(90 days)
VISUALIZATION AND MEASUREMENT OF ECG BY TRAINED USED RECORDINGS TO BE MEDICAL CONDITION. MON | TORING CARDIAC IN THE OF STAFF
The Cardio Vision software is a program which runs on a personal computer and is used for the display and storage of Electrocardiogram recordings. The software receives an input signal containing the ECG data from an ECG receiving center. The receiving center is connected to the computer on which the Cardio Vision software is running via a serial port. The ECG receiving center receives the ECG signal from an ECG recording device either via direct connection or via telephone. The software interprets the digital signal and displays it on the screen in real time as a single or multiple lead ECG plot.
The received ECG signal can be stored on the disk and can be compared to previous ECG recordings for that patient. In addition, measurements can be performed on the ECG plot.
The provided text describes the Cardio Vision Software, an ECG display and storage program. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Data sampling and processing accuracy | "Comparison of the log file with the original signal verified that the data sampling and data processing modules function properly." |
| Data display accuracy and scaling | "Using the ECG display module to display data from prepared files verified that the data was displayed properly and in the correct scale." |
| Consistency and accuracy of ECG data processing and presentation | "The comparison of Cardio Vision Software printouts with simultaneous ECG strip chart output demonstrated that the Cardio Vision Software processes and presents ECG data consistently and accurately." |
| Substantial equivalence to predicate devices | "The safety and effectiveness of the Cardio Vision software are similar to that of its predicate devices. It is SHL's opinion that the Cardio Vision software is substantially equivalent to its legally marketed predicate devices in terms of safety and effectiveness." (This is a claim of equivalence, supported by the above bench and clinical data). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a "test set" in the context of clinical trials or an independent validation study. The "Bench Data" section refers to an "artificial signal" and "prepared files," which implies synthetic or pre-recorded data for testing specific functionalities. The "Clinical Data" section refers to "simultaneous ECG strip chart output," suggesting real patient data, but no further details on the number of patients, recordings, or their provenance (country, retrospective/prospective) are provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not detail any expert review process for establishing ground truth for a test set. The validation primarily relies on comparison with "original signals" (for bench data) and "simultaneous ECG strip chart output" (for clinical data), implying these were considered the ground truth references. There is no mention of human experts directly annotating or establishing ground truth for the purpose of evaluating the device.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned, as there is no indication of multiple independent expert reviewers establishing a ground truth that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The document does not describe any study involving human readers with and without AI assistance, nor does it provide an effect size for such a comparison.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies described are essentially standalone evaluations of the algorithm's performance.
- Bench Data: "An artificial signal was fed into the receiving center, and the resulting ECG data was displayed and written to a log file. Comparison of the log file with the original signal verified that the data sampling and data processing modules function properly." This is an algorithm-only test.
- Clinical Data: "The comparison of Cardio Vision Software printouts with simultaneous ECG strip chart output demonstrated that the Cardio Vision Software processes and presents ECG data consistently and accurately." This also evaluates the software's output against a reference without explicit human intervention in the interpretation of the software's output for evaluation purposes.
7. Type of Ground Truth Used
- Bench Data: The ground truth for the bench data was the "original artificial signal."
- Clinical Data: The ground truth for the clinical data was "simultaneous ECG strip chart output." This suggests the output from a traditional, established ECG recording method was used as the reference standard.
8. Sample Size for the Training Set
The document does not provide any information about a training set for the Cardio Vision Software. This suggests the software is primarily a display and storage tool, not an AI/ML-based diagnostic algorithm that learns from a training set. The descriptions focus on its functionality in processing and presenting data, rather than making automated interpretations or diagnoses.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied, the establishment of ground truth for a training set is not applicable to this device description.
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AUG 20 1998
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510(k) Summary of Safety and Effectiveness
SHL Telemedicine International Ltd. Submitter Information: 90 Yigal Alon St. Tel Aviv, 67891 lsrael tel: 972-3-5612212
fax: 972-3-6242414
Proprietary Name and Model: Cardio Vision Software
FDA/CDRH/ODE/DAG
21 May 98
1526
Common/Usual Name: ECG Display and Storage Software
Classification Name: Electrocardiograph (21 CFR 870.2340)
Predicate Device: The predicate devices are the Micromedical Cardioview Transtelephonic Software (K955891) and the Instromedix Cardiomagic Software (K925639).
Device Description:
The Cardio Vision software is a program which runs on a personal computer and is used for the display and storage of Electrocardiogram recordings. The software receives an input signal containing the ECG data from an ECG receiving center. The receiving center is connected to the computer on which the Cardio Vision software is running via a serial port. The ECG receiving center receives the ECG signal from an ECG recording device either via direct connection or via telephone. The software interprets the digital signal and displays it on the screen in real time as a single or multiple lead ECG plot.
The received ECG signal can be stored on the disk and can be compared to previous ECG recordings for that patient. In addition, measurements can be performed on the ECG plot.
Intended Use:
The Cardio Vision software is intended for use by trained medical staff for visualization and measurement of ECG recordings to be used in the monitoring of a patient's cardiac condition together with knowledge of the patient's general condition and other medical data on record.
Comparison to Predicate Device:
The Cardio Vision Software has the same intended use, basic features, and target population as its predicate devices. The Cardio Vision Software and its predicate devices all display, store, and enable convenient analysis of
TEL: 972-3-5612212 FAX: 972-3-62424 14
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E-MAIL: shl@shahal.co.il http://www.shahal.co.il
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ECG signals received via a serial port from a locally or transtelephonically connected ECG receiving center.
Safety:
The risk of all identified potential safety hazards is reduced by software design and testing and by the use of the device only by trained medical staff.
Bench Data:
An artificial signal was fed into the receiving center, and the resulting ECG data was displayed and written to a log file. Comparison of the log file with the original signal verified that the data sampling and data processing modules function properly.
Using the ECG display module to display data from prepared files verified that the data was displayed properly and in the correct scale.
Clinical Data:
The comparison of Cardio Vision Software printouts with simultaneous ECG strip chart output demonstrated that the Cardio Vision Software processes and presents ECG data consistently and accurately.
Substantial Equivalence:
The safety and effectiveness of the Cardio Vision software are similar to that of its predicate devices. It is SHL's opinion that the Cardio Vision software is substantially equivalent to its legally marketed predicate devices in terms of safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 19 1998
Mr. Alroy Yariv Vice President SHL Telemedicine International, Ltd. 90 Yiqal Alon Street TEL AVIV, ISRAEL
K981807 Re : CardioVision Software Model S-CV5096 Requlatory Class: II (Two) Product Code: DPS Dated: May 21, 1998 Received: May 21, 1998
Dear Mr. Yariv
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, Drug, and Cosmetic Act (Act). You mav. 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 Requlations, 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 - Mr. Alroy Yariv
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" (21CFR 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. Callahion
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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1981807 510(k) Number (if known):
Device Name: _CARDIO VISION SOFT WARE
Indications For Use:
VISUALIZATION AND MEASUREMENT OF ECG BY TRAINED USED RECORDINGS TO BE MEDICAL CONDITION. MON | TORING CARDIAC IN THE OF STAFF
(Please do not write below this line-continue on another page if needed)
(Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Üse (Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).