(56 days)
Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological 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 handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tips of deflectable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape.
Alliance Medical Corporation's reprocessing of electrophysiology catheters includes removal of adherent visible soil and decontamination. Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations.
Alliance Medical Corporation's Reprocessed Electrophysiology Catheters are designed to be substantially equivalent to predicate devices. The submission focuses on demonstrating that the reprocessing method does not alter the device's original performance, safety, or effectiveness.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Functional Performance | The reprocessed device must retain the "appropriate function of its components" and "perform as originally intended" for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping. This implies that electrical and mechanical properties should be maintained. | "Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations." "Performance testing demonstrates that Reprocessed EP Catheters perform as originally intended." The device's technological characteristics are identical to predicate devices. |
| Biocompatibility | The reprocessed device must be biocompatible, meaning it does not cause adverse biological reactions in the patient. This would involve ensuring that the reprocessing procedure does not introduce new toxic substances or residues beyond acceptable limits. | "Biocompatibility" testing was conducted. |
| Reprocessing Validation | The reprocessing procedure (removal of adherent visible soil and decontamination) must be validated to ensure it effectively cleans and decontaminates the devices without compromising their structural integrity or functionality. | "Validation of reprocessing" was conducted. This includes "removal of adherent visible soil and decontamination." |
| Sterilization Validation | The sterilization method applied after reprocessing must be validated to consistently achieve the required Sterility Assurance Level (SAL) to prevent infection. | "Sterilization Validation" was conducted. |
| Packaging Validation | The packaging must maintain the sterility and integrity of the reprocessed device until the point of use, and protect it from damage during storage and transport. | "Packaging Validation" was conducted. |
| Equivalence to Predicate | The reprocessed device must be substantially equivalent to the original predicate devices in terms of design, materials, intended use, clinical applications, patient population, performance specifications, and method of operation. The mechanism of action must remain identical. | "The design, materials, and intended use of Reprocessed Electrophysiology (EP) Catheters are identical to the predicate devices." "The mechanism of action...is identical...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." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed EP Catheter."
- Sample Size for Test Set: The exact sample size used for performance testing (functional, biocompatibility, reprocessing, sterilization, packaging) is not specified in the provided text.
- Data Provenance: The detailed provenance (e.g., country of origin of data, retrospective or prospective) is not specified. The testing was conducted internally by Alliance Medical Corporation, as implied by statements like "Alliance Medical Corporation's reprocessing... includes... testing..."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of information is not applicable to this submission. The "ground truth" here is based on objective scientific/engineering standards and measurements (e.g., cleanliness levels, sterility, electrical conductivity, mechanical deflection forces, material integrity after reprocessing, standard biocompatibility assays) rather than expert interpretation of images or clinical outcomes that require human assessment for ground truth determination.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1 or 3+1) is not applicable to the type of bench and laboratory testing described in this submission. Adjudication processes are typically used in clinical studies involving human interpretation or subjective clinical endpoints, where disagreements between evaluators need to be resolved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance, typically in image-based diagnostics. The Reprocessed Electrophysiology Catheter is a medical device, and its evaluation focuses on its physical and functional integrity after reprocessing, not on diagnostic interpretive tasks.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This submission does not involve an AI algorithm with standalone performance. The device is a reprocessed physical medical instrument.
7. Type of Ground Truth Used
The ground truth used for this device evaluation is based on objective scientific and engineering metrics and standards. This includes:
- Physical/Functional Measurements: To confirm "appropriate function of its components" and "perform as originally intended," likely involving electrical conductivity tests, mechanical integrity tests (e.g., for shaft flexibility, deflection in deflectable catheters, electrode integrity), and dimensional analysis.
- Chemical Analysis/Microbiology: For "Biocompatibility," "Validation of reprocessing" (e.g., residual protein, bioburden, endotoxin levels), and "Sterilization Validation" (e.g., sterility testing, often using Biological Indicators).
- Packaging Integrity: For "Packaging Validation."
- Reference Standards: Comparison against the performance specifications of the original, new predicate devices.
8. Sample Size for the Training Set
Not applicable. This submission does not involve an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As no AI algorithm requiring a training set is involved, this question does not apply.
§ 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).