(446 days)
The Medline Integrated Arterial Catheter permits access to the peripheral arterial circulation system for short-term access (less than 30 days).
The Medline Integrated Arterial Catheter is a single-use device supplied sterile and nonpyrogenic; it will be packaged inside convenience kits alongside various components outside the scope of this 510(k) submission. The proposed device is a single lumen peripherally inserted catheter device designed to permit short-term access to the peripheral arterial circulatory for less than 30 days. The device assembly comprises a 20-Gauge catheter, 22-Gauge introducer needle, and a 0.018" guidewire with slide advancer. The catheter is made of radiopaque polyurethane tubing, echogenic needle, and removable stainless steel guidewire with slide advancer. The subject device has a kink-resistant catheter design. The device features dual flash with two distinct points of visualization, one with the clear introducer needle proximal hub and the second point at the notch cutout in the needle shaft. The final finished device is packaged with a suture wing (ALCS004). The suture wing is a Class I, 510(k) exempt device.
I'm sorry, but the provided text describes a medical device submission (a 510(k) for the Medline Integrated Arterial Catheter) to the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance and technological characteristics, rather than clinical studies with acceptance criteria for an AI/CADe device.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance for an AI/CADe system.
- Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods for an AI/CADe system.
- MRMC studies, standalone AI performance, or effect sizes for human reader improvement with AI assistance.
- Details on training set sample size or how ground truth for the training set was established for an AI/CADe system.
The document discusses non-clinical functional performance testing (e.g., stress cracking, leakage, kink resistance) and biocompatibility testing for a physical medical catheter, along with a comparison to predicate catheter devices. It explicitly states: "Summary of Clinical Testing: Not applicable. No clinical testing was conducted on the proposed device."
Without information about an AI/CADe device's clinical performance or a corresponding study, I cannot provide the details you've requested.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.