(52 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 Irvine Biomedical EP diagnostic catheters consist of a shaft with a handle at the proximal end and some models are considered to be steerable. These catheters have a varying outer diameter (French size) and length. These catheters also feature a number of platinum, radiopaque electrodes with a variety of inter-electrode spacing configurations and curve styles at the distal tip. The distal tip may be 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.
This document is a 510(k) premarket notification for SterilMed, Inc.'s Reprocessed Electrophysiology Diagnostic Catheters. The purpose of the submission is to demonstrate substantial equivalence to predicate devices, not necessarily to prove effectiveness against clinical endpoints. Therefore, many of the typical acceptance criteria and study data points that might be found for a novel AI device are not present here.
Here's an breakdown of the available information regarding acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding reported device performance values in the format typically seen for algorithm performance (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the scope of the non-clinical tests performed, aiming to demonstrate that the reprocessed devices perform equivalently to new, un-reprocessed predicate devices.
The "acceptance criteria" can be inferred as successful completion of the specified validation tests, demonstrating that the reprocessed catheters maintain their functional characteristics, sterility, and biocompatibility. The "reported device performance" is the conclusion that the devices met these criteria.
| Acceptance Criteria (Inferred from tests) | Reported Device Performance (Summary) |
|---|---|
| Cleaning Validation | Process validation testing performed to validate cleaning. |
| Sterilization Validation (ISO 11135, USP ) | Sterilization validation performed. |
| Biocompatibility Testing (ISO 10993-1) | Biocompatibility testing performed. |
| Ethylene Oxide Residual Testing (ISO 10993-7) | Ethylene oxide residual testing performed. |
| Packaging Validation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096) | Packaging validation performed. |
| Shelf Life Validation (ASTM 1980-99) | Shelf life validation performed. |
| Functional Performance (Bench Testing) | Validation of functional performance (bench testing) performed for: electrical leakage, torsional strength, flexation fatigue, fluid integrity, joint bond strength, deflection fatigue, catheter stiffness, and tip buckling. |
The conclusion states: "The reprocessed EP diagnostic catheters are substantially equivalent to the Irvine Biomedical, Inc. electrophysiology diagnostic catheters. This conclusion is based upon the devices' similarities in functional design (principle of operation), materials, indications for use and methods of construction." This implies that all non-clinical acceptance criteria were met to support this claim of substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Representative samples of reprocessed EP diagnostic catheters were tested" for functional characteristics. However, specific sample sizes for each test (e.g., number of catheters tested for electrical leakage) are not provided. The provenance of the data is internal to SterilMed, Inc., as these are tests performed on their reprocessed devices. The tests are "non-clinical" and "bench testing," meaning they were conducted in a lab environment on physical devices, not on human patients, so there is no patient data provenance (country of origin, retrospective/prospective).
3. 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)
This is not applicable as the submission pertains to a reprocessed medical device, not an AI/algorithm-based diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for the reprocessed catheters is their adherence to specified engineering and performance standards, which are objectively measurable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a reprocessed medical device. No human adjudication is mentioned or implied for the performance testing of the catheters.
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 a submission for a reprocessed physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective engineering and performance standards for medical devices (e.g., electrical leakage measurements, tensile strength, sterility through biological indicator testing, biocompatibility testing via ISO standards). The reprocessed catheters are compared to these established standards and to the performance of the original, un-reprocessed devices.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical medical 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).