(251 days)
MF SAFECATH, an intravascular catheter is a device 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. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
This medical device is a disposable intravascular tube catheter composed of cap, cannula, catheter tube, catheter hub, gasket, g-holder, cannula hub, plug, filter. This device has a passive needlestick safety feature that prevents the cannula from escaping forward during the use. MF SAFECATH are available in 16G, 18G, 20G, 22G, and 24G and various lengths.
I'm sorry, but the provided text does not contain the specific information required to answer your request in the specified format. The document describes a 510(k) premarket notification for a medical device (MF SAFECATH Intravascular Catheter) and details its indications for use, device description, comparison to a predicate device, and a summary of performance and other tests conducted.
However, it does not include:
- A table of specific acceptance criteria and reported device performance metrics in numerical or qualitative terms for the device to meet those criteria.
- Details about sample sizes specifically for test sets, data provenance, or information on training sets for any AI/algorithm-based component.
- Information regarding the number and qualifications of experts for establishing ground truth or the adjudication methods used.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- A standalone (algorithm only) performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
The document mentions "Simulated Clinical Use Study" and that "the safety function has been activated correctly" but does not provide specific acceptance criterion or quantitative results from this study. It primarily focuses on demonstrating substantial equivalence to a predicate device through conformity to international standards and biocompatibility testing, rather than reporting on specific performance metrics against defined acceptance criteria in the context of an AI/algorithm.
§ 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).