(161 days)
The Reprocessed Supreme Diagnostic Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The Reprocessed Supreme Diagnostic Electrophysiology Catheters are manufactured in various fixed curves and electrode spacing for electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
This document is a 510(k) Summary for Reprocessed Supreme Diagnostic Electrophysiology Catheters, outlining their substantial equivalence to predicate devices. It describes the device, its indications for use, and a summary of testing conducted to demonstrate safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Functional and Safety Testing" section. The document states that testing was conducted "to demonstrate performance (safety and effectiveness)". However, specific quantitative acceptance criteria or detailed reported device performance values are not provided in this summary document. The summary only lists the types of tests performed and generally states that the device is "as safe and effective as the predicate devices".
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compatible with biological systems for intended use | Demonstrated as safe and effective (specific results not provided) |
| Cleaning Validation | Meets cleanliness standards for reprocessed devices | Demonstrated as safe and effective (specific results not provided) |
| Sterilization Validation | Meets sterilization standards for reprocessed devices | Demonstrated as safe and effective (specific results not provided) |
| Visual Inspection | Meets visual quality and integrity standards | Demonstrated as safe and effective (specific results not provided) |
| Dimensional Verification | Meets specified dimensional requirements | Demonstrated as safe and effective (specific results not provided) |
| Electrical Continuity & Resistance | Meets electrical specifications | Demonstrated as safe and effective (specific results not provided) |
| Simulated Use | Performs as intended during simulated clinical use | Demonstrated as safe and effective (specific results not provided) |
| Mechanical Characteristics | Meets mechanical strength and functional requirements | Demonstrated as safe and effective (specific results not provided) |
| Electrical Safety Testing (Dielectric & Current Leakage) | Meets electrical safety standards | Demonstrated as safe and effective (specific results not provided) |
| Packaging Validation | Maintains device integrity and sterility until use | Demonstrated as safe and effective (specific results not provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the functional and safety testing. It also does not explicitly state the provenance of the data (e.g., country of origin) or whether it was retrospective or prospective. It implies that "bench and laboratory testing" were conducted by Innovative Health, LLC.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not provided in the document. The testing described focuses on physical and electrical device performance rather than interpretation of data by human experts for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable to the type of device and testing described. The tests are objective measurements of the device's physical and electrical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs without AI Assistance
This information is not applicable. The device is a reprocessed electrophysiology catheter, which is a physical medical device, not an AI or imaging diagnostic tool that would involve human readers or comparative effectiveness studies with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done
This information is not applicable as the device is a physical medical device and not an algorithm or software.
7. The Type of Ground Truth Used
For the functional and safety testing, the "ground truth" would be the engineering and performance specifications for the original, new device, and relevant regulatory standards (e.g., for biocompatibility, sterility, electrical safety). The reprocessed devices are tested to ensure they meet these established specifications.
8. The Sample Size for the Training Set
This information is not applicable as this is a reprocessing of a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
§ 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).