(30 days)
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 by a peripheral or poundine patient theter may be used to administer fluids simultaneously for hydration and parenteral nutrition, as well as other commonly used intravenous medications.
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 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 describes a medical device, the Kendall Argyle® 1.9 Fr Dual Lumen Neonatal/Pediatric Peripherally Inserted Central Catheter, and its 510(k) submission to the FDA. It does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or information on reader studies, training sets, or ground truth establishment.
The document primarily focuses on:
- Device Identification: Proprietary name, common name, classification, and predicate devices.
- Description: Physical characteristics of the catheter.
- Intended Use: For venous catheterization or long-term IV administration in neonates/pediatric patients, with details on placement and types of fluids/medications administered.
- Technological Characteristics: Stating equivalence to predicate devices in materials, function, indications for use, and design.
- Nonclinical Testing: Biocompatibility testing performed according to ISO-10993, confirming material biocompatibility.
- FDA Communication: The 510(k) clearance letter confirming substantial equivalence to legally marketed predicate devices.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from the given text. This information would typically be found in a more detailed clinical study report or performance evaluation document, which is not part of this 510(k) summary.
§ 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.”