(196 days)
The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and pacing for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias. The catheter is designed for use in the coronary sinus.
The EP diagnostic catheters are steerable, multi-electrode catheters with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The catheters have a high-torque shaft with a braided uni-directional deflectable tip section containing an array of ten platinum electrodes that includes a 2 mm tip dome, which can be used for stimulation and recording. The catheters are 6 French with a usable length of 115 cm. The braided tip is controlled by a proximal hand piece that features a thumb operated sliding piston, and is offered in various curve types. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.
The provided text describes a 510(k) premarket notification for Reprocessed Electrophysiology Diagnostic Catheters. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a novel device meets specific performance criteria in a typical clinical study involving AI or diagnostic accuracy.
Therefore, many of the requested points related to AI, clinical studies, ground truth, expert consensus, and sample sizes for training/test sets are not applicable to this type of regulatory submission. The "acceptance criteria" here are primarily about demonstrating that the reprocessed device performs as intended and is as safe and effective as the original, rather than meeting specific diagnostic accuracy thresholds.
Here's a breakdown of the information that can be extracted or inferred from the provided text, and where it doesn't apply:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from testing performed) | Reported Device Performance (Summary from text) |
|---|---|
| Cleaning Validation: Removal of bioburden and residues. | Process validation testing was performed to validate the cleaning procedures. Specific non-clinical tests included "cleaning validation." (Implies successful validation as part of SE determination). |
| Sterilization Validation: Sterility Assurance Level (SAL). | "Sterilization validation (ISO 11135, USP )." (Implies successful validation to meet industry standards). |
| Biocompatibility: No adverse biological reactions. | "Biocompatibility testing (ISO 10993-1)." (Implies successful testing to demonstrate that the reprocessed device is biocompatible). |
| Ethylene Oxide Residuals: Levels below safety thresholds. | "Ethylene oxide residual testing (ISO 10993-7)." (Implies successful testing to ensure residuals are within acceptable limits). |
| Packaging Validation: Maintain sterility and integrity. | "Packaging validation (ASTM D 4169, ASTM F 88, ASTM F 2096)." (Implies successful validation to protect the device until use). |
| Shelf Life Validation: Maintain performance over time. | "Shelf life validation (ASTM F 1980)." (Implies successful validation of the reprocessed device's shelf life). |
| Functional Performance (Bench Testing): Equivalent to original device under simulated use. | "Validation of functional performance (bench testing) was performed through simulated use, visual inspection, fatigue testing, and function testing. Performance testing shows the reprocessed EP diagnostic catheters to perform as originally intended." (Concludes successful performance, implying equivalence to the predicate). Additionally, "The manufacturing process includes visual and validated functional testing of 100% of products reprocessed." |
| Reprocessing Cycle Limit: Device integrity maintained for stated number of reprocesses. | "The reprocessed EP diagnostic catheters are reprocessed no more than four (4) times. Each device is marked and tracked through each reprocessing cycle. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing." (Implies demonstration that the device remains safe and effective for up to 4 reprocessing cycles). |
| Substantial Equivalence: All characteristics (design, materials, intended use, performance, safety) are substantially the same as the predicate or differences do not raise new questions of safety/effectiveness. | "Sterilmed concludes that the reprocessed EP diagnostic catheters are safe, effective, and substantially equivalent to the predicate devices... as described in this premarket notification submission." (The entire submission is dedicated to proving this.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "Representative samples of reprocessed EP diagnostic catheters were tested." It does not specify the exact sample size for the various non-clinical and functional tests.
- "Data provenance" is not directly applicable in the sense of patient data. The tests are laboratory-based and simulated use, conducted by the manufacturer (Sterilmed, Inc., from Plymouth, Minnesota, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is not applicable. This submission is for a reprocessed medical device, not a diagnostic AI device requiring expert ground truth for image or data interpretation. The "ground truth" for the reprocessed device is its ability to meet performance specifications, safety standards, and functional equivalence to the original device, which is evaluated through engineering and laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations in diagnostic studies, which is not the nature of this device's evaluation.
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
- This is not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is established through objective engineering performance specifications, industry standards (ISO, ASTM, USP), and validated testing protocols. The desired outcome (e.g., sterility, biocompatibility, functional performance like the original device) is the "truth" that the tests aim to confirm.
8. The sample size for the training set
- This is not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
- This is not applicable for the same reason as above.
§ 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).