(169 days)
The Nexiva™ intravascular catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature and luer access port aid in the prevention of needlestick injuries. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The 18-24 gauge Nexiva catheters are suitable for use with power injectors rated for a maximum of 300 psi when the luer access port(s) is removed and a direct connection is made.
The BD Nexiva Closed IV Catheter System consists of an over-the-needle, peripheral intravascular catheter made from Vialon™ polyurethane, integrated extension tubing with a Y adapter and clamp, BD Q-Syte™ luer access port, and a passive needle-shielding mechanism.
The design of the Nexiva IV catheter can be described as a closed system since it protects clinicians from blood exposure during the catheter insertion procedure. Since the needle is withdrawn through a septum that seals after the needle has been removed and both ports of the Y adapter are closed, blood is contained within the Nexiva device during catheter insertion. The pressure exerted on the needle as it passes through the septum wipes blood from the needle, further reducing potential blood exposure. The slide clamp on the integrated extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection or a BD Q-Syte luer access port.
The provided document is a 510(k) premarket notification for the BD Nexiva™ Closed IV Catheter System, seeking substantial equivalence to predicate devices. It describes the device's intended use and technological characteristics but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through empirical data analysis, comparative effectiveness, or standalone performance metrics typically associated with AI/algorithm review.
Therefore, I cannot provide the requested information in the format of acceptance criteria, reported device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results because this information is not present in the provided text.
The document primarily focuses on:
- Description of the Device: BD Nexiva™ Closed IV Catheter System, its components, and its closed system features for blood exposure prevention.
- Intended Use: Short-term intravascular use for blood sampling, pressure monitoring, or fluid administration, with needle-shielding and luer access port for preventing needlestick injuries and blood exposure. It also notes suitability for power injectors.
- Technological Characteristics Comparison: Highlighting similarities to predicate devices (BD Saf-T-Intima™ IV Catheter and B. Braun Introcan® Safety™ IV Catheter) in materials, design features, and use with power injectors.
- Nonclinical Tests: Stating that the device materials were tested per ANSI/AAMI/ISO 10993-1 (1997) and a simulated use study compared Nexiva and Introcan catheters.
- Conclusion: The sponsor concluded substantial equivalence based on these nonclinical tests.
- FDA Communication: The FDA's letter confirming substantial equivalence to legally marketed predicate devices.
Missing Information:
The document is a regulatory submission for a medical device (intravascular catheter), not an AI/algorithm-based diagnostic or assistive system. As such, concepts like "acceptance criteria" and "device performance" in the context of sensitivity, specificity, accuracy, or other statistical measures, along with details on ground truth, expert adjudication, or MRMC studies for AI, are not applicable or reported here. The "study" mentioned is a "simulated use study" and materials testing, which are part of establishing substantial equivalence for physical medical devices rather than evaluating performance against specific diagnostic or prognostic metrics.
§ 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).