a clinical test" and "the electrodes were given to a cardiologist for comparison," but does not provide details on the number of patients or ECGs involved in this comparison.
- Data Provenance: Not explicitly stated. Given the submitter's address in Israel (Aerotel Ltd., Holon, Israel), it is likely the clinical tests were conducted in Israel, but this is not confirmed in the document. The study was presented as a prospective comparison of the new device's method against the predicate device's method.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: One ("a cardiologist").
- Qualifications of Experts: A "cardiologist." No further details on experience level (e.g., years of experience) are provided.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not formally described (e.g., 2+1, 3+1). The ground truth was established by a single cardiologist who compared the ECGs. There is no mention of multiple readers or an adjudication process for discrepancies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? No. The study involved a single cardiologist making a comparative judgment, not an MRMC study designed to assess improvement of human readers with AI assistance. This device is an event recorder, not an AI-driven diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Was a standalone study done? Not applicable in the context of an "algorithm only" study as understood for AI devices. The device's performance was assessed by human evaluation of the ECG output, focusing on the quality of the waveform itself when recorded by the patient versus a professional. It's a device that records, stores, and transmits ECGs, not one that automatically interprets them via an algorithm for standalone performance evaluation.
7. Type of Ground Truth Used:
- Type of Ground Truth: Expert consensus (from a single cardiologist) and comparative assessment of ECG quality. The ground truth was the cardiologist's judgment that the ECGs were "equivalent in quality."
8. Sample Size for the Training Set:
- Sample Size: Not applicable/not specified. This device is a hardware event recorder with a simple recording/transmission function. It is not an AI/ML model that undergoes a "training set" process in the conventional sense. The "training" in this context refers to the development and iterative design of the device itself rather than a data-driven model training.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, there is no "training set" for an AI/ML model. The device's design and functionality were refined through engineering and clinical understanding of ECG recording, likely informed by previous device designs (like K950004) and medical requirements for ECG quality.
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K980144
Page A 3
JUN 16 1998
Aerotel Ltd HeartView P 12/8 Event Recorder 510(k) Submission
510(k) Summary
(1) Submitter Information
Name: Aerotel Ltd.
Address: 5 Hazoref Street 58858 Holon Israel
Telephone Number: 972-3-559-6111
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703
Date Prepared: Jan. 5, 1998
(2) Name of Device:
Trade Name: HeartView P 12/8 Event Recorder Common Name: Cardiac Event Recorder Classification Name: Transmitters and Receivers, Electrocardiograph, Telephone (74DXH)
(3) Equivalent legally-marketed devices:
1.Aerotel HeartView 12-lead event recorder, K950004
(4) Description
The HeartView P12/8 is a 12/8-lead Transtelephonic electrocardiographic recorder and transmitter which is intended to be used to record and transmit a patient's electrocardiogram (ECG) via the telephone to a diagnostic/emergency center. It is a modification to the Aerotel HeartView event recorder, K950004. For the original HeartView, the patient had 10 standard disposable electrodes attached to his chest by a physician, and the unit always recorded and over and electrocardiogram. The HeartView P 12/8 can record either an eight lead or a 12 clead electrocardiogram, and has been designed so that the patient can attach the electredes him/le rself.
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Aerotel HeartView P12/8
Page A 4
To record an 8-lead electrocardiogram, three standard disposable electrodes are attached to the patient's chest, and in addition the patient places the recorder in a specific place on his chest and makes recordings using "button" electrodes embedded in the case. To record a 12-lead electrocardiogram, the disposable electrodes are in the same locations but the patient makes three recordings using the embedded "button" electrodes, each with the recorder in a different location on the chest (also explained later). The system is designed so that the patient can attach the electrodes and place the embedded electrodes him/herself with the recorder in the proper locations. Clinical tests have been done which show that the electrocardiograms produced when the patient attaches the electrodes and manipulates the recorder are of the same quality as in the original HeartView, K950004, in which disposable electrodes are attached by the physician.
Heart View P12/8 has internal memory, which enables it to record and store the ECG of a cardiac event when the Record Transmit button is pressed. The stored ECG can then be transmitted to the center by telephone at a later time. Transmitting the ECG does not erase it, so that an inadvertent or faulty transmission does not affect the recording.
The system is designed so that the patient can record an episode on the recorder and then transmit it in a simple, non-confusing way.
(5) Intended Use
The HeartView P12/8 is a 12/8-lead Transtelephonic electrocardiographic recorder and transmitter which is intended to be used to record and transmit a patient's electrocardiogram (ECG) via the telephone, to a diagnostic/emergency center. The Heart View P 12/8 can record either an eight lead or a twelve lead electrocardiogram, and has been designed so that the patient can attach the electrodes him/herself.
(b) Performance data
(1) Non-clinical tests
The HeartView P 12/8 has had to undergo safety and emissions tests. The HeartView P/12/8 has been tested for compliance with IEC 60601-1/1990 by Israel Testing Laboratories (ITL).
(2) Clinical tests
In a clinical test, electrocardiograms taken with the HeartView P 12/8 with the electrodes attached by the patient were compared to electrocardiograms taken with the predicate device, the HeartView 12-lead event recorder, with electrodes professionally attached. The electrodes were given to a cardiologist for comparison, who determined that the quality of the electrocardiograms from the two devices was equivalent.
(3) Conclusions
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Aerotel HeartView P12/8
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The HeartView P 12/8 is equivalent in safety and efficacy to the legally-marketed predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, with three curved lines forming the body and wings.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 1998
George H. Myers, Sc.D. Official Correspondent for Aerotel, Ltd. C/O Medsys, Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604
K980144 Re: Aerotel HeartView P12/8 Cardiac Event Recorder Trade Name: Regulatory Class: II (two) Product Code: 74 DHX April 8, 1988 Dated: April 9, 1998 Received:
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, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 - George H. Myers, Sc.D.
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 regulation (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. Callahon
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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Question 14. Indications for Use
The revised statement follows.
1 of of ______________________________________________________________________________________________________________________________________________________________________ Page _________________________________________________________________________________________________________________________________________________________________________ 1
K980144 510(k) Number (if known):
Device Name: HeartView Cardiac Event Recorder
Indications for Use:
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The HeartView P12/8 is a 12/8-lead Transtelephonic electrocardiographic recorder and transmitter which is intended to be used to record and transmit a patient's electrocardiogram (ECG) via the telephone to a diagnostic/emergency center. The HeartView P 12/8 can record either an eight lead or a twelve lead electrocardiogram, and has been designed so that the patient can attach the electrodes him/herself.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
| 510(k) Number | K980144 |
|---|---|
| --------------- | --------- |
| Prescription Use Use (Per 21 CFR 810.109) | OR | Over-the-Counter |
|---|---|---|
| ------------------------------------------- | ---- | ------------------ |
(Optional Format 1-2-96)
§ 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).