(217 days)
The Supercath 5 is intended to access a vein or artery and to administer fluids. The Supercath 5 is designed for single use, and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks.
The Supercath 5 (26G) is intended to access a vein or artery and to administer fluids. The Supercath 5 (26G) is designed for single use, and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks.
This device is a single-use and provided with ethylene oxide (EO) sterilization. Its shelf life is 3 years. The device is available in 26G and effective length of 19mm.
The introducer needle of the Supercath 5 (26G) has a side-notch to provide rapid visual confirmation of vessel entry. When the introducer needle is inserted into a vessel, blood passes through the side-notch and flows back along the inside of the catheter.
The Supercath 5 (26G) has a safety system. Pressing an activation button results in retracting the metallic introducer needle into a safety cover. This safety system enables to avoid needle-stick accident and further exposure of blood or body fluid attached to the introducer needle.
Some versions of the Supercath 5 (26G) have a built-in check valve which together with a healthcare professional's finger pressure on a blood vessel assists to reduce blood flashback during and after the retraction of the metallic introducer needle to the safety cover until the connection of an infusion or transfusion set to the catheter hub. The built-in check valve is not intended to stop bleeding completely.
The provided document is a 510(k) premarket notification for a medical device called "Supercath 5 (26G)", an intravascular catheter. This document does not describe a study involving an AI/algorithmic device, but rather a traditional medical device (a catheter). Therefore, the requested information about acceptance criteria for AI performance, study design, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as well as the method for establishing ground truth for AI algorithms, cannot be extracted from this document, as it pertains to a different type of device evaluation.
The document focuses on demonstrating substantial equivalence to a predicate device (Supercath 5, K140419) based on design, materials, technological characteristics, sterilization, biocompatibility, and bench performance testing for the physical device.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).