(28 days)
The Catheter is intended for use in electrogram recording and cardiac stimulation during diagnostic electrophysiology study.
6-French 20-Electrode Electrophysiology Diagnostic Catheter
The provided text is a 510(k) clearance letter from the FDA for a medical device. This document does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.
The letter simply states that the FDA has reviewed the 510(k) notification for the "6-French 20-Electrode Electrophysiology Diagnostic Catheter" and determined it to be substantially equivalent to legally marketed predicate devices for its intended use (electrogram recording and cardiac stimulation during diagnostic electrophysiology study).
To answer your questions, I would need access to the actual 510(k) submission document, which would include the performance testing data and clinical study reports.
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Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the symbol of the Department of Health & Human Services, which is an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the edge of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2001
Mr. Jamil Mogul Mogul Enterprises, Inc. 6387 San Ignacio Avenue San Jose, CA 95119
Re: K011734
Trade Name: 6-French 20-Electrode Electrophysiology Diagnostic Catheter Regulation Number: 870.1220 Regulatory Class: II (two) Product Code: 74 DRF Dated: June 4, 2001 Received: June 5, 2001
Dear Mr. Mogul:
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 response to your premarket notification submission does not affect any obligation you might
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Page 2 -- Mr. Jamil Mogul
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) 594-4646. 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,
Ren Tell
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K011734 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: 6-French 20-Electrode Electrophysiology Diagnostic Catheter
Indications For Use:
The Catheter is intended for use in electrogram recording and cardiac stimulation during diagnostic electrophysiology study.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use $\checkmark$
(Optional Format 3-10-98)
Division of Cardiovascular & Respiratory Devices
510(k) Number K011734
§ 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).