(97 days)
The support catheter is intended for use during coronary and peripheral interventional procedures to guide and support guidewires, traverse discrete portions of the vasculature, allow for guidewire exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.
The subject Support Catheter is an over-the-wire (OTW) single-lumen catheter with a tapered atraumatic tip. The catheter is available in fifteen (15) size models compatible with standard 0.014", 0.018" and 0.035" diameter guidewires and with effective lengths of 65 cm, 90 cm, 135 cm, 150 cm and 180 cm. The distal end of the catheter incorporates three (3) distal radiopaque markers to assist with fluoroscopic guidance and estimating distances. A hydrophilic coating on the distal end assists with catheter advancement. The proximal end of the catheter has a molded manifold with a female luer connection in fluid communication with the catheter lumen. The catheter lumen is used for guidewire passage and exchanges as well as fluid infusion. The catheter guidewire size and length are printed on the strain relief. The device is supplied sterile and intended for single use only.
The provided text is a 510(k) summary for the QXMédical Support Catheter. It outlines the device's description, intended use, and a comparison to a predicate device, focusing on non-clinical testing to demonstrate substantial equivalence.
However, the document does not describe a study involving an AI/software device or statistical performance metrics (like sensitivity, specificity, AUC) typically associated with such devices and their acceptance criteria. Instead, it refers to a medical device (a catheter) that undergoes physical, mechanical, and biocompatibility testing. The "acceptance criteria" discussed are related to these non-clinical performance aspects of a physical device, not an AI algorithm.
Therefore, I cannot extract the information required by your prompt, such as:
- A table of acceptance criteria and reported device performance: The document lists mechanical and performance tests (e.g., visual/dimensional inspections, kink resistance, tensile strength, fluid flow rates) but does not provide numerical acceptance criteria or the specific results for these tests. It simply states that the tests provide "reasonable assurance that the device meets the established performance criteria and will perform as intended."
- Sample sized used for the test set and the data provenance: Not applicable to this type of device and testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the context of an AI study. The "ground truth" for a physical device is its performance against engineered specifications.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The relevant section from the document states:
"### Summary of Non-Clinical Testing:
The subject Support Catheter underwent mechanical, performance, and biocompatibility assessments to support a determination of substantial equivalence. These tests provide reasonable assurance that the device meets the established performance criteria and will perform as intended. The testing did not raise any new questions of safety and effectiveness.
| Tests Performed | |
|---|---|
| Visual/Dimensional inspections | Catheter stiffness & flexibility |
| Freedom from leakage | Kink resistance and radius |
| Luer syringe compatibility | Guidewire support |
| Guidewire compatibility | Catheter fatigue |
| Sheath compatibility | Tensile strength |
| Guiding catheter compatibility | Markerband retention |
| Simulated use | Particulate evaluations |
| Coating integrity | Torque strength |
| Fluoroscopic visualization | Burst pressure |
| Corrosion resistance | Shelf life testing |
| Fluid flow rates | Package integrity |
| Shipping/distribution testing | Environment conditioning |
Clinical Testing
Clinical evaluation was not required for this device."
In summary, this document is for a physical medical device (catheter) and discusses non-clinical engineering and biocompatibility testing, not the performance evaluation of an AI or software algorithm against clinical ground truth data. Therefore, most of your prompt's questions, which are geared towards AI/machine learning device evaluations, cannot be answered from this text.
§ 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).