(61 days)
BD Nexiva closed IV catheter systems are intended to be inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.
BD Nexiva Diffusics closed IV catheter systems are intended to be inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.
BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon™ catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer adapter, vent plug and, with dual port configurations, a pre-attached BD Q-Syte Luer Access Split Septum. The needle and catheter are protected by a needle cover. For dual port configurations, a BD Q-Syte device or an end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and Luer