(53 days)
Permanent pacing lead, Model Physique™ is indicated for pacing and sensing of the ventricle and/or atrium of the heart. This lead is used in conjunction with a compatible implantable pulse generator (pacemaker).
Permanent Pacing Lead, Model Physique™
The provided text is a 510(k) clearance letter from the FDA for a medical device: a Permanent Pacing Lead, Model Physique™. This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed.
However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The letter explicitly states that the device is approved based on its substantial equivalence to a legally marketed predicate device. This means that the FDA reviewed existing data and information for similar devices already on the market and determined that the new device is as safe and effective as those already approved.
Therefore, I cannot provide the requested information from this document. The document's purpose is to grant marketing clearance, not to detail the specific studies and acceptance criteria for product development and validation.
§ 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.