(298 days)
The Model 6495 bipolar temporary myocardial pacing lead is designed for temporary atrial and ventricular pacing and sensing, for a maximum of 7 days, during and after cardiac surgery. The Model 6495 bipolar temporary myocardial pacing lead is intended for SINGLE USE ONLY.
The bipolar temporary myocardial pacing wire, Model 6495 consists of a distal electrode, and a coaxial conductor which are crimped together. A blue polypropylene fiber proximally coiled (flattered coil) for fixation of the lead is attached to the distal electrode and terminated in an atraumatic curved needle. An atraumatic breakaway chest needle at the other end of the conductor wire permits running the lead through the chest wall. Proximal to the chest needle is a connector ring crimped to the conductor wire. After removal of the pacing wire, which is performed by gentle traction, no part of the wire remains in the body.
The provided text describes a 510(k) submission for the Medtronic Model 6495 Bipolar Temporary Myocardial Pacing Wire. This submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove performance as would be seen for novel devices or software.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly define numerical acceptance criteria for "device performance" in terms of clinical outcomes or specific thresholds for functionality. Instead, it relies on demonstrating that the device meets "specified requirements" through integrity testing and is substantially equivalent to existing, legally marketed predicate devices.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Visual Verification | Met specified requirements |
| X-ray & Dimensional Verification | Met specified requirements |
| Electrical Verification | Met specified requirements |
| Pull Strength Verification | Met specified requirements |
| Flex Life Verification | Met specified requirements |
| Connector Compatibility | Met specified requirements |
| Break Moment of Thorax Needle | Met specified requirements |
| Substantial Equivalence | Demonstrated to predicate devices (Model 6500, TME 65 C) based on technological characteristics and integrity testing. |
Note: The specific "specified requirements" (e.g., exact pull strength values, dimensional tolerances) are not detailed in this summary document.
2. Sample Size for the Test Set and Data Provenance
The document does not specify the sample size used for the device integrity testing (e.g., how many units were subjected to pull strength or flex life tests). It also does not provide information on the data provenance in terms of country of origin or whether the tests were retrospective or prospective, as these are engineering tests on the device itself, not clinical data.
Summary:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not applicable in the context of device integrity tests; these are laboratory engineering tests.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable to this type of 510(k) submission. The "ground truth" here is the device's adherence to engineering specifications and comparison to predicate device characteristics. Experts typically establish ground truth in clinical studies involving interpretation (e.g., radiologists for imaging, pathologists for tissue samples), which is not the nature of the presented device integrity testing.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert disagreement on ground truth needs to be resolved. This is not relevant for the device integrity testing described, as the tests (e.g., pull strength, electrical verification) have objective pass/fail criteria based on engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or mentioned. This is a medical device (pacing wire), not an AI/software device that assists human readers.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the device integrity testing was based on engineering specifications and established test methodologies to ensure the device met its design requirements and was comparable to predicate devices. For substantial equivalence, the "ground truth" was a comparison of technological characteristics to existing devices (Medtronic Model 6500 and Oscor Model TME 65 C).
8. Sample Size for the Training Set
Not applicable. "Training set" refers to data used to train machine learning models. This document describes a physical medical device undergoing engineering integrity tests, not an AI/ML product.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a physical medical 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.