(41 days)
The Arrow Echogenic Introducer Needle allows access to the vascular system for the introduction of a guidewire. A peripherally inserted central catheter permits venous access to the central circulation through a peripheral vein. It offers an alternative method of intravenous therapy for select adult and pediatric patients.
The Peripherally Inserted Central Catheter Kits contains many of the components required for the user to place the PICC. An introducer needle is used to gain access to the vein. A guidewire is then placed through the introducer to provide a track for the remaining devices. After removal of the introducer needle from the vein, the guide wire is left in place and a dilator/peel-away introducer assembly is advanced into the vessel thereby enlarging the subcutaneous track. When positioned, the dilator is removed and the peel-away introducer remains along with the guide wire. The PICC is placed through the introducer catheter. After catheter positioning is confirmed, the guide wire and peel-away introducer are removed. A "Stat-Lock" catheter fixation device secures the catheter during use.
The provided text describes a 510(k) summary for the Arrow Echogenic Introducer Needle, a component of Peripherally Inserted Central Catheter Sets. It includes information about the device, its intended use, and performance tests conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain the detailed acceptance criteria and a study report with performance metrics in numerical form as requested in the prompt.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the questions related to sample sizes, data provenance, ground truth establishment, MRMC studies, or standalone performance. The document focuses on establishing substantial equivalence through a general statement of "Performance tests: Tests were performed to demonstrate substantial equivalence in the following areas: - Needle penetration - Hub bond tensile strength test" and a conclusion that "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices."
This type of submission typically relies on comparing the device's physical and functional characteristics to a legally marketed predicate device rather than presenting a detailed clinical study with numerical performance metrics against pre-defined acceptance criteria.
§ 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.