(60 days)
The UNI-PICC™ is intended to be used by medical professionals for short-term or long-term peripheral access to the central venous system for infusion, intravenous therapy and for blood sampling.
The UNI-PICC™ Peripherally Inserted Central Catheter is indicated for short or long term access to the central venous system for intravenous administration of fluids, medications and/or nutritional therapy when prescribed. Blood sampling may also be conducted with UNI-PICC™.
The 3F UNI-PICC™ Peripherally inserted Central Catheter is indicated for short or long term access to the central venous system via peripheral insertion in neonates, infants and children. It may be used for administration of fluids, medications and/or nutritional therapy when prescribed.
The UNI-PICC™ is a family of peripherally inserted central venous catheters designed to perform infusion, intravenous therapy and blood sampling. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each UNI-PICC™ has a kink resistant catheter design. The UNI-PICC™ kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.
The UNI-PICC™ is indicated for dwell times shorter or greater than 30 days. The UNI-PICC™ product line has catheters in 3Fr, 4 Fr and 5 Fr single lumen, 4 Fr, 5 Fr and 6 Fr dual lumen and 5 Fr and 6 Fr triple lumen. All catheters range from approximately 30 - 60 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment.
The provided 510(k) summary for the UNI-PICC™ focuses on demonstrating substantial equivalence to predicate devices, primarily through technological comparison and performance testing that adheres to established guidance documents and standards. It does not detail specific acceptance criteria in quantitative terms nor the performance of a device against such criteria in a tabular format as you've requested for typical AI/ML medical devices.
Instead, the submission states:
"The UNI-PICC™ met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the UNI-PICC™ is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the SYNERGY™ CT PICC (K101329), 2.6F Vascu-PICC® (K102966) and Vascu-PICC® and Midline Catheters, Single, Double and Triple Lumen (K091586)."
The study described is a design verification testing based on FDA guidance and international standards, aiming to show that the UNI-PICC™ performs comparably to pre-existing, legally marketed predicate devices.
Given the nature of the information provided in the K130034 submission, I cannot create the requested table of acceptance criteria and reported device performance with quantitative metrics. The document confirms that all established acceptance criteria were met, but it does not list them or the specific performance values achieved.
Furthermore, this submission describes a traditional medical device (a catheter), not an AI/ML powered device. Therefore, questions related to test set sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable to this document.
§ 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.”