(217 days)
The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral and neurovasculature.
The Vista Brite Tip Guiding Catheters are single lumen catheters which features a nylon body reinforced with a tightly wound stainless braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheters are designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheters' tip, is pellethane with a radiopaque filler, this is the softest material in the catheter.
This document is a Premarket Notification 510(k) for a Cordis Guiding Catheter (K6346a). It is focused on demonstrating substantial equivalence to predicate devices.
Based on the provided text, the device is a physical medical device (a catheter), not an AI/software-based medical device. Therefore, the questions related to AI performance, ground truth, expert adjudication, training sets, test sets, and multi-reader multi-case studies are not applicable.
The acceptance criteria for such a device would typically involve physical and mechanical performance testing, biocompatibility, and sterilization validation, rather than metrics like sensitivity, specificity, or AUC which are relevant for diagnostic algorithms.
Here's a breakdown of what is provided and why the AI-related questions are not answerable from this document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail values in this summary document. For a physical device like a catheter, general acceptance criteria would revolve around:
- Biocompatibility: Passed (stated: "All appropriate biocompatibility tests for the guiding catheters were successfully completed.")
- Mechanical Integrity/Performance: Implied to be acceptable through demonstration of substantial equivalence to predicate devices which are already cleared. This would typically include tests for tensile strength, torque transmission, kink resistance, pushability, trackability, lubricity, etc., but specific values are not in this summary.
- Dimensional Specifications: Implied to be acceptable to fit the intended use with other devices.
- Material Properties: Implied to be acceptable and consistent with predicate devices.
- Radiopacity: The "Brite Tip segment...is pellethane with a radiopaque filler," indicating it meets a functional requirement for visibility under fluoroscopy.
- Reported Device Performance:
- Biocompatibility: "Successfully completed."
- General Performance: "similar in design, construction, indication for use and performance characteristics to other commercially available guiding catheters." This is the core 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)
- Not Applicable. This is a physical device. Performance testing would involve physical samples of the catheter, not a "test set" of data in the AI sense. This document does not detail the number of catheters subjected to physical testing.
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)
- Not Applicable. No "ground truth" establishment in the context of diagnostic accuracy is relevant for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable.
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 device is a tool for a physician, not a diagnostic algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for a physical device is its adherence to design specifications, material properties, and functional performance under various conditions, which are evaluated through engineering tests, not clinical "ground truth" as for diagnostics.
8. The sample size for the training set
- Not Applicable. This device uses physical engineering and manufacturing processes, not machine learning training.
9. How the ground truth for the training set was established
- Not Applicable.
In summary: The provided document is a 510(k) for a conventional medical device (a catheter). The questions posed are primarily relevant to AI/software as a medical device (SaMD) and therefore cannot be answered from this document. The "study that proves the device meets the acceptance criteria" in this context is the demonstration of substantial equivalence to legally marketed predicate devices, supported by biocompatibility testing and presumably other engineering verification and validation (V&V) activities which are not detailed in this high-level summary.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).