(27 days)
The Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for temporary post-surgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for SINGLE USE ONLY.
The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary post-surgical atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for SINGLE USE ONLY.
The Model 6495 Bipolar Temporary Myocardial Pacing Lead is intended for temporary post-surgical 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 6500 Unipolar Temporary Myocardial Pacing Lead is designed for temporary post-surgical pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and 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. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied. No part of the Medtronic Model 6491 Unipolar Pediatric Temporary Pacing Lead remains in the body.
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. To remove the pacing lead, gentle traction should be applied. No part of the Medtronic Model 6492 Unipolar Temporary Atrial Pacing Lead remains in the body.
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. No part of the Medtronic Model 6495 Bipolar Temporary Myocardial Pacing Lead remains in the body.
The Medtronic Model 6500 Unipolar Temporary Myocardial 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 6500 Unipolar Temporary Myocardial 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. To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body, except the silicone rubber disc in the case of atrial application.
The provided text is a 510(k) summary for the Medtronic Streamline family of temporary pacing leads. It focuses on demonstrating substantial equivalence to predicate devices based on bench testing and does not include information about acceptance criteria or studies related to AI/algorithm performance. Therefore, I cannot extract the requested information.
Here's why each point cannot be addressed with the given text:
- A table of acceptance criteria and the reported device performance: The document mentions "bench testing" to "verify the performance characteristics," but it does not specify what those characteristics are, what the acceptance criteria were, or the reported performance values. It only lists the types of tests conducted (Biocompatibility, Junction Strength, Component Qualification).
- Sample sized used for the test set and the data provenance: Not mentioned. The document only refers to "bench testing" generally.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document describes a medical device, not an AI/algorithm where expert-established ground truth would be relevant.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device submission.
- 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: Not applicable. This is a physical pacing lead, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this type of device. Performance is likely measured against engineering specifications or established standards for medical leads.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
The document makes it clear that:
- "Bench testing was used to verify the performance characteristics of these devices. Clinical testing was not required." (Page 9)
- The submission is a "Special 510(k)" primarily due to a minor formulation change and a new supplier for the blue monofilament suture (Page 8). The focus is on demonstrating "substantial equivalence" to existing predicate devices, not on proving new performance claims through extensive clinical trials or AI/ML evaluations.
§ 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.