(412 days)
The Bipolar Temporary Pacing Catheter with Stylet is indicated for use in temporary transvenous cardiac pacing when impulse formation or conduction is impaired.
Harmac Temporary Pacing Catheter with Stylet
This document is a 510(k) clearance letter from the FDA for a medical device, the Harmac Temporary Pacing Catheter with Stylet. It is not a study report or a technical performance document for an AI/ML powered device. As such, it does not contain the requested information regarding acceptance criteria or a study proving device performance against such criteria.
The letter primarily states that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, and outlines the regulatory framework for its marketing.
Specifically, the requested information cannot be found in this document:
- A table of acceptance criteria and the reported device performance: Not present. This document only includes the Indications for Use.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This is a traditional medical device, not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is a traditional medical device, not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
AUG 1 4 1997
Mr. Michael Guzzo Quality Assurance Engineer Harmac Medical Products, Inc. 2201 Bailey Avenue Buffalo, New York 14211-1797
Re: K963073 Harmac Temporary Pacing Catheter with Stylet Regulatory Class: II (two) Product Code: 74 LDF Dated: July 31, 1997 Received: August 7, 1997
Dear Mr. Guzzo:
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 Requlations, 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 8.0) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMF 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. Michael Guzzo
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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. 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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INDICATIONS FOR USE
510(K) Number: K963073
Device Name: Harmac Bipolar Temporary Pacing Catheter with Stylet
Indications for Use : . . . . . . . . .
"The Bipolar Temporary Pacing Catheter with Stylet is indicated for use in temporary transvenous cardiac pacing when impulse formation or conduction is impaired."
Contraindications:
"This device is not designed, sold, or intended for use except as indicated."
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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
Gyer-The-Counter Use ________
Harmac Medical Products, Inc. K963073 Attachment 3
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.