(160 days)
The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.
The Arrow® Quickflash Arterial Catheterization Device, which is a sterile, single use arterial catheterization device, is designed to permit access to the peripheral arterial circulation or to other small vessels. The Arrow® Quickflash Arterial Catheterization Device is an all-in-one design consisting of a translucent polyurethane, radiopaque single lumen arterial catheter-over-needle device that includes a clear chamber as part of the needle hub which allows visualization of blood flashback. The needle has openings to enhance flashback visibility and the hub is connected proximally to a slotted housing that contains the integral spring wire guide. A handle projects through the slotted housing to permit the advancement of the spring wire guide through the introducer needle into the vessel. This design allows for quick and simple catheter insertion since all of the devices required for insertion are provided together.
The Arrow Quickflash Arterial Catheterization Device is available with and without integrated molded suture wings in 20 gauge configurations with usable lengths of 3.81 cm (1 ½").
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically associated with AI/ML systems.
Instead, the document is a 510(k) summary for a medical device (Arrow Quickflash Arterial Catheterization Device) and focuses on demonstrating substantial equivalence to a predicate device. The information provided pertains to:
- Substantial Equivalence: The primary goal is to show the new device is substantially equivalent to an older, legally marketed predicate device (Arrow Radial Artery Catheterization Set K810675). This is achieved through comparisons of indications for use, technological characteristics, and non-clinical testing.
- Technological Characteristics Comparison: A table compares design features of the predicate and subject device (e.g., catheter body OD and length, material, blood flashback visualization, integrated guidewire, sterilization method).
- Nonclinical Testing: A list of bench tests performed for design verification (e.g., biocompatibility, corrosion resistance, leakage, tensile testing, luer testing, simulated use, penetration/insertion force, kink resistance, dimensional verification, needle flexing, spring wire guide flexing, catheter resistance to collapse).
Therefore, I cannot provide the requested information about acceptance criteria and device performance as this document does not contain such details relevant to AI/ML or comparative effectiveness studies.
Here's why the requested information cannot be extracted from the provided text:
- AI/ML Context: The device is an "Arterial Catheterization Device" and appears to be a physical medical instrument, not an AI/ML software device.
- Acceptance Criteria & Performance Metrics: The document lists nonclinical testing to demonstrate safety and performance relative to the predicate, but these are not the "acceptance criteria" and "reported device performance" in the sense of accuracy, sensitivity, specificity, or other statistical measures typically associated with AI/ML model evaluation.
- Study Details (Sample Size, Ground Truth, Experts): Since it's not an AI/ML product study, there is no mention of training sets, test sets, data provenance, expert ground truth, adjudication methods, or MRMC studies.
In summary, the provided text is a regulatory submission for a physical medical device and does not contain the specifics required to answer your prompt, which seems to imply an AI/ML driven device evaluation.
§ 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.