(122 days)
The intended use of the VanishPoint® I.V. Catheter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint® I.V. Catheter aids in the prevention of needlestick injuries.
Not Found
The provided text is a 510(k) clearance letter for the VanishPoint I.V. Catheter, which is a medical device. It does not contain any information about acceptance criteria or a study proving device performance as typically understood for AI/ML or diagnostic devices.
The letter states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination implies that the device meets the safety and effectiveness requirements for its intended use, but it doesn't detail performance metrics in the way you've requested.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
§ 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).