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510(k) Data Aggregation
(72 days)
The SureLink extension cable is indicated for use during electrophysiology studies in conjunction with the appropriate electrode catheter. This cable may be reused subject to the cleaning and sterilization restrictions herein.
The TempLink extension cable when used in conjunction with a thermistor configured Stinger/Stinger S catheter is indicated for use during cardiac ablation with set power to 50W.
The TempLink M extension cable when used in conjunction with a thermocouple configured Stinger M/Stinger SM catheter is indicated for use during cardiac ablation with set power to 50W.
These cables may be reused subject to the cleaning and sterilization restrictions herein.
The SureLink, TempLink, and TempLink M Extension Cables are accessories that are used in conjunction with the appropriate diagnostic or ablation catheter. Cables, when initially introduced, provided an alternate means of electrically connecting EP catheters to recorders versus the catheter connecting directly to the recorder. The use of cables allows the catheter to remain in the sterile field, the recorder junction box doesn't have to enter the sterile field, and the cable provides more working length. The cables are offered in several lengths ranging from 7 to 10 feet in length.
The provided document is a 510(k) premarket notification for the reuse claim of Bard Electrophysiology's SureLink, TempLink, and TempLink M Extension Cables. It seeks to demonstrate substantial equivalence to previously marketed versions of the same devices, with the primary difference being the addition of a reuse claim.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a direct table of specific quantitative acceptance criteria or detailed performance metrics. Instead, it refers to performance data demonstrating that the cables continue to perform as intended after cleaning and sterilization. The "acceptance criteria" are implicitly met by demonstrating that the reused devices are "Substantially Equivalent" to the predicate devices and that the "new characteristics" (the reuse claim) do not affect safety or effectiveness.
| Performance Aspect (Implied Acceptance Criteria) | Reported Device Performance |
|---|---|
| Safety: | The addition of a reuse claim does not affect patient safety. The cables are accessory devices, not placed intravascularly, and have no patient body contact. |
| Effectiveness: | The cables continue to perform as intended after the specified number of cleanings and resterilizations. Failure of the cable would result in physician inconvenience and have no negative impact on the patient. The reuse claim is supported by performance data in the Appendices. |
| Functional Equivalence: | The SureLink, TempLink, and TempLink M cables with the reuse claim are "Substantially Equivalent" to their respective predicate devices. The internal tail component was changed from tinsel wrapped kevlar to standard copper wire, and this was found to be equivalent. |
| Compliance with Sterilization/Cleaning: | Data is provided to support the reuse claim for Ethylene Oxide (EO), steam autoclave, and Sterrad sterilization, subject to cleaning and sterilization restrictions in the Instructions for Use (IFU). |
2. Sample Size Used for the Test Set and the Data Provenance:
The document explicitly states: "Performance data is provided in the Appendices with respect to the reuse claim." However, the specific sample sizes for this performance data (test set) are not provided within the body of this summary.
Data Provenance: Not explicitly stated within this summary. It's highly probable to be internal company testing, but no details like country of origin or whether it was retrospective/prospective are given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. This submission is for a medical device (extension cables) and focuses on engineering and performance testing for repeated sterilization cycles rather than diagnostic accuracy or clinical interpretation. Therefore, a "ground truth" derived from expert consensus, as would be common in diagnostic imaging studies, is not relevant to this type of device submission.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this study is not evaluating a diagnostic algorithm where adjudication of expert opinions would be necessary. The evaluation centers on testing the physical and electrical integrity of the cables after repeated sterilization, likely through objective performance tests.
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 document describes a 510(k) submission for extension cables and does not involve AI or human reader assessment. Therefore, an MRMC study or an effect size for human readers with AI assistance is not relevant or included.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No. This document pertains to physical medical devices (cables) and does not involve any algorithms or software performing an independent assessment.
7. The Type of Ground Truth Used:
The "ground truth" for this type of device is the expected performance specifications and functional integrity of the cables. The performance data in the Appendices would have compared the cable's electrical and physical properties (e.g., conductivity, insulation, physical damage) after multiple sterilization cycles against pre-defined engineering specifications for a functional cable. This is a form of objective performance data rather than expert consensus, pathology, or outcomes data in the typical sense.
8. The Sample Size for the Training Set:
Not applicable. This submission is for hardware (cables) and not a machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set, there is no ground truth established for one.
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