(77 days)
The TransRadial Artery Access Device is intended for use for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
The TransRadial Artery Access devices are comprised of the components required to perform percutaneous transradial artery access: an introducer needle, a guide wire, a dilator, and a percutaneous sheath introducer with hemostasis valve and sidearm assembly with a stopcock.
The provided text describes a 510(k) premarket notification for a medical device, the TransRadial Artery Access Device. However, it does not include the type of information requested about acceptance criteria and a study proving the device meets those criteria, as typically found in an AI/Software as a Medical Device (SaMD) submission.
This document describes a traditional medical device (a percutaneous sheath introducer) and focuses on substantial equivalence to predicate devices based on functional performance tests and biocompatibility. It does not involve a study with a test set, ground truth, experts, or AI performance metrics.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study proving the device meets them in the context of AI/SaMD, as this type of information is not present in the provided K112554 document.
The document primarily states that the device's safety and functional efficacy were demonstrated through various performance tests on its components, and these "met acceptability requirements." It also establishes substantial equivalence to predicate devices.
Summary of what is available in the document regarding performance and testing (not AI-related):
- Performance Tests Performed (and met acceptability requirements):
- Biocompatibility: Cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, hemocompatibility, rabbit pyrogen (in accordance with ISO 10993-1).
- Introducer Needle Testing: Surface, bevel, and needle point visual inspections; corrosion resistance; radiodetectability; hub to cannula and guidewire interface; hub female luer lock testing (air and liquid leakage, separation force, unscrewing torque, ease of assembly, resistance to overriding, and stress cracking); strength of union of needle tube and needle hub; penetration force; needle bevel alignment and dimensional analysis.
- Introducer Testing (Sheath): Surface visual inspection; sheath radiodetectability; freedom from leakage from sheath introducer; freedom from leakage through hemostasis valve; sidearm stopcock hub luer lock testing (air and liquid leakage, separation force, unscrewing torque, ease of assembly, resistance to overriding, and stress cracking); force at break between sheath introducer and the junction between sheath introducer and the hub (hemostasis valve); force at break between hemostasis valve body barb to side arm extrusion and side arm extrusion to stopcock.
- Guidewire Testing: Surface visual inspection; lateral stiffness; corrosion resistance; radiodetectability; fracture; flexing; strength of union of core wire and coil; tensile strength pull testing.
- Dilator Testing: Surface visual inspection; radiodetectability; dilator hub luer slip testing (air and liquid leakage, separation force, stress cracking); strength of union between hub and dilator.
- Sheath/Dilator Assembly Testing: Sheath/dilator rollback upon insertion; sheath/dilator insertion force; sheath/dilator assembly rigidity; sheath and dilator dimensional inspections.
- Overall device component compatibility testing.
The document concludes that the described intended use, results of verification testing, and comparison to predicate devices demonstrated substantial equivalence, and that "Any differences between the proposed and predicate devices do not raise new issues of safety and effectiveness."
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).