(119 days)
BIOTRONIK's ELOX (EX xx-BP) transvenous, active fixation endocardial 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 with IS-1 headers. The leads may be used with single or dual chamber pacing systems.
The ELOX (EX xx-BP) lead models are intended for placement in either the right atrium or right ventricle.
Elox (EX xx-BP) is a straight, bipolar endocardial pacing lead utilizing an electrically active extendable/retractable fixation helix. The extendable/retractable fixation helix is comprised of a 70% Pt / 30% Ir alloy with a fractal Iridium coating. The non-insulating distal sleeve, consisting of an inner and outer sleeve, is composed of Polyurethane (Pellethane 2363-75D). The lead contains two conductors composed of quadrifilar MP35N wire in coaxial configurations and is insulated with silicone tubing. A 3.2 mm IS-1 bipolar connector attaches the lead to the pulse generator. The Elox lead is available in lead lengths of 45 cm, 53 cm, and 60 cm.
The provided text is a 510(k) summary for the Elox Active Fixation Endocardial Lead. It describes the device, its indications for use, and lists predicate devices. However, it does not contain any information about acceptance criteria, device performance results, sample sizes for testing or training, ground truth establishment, or clinical study details (like MRMC studies) that would be needed to answer your questions.
Therefore, I cannot generate the requested table and information based on the provided text. The document is primarily a regulatory submission for substantial equivalence rather than a detailed report of performance studies.
§ 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.