(225 days)
The HomeTrak Plus Cardiac Twelve-Lead Event Recorder is a patient-activated ambulatory cardiac event monitor and associated central-station receiving equipment which are to be used for recording infrequent and elusive heart arrhythmias and transmitting them by telephone at a later time to a central analysis center, with the ability to record three electrocardiographic leads or to derive 12 electrocardiographic leads from the three transmitted.
The HomeTrak Plus Cardiac Twelve-Lead Event Recorder is a patient-activated ambulatory cardiac event monitor and associated central-station receiving equipment which are to be used for recording infrequent and elusive heart arrhythmias and transmitting them by telephone at a later time to a central analysis center. It records three electrocardiographic leads and derives 12 electrocardiographic leads from the three transmitted. When the five electrodes are attached to the patient in the special configuration shown in the manual and the PaceArt WINCPTS central-station software with 12-lead option is used, the physician can either record a twelve-lead electrocardiogram or a three-lead electrocardiogram at the analysis center. The system for derivation of the 12-lead electrocardiogram from the five-electrode recording is called the "EASI" system. There are two elements to the Home Trak Plus system: a "looping" cardiac event recorder, and a special central-station program.
Here's an analysis of the provided text regarding the HomeTrak Plus EASI Event Recorder System's acceptance criteria and studies:
Summary of Device Performance Study Information for HomeTrak Plus EASI Event Recorder System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Devices: - Ability to record 3 ECG leads. - Ability to derive 12 ECG leads from 3 transmitted leads (EASI system). - Safety and efficacy equivalent to legally marketed predicate devices. | Clinical Test 1: "A series of patients had 12-lead electrocardiograms taken with the EASI predicate device and this system. The electrocardiograms were equivalent." Clinical Test 2: "An electrocardiogram was taken with the HomeTrak Plus system and a Burdick 12-lead electrocardiograph. The recordings are equivalent." Overall Conclusion: "The HomeTrak Plus system is equivalent in safety and efficacy to the legallymarketed predicate devices." This implies that the system successfully records and derives ECG leads in a manner comparable to established, approved devices, meeting the functional and safety expectations. |
| Correct EASI Coefficient Application: Ensures the 12-lead derivation is accurate. | "The system was tested to show that electrocardiograms are operated on by the correct EASI coefficients." This directly addresses the internal logic and accuracy of the EASI derivation process. |
| Software Validity: Ensures the underlying software functions reliably. | "The software has had extensive validity testing." This is a general statement indicating a robust testing process for the software component. |
| Electrical Safety Standards: Compliance with relevant electrical safety regulations. | "The HomeTrak Plus event recorder has had standard electrical safety tests and been tested to EC38." This confirms adherence to recognized electrical safety standards. |
| Central Station Equipment Compliance: The central station component (CPTS) meets the requirements of a 12-lead ECG system. | "The CPTS central station equipment has been also cleared by the FDA as a 12-lead ECG system (K915632), and meets the requirements for those devices." This confirms the central station's approved status and compliance with relevant standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states "A series of patients" in Clinical Test 1. No specific number for the test set is provided.
- Data Provenance: Not explicitly stated, but clinical tests imply prospective data collection from patients. The country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not provide details on the number of experts or their qualifications involved in establishing the ground truth. The comparison is made to a "predicate device" and a "Burdick 12-lead electrocardiograph," implying these established devices served as the de-facto gold standard for comparison, rather than a separate expert panel establishing a new ground truth.
4. Adjudication Method for the Test Set
- No specific adjudication method is mentioned. The comparison is stated as "equivalent," implying a direct comparison of the ECG recordings without a formal multi-reader adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study is not mentioned. The studies described are focused on demonstrating equivalence of the device's output to existing technologies, not on improving human reader performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the clinical tests essentially demonstrate standalone performance in the sense that the device's output (ECG recordings) is directly compared to other devices. The "equivalent" determination is based on the device's ability to produce similar ECGs, independent of human interpretation during the testing phase.
7. The Type of Ground Truth Used
- The ground truth was established by comparison to legally marketed predicate devices and established medical equipment. Specifically:
- An "EASI predicate device" (Clinical Test 1)
- A "Burdick 12-lead electrocardiograph" (Clinical Test 2)
- The "CPTS central station equipment" previously cleared by FDA (K915632) for 12-lead ECG systems.
- This indicates a "comparison to a gold standard device" approach.
