(95 days)
ProCath® Electrophysiology (EP or Electrode) Catheters are indicated for temporary use in electrophysiology studies (mapping), intracardiac pacing, stimulation, sensing and ECG recording of the heart only.
ProCath® Electrophysiology Catheter
The provided text is an FDA 510(k) clearance letter for the ProCath Electrophysiology Catheter. This document indicates that the device has been found substantially equivalent to a legally marketed predicate device.
However, this document does NOT contain the acceptance criteria, details of a study demonstrating device performance, or any of the specific information requested in your prompt regarding a study (e.g., sample sizes, expert qualifications, ground truth, MRMC studies, standalone performance, training set details).
The letter primarily focuses on:
- Confirming the substantial equivalence determination.
- Indicating the regulatory class (Class II).
- Listing the product code (DRF).
- Stating the intended use/indications for use for the device.
- Explaining the general controls and provisions of the Federal Food, Drug, and Cosmetic Act that apply to the device.
To answer your questions, additional documentation, specifically related to the performance data submitted by ProCath Corporation for their 510(k) application, would be required. This letter merely confirms the FDA's decision based on that submission, but does not detail the submission's contents.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 1999
Mr. Joseph C. Griffin, III President ProCath Corporation Cooper Run Executive Park 575 Route 73 North, Bldg. D West Berlin, NJ 08091-9293
Re : K984150 ProCath Electrophysiology Catheter Regulatory Class: II (two) Product Code: DRF Dated: November 13, 1999 Received: November 19, 1999
Dear Mr. Griffin:
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 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
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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.
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, 2 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. 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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510 (k) NUMBER (IF KNOWN) :
DEVICE NAME : ProCath® Electrophysiology Catheter
INDICATIONS FOR USE :
ProCath® Electrophysiology (EP or Electrode) Catheters are indicated for temporary use in electrophysiology studies (mapping), intracardiac pacing, stimulation, sensing and ECG recording of the heart only.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
V. Oally Still
(Division Sign-O Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
§ 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).