(142 days)
The Model 6491 Unipolar Pediatric Temporary Pacing Lead is intended for temporary postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.
The Model 6492 Unipolar Temporary Atrial Pacing Lead is intended for temporary postsurgical atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY
The Model 6494 Unipolar Temporary Myocardial Pacing wire is intended for temporary postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.
The Model 6495 Bipolar Temporary Myocardial Pacing Lead is intended for temporary postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.
The Medtronic Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for use in both the atrium and the ventricle. The unipolar lead is comprised of a lead body with the distal and proximal segment. The Model 6491 Unipolar Pediatric Temporary Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. A curved atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall.
The Medtronic Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for use in the atrium. The unipolar lead is comprised of a lead body with distal and proximal segments. The Model 6492 Unipolar Temporary Atrial Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall.
The Medtronic Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for use in both the atrium and the ventricle. The two leads are comprised of a lead body with distal and proximal segment. The Model 6494 Unipolar Temporary Myocardial Pacing Wire consists of two insulated multi-filament wire. At one end of each wire has been stripped to have an electrode surface. This surface area can partly or completely be used as an electrode. The stripped end terminates distally in an atraumatic myocardial curved needle. An atraumatic chest needle at the proximal end of the conductor wire permits running the pacing wire to exit through the chest wall.
The Medtronic Model 6495 Bipolar Temporary Myocardial Pacing Lead is designed for use in both the atrium and the ventricle. The bipolar lead is comprised of a lead body with distal and proximal segments which includes the integrated bifurcated proximal lead connection. The Model 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multifilament lead, which contains a distal, discrete, ring electrode, a discrete, tip electrode, and a coaxial conductor lead body. Each discrete electrode is crimped onto a conductor and terminates in an atraumatic myocardial curved needle. The curved needle is used to create a channel in the myocardium for embedding the electrodes. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. Terminated on the back of the chest needle are two breakaway connector pins, which provide an attachment to an external pulse generator.
This document describes a 510(k) premarket notification for Medtronic Streamline Temporary Pacing Leads (Models 6491, 6492, 6494, and 6495). The submission primarily addresses a minor formulation change to the base polyethylene (PE) material used for the insulation coating of the pacing wires.
Here's an analysis of the provided text in relation to your request about acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance" values for each criterion. Instead, it states that the devices successfully passed the acceptance criteria for various tests. The acceptance criteria are "pre-established specifications," but these specifications are not detailed.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Successfully passed pre-established specifications. |
| Component Qualification | Successfully passed pre-established specifications. |
| Design Verification | Successfully passed pre-established specifications. |
| Shelf Life | Successfully passed pre-established specifications. |
| PE base material qualification | The new PE formulation is considered qualified for its intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the precise sample sizes used for each of the bench tests (Biocompatibility, Component Qualification, Design Verification, Shelf Life). It only states that "Bench testing was used to verify the performance characteristics."
The data provenance (country of origin, retrospective/prospective) is not mentioned. Given that this is bench testing for a medical device, it's typically conducted in a controlled laboratory environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to the information provided. The study described is bench testing, not a clinical study involving diagnostic interpretation or "ground truth" established by medical experts in the traditional sense (e.g., radiologists, pathologists). The "ground truth" for bench testing would be the engineering and material science standards and specifications that the device is required to meet, established by Medtronic's internal R&D and quality teams, and aligned with regulatory requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. Bench testing involves objective measurements against predefined specifications, not subjective interpretation.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required." This submission is for a material change in a physical medical device (pacing leads), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical device (pacing leads) and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As mentioned in point 3, the concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For bench testing of a physical medical device, the "ground truth" is defined by the technical specifications, industry standards, and regulatory requirements that the device must meet. This involves objective measurements and adherence to predefined engineering and material science parameters.
8. The sample size for the training set
This question is not applicable. There is no AI or machine learning component to this device, and therefore no "training set" in the context of AI development.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this device.
§ 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.