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510(k) Data Aggregation
(448 days)
Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
Reprocessed Cordis Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.
The reprocessed Cordis Catheters are available in a broad variety of French sizes and configurations. These catheters combine an atraumatic tip with a braided body.
The provided text describes the 510(k) summary for Reprocessed Cordis Super Torque and Super Torque Plus Diagnostic Angiographic Catheters. This document is a premarket notification for a medical device and thus does not contain information about studies related to AI or ground truth as it pertains to AI/ML models. Instead, it focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing.
Here's the relevant information based on the provided text, adapted for the requested format where applicable, and noting where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity, Hemocompatibility, Sensitization, Irritation, Systemic Toxicity | Not explicitly detailed in terms of specific numeric results. The document states "Bench and laboratory testing was conducted to demonstrate substantially equivalent performance." Implies that the reprocessed device met established biocompatibility standards. |
| Cleaning Validation | (Implicit based on reprocessing nature) | Not explicitly detailed in terms of specific numeric results. The document states "reprocessing of these devices includes removal of visible soil and decontamination." Implies validation demonstrated effective cleaning to specified standards. |
| Sterilization Validation | (Implicit based on reprocessing nature) | Not explicitly detailed in terms of specific numeric results. Implies validation demonstrated effective sterilization to specified standards. |
| Functional Testing | Visual Inspection, Dimensional Verification, Radiopacity Testing, Simulated Use Testing, Leak Testing, Torsion Testing, Tip Buckling Testing, Tensile Testing, Coating Coverage, Particulate Testing | Not explicitly detailed in terms of specific numeric results. The document states "Bench and laboratory testing was conducted to demonstrate substantially equivalent performance." Implies the reprocessed device met established functional performance standards in these areas. |
| Packaging Validation | (Implicit) | Not explicitly detailed in terms of specific numeric results. Implies validation demonstrated effective packaging to maintain sterility and integrity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each of the listed functional and safety tests. It generally refers to "Bench and laboratory testing." It is a regulatory submission for a reprocessed medical device, not an AI/ML study. Therefore, the concept of "test set" in the context of AI/ML models, data provenance (country of origin), and retrospective/prospective data collection is not applicable here. The testing would have been performed on samples of the reprocessed devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a physical medical device (angiographic catheter), and "ground truth" as it relates to expert-labeled data for an AI/ML model is not relevant to this submission. The "ground truth" in this context would be the established performance specifications for diagnostic angiographic catheters, and the testing validates that the reprocessed device meets those specifications.
4. Adjudication Method for the Test Set
This information is not applicable, as it pertains to expert consensus on AI/ML model outputs, which is not relevant for this device.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable as this is a physical medical device (angiographic catheter) and does not involve AI or human readers evaluating images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical medical device and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance criteria would be the established performance specifications and safety standards for diagnostic angiographic catheters as defined by relevant industry standards (e.g., ISO, ASTM) and FDA guidance for these types of devices and for reprocessed devices. This includes physical properties, biocompatibility, sterility, and functional performance. It is based on engineering specifications and scientific testing standards, not expert consensus on medical images or pathology.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI/ML model; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this physical medical device.
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