8. The Sample Size for the Training Set
- The document does not provide any information regarding a "training set" or its sample size. This type of device (an event recorder) primarily records and derives signals based on known physiological principles and algorithms (like the EASI system), rather than using a machine learning model that would require a distinct training set. The "software has had extensive validity testing," but this refers to traditional software engineering validation, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set for an AI/machine learning model is described. The "EASI coefficients" are likely pre-determined constants based on physiological modeling, not learned from a training set.
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HomeTrak Plus
Page A 2
JAN 26 1999
PaceArt Associates LK.P HomeTrak Plus EASI Event Recorder System 510(k) Submission
510(k) Summary
(1) Submitter Information
Name: PaceArt Associates L.P.
Address: 22 Riverview Drive Wayne, New Jersey 07470
Telephone Number: 973-696-3357
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703 fax 201-727-1708 Date Prepared: June 8, 1998
(2) Name of Device:
Trade Name: HomeTrak Plus EASI Event Recorder System Common Name: Cardiac Event Trans-Telephonic Recorder and Receiving System Classification Name: Transmitters and Receivers, Electrocardiograph, Telephone (74DXH)
(3) Equivalent legally-marketed devices:
- Braemar ER370, K923930
(4) Description
The HomeTrak Plus Cardiac Twelve-Lead Event Recorder is a patientactivated ambulatory cardiac event monitor and associated central-station receiving equipment which are to be used for recording infrequent and elusive heart arrhythmias and transmitting them by telephone at a later time to a central analysis center. It records
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HomeTrak Plus
three electrocardiographic leads and derives 12 electrocardiographic leads from the three transmitted. When the five electrodes are attached to the patient in the special configuration shown in the manual and the PaceArt WINCPTS central-station software with 12-lead option is used, the physician can either record a twelve-lead electrocardiogram or a three-lead electrocardiogram at the analysis center. The system for derivation of the 12-lead electrocardiogram from the five-electrode recording is called the "EASI" system. There are two elements to the Home Trak Plus system: a "looping" cardiac event recorder, and a special central-station program.
(5) Intended Use
The HomeTrak Plus Cardiac Twelve-Lead Event Recorder is a patient-activated ambulatory cardiac event monitor and associated central-station receiving equipment which are to be used for recording infrequent and elusive heart arrhythmias and transmitting them by telephone at a later time to a central analysis center, with the ability to record three electrocardiographic leads or to derive 12 electrocardiographic leads from the three transmitted.
(b) Performance data
(1) Non-clinical tests
The HomeTrak Plus event recorder has had standard electrical safety tests and been tested to EC38. The CPTS central station equipment has been also cleared by the FDA as a 12-lead ECG system (K915632), and meets the requirements for those devices.
The system was tested to show that electrocardiograms are operated on by the correct EASI coefficients.
The software has had extensive validity testing.
(2) Clinical tests
-
- A series of patients had 12-lead electrocardiograms taken with the EASI predicate device and this system. The electrocardiograms were equivalent.
-
- An electrocardiogram was taken with the HomeTrak Plus system and a Burdick 12-lead electrocardiograph. The recordings are equivalent.
- (3) Conclusions
The HomeTrak Plus system is equivalent in safety and efficacy to the legallymarketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a stylized image of an eagle. The eagle is depicted with three curved lines representing its body and wings. The text is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 26 1999
Dr. George Myers PaceArt Associates L.P. c/o Medsys, Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604
Re: K982090 PaceArt HomeTrak Plus EASI Event Recorder System Regulatory Class: II (two) Product Code: 74 DXH Dated: October 27, 1998 Received: October 29, 1998
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 legally marketed predicate 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 Requlation (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 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/dsma/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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PaceArt HomeTrak Plus
| Page | 1 of 1 |
|---|---|
| 510(k) Number (if known): | K982090 |
Device Name: HomeTrak Plus EASI Event Recorder System
Indications for Use:
The HomeTrak Plus Cardiac Twelve-Lead Event Recorder is a patient-activated ambulatory cardiac event monitor and associated central-station receiving equipment which are to be used for recording infrequent and elusive heart arrhythmias and transmitting them by telephone at a later time to a central analysis center. It records three electrocardiographic leads and derives 12 electrocardiographic leads from the three transmitted, called the "EASI" system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Use
(Per 21 CFR 810.109)
OR
Over-the-Counter
(Optional Format 1-2-96)
Valerilla
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological D 510(k) Number
§ 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).