(182 days)
The reprocessed electrophysiology diagnostic catheters are indicated for temporary use during electrophysiology studies for intracardiac sensing, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.
SterilMed Reprocessed Reflexion EP diagnostic catheters consist of a shaft with a handle at the proximal end, and are considered to be steerable. These catheters have an outer diameter of either 6 or 7F and are either 99 or 105cm in length, with 2 - 20 platinum, radiopaque tip electrodes and a variety of inter-electrode spacing's and curve styles at the distal tip. The distal tip is steerable and cables connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiological recorder.
Note: Only the catheter is the subject of this submission, the external stimulator and/or electrophysiological recorder and any other related equipment are not included in the scope of this submission.
The provided text is related to a 510(k) submission for reprocessed electrophysiology diagnostic catheters, demonstrating substantial equivalence to a predicate device. It focuses on the safety and functional testing of the reprocessed device, rather than the performance of a software algorithm or AI.
Therefore, the requested information regarding acceptance criteria and a study proving a device meets acceptance criteria in the context of AI/software performance (e.g., sample size for test set, ground truth experts, MRMC studies, standalone algorithm performance, training set details) is not applicable to this document.
The document describes the functional and safety testing performed on the reprocessed catheters to demonstrate appropriate functional characteristics and validate cleaning and sterilization procedures. However, it does not provide specific acceptance criteria or detailed results in a structured table or outline a study comparing algorithmic performance to established metrics for AI/software devices.
Here's the relevant information that can be extracted, framed within the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria in a table format for reprocessed catheter performance that would be directly comparable to a software algorithm's output. Instead, it broadly states:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Characteristics | "demonstrate appropriate functional characteristics" |
| Cleaning Procedures | "Process validation testing was performed to validate the cleaning... procedures" |
| Sterilization Procedures | "Process validation testing was performed to validate the ... sterilization procedures" |
| Device Packaging | "Process validation testing was performed to validate the ... device packaging" |
| Manufacturing Process (Visual & Functional Testing) | "manufacturing process includes visual and validated functional testing of all products produced" |
| Substantial Equivalence | "substantially equivalent to the St. Jude Medical Reflexion™ electrophysiology diagnostic catheters" based on "functional design (principle of operation), materials, indications for use and methods of construction." |
2. Sample size used for the test set and the data provenance:
- Sample Size: "Representative samples of reprocessed EP diagnostic catheters were tested." The exact number of samples is not specified in the provided text.
- Data Provenance: The testing was "performed to validate the cleaning and sterilization procedures as well as device packaging" and includes "visual and validated functional testing of all products produced" by SterilMed, Inc. This implies the data is prospective and generated internally during the reprocessing and manufacturing process. The country of origin of the data is implicitly the USA given the submission to the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document concerns physical device reprocessing and testing, not AI/software performance requiring expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are typically for subjective expert review in AI/software performance studies. The testing described is objective functional and validation testing.
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:
- Not Applicable. This is not an AI or imaging device, so no MRMC study or AI assistance comparison was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. There is no algorithm described in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the functional and safety testing, the "ground truth" would be established by engineering specifications, validated test protocols, and performance standards for electrophysiology diagnostic catheters, ensuring they meet pre-defined criteria for safety and efficacy after reprocessing. This is inherent in process and design validation, not typically referred to as "ground truth" in the same way as in AI studies.
8. The sample size for the training set:
- Not Applicable. There is no "training set" for an AI model described.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" for an AI model described.
§ 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).