(30 days)
The Medtronic Model 5071 sutureless, unipolar, myocardial, screw-in lead is designed for ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated.
The Medtronic Model 5071 sutureless, unipolar, myocardial, screw-in lead is designed for ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated. Two leads may be used for bipolar pacing. The lead's screw-in electrode is designed to be secured to the myocardium with two clockwise turns. A polyester mesh allows fibrous ingrowth for additional fixation. The lead requires no stab wounds or sutures for electrode placement and fixation. Tissue damage from electrode insertion may be compared to the insertion of a 15guage needle. The lead features a MP35N nickel alloy conductor, silicone rubber insulation, and an IS-1 Unipolar (UNI) lead connector.
The provided document is a 510(k) summary for the Medtronic Model 5071 Myocardial Pacing Lead, seeking substantial equivalence to an already marketed predicate device (the original Model 5071 Lead). This type of submission focuses on demonstrating that a modified device is as safe and effective as a legally marketed predicate device, rather than proving efficacy from scratch with a new device.
Therefore, the document does not contain information typically found in studies designed to prove a device meets specific performance acceptance criteria through clinical trials or detailed standalone algorithm performance evaluations. Instead, it relies on bench testing and material characterization to show that the modified device is still substantially equivalent to the predicate device.
Here's an analysis based on the provided text, addressing the requested points where possible, and noting when the information is not applicable or present for a 510(k) submission of this nature:
1. Table of acceptance criteria and the reported device performance
This information is not provided in the document. A 510(k) Special submission for minor modifications typically focuses on showing that the modifications do not affect the safety or effectiveness, often by referencing existing predicate device performance and material equivalency. Specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy for an AI device) are not part of this submission type for a pacing lead.
2. Sample size used for the test set and the data provenance
The document mentions "bench test results for lead Models 5568, 5024M, and 5524M and the MED-4719 material characterization and biocompatibility testing," but does not specify sample sizes for these tests nor the data provenance (e.g., country of origin, retrospective/prospective). These are likely internal engineering tests rather than clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes bench testing and material characterization for a pacing lead, not a device requiring expert interpretation of diagnostic output (like an AI imaging device). Ground truth for a pacing lead would involve physical integrity, electrical performance, and biocompatibility, typically assessed through engineering standards and laboratory analyses.
4. Adjudication method for the test set
This information is not applicable for the same reasons as point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a myocardial pacing lead, not an AI-powered diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical implant (pacing lead), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Summary of Studies," the "ground truth" implicitly refers to engineering standards, material specifications, and validated characterization methods for the lead and insulation material. For example, biocompatibility testing would compare against established safety profiles for materials in contact with human tissue.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of a physical medical device like a pacing lead. This concept applies to AI/machine learning algorithms.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device.
In summary:
The provided K031274 document is a 510(k) submission for a modification to a myocardial pacing lead, focusing on demonstrating substantial equivalence to a predicate device. It primarily relies on bench test results and material characterization to support this claim, rather than clinical studies with human subjects or AI algorithm performance evaluations. As such, most of the requested information pertains to study designs not relevant to this specific regulatory submission for this type of product.
§ 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.