(26 days)
The HeartOne is intended to be used as a Patient/physician activated single lead ECG data recorder/transmitter, for recording ECGs and transmitting them over telephone lines to Aerotel's Heartline Receiving Station
The unit is indicated whenever it is desired to have single-lead electrocardiograms of a patient. There are no known contraindications.
The HeartOne is a battery-powered ECG event recorder and transmitter that is capable of recording and storing an electrocardiogram and transmitting it by means of a telephone to a central receiving station.
The HeartOne is a battery powered post-event ECG Event Recorder and Transmitter which is intended to be used by the patient to record portions of a patient's electrocardiogram (ECG) and to send it to a receiving center such as the Aerotel Heartline Receiving Station K022073 or equivalent.
The provided document is a 510(k) summary for the Aerotel Medical Systems (1998) Ltd. HeartOne Cardiac Event Recorder. It describes a medical device and its substantial equivalence to a predicate device, rather than a study evaluating the performance of an AI algorithm. Therefore, most of the requested information regarding acceptance criteria, study design for AI models, sample sizes for training/test sets, expert adjudication, and MRMC studies is not applicable to this document.
However, I can extract the relevant information from the document regarding the device's performance validation.
Here's the information that can be extracted, and where the requested AI-specific information is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical safety (IEC 601-1) | Validated by repeating IEC 601-1 tests. (Implies meeting the standard's requirements, though specific values are not provided.) |
| Electromagnetic compatibility (IEC 601-1-2) | Validated by repeating IEC 601-1-2 tests. (Implies meeting the standard's requirements, though specific values are not provided.) |
| Electrical characteristics (EC38) | Validated by repeating the electrical characteristic tests of standard EC38. (Implies meeting the standard's requirements, though specific values are not provided.) |
| Clinical performance | No clinical tests were performed. The device relies on substantial equivalence to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set was used for this device for performance evaluation in the context of an AI model. The validation was based on non-clinical engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth established by experts in the context of AI model evaluation. The non-clinical tests rely on established engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring expert adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a medical device, not an AI algorithm for diagnostic assistance. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a medical device, not an AI algorithm. Its performance is evaluated based on its ability to record and transmit ECGs, not on an algorithm's diagnostic capabilities.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" is defined by adherence to established engineering standards such as IEC 601-1, IEC 601-1-2, and EC38.
8. The sample size for the training set
- Not applicable. There is no AI model or training set described in this document.
9. How the ground truth for the training set was established
- Not applicable. There is no AI model or training set described in this document.
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6 2002
Aerotel Medical Systems (1998) Ltd. Special 510(k) HeartOne Cardiac Event Recorder
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements Regulation par. 807.92, effective March 14, 1995.
1. Submitter
Name: Aerotel Medical Systems (1998) Ltd Address: 5 Hazoref St., Holon 58856, Israel Telephone Number: 972-3-5596111 Contact person: Dr. George Myers, 210-787- 1703 Date prepared: March 7, 2000
2. Device
Proprietary name: Heart One Common Name: Electrocardiograph Event Recorder and Telephonic Transmitter Classification Name: Transmitters and Receivers, electrocardiograph, telephone
The HeartOne is a battery-powered ECG event recorder and transmitter that is capable of recording and storing an electrocardiogram and transmitting it by means of a telephone to a central receiving station.
3. Predicate Device
Aerotel H1001 Cardiac event recorder, K931020.
4. Description
The HeartOne is a battery powered post-event ECG Event Recorder and Transmitter which is intended to be used by the patient to record portions of a patient's electrocardiogram (ECG) and to send it to a receiving center such as the Aerotel Heartline Receiving Station K022073 or equivalent.
5. Intended Use
The HeartOne is intended to be used as a Patient/physician activated single lead ECG data recorder/transmitter, for recording ECGs and transmitting them over telephone lines to Aerotel's. Heartline Receiving Station
The unit is indicated whenever it is desired to have single-lead electrocardiograms of a patient. There are no known contraindications.
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6. Comparison
The HeartOne is a modified version of the predicate device. It has basically the same electrical and mechanical characteristics, and the use of the two devices by the patient is equivalent It differs from the predicate device mainly in the construction methods, and in the fact that it can record four events, as contrasted to one event for the predicate device
7. Performance Data
(1) Non-clinical tests
The modifications were validated by repeating IEC 601-1 and IEC 601-1-2 tests (electrical safety and electromagnetic compatibility) and the electrical characteristic tests of standard EC38.
(2) Clinical Tests
No clinical tests were performed.
8. Conclusion
The conclusion drawn from these tests is that the HeartOne is equivalent in safety and efficacy to its predicate device.
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THEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, and three horizontal bars.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2007 NOV
Medsys Inc. c/o George H. Myers. Sc.D. Official Correspondent 377 Route 17 South Hasbrouck Heights, NJ 07604
Re: K023418
Trade Name: HeartOne Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: October 7, 2002 Received: October 11, 2002
Dear Dr. Myers:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - George H. Myers, Sc.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set . forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours.
Ufe
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Aerotel Event Recorder
Page
Kon 419 510(k) Number (if known):
Device Name: HeartOne
Indications for Use:
The HeartOne is intended to be used as a Patient/physician activated single lead ECG data recorder/transmitter, for recording ECGs and transmitting them over telephone lines to Aerotel's Heartline Receiving Station
The unit is indicated whenever it is desired to have single-lead electrocardiograms of a patient. There are no known contraindications.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular Devices
510(k) Number KC23418
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).