(232 days)
The Nouvo Safety Set IV Catheter are indicated for insertion into a patient's vascular system to sample blood. Infusion of fluids such as solutions, parenteral nutrition of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 18G-22G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.
The Nouvo Safety Set is an over the Needle Intravascular Catheter, peripheral, it incorporates the passive safety clip to help prevent needle stick injuries. The catheter is made from a radio-opaque polyurethane (PUR) material. The devices have a septum, stabilization platform, integrated extension tubing, c-clamp, single luer, needle free connector, safety clip, access split septum with site luer and vent plug. The needle cover protects the needle and catheter. The color of the catheter hub identifies the gauge size, the catheter gauge size and length are identified on the product packaging. The Nouvo safety set IV catheter is provided sterile and non-pyrogenic for single use only. The Nouvo safety set IV catheter is not made with natural rubber latex or PVC. The subject device shares the similar technological characteristics, principles of operation and the same fundamental scientific technology as the predicate device. Both devices have needleless adaptors and passive safety features. The Needleless adaptor used in the subject device is FDA cleared. The Nouvo Safety Set has the following features: needle cover, introducer needle, needle hub, radiopaque catheter, colored wings, catheter hub, C-clamp, extension tube with or without the N-Pules needles connection (single port, single port with needle free valve, dual port with needle free valve) cleared under K220288 (NP Medical). The immediate flashback system has a plug that prevents leaking and seepage. Upon removal, the safety clip is engaged to prevent needle sticks. There are no additional accessories included with the Nouvo Safety Set.
The provided text describes a 510(k) premarket notification for the "Nouvo Safety Set" intravascular catheter and does not contain information about a study comparing the device's performance against specific acceptance criteria in the context of an AI/human-in-the-loop study. Instead, it details bench testing, biocompatibility, packaging, sterilization, and shelf-life testing to demonstrate substantial equivalence to a predicate device, as required for FDA clearance.
Therefore, I cannot provide the specific details you requested regarding:
- A table of acceptance criteria and reported device performance related to AI/human-in-the-loop.
- Sample size used for the test set and data provenance for an AI study.
- Number of experts and their qualifications for establishing ground truth in an AI study.
- Adjudication method for an AI study.
- Effect size of human readers with AI vs. without AI assistance.
- Standalone performance (algorithm only) of an AI.
- Type of ground truth used for an AI study.
- Sample size for the training set of an AI.
- How ground truth for the training set of an AI was established.
The document focuses on the safety and effectiveness of a medical device (intravenous catheter) through traditional engineering and biological testing, rather than the performance 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).