(112 days)
ProCath® Electrophysiology (EP or Electrode) Catheters are indicated for temporary use in electrophysiology studies, intracardiac pacing, stimulation, sensing and ECG recording only.
Electrophysiology Catheter (Steering Modification)
This document is a 510(k) clearance letter from the FDA for a medical device: "ProCath Electrophysiology Catheter (Steering Modification)". It confirms that the device is substantially equivalent to a legally marketed predicate device.
Unfortunately, the provided text does not contain the detailed information necessary to answer your specific questions regarding:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The letter focuses on the regulatory clearance process, stating that the device is substantially equivalent to existing devices and can be marketed. It does not elaborate on the specific performance studies, test methodologies, or data characteristics beyond stating the "Indications for use" of the catheter.
To get the information you are looking for, you would generally need to refer to the actual 510(k) submission document (if publicly available in more detail than this summary letter) or any related clinical/performance study reports.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 15 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 : K991001 Modification of ProCath Electrophysiology Catheter Requlatory Class: II (two) Product Code: DRF Dated: June 10, 1999 Received: June 18, 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, qood 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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
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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.
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. Callehan
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): K991001
Device Name: Electrophysiology Catheter (Steering Modification)
Indications for use:
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ProCath® Electrophysiology (EP or Electrode) Catheters are indicated for temporary use in electrophysiology studies, intracardiac pacing, stimulation, sensing and ECG recording only.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Or K. T. M.
ivision Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devi
Neurological Devices
510(k) Number K991001
| Prescription Use | V |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The -Counter Use - - -
(Optional Format 1-2-96)
§ 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).