(214 days)
The Temporary Bipolar Myocardial Pacing Wire functions as a temporary implant for the transmission of electrical heart pacing signals. The heart wire is placed following cardiac surgery to be in direct contact with the native myocardium while the natural heart is surgically exposed. The wire may be used on either the atrium or ventricle.
Temporary Bipolar Myocardial Pacing Wire
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study that proves the device meets specific criteria. The document is a 510(k) clearance letter from the FDA for a "Temporary Bipolar Myocardial Pacing Wire," stating that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory information and indications for use but does not include details about device testing or study results.
§ 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.