(152 days)
HydroPICC is indicated for short- or long-term peripheral access to the central venous system for intrapy, including but not limited to; the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast.
HydroPICC is rated for a Maximum Power Injection Flow Rate of 3.5ml/sec.
The HydroPICC is a peripherally inserted central catheter (PICC) intended for short or long-term use. The HydroPICC is a 4Fr, 55cm long catheter suitable for periodic access to the superior vena cava (SVC). HydroPICC has been shown to be effective in reducing thrombosis accumulation. Reduction of thrombosis accumulation was evaluated using in vitro and in vivo models. Preclinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombosis formation.. HydroPICC is supplied in a kit with the necessary accessories to insert and maintain the catheter.
The provided text describes the 510(k) premarket notification for the HydroPICC device, focusing on its substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the format requested for an AI/algorithm-based device.
The HydroPICC is a medical device (a peripherally inserted central catheter), and the performance data presented relates to its physical and biological properties. This document does not describe an AI or algorithm-driven device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and studies for an AI/algorithm.
Specifically, the document focuses on:
- Biocompatibility Testing: Cytotoxicity, intracutaneous reactivity, sensitization, intramuscular implant, pyrogenicity, chemical extractables, in vivo thrombogenicity.
- Mechanical Testing: Power Injection Flow Rate, Static Burst Strength, Lifecycle Power Injections, Gravity Flow Rate, Catheter Length, Priming Volume, Dimensional Verification, Catheter Kink/Flex Resistance, Alcohol Compatibility, Catheter Marking & Identification/Radio Detectability Testing, Tensile Testing, Catheter Compatibility with Medications, Catheter Thrombus Accumulation Evaluation Using in Vitro Blood Loop, Catheter Collapse Resistance, Central Venous Pressure Monitoring, Pyrogens testing.
- Sterilization: Validated overkill Ethylene Oxide (EO) method.
These are standard tests for a physical medical device and do not involve AI/algorithm performance metrics such as sensitivity, specificity, AUC, or the involvement of expert readers for ground truth establishment.
Therefore, I cannot fulfill the request as the provided text does not contain information about an AI/algorithm-driven device or its associated acceptance criteria and study proving its performance.
§ 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.”