(362 days)
Mapping of electrical signals of the His bundle and also used to stimulate the myocardium to depolarize at a rate higher than the intrinsic heart rate or at a rate sufficient to maintain adequate cardiac output until definitive treatment can be instituted.
Harmac Quadpolar MappingPacing Catheter with Stylet
The provided document is limited to a 510(k) clearance letter for the Harmac Quadpolar Mapping Pacing Catheter with Stylet. This type of document primarily confirms that the device is substantially equivalent to a predicate device and is cleared for marketing. It does not contain the detailed information required to describe acceptance criteria, the specific study design, or device performance metrics as requested in your prompt.
Therefore, I cannot provide the information requested in your prompt based on the provided text. The document refers to "indications for use" but does not elaborate on performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract design resembling an eagle or bird in flight, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 1997
Mr. Joseph M. Konieczny Requlatory Affairs Engineer Harmac Medical Products, Inc. 2201 Bailey Avenue · Buffalo, New York 14211-1797
Re: K963074 Harmac Quadpolar Mapping Pacing Catheter Trade Name: Requlatory Class: II Product Code: 74DRF Dated: March 25, 1997 Received: March 28, 1997
Dear Mr. Konieczny:
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 requirement, 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 Failure to comply with the GMP regulation may result in assumptions. 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 requlations.
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Page 2 - Mr. Joseph M. Konieczny
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 FOR USE
510(K) Number: K963074
Harmac Quadpolar MappingPacing Catheter with Stylet Device Name:
Indications for Use:
"Mapping of electrical signals of the His bundle and also used to stimulate the myocardium to depolarize at a rate higher than the intrinsic heart rate or at a rate sufficient to maintain adequate cardiac output until definitive treatment can be instituted."
Contraindications:
"This device is not designed, sold, or intended for use except as indicated."
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
OR
ver-the-counter use
Thomas J. Collethon
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurosogical Devices 510(k) Number
Harmac Medical Products, Inc. K963074 Attachment 3
§ 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).