(13 days)
The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary 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 Medtronic 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 lead remains in the body.
This document describes a Special 510(k) Premarket Notification for the Medtronic Model 6492 Unipolar Temporary Atrial Pacing Lead. This type of submission is for modifications to a legally marketed device where the modifications do not affect the intended use or alter the fundamental scientific technology. Therefore, the submission focuses on demonstrating that the modified device maintains substantial equivalence to the predicate device through specific testing. It does not contain an "acceptance criteria" table in the traditional sense for a new device's performance, but rather a "summary of studies" showing that the modified device still meets all specified requirements.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of "acceptance criteria" and "reported device performance" as would be seen for a new device's clinical efficacy study. Instead, it states that "All system compatibility tests performed have demonstrated that the modified Model 6492 heartwire meets the specified requirements." This implies that the acceptance criteria are inherent in the "specified requirements" for each test.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Environmental Conditioning: Meets specified requirements. | Demonstrated that the modified Model 6492 heartwire meets the specified requirements. |
| Visual Verification: Meets specified requirements. | Demonstrated that the modified Model 6492 heartwire meets the specified requirements. |
| Electrical Testing: Meets specified requirements. | Demonstrated that the modified Model 6492 heartwire meets the specified requirements. |
| Mechanical Testing: Meets specified requirements. | Demonstrated that the modified Model 6492 heartwire meets the specified requirements. |
| Sterilization Validation: Achieves required sterility assurance level (SAL) through 100% Ethylene Oxide (ETO) process. | Processes appropriate for sterilizing the devices were validated. |
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 sample size for the "system compatibility testing" (Environmental Conditioning, Visual Verification, Electrical Testing, Mechanical Testing) or for the Sterilization Validation. It also does not mention the data provenance (country of origin, retrospective/prospective). This is common for Special 510(k) submissions focusing on engineering and bench testing rather than clinical trials.
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)
Not applicable. This device submission relies on engineering and bench testing, not expert-derived ground truth from human observations or interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This submission concerns physical device testing, not assessment of human interpretation or diagnostic accuracy.
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
Not applicable. This is not an AI/software device and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device. The testing described (Environmental Conditioning, Visual Verification, Electrical Testing, Mechanical Testing, Sterilization Validation) represents the "standalone" performance of the physical device in meeting its engineering specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the engineering and sterilization tests, the "ground truth" is defined by the specified requirements and validated test methods. For example, in electrical testing, the ground truth would be the expected electrical parameters as per the device's design specifications. For sterility, the ground truth is a validated Sterility Assurance Level (SAL).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning 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.