(91 days)
The catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from a peripheral venous site, but the catheter may be placed via subclavian cutdown as well. The catheter may be used to administer fluids for hydration and parenteral nutrition, as well other commonly used intravenous medications.
The proposed PICC catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary in the neonate or pediatric patient. Placement is routinely achieved from a peripheral venous site. The catheter may be used to administer fluids simultaneously for hydration and parenteral nutrition, as well as other commonly used intravenous medications.
The Argyle 1.9 Fr Neonatal/Pediatric Peripherally Inserted Central Catheter PICC) is a dual lumen polyurethane tube that bifurcates into two 5.0 Fr polyurethane tubes (pigtails), the proximal ends of the tubes ending in insert molded hubs. One pigtail is longer than the other. The primary longer lumen will be clear. The shorter secondary lumen will be tinted a lavender color to distinguish it from the primary lumen.
The provided text is a 510(k) premarket notification summary for a medical device, the Kendall/Argyle 1.9 Fr. Neonatal/Pediatric Peripherally Inserted Central Catheter (PICC). This document primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria, a study proving the device meets those criteria, or details regarding AI/algorithm performance.
Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets those criteria based on the given text.
The text does briefly mention "Nonclinical testing," specifically "Biocompatibility testing... following ISO-10993 Biological Evaluation of Medical Devices." This testing found that "the materials used in the Kendall Argyle PICC catheter are biocompatible." However, this is a general statement about biocompatibility and not a detailed study report with specific acceptance criteria or performance metrics as requested in your prompt.
The document does not contain information on:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts for ground truth, or adjudication methods for any test set.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI.
- Standalone (algorithm-only) performance, as this is not an AI/algorithmic device.
- The type of ground truth used.
- Sample size for training set or how ground truth for a training set was established.
This type of 510(k) submission generally relies on demonstrating that the new device has the same intended use and similar technological characteristics to legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The core of the submission is often non-analytical and comparative, rather than a detailed performance study against specific acceptance criteria for a novel technology.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”