(361 days)
The models 436-07 and 437-07 pacing leads are intended for use with implantable cardiac pulse generators for long-term pacing of the heart. The indications for ventricular pacing include, but are not limited to: Sick sinus syndrome, sinus bradycardia, complete heart block, symptomatic second-degree heart block, and certain conditions of asymptomatic second-degree block.
In the presence of normal A-V conduction the indications for atrial pacing include, but are not limited to: Sinus arrest, sick sinus syndrome, sinus bradycardia and conditions requiring increased cardiac efficiency, enhanced cardiac output or the overdrive of certain cardiac arrhythmias.
In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual chamber pacing system to restore A-V synchrony.
The Intermedics Models 436-07 (bipolar) and 437-07 (unipolar) endocardial pacing leads are designed for use with implantable cardiac pulse generators configured for ventricular applications for long term cardiac pacing. The nominal lead length for the model 436-07 lead is 58 cm and is available in lengths from 40 to 110 cm. The nominal lead length for the model 437-07 lead is also 58 cm and is available in lengths from 40 to 110 cm. The lead connectors are designed to meet VS-1 specifications (an intra-industry agreement standardizing lead-to-pulse generator connection dimensions) for lead connectors.
The models 436-07 and 437-07 pacing leads are packaged with the model 367-01 vein lifter and the following stylets: model 367-11 (straight stylet, limber), model 365-12 (straight stylet, firm), model 365-81(tapered stylet, limber), and model 365-82 (tapered stylet, firm).
The model 437-07 is also packaged with the following adapters: model 366-29 (Step up adapter, VS-1 unipolar lead to 5 mm unipolar pacer) and model 366-30 (Step up adapter, VS-1 unipolar lead to 6 mm unipolar pacer).
The minimum introducer size recommended for both lead models is 10 French.
The models 436-07 and 437-07 pacing leads are identical to the Intermedics models 436-02 (K883602, K954719) and 437-02 (K883602, K954719) respectively, except for the use of iridium-oxide (IROX) coated titanium for the electrodes. The IROX-coated electrodes are identical to those used in models 430-07 (K902672, K954719) and 431-07 (K902672, K954719).
The provided text is a 510(k) summary for pacing leads, not an AI/ML device. Therefore, it does not contain information about acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies typically associated with AI/ML device submissions.
The document focuses on demonstrating substantial equivalence to predicate devices for traditional medical devices (pacing leads) through:
- Device Description: Highlighting similarities in design and materials.
- Biocompatibility Studies: Testing the materials to ensure safety.
- Qualification Testing: Relying on previous testing of predicate leads.
- Clinical Summary: Referencing the low incidence of complications and effective performance of existing, similar devices.
Therefore, I cannot fulfill the request as the necessary information for Acceptance Criteria and Study details for an AI/ML device is not present in the provided text.
§ 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.