(378 days)
The Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Medline ReNewal Reprocessed St. Jude Supreme and Response 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 electrophysiology catheters are manufactured in various fixed curves and electrode spacings for electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than proving independent efficacy or safety through clinical trials typically associated with AI/software devices. Therefore, the "study" described herein is a series of performance tests to show the reprocessed device functions similarly to the original predicate device. It does not involve human readers, AI assistance, or complex ground truth establishment in the way AI/ML devices do.
Acceptance Criteria and Device Performance Study for Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters (K161272)
This document describes the regulatory submission for reprocessed electrophysiology catheters, not an AI or software device. The "acceptance criteria" and "study" are therefore focused on the physical and functional performance of the reprocessed medical devices, demonstrating that they are substantially equivalent to their original, legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests conducted to demonstrate substantial equivalence. It implies that the test results met the internal acceptance criteria for each test, thereby proving the reprocessed device performs as intended and is equivalent to the predicate. Specific numerical acceptance criteria values are not explicitly stated in this summary document, but the statement "found to be substantially equivalent to the predicate device based on the following tests" implies successful completion against pre-defined criteria.
| Test Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Functional Performance | Simulated use and artificial soiling | Met acceptance criteria (implied by "found to be substantially equivalent") |
| Bond strength (tensile testing) | Met acceptance criteria (implied) | |
| Torsional strength | Met acceptance criteria (implied) | |
| Leakage current | Met acceptance criteria (implied) | |
| Catheter/handle joint flexibility and continuity (flex fatigue) | Met acceptance criteria (implied) | |
| Electrode adherence | Met acceptance criteria (implied) | |
| Shaft flexibility | Met acceptance criteria (implied) | |
| Tip buckling | Met acceptance criteria (implied) | |
| Direct current resistance | Met acceptance criteria (implied) | |
| Impedance at 5 kHz | Met acceptance criteria (implied) | |
| Corrosion resistance | Met acceptance criteria (implied) | |
| Cleaning | Protein, total organic carbon, and endotoxins | Met acceptance criteria (implied) |
| Visual inspection under magnification | Met acceptance criteria (implied) | |
| Cleaning performance qualification | Met acceptance criteria (implied) | |
| Biocompatibility | Cytotoxicity | Met acceptance criteria (implied) |
| Sensitization | Met acceptance criteria (implied) | |
| Irritation | Met acceptance criteria (implied) | |
| Acute systemic toxicity | Met acceptance criteria (implied) | |
| Pyrogenicity | Met acceptance criteria (implied) | |
| Hemocompatibility (hemolysis, thrombogenicity, & complement activation) | Met acceptance criteria (implied) | |
| Other | Packaging and shelf life validation | Met acceptance criteria (implied) |
| Sterilization validation (bioburden testing; ethylene oxide and ethylene chlorohydrin residuals) | Met acceptance criteria (implied) | |
| Product stability | Met acceptance criteria (implied) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of reprocessed catheters used for each test. Medical device testing typically involves statistically significant sample sizes to ensure reliability, but these specific numbers are not disclosed in this summary.
- Data Provenance: The testing was performed internally by the manufacturer, Medline ReNewal, based in Redmond, Oregon, USA. The data is prospective in the sense that the tests were conducted specifically for this 510(k) submission on reprocessed devices. The "origin" of the devices themselves would be from healthcare facilities where they were initially used, then collected by Mecline ReNewal for reprocessing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given this is a physical medical device (catheter) rather than a diagnostic AI/ML device, the concept of "ground truth" and "experts" in the context of interpreting medical images is not directly applicable. The "ground truth" here is established through objective engineering and laboratory measurements against predefined specifications and comparisons to the performance of the predicate device. The experts involved would be engineers, scientists, and quality assurance personnel with expertise in medical device testing, materials science, biocompatibility, and sterilization, rather than clinical experts like radiologists. The number and specific qualifications of these personnel are not detailed in this public summary.
4. Adjudication Method for the Test Set
Not applicable in the context of physical medical device performance testing. Results are generated through objective measurement and comparison to specifications, not through human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML or diagnostic imaging device. Its function is to perform electrophysiology procedures, and the study focuses on its physical and functional equivalence to a predicate catheter.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an algorithm. The "performance" is of the physical device itself.
7. Type of Ground Truth Used
The "ground truth" is based on objective, quantitative measurements of the catheter's physical and functional properties (e.g., tensile strength, leakage current, resistance, biocompatibility characteristics, cleanliness) compared against:
- Engineering specifications.
- Performance characteristics of the original, new predicate device.
- Relevant industry standards (e.g., for sterilization, biocompatibility).
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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).