(260 days)
The Medtronic Model 6416 Temporary. Transvenous Pacing Lead System features an active fixation, bipolar lead and a soft-tipped lubricated guide catheter. The system is designed for temporary intracardiac pacing and/or EGM recording.
The system is disposable, for temporary single patient use with a contemplated implant duration of 7 days or less. The lead and accessories are supplied sterile.
The lead is introduced transvenously using the guide catheter. Once within the appropriate chamber, the helical tip electrode of the lead is actively fixed into the endocardium. After lead placement, the guide catheter is removed by sliding it over the lead's bifurcated connector.
The Model 6416 lead consists of a small distal active fixation helix, tip and ring electrodes, an insulated coaxial conductor, and two staggered pin, low-profile bifurcation connectors. The Model 6416 system also includes a guiding catheter which is used for percutaneous lead introduction and placement in the heart. After implantation of the lead, the catheter is removed, and the lead's connectors are attached to an external pulse generator for a contemplated implant duration of up to 7 days. After completion of therapy, the lead is removed by counter-rotation and gentle traction. No part of the device remains in the body.
The provided text describes a 510(k) summary for the Medtronic Model 6416 Bipolar Temporary Transvenous Pacing Lead. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel performance criteria through a clinical study with acceptance criteria in the typical sense of new device development.
Therefore, the information you're requesting regarding acceptance criteria, study details, expert involvement, and ground truth establishment, as typically found for algorithms or diagnostic devices making claims about accuracy or effectiveness, is not present in this type of submission. This 510(k) is about device integrity and comparison to a predicate, not clinical performance measures like sensitivity, specificity, or reader improvement with AI.
However, I can extract the "performance" data that is usually presented in these types of submissions, which relates to device integrity testing.
Here's a summary of what's available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a 510(k) submission like this are generally that the new device meets its own internal specifications and is substantially equivalent to a predicate device. The "device performance" in this context refers to the results of engineering and integrity testing.
| Acceptance Criteria (Implicit: Met specified requirements) | Reported Device Performance |
|---|---|
| Visual verification to specified requirements | All test results met specified requirements. |
| Dimensional verification to specified requirements | All test results met specified requirements. |
| Electrical verification to specified requirements | All test results met specified requirements. |
| Flex life verification to specified requirements | All test results met specified requirements. |
| Pull strength verification to specified requirements | All test results met specified requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "device integrity testing" which implies a set of physical devices were tested, but the number is not provided.
- Data Provenance: Not applicable in the sense of patient data. The provenance is from internal Medtronic engineering testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for these tests are engineering specifications and measurements, not clinical expert consensus.
- Qualifications of Experts: Not applicable. The tests are industrial engineering and quality control tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Results are based on measurable physical and electrical properties compared to predefined specifications.
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
- MRMC Study: No. This is a medical device (pacing lead), not a diagnostic algorithm. Therefore, an MRMC study and AI-assisted performance metrics are not relevant or performed for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No. This is not an algorithm; it is a physical medical device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Engineering specifications and physical/electrical measurement standards.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/ML model that requires a training set. The device design is based on engineering principles and previous device models.
9. How the Ground Truth for the Training Set was Established
- Establishment of Ground Truth for Training Set: Not applicable. There is no training set in the context of this device. The design and validation are based on established engineering and manufacturing standards.
In summary: The provided text is a 510(k) summary for a physical medical device, not a diagnostic algorithm or a device requiring clinical performance claims in the traditional statistical sense. The "studies" performed relate to ensuring the device meets its own engineering specifications and demonstrating substantial equivalence to predicate devices, which is the primary requirement for 510(k) clearance.
§ 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.