(109 days)
The Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology Catheter is a steerable electrophysiology catheter used for recording intracardiac stimulation during diagnostic electrophysiological studies. The catheters are to be used to map the atrial regions of the heart.
The Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology (EP) Catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle at the proximal end of the catheter.
The provided text is a 510(k) summary for a reprocessed medical device, specifically, the Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology Catheters. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a novel device or an AI/ML powered device.
Therefore, the information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML powered device is not available in this document. The document describes a traditional medical device (a catheter) and its reprocessing.
However, I can extract the safety and functional testing performed for this reprocessed device, which serves as its "demonstration of performance" to support its substantial equivalence claim.
Device Type: Reprocessed Steerable Diagnostic Electrophysiology Catheters (not an AI/ML powered device).
Summary of Device Performance and Testing (as described in the document):
The document lists "Functional and Safety Testing" conducted to demonstrate the performance, safety, and effectiveness of the reprocessed catheters. This is the closest equivalent to "proving the device meets acceptance criteria" for this type of device.
| Acceptance Criteria Category | Reported Test Performed / Device Performance |
|---|---|
| Biocompatibility | Biocompatibility testing was performed. |
| Cleaning Validation | Cleaning validation was performed. |
| Sterilization Validation | Sterilization validation was performed. |
| Visual Inspection | Visual inspection was performed. |
| Dimensional Verification | Dimensional verification was performed. |
| Electrical Continuity and Resistance | Electrical continuity and resistance testing was performed. |
| Simulated Use | Simulated use testing was performed. |
| Mechanical Characteristics | Mechanical characteristics testing was performed. |
| Dielectric and Current Leakage | Dielectric and current leakage testing was performed. |
| Packaging Validation | Packaging validation was performed. |
Additional Details from the Document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified. The document only states that "Bench and laboratory testing was conducted."
- 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 for this type of device and testing. The testing is laboratory-based physical and electrical property assessment rather than expert evaluation of diagnostic output.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/ML powered device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML powered device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the tests performed (e.g., electrical continuity, mechanical characteristics), the "ground truth" would be established engineering specifications, performance standards, and established laboratory test methodologies for the predicate device.
- The sample size for the training set: Not applicable. This is not an AI/ML powered device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML powered 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).