(51 days)
Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the LASSO® 2515 Variable Circular Mapping Catheter and the Reflexion Spiral 140 Variable Radius Catheter are designed for electrophysiological mapping of the atria of the heart.
Diagnostic Electrophysiology (EP) Catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.
The provided text describes the 510(k) summary for Ascent Healthcare Solutions' Reprocessed Electrophysiology Catheters (K090323). This submission focuses on demonstrating substantial equivalence to predicate devices through various performance tests, but it does not include a study design or acceptance criteria related to a diagnostic algorithm or AI performance.
Therefore, I cannot provide information on acceptance criteria for a diagnostic device's performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not discussed in the provided regulatory document.
However, I can extract the information regarding the performance data presented in the 510(k) summary, which focuses on the safety and effectiveness of the reprocessing procedure and the reprocessed physical device, rather than the diagnostic accuracy of an algorithm.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance (as pertaining to reprocessed physical device, not AI/diagnostic algorithm performance):
| Acceptance Criteria (Bench/Laboratory Test Area) | Reported Device Performance (Conclusion) |
|---|---|
| Biocompatibility | Demonstrated performance, ensuring safety and effectiveness. |
| Validation of Reprocessing | Demonstrated performance, ensuring safety and effectiveness. |
| Sterilization Validation | Demonstrated performance, ensuring safety and effectiveness. |
| Function Test(s) | Each individual Electrophysiology Catheter is tested for appropriate function of its components prior to packaging and labeling operations. Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended. |
| Packaging Validation | Demonstrated performance, ensuring safety and effectiveness. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The document mentions "Bench and laboratory testing," implying physical testing of reprocessed devices, but does not quantify the number of units tested.
- Data Provenance: Not specified. The testing was conducted by Ascent Healthcare Solutions. There is no mention of country of origin or whether it was retrospective or prospective, as these terms are typically used for clinical data rather than bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This submission concerns the reprocessing of a physical medical device, not a diagnostic algorithm that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for this submission would be defined by engineering specifications and industry standards for medical device performance and reprocessing.
4. Adjudication method for the test set:
- Not Applicable. As explained above, this is not a study assessing diagnostic accuracy requiring expert adjudication.
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:
- No. This type of study is completely unrelated to the content of this 510(k) submission. No AI component is mentioned or evaluated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. There is no algorithm or AI component in this device.
7. The type of ground truth used:
- The "ground truth" for the performance tests (biocompatibility, reprocessing validation, sterilization validation, function tests, packaging validation) would be based on established engineering specifications, industry standards, and regulatory requirements for medical devices and their reprocessing. For example, sterilization validation would have standards for sterility assurance levels, and function tests would have specified electrical and mechanical performance criteria that the reprocessed catheters must meet to perform "as originally intended," mirroring the predicate device.
8. The sample size for the training set:
- Not Applicable. There is no training set mentioned or implied as this is not an AI or diagnostic algorithm submission.
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set.
§ 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).