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510(k) Data Aggregation
(221 days)
The Medline ReNewal Reprocessed St. Jude Medical Livewire Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Medline ReNewal Reprocessed St. Jude Livewire Electrophysiology Catheters are commonly placed at the high right atrium, right ventricular apex and His bundle, and in the coronary sinus, and are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies.
The Medline ReNewal Reprocessed St. Jude Medical Livewire Electrophysiology Catheter (K151617) underwent performance testing to demonstrate substantial equivalence to its predicate device, the St. Jude Medical Livewire Electrophysiology Catheter (K022380).
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a list of functional performance studies, cleaning validation, biocompatibility testing, packaging/sterilization validation, and product stability tests performed. However, it does not explicitly define specific numerical acceptance criteria for each test nor provides detailed quantitative results (e.g., "bond strength was X N, meeting the criteria of >Y N"). Instead, it states that the functional characteristics were "evaluated and found to be substantially equivalent to the predicate device."
Here’s a summary of the tests performed, which implicitly form the basis for acceptance:
| Acceptance Criteria (Implicitly: Performance comparable to predicate) | Reported Device Performance (Implicitly: Met comparable performance) |
|---|---|
| Functional Performance Studies: | |
| Bond strength (tensile testing) | Tested and found comparable |
| Torsional strength | Tested and found comparable |
| Leakage current | Tested and found comparable |
| Steerable deflection and continuity | Tested and found comparable |
| Catheter/handle joint flexibility and continuity (flex fatigue) | Tested and found comparable |
| Electrode adherence | Tested and found comparable |
| Applied force deflection (tip flexibility) | Tested and found comparable |
| Shaft flexibility | Tested and found comparable |
| Tip buckling | Tested and found comparable |
| Direct current resistance | Tested and found comparable |
| Impedance at 5 kHz | Tested and found comparable |
| Corrosion resistance | Tested and found comparable |
| Cleaning: | |
| Protein, total organic carbon, and endotoxins | Tested and cleaning performance qualified |
| Visual inspection under magnification | Tested and cleaning performance qualified |
| Cleaning performance qualification | Performed and qualified |
| Biocompatibility: | |
| Cytotoxicity | Tested and found acceptable |
| Sensitization | Tested and found acceptable |
| Irritation | Tested and found acceptable |
| Acute systemic toxicity | Tested and found acceptable |
| Pyrogenicity | Tested and found acceptable |
| Hemocompatibility (hemolysis, thrombogenicity, complement activation) | Tested and found acceptable |
| Packaging and sterilization validation: | |
| Bioburden testing | Tested |
| Ethylene oxide and ethylene chlorohydrin residuals testing | Tested |
| Product stability | Tested and found acceptable |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each of the performance tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth:
This information is not applicable and not provided in the context of this 510(k) summary, as it describes a reprocessed medical device's physical and functional performance, not an AI/algorithmic medical device requiring expert ground truth for classification or diagnosis.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided for the reasons stated in point 3. The testing involves laboratory and benchtop evaluations of device properties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not performed, as it is not relevant for the type of device (reprocessed catheter) described. This type of study is typically used for diagnostic imaging or AI devices that interact with human readers/clinicians.
6. Standalone (Algorithm Only) Performance:
Standalone performance (algorithm only) was not performed, as it is not relevant for this reprocessed physical medical device. This concept applies to AI/software as a medical device.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance evaluation is based on established engineering and biological standards relevant to medical devices, as well as comparison to the performance characteristics of the original, new device (predicate device). For instance, for bond strength, the "ground truth" would be the required mechanical integrity, and for cleaning, it would be the absence of specified contaminants below acceptable thresholds.
8. Sample Size for the Training Set:
This information is not applicable and not provided. The listed tests are for verifying the performance of the reprocessed device itself, not for training an algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided for the reasons stated in point 8.
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