(75 days)
Reprocessed Diagnostic Electrophysiology Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
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.
This document describes the 510(k) submission for Reprocessed Electrophysiology Catheters by Alliance Medical Corporation. The focus is on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for novel performance features. Therefore, many of the requested data points related to clinical study design and ground truth are not applicable or not provided in the typical sense for an AI/CAD device.
Given the information provided, here's a breakdown of the acceptance criteria and the "study" that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are primarily related to proving that the reprocessed device performs identically and as originally intended compared to new, predicate devices. The performance data focuses on demonstrating that the reprocessing does not negatively impact the catheter's function and safety.
| Acceptance Criteria Category | Specific Criteria / Goal | Reported Device Performance | Comments |
|---|---|---|---|
| Material & Design Equivalence | The design, materials, and intended use of Reprocessed Electrophysiology Catheters are identical to the predicate devices. | Stated that "The design, materials, and intended use of Reprocessed Electrophysiology Catheters are identical to the predicate devices." and "The mechanism of action...is identical to the predicate devices in that the same standard mechanical design, materials and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." | This is a foundational criterion for reprocessing; the reprocessed device must function exactly like the original. |
| Biocompatibility | Reprocessing does not negatively impact the biocompatibility of the device, ensuring it is safe for patient contact. | "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Electrophysiology (EP) Catheters." Biocompatibility is explicitly listed. | Specific metrics or thresholds for biocompatibility are not provided in this summary. |
| Reprocessing Validation | The reprocessing methods (cleaning, decontamination, sterilization) are effective and validated to render the device safe and functional. | "Validation of reprocessing" and "Sterilization Validation" are explicitly listed as conducted. | Details of the validation process (e.g., sterilization assurance level, cleanliness levels) are not provided. |
| Functionality | The reprocessed catheter performs all its intended functions (sensing, recording, stimulation, mapping) as effectively as a new device. | "Function test(s)" is explicitly listed as conducted. | Specific functional parameters (e.g., signal integrity, impedance, deflection capabilities) or their acceptance thresholds are not detailed in this summary. |
| Packaging Validation | The packaging maintains sterility and protects the device until use. | "Packaging Validation" is explicitly listed as conducted. | No further details provided. |
Overall Conclusion regarding "Acceptance Criteria"
The overall acceptance criterion is: "Reprocessed Electrophysiology (EP) Catheters perform as originally intended" and are "safe, effective and substantially equivalent to the predicate devices." The "study" (bench and laboratory testing) aimed to demonstrate this equivalence across the listed categories.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document does not specify the sample size for the bench and laboratory testing. It merely states that such testing was conducted.
- Data Provenance: Not applicable in the context of patient data provenance, as this is bench/laboratory testing on devices, not a clinical study involving patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This is not applicable to this type of submission. "Ground truth" in the context of device reprocessing is typically established through established engineering standards, material science, microbiology (for sterility validation), and performance specifications for the original device. There isn't a need for "expert consensus" on diagnostic findings or clinical outcomes in the same way as an AI/CAD device.
4. Adjudication Method for the Test Set
- Not applicable as this is bench and laboratory testing against predetermined specifications and scientific principles, not a clinical trial requiring adjudicators for patient outcomes or diagnostic interpretations.
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, an MRMC comparative effectiveness study was not done. This is a 510(k) for a reprocessed medical device (a catheter), not an AI/CAD system. Therefore, the concept of "human readers improving with AI" is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a reprocessed physical medical instrument, not an algorithm or software. Its performance is inherent to its physical properties and functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this submission is based on the original performance specifications and safety profiles of the new, predicate electrophysiology catheters, coupled with established engineering, material science, and sterilization validation standards. For example:
- Biocompatibility: Demonstrated against ISO standards for medical devices.
- Sterilization: Validated to achieve a specific Sterility Assurance Level (SAL), often 10^-6, through established microbiological methods.
- Functionality: Measured against the mechanical and electrical specifications of the original device (e.g., impedance range, signal-to-noise ratio, deflection force, physical integrity).
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI/ML model, there is no corresponding ground truth to establish for it.
§ 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).