ARRHYTHMIA MAPPING SYSTEM (8100/8300) by CARDIAC PATHWAYS CORP.

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.

Device Description

Not Found

AI/ML Overview

This is a 510(k) clearance letter for a device called "Arrhythmia Mapping System (8100/8300)" from 1997. It declares the device to be substantially equivalent to a predicate device.

Crucially, 510(k) clearance letters typically do not contain detailed acceptance criteria, study methodologies, or performance statistics like those requested in your prompt. Their primary purpose is to confirm substantial equivalence to a legally marketed predicate device, often based on comparisons of technological characteristics, intended use, and sometimes non-clinical (e.g., bench) testing, rather than complex clinical performance studies with acceptance criteria and defined statistical metrics.

Therefore, I cannot extract the requested information from the provided text. The document states the intended use of the device but provides no data on its performance, studies conducted, or the criteria for its acceptance.

Summary

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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

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number	K965060

Inscription Use V

Regulation Number and Section

§ 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).