(414 days)
The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter is a flexible electrode catheter constructed of a polyurethane insulation/shaft and incorporates platinum electrodes. The active tip may be manipulated by a remote means located at the proximal end of the catheter.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:
Disclaimer: The provided text is a 510(k) summary for a reprocessed medical device. These summaries typically focus on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than conducting new clinical trials for effectiveness in the way an AI/ML algorithm might. Therefore, many of the requested points related to AI/ML clinical studies (e.g., MRMC studies, ground truth establishment for training sets) are not directly applicable or explicitly stated in this type of document. I will address the points as best as possible given the information provided.
Device: Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
The document demonstrates that the reprocessed device is substantially equivalent to the predicate device, St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter (K151622). The acceptance criteria are primarily defined by successful completion of various non-clinical performance, safety, and reprocessing validation tests, ensuring the reprocessed device maintains the same technological characteristics and performance as the original predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance (Summary from submission) |
|---|---|---|
| Functional Performance | - Simulated use and artificial soiling | "Functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on... simulated use and artificial soiling." |
| - Tensile testing | "Functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on... tensile testing." | |
| - Torsional strength | "Functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on... torsional strength." | |
| - Leakage current | "Functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on... leakage current." | |
| - Continuity | "Functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on... continuity." | |
| - Isolation resistance | "Functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on... isolation resistance." | |
| - Three-point bend corrosion resistance | "Functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on... three-point bend corrosion resistance." | |
| Cleaning | - Protein, total organic carbon, and endotoxins (residual limits) | "Cleaning: protein, total organic carbon, and endotoxins; visual inspection under magnification; and cleaning performance qualification." (Implies compliance with established limits). |
| - Visual inspection under magnification (absence of visible residues) | "Cleaning: ...visual inspection under magnification..." (Implies absence of visible residues was met). | |
| - Cleaning performance qualification | "Cleaning: ...cleaning performance qualification." (Implies successful qualification). | |
| Biocompatibility | - Cytotoxicity | "Biocompatibility: cytotoxicity..." (Implies satisfactory results). |
| - Sensitization | "Biocompatibility: ...sensitization..." (Implies satisfactory results). | |
| - Irritation | "Biocompatibility: ...irritation..." (Implies satisfactory results). | |
| - Acute systemic toxicity | "Biocompatibility: ...acute systemic toxicity..." (Implies satisfactory results). | |
| - Materials-mediated pyrogen complement activation | "Biocompatibility: ...materials-mediated pyrogen complement activation..." (Implies satisfactory results). | |
| - Hemolysis (direct and indirect) coagulation complement activation thrombosis | "Biocompatibility: ...hemolysis (direct and indirect) coagulation complement activation thrombosis." (Implies satisfactory results). | |
| Packaging & Sterilization | - Packaging and shelf life validation (maintaining sterility and device integrity) | "Packaging and shelf life validation;" (Implies successful validation of packaging integrity and established shelf life). |
| - Sterilization validation (Sterility Assurance Level) | "sterilization validation: bioburden testing; and ethylene oxide and ethylene chlorohydrin residuals testing; bacteriostasis/fungistatis." (Implies successful validation to a specified SAL). | |
| - Bioburden testing | "sterilization validation: bioburden testing..." (Implies compliance with bioburden limits prior to sterilization). | |
| - Ethylene oxide and ethylene chlorohydrin residuals testing (to safe limits) | "sterilization validation: ...ethylene oxide and ethylene chlorohydrin residuals testing..." (Implies residuals are within safe limits). | |
| - Bacteriostasis/Fungistasis testing | "sterilization validation: bacteriostasis/fungistatis." (Implies satisfactory results to ensure sterilization effectiveness). | |
| Product Stability | - Product stability over time | "Product stability" (Implies studies were conducted to ensure device performance and integrity over its shelf life). |
| Reprocessing Limits | - Each catheter is reprocessed no more than two times. | "Each catheter is reprocessed no more than two times." (This is a condition of the reprocessing, rather than a test result, but implicitly the performance tests support that this limit is safe and effective). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes for each non-clinical test. It lists the types of tests performed. For reprocessed devices, the "test set" would typically involve multiple units of the reprocessed devices subjected to each of the listed functional, cleaning, biocompatibility, and sterilization tests.
- Sample Size: Not explicitly stated for each test. It would be an industry standard sample size for each specific test (e.g., a certain number of devices for tensile strength, a certain number for biocompatibility assays).
- Data Provenance: Retrospective (reprocessed existing devices from St. Jude Medical) and prospective (testing performed on these reprocessed devices). The "country of origin of the data" is not specified, but the submission is to the U.S. FDA, implying compliance with U.S. regulatory standards and potentially testing done within the U.S. or by labs recognized by U.S. standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This point is not applicable here. This submission is for a reprocessed electrophysiology catheter, which is a hardware device, not an AI/ML diagnostic or image analysis algorithm. Therefore, there is no "ground truth" in the clinical AI sense (e.g., expert labels on images) to be established by experts for an AI test set. The "ground truth" for this device is based on physical and biological testing against established engineering and safety standards.
4. Adjudication Method for the Test Set:
Not applicable in the context of an AI/ML algorithm's clinical performance. The "adjudication" for this type of device is the assessment of test results against predefined acceptance criteria (e.g., pass/fail for functional tests, within limits for chemical residuals, absence of adverse effects for biocompatibility).
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 a reprocessed medical device, not an AI-assisted diagnostic tool. No MRMC study was performed as it is irrelevant to the substantial equivalence of a physical catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance relies on a combination of:
- Engineering Specifications: Performance parameters (e.g., tensile strength, electrical properties) are measured against established engineering standards and the specifications of the original predicate device.
- Biological/Chemical Standards: Residual limits for cleaning agents, sterility assurance levels, and biocompatibility endpoints are evaluated against recognized biological and chemical safety standards (e.g., ISO standards for biocompatibility).
- Predicate Device Performance: The original, new St. Jude Medical Livewire catheter establishes the benchmark for "ground truth" performance and safety, to which the reprocessed device must demonstrate substantial equivalence.
8. The Sample Size for the Training Set:
Not applicable. This is a medical device, not an AI/ML algorithm. There is no concept of a "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for a physical medical device.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).