(197 days)
The Medline ReNewal Reprocessed Biosense Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.
The reprocessed catheters are diagnostic bi-directional 7F deflectable mapping electrophysiology EP catheters. The devices have the ability to map electrical activity within the Coronary Sinus (CS) through electrodes along the catheters' pre-shaped tip. The catheters have a braided bi-directional tip section that provides the user with two 180° opposed single plane curves (available curves are DF and FJ). The tip is deflected with a Rocker Lever, and the high torque shaft permits the tip's plane to rotate to ease accurate positioning of the catheter tip at the desired site. The Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID are equipped with an Electronically Erasable Programmable Read Only Memory (EEPROM) that is used to store unique catheter identification information.
The provided document is a 510(k) premarket notification from the FDA for a reprocessed medical device: "Medline ReNewal Reprocessed Biosense Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID".
This document is not about an AI/ML medical device. It's about a reprocessed catheter and demonstrates substantial equivalence to existing predicate devices based on non-clinical performance data. Therefore, the specific questions related to AI/ML device acceptance criteria, study methodologies (like MRMC, standalone performance, training sets, expert consensus for ground truth), and effect sizes of AI assistance are not applicable to this document.
The document discusses "non-clinical testing" and "functional performance studies" for the reprocessed catheters to demonstrate their equivalence to new, original equipment manufacturer (OEM) catheters.
Here's an attempt to extract the relevant information from the provided text, while noting the limitations regarding the AI/ML specific questions:
Acceptance Criteria and Device Performance (based on non-clinical testing for a reprocessed device):
The document does not provide a table of precise quantitative acceptance criteria with corresponding performance metrics for the reprocessed catheter in the way one would expect for an AI/ML device's diagnostic performance. Instead, it states that the functional characteristics of the subject device (reprocessed catheter) have been evaluated and found to be substantially equivalent to the predicate device. This substantial equivalence is based on various non-clinical tests.
The types of non-clinical tests performed and implicitly, the areas where acceptance criteria would have been applied (though not explicitly listed with values), include:
| Test Category | Specific Tests Mentioned | Reported Performance (Qualitative, as quantitative data is not provided) |
|---|---|---|
| Functional Performance | Simulated use and artificial soiling | Found to be substantially equivalent to the predicate device. |
| Mechanical | Continuity, isolation, resistance; corrosion resistance | Found to be substantially equivalent to the predicate device. |
| Cleaning | Protein, total organic carbon, visual inspection under magnification; cleaning qualification | Found to be substantially equivalent to the predicate device. |
| Biocompatibility | Cytotoxicity; irritation; acute systemic toxicity; materials-mediated pyrogen; complement activation; hemolysis; coagulation | Found to be substantially equivalent to the predicate device. |
| Sterilization | Bioburden; ethylene oxide/ethylene chlorohydrin residuals; bacteriostasis/fungistasis; endotoxin | Found to be substantially equivalent to the predicate device. |
| Other | Packaging and shelf life validation; Product stability | Found to be substantially equivalent to the predicate device. |
The evidence for "proof" that the device meets "acceptance criteria" is the FDA's determination of substantial equivalence (SE) to legally marketed predicate devices. This SE determination is based on the provided non-clinical testing data which, by inference, met the internal acceptance criteria set by Medline ReNewal and deemed sufficient by the FDA for establishing SE.
Regarding the AI/ML specific questions:
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A table of acceptance criteria and the reported device performance: As explained above, for this reprocessed medical device, specific quantitative metrics are not provided in the summary. The acceptance is based on demonstrating substantial equivalence through various functional, mechanical, cleaning, biocompatibility, and sterilization tests.
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Sample sizes used for the test set and the data provenance: The document mentions "non-clinical testing data" and "functional performance studies" but does not specify the sample sizes (e.g., number of catheters tested) or the provenance (country of origin, retrospective/prospective) of this data. It is inherently laboratory/bench testing data, not clinical data from patients.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. For a reprocessed physical device, "ground truth" would be established through laboratory methods and validated testing protocols against known engineering and biological standards, not through human expert consensus in the medical imaging sense.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no expert adjudication of diagnostic outputs occurred.
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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 physical catheter, not an AI/ML diagnostic algorithm.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an AI algorithm. Its "standalone" performance would refer to its physical properties and functionality outside of human use, as evaluated through the non-clinical tests.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic "ground truth" for AI. For this device, "ground truth" refers to the established performance and safety specifications of the original predicate device, against which the reprocessed device's performance is compared through physical and chemical testing.
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The sample size for the training set: Not applicable. This is a reprocessed physical medical device, not an AI/ML algorithm that undergoes "training."
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How the ground truth for the training set was established: Not applicable. No training set or ground truth in the AI/ML context exists for this 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).