(13 days)
The Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for temporary 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 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.
The document provided describes a Special 510(k) Premarket Notification for the Medtronic Model 6491 Unipolar Pediatric Temporary Pacing Lead. This type of submission is for modifications to a manufacturer's own legally marketed device, where the modification does not affect the intended use or fundamental scientific technology. Therefore, the study details provided focus on demonstrating that the modified device remains substantially equivalent to the predicate device, rather than proving performance against specific acceptance criteria for a novel device.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Environmental Conditioning | Meets specified requirements |
| Visual Verification | Meets specified requirements |
| Electrical Testing | Meets specified requirements |
| Mechanical Testing | Meets specified requirements |
| Sterilization Validation | Processes validated |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the described device testing (Environmental Conditioning, Visual Verification, Electrical Testing, Mechanical Testing, and Sterilization Validation). It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). These tests are typically performed in a laboratory setting by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The concept of "ground truth" and expert adjudication as typically understood in AI/imaging studies does not apply here. This submission is for a physical medical device (a temporary pacing lead), and its performance is evaluated through engineering and laboratory tests, not by human interpretation of data.
4. Adjudication method for the test set
Not applicable. The performance is determined by meeting engineering specifications through objective measurements, not through human adjudication of interpretations.
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-assisted diagnostic or interpretative device. It is a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the device testing described, the "ground truth" is established by adherence to predefined engineering specifications and validated test methods for a physical device. This isn't observational data requiring expert consensus or pathology.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML model that requires a "training set" with established ground truth.
Summary of the Study:
The study performed by Medtronic, Inc. was a series of system compatibility tests to demonstrate that the modified Model 6491 Unipolar Pediatric Temporary Pacing Lead is substantially equivalent to its predicate device. The tests included:
- Environmental Conditioning: To assess the device's performance under various environmental stresses.
- Visual Verification: To ensure the device meets specified visual and aesthetic quality standards.
- Electrical Testing: To confirm the electrical characteristics and functionality of the lead (e.g., impedance, pacing threshold).
- Mechanical Testing: To evaluate the physical integrity, strength, and durability of the lead components (e.g., tensile strength, flexibility).
- Sterilization Validation: To ensure the Ethylene Oxide (ETO) sterilization process effectively sterilizes the device.
The document states that "All system compatibility tests performed have demonstrated that the modified Model 6491 heartwire meets the specified requirements." This indicates that the device successfully passed these engineering and performance tests, supporting its substantial equivalence claim.
§ 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.