(26 days)
The Model 6416 Bipolar Transvenous Temporary Pacing 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 Bipolar Transvenous Temporary Pacing Lead System comprises a temporary lead and a soft-tipped Medtronic guiding catheter. The pacing lead is designed to provide pacing characteristics similar to presently marketed bipolar temporary leads. The lead is introduced percutaneously through the guiding catheter. The lead system is provided in varying lengths to allow for jugular, subclavian, or femoral approach. A removable silicone rubber torque tool is provided on the proximal portion of the lead, to facilitate rotation of the lead during implant and explant. The disposable introducer currently packaged with the system is the Medtronic Vector X coronary guiding catheter, size 6 French. This catheter guides or steers the temporary lead during placement, and shrouds the active fixation helix from blood vessel walls and other inappropriate tissue until actual implantation in the atrium or ventricle. A hemostasis valve tightens and loosens around the lead and controls the passage of the lead through the guide catheter.
This document, K042190, is a Special 510(k) Premarket Notification for the Medtronic Model 6416 Bipolar Transvenous Temporary Pacing System. This submission focuses on a modification to an already marketed device, not the introduction of a completely new device or a typical AI/ML device. Therefore, the standard metrics often associated with AI/ML device performance and acceptance criteria using large datasets, ground truth, and expert adjudication are not applicable here.
The document primarily demonstrates that the modified device is substantially equivalent to its predicate device and that the modifications do not alter its fundamental scientific technology or intended use. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and compatibility tests, not AI model performance evaluations.
Here's an interpretation based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Required for Substantial Equivalence) | Reported Device Performance (Summary of Studies) |
|---|---|
| Maintain existing safety and performance characteristics | Met specified requirements for system compatibility. |
| Maintain existing technological characteristics | No change with the modified device. |
| No change to material type or formulation | Biocompatibility testing not repeated; materials unchanged. |
| Maintain existing sterilization process and effectiveness | Uses the same 100% Ethylene Oxide (EtO) sterilization process as the predicate device. |
| Demonstrate compatibility with the guiding catheter and lead | "Lead/Catheter Compatibility testing" performed. |
| Preclinical confirmation of safety and performance | "Preclinical confirmation of safety and performance" performed. |
| Visual verification to ensure no adverse changes | "Visual Verification" performed. |
| Environmental conditioning to ensure device integrity | "Environmental Conditioning" performed. |
2. Sample sizes used for the test set and the data provenance
The document does not specify exact sample sizes for the "system compatibility testing." The tests listed (Environmental Conditioning, Visual Verification, Lead/Catheter Compatibility testing, Preclinical confirmation) are typically done on a smaller, representative number of devices to demonstrate functionality and safety, not large patient datasets. The data provenance is internal Medtronic testing for device modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the studies are engineering verification and validation tests, not clinical studies requiring expert ground truth for interpretation of medical images or patient data.
4. Adjudication method
Not applicable. The tests performed are objective engineering and performance evaluations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a MRMC study was not done. This type of study is relevant for evaluating human performance with and without AI assistance in diagnostic tasks, which is not the purpose of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an AI algorithm. The performance evaluation is for the physical device's function, not an algorithm.
7. The type of ground truth used
The "ground truth" for the tests mentioned would be the established engineering specifications, performance standards, and safety requirements for the device. For example:
- Environmental Conditioning: Ground truth would be the device's ability to withstand specified environmental stressors without degradation in performance.
- Visual Verification: Ground truth would be adherence to design specifications and absence of manufacturing defects.
- Lead/Catheter Compatibility testing: Ground truth would be successful and safe interaction between components as per design.
- Preclinical confirmation of safety and performance: Ground truth would likely be established in animal models or benchtop tests demonstrating the intended function (pacing, EGM recording, fixation) without causing harm.
8. The sample size for the training set
Not applicable. There is no AI model or "training set" in the context of this device and its modification.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned.
§ 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.