(13 days)
The Model 6495 Bipolar Temporary Myocardial 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 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multi-filament 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. 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. To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body.
This document does not contain acceptance criteria or a study proving the device meets acceptance criteria in the manner requested. The submission is a Special 510(k) Premarket Notification for a modified medical device. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
Here's why the requested information cannot be fully extracted and what the document does provide:
- No specific acceptance criteria table for device performance: The document does not present a table of quantitative acceptance criteria (e.g., "sensitivity > X%", "accuracy > Y%") alongside reported performance metrics for the device.
- No clinical study demonstrating device performance: The submission outlines "system compatibility testing" which includes environmental conditioning, visual verification, dimensional testing, electrical testing, and mechanical testing. These are bench tests, not clinical studies involving patients or human readers.
- Comparison to a predicate device: The core of a 510(k) submission is to show that the new device is "substantially equivalent" to a legally marketed predicate device, implying that its safety and effectiveness are comparable.
Here's the information that can be extracted or inferred from the provided text, structured to address your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Environmental Conditioning | "meets the specified requirements" |
| Visual Verification | "meets the specified requirements" |
| Dimensional Testing | "meets the specified requirements" |
| Electrical Testing | "meets the specified requirements" |
| Mechanical Testing | "meets the specified requirements" |
| Sterilization Validation | "Processes appropriate for sterilizing the devices were validated." |
Note: The document only states that the device "meets the specified requirements" for each test. It does not provide the specific quantitative requirements or the exact performance values achieved.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The "Summary of Studies" refers to "system compatibility testing" which typically involves a defined number of units, but this number is not provided in the document.
- Data Provenance: Not explicitly stated, but these are bench tests and likely conducted internally by Medtronic, Inc. There is no indication of country of origin of data or whether it was retrospective or prospective in the context of human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This document describes engineering and product safety testing (e.g., electrical, mechanical, dimensional, sterilization), not a study requiring expert clinical ground truth assessment.
4. Adjudication method for the test set
- Not applicable. As the tests are technical and functional, not clinical assessments requiring human interpretation or consensus.
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
- No. This is not an AI/software device or an imaging device, and therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (pacing lead), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the conventional sense. The "ground truth" for the tests performed (e.g., electrical testing, dimensional testing) would be the established engineering specifications and industry standards for safety and performance of such a device.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is manufactured, and its performance is verified against specifications.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary: This 510(k) submission for the Medtronic Model 6495 Bipolar Temporary Myocardial Pacing Lead focuses on establishing substantial equivalence to an existing predicate device through a series of bench and validation tests (environmental, visual, dimensional, electrical, mechanical, and sterilization). It does not involve a clinical study with human subjects, AI performance, or expert evaluation of clinical cases to determine acceptance criteria for diagnostic or prognostic accuracy. The acceptance criteria for the tests performed are implicitly meeting "specified requirements," which would be Medtronic's internal engineering and quality standards for the 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.