(88 days)
BIOTRONIK's YP xx/15-BP leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators. The leads may be used with single or dual chamber pacing systems. The YP xx/15-BP lead models are intended for placement in either the patient's right atrium or right ventricle.
BIOTRONIK's YP xx/15-BP leads are transvenous, bipolar, active fixation, endocardial pacing leads. The lead conductor is quadrifilar MP35N wire in a coaxial configuration, insulated with silicone tubing, and electrodes surfaces with a fractal iridium surface treatment. The leads are available in 45, 53, and 60 cm lenaths and have IS-1 connectors.
The provided text is a 510(k) Premarket Notification for a medical device (an active fixation endocardial lead), not a study report. It does not contain information on acceptance criteria, device performance, sample sizes used, ground truth establishment, or any comparative effectiveness studies. Therefore, it is impossible to extract the requested information from this document.
The document primarily focuses on:
- Device Description: General characteristics, materials, and predicate devices.
- Indications for Use: What the device is intended for.
- Regulatory Information: Classification, manufacturing site, and contact details.
To answer your questions, a study report detailing the device's performance against specific criteria would be needed.
§ 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.