(260 days)
The Reprocessed Inquiry Optima and Inquiry Optima Plus Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic studies. The reprocessed Inquiry Optima catheters are to be used to map the atrial regions of the heart.
The Reprocessed Inquiry Optima and Inquiry Optima Plus Steerable Diagnostic Electrophysiology (EP) Catheter incorporates both a distal end with a variable loop diameter, which allows selection of diameters within a specific range, and a deflectable shaft steering mechanism. The diameter of the distal loop may be contracted or expanded by turning the rotating knob. The distal shaft may be deflected by pushing and pulling the thumb control.
The provided text describes a 510(k) premarket notification for reprocessed electrophysiology catheters. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device meets specific acceptance criteria through a traditional clinical study with performance metrics like sensitivity, specificity, or accuracy for a diagnostic algorithm.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and training set details) are not applicable in the context of this regulatory filing for a reprocessed medical device.
The "acceptance criteria" here refer to the tests and validations performed to ensure the reprocessed device maintains the same safety and effectiveness as the original predicate device. The "study" proving this involves a series of bench and laboratory tests.
Here's the information that can be extracted and a clear indication of what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document lists the types of tests performed rather than specific quantitative acceptance criteria or performance metrics in a table. The "reported device performance" is implicitly that the reprocessed device meets the standards of the predicate device.
| Acceptance Criteria Category | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Biocompatibility | Demonstrated equivalent biocompatibility. |
| Cleaning Validation | Demonstrated effective cleaning. |
| Sterilization Validation | Demonstrated effective sterilization. |
| Functional Testing (Visual) | Passed visual inspection. |
| Functional Testing (Dimensional) | Passed dimensional verification. |
| Functional Testing (Electrical) | Passed electrical continuity and resistance tests. |
| Functional Testing (Simulated Use) | Performed equivalently during simulated use. |
| Functional Testing (Mechanical) | Maintained mechanical characteristics. |
| Electrical Safety Testing | Passed dielectric and current leakage tests. |
| Packaging Validation | Passed packaging validation. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable for a reprocessing submission in this format. The device is reprocessed; the tests are laboratory/bench-based, not clinical studies with patient data.
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)
- Not applicable. This pertains to diagnostic accuracy studies, which are not described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This pertains to diagnostic accuracy studies, which are not described here.
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 medical device reprocessing submission, not an AI or diagnostic imaging study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. Ground truth generation is relevant for diagnostic performance assessments. For this device, the "ground truth" for comparison is the performance and safety profile of the original, new predicate device.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
§ 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).