(236 days)
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Not Found
No
The summary does not mention AI, ML, or related terms, and the described functions (recording, viewing, analyzing signals) are typical for non-AI mapping systems.
No
The device is intended for diagnosis and localization of cardiac arrhythmias, not for treating them.
Yes
The text explicitly states that the system "assists in the collection and presentation of signal information necessary for the diagnosis and localization of cardiac arrhythmias." This indicates a diagnostic purpose.
Unknown
The provided summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. The intended use describes recording and analyzing signals, which could be performed by software, but it doesn't explicitly exclude the presence of hardware for signal acquisition or processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is used to record, view, and analyze intracardiac electrogram (EGM) and surface electrocardiograph (EKG) signals. These are electrical signals measured directly from or on the body, not from samples taken from the body (like blood, urine, or tissue).
- Nature of the Signals: EGM and EKG signals are physiological measurements, not diagnostic tests performed on biological samples in vitro (outside the body).
- Lack of Mention of Samples: There is no mention of analyzing biological samples or performing tests on them.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is focused on capturing and analyzing electrical activity within and on the body itself.
N/A
Intended Use / Indications for Use
The Arrhythmia Mapping System is intended to be used to record, view, and analyze intracardiac electrogram (EGM) and surface electrocardiograph (EKG) signals. By performing these functions, the Mapping System assists in the collection and presentation of signal information necessary for the diagnosis and localization of cardiac arrhythmias. The system is intended to be used by a Cardiologist (subspecialty Cardiac Electrophysiology) during electrophysiology studies.
Product codes
74 DRF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Cardiologist (subspecialty Cardiac Electrophysiology) during electrophysiology studies.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Earle L. Canty Cardiac Pathways Corporation 995 Benecia Avenue Sunnyvale, California 94086
AUG | | 1997 | | |
Re: K965066 Arrhythmia Mapping System (8100/8300) Requlatory Class: II (two) Product Code: 74 DRF Dated: July 29, 1997 Received: July 30, 1997
Dear Mr. Canty:
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 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. Earle L. Canty
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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Indications
The Arrhythmia Mapping System is intended to be used to record, view, and analyze intracardiac electrogram (EGM) and surface electrocardiograph (EKG) signals. By performing these functions, the Mapping System assists in the collection and presentation of signal information necessary for the diagnosis and localization of cardiac arrhythmias. The system is intended to be used by a Cardiologist (subspecialty Cardiac Electrophysiology) during electrophysiology studies.
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices | |
| 510(k) Number | K965060 |
Inscription Use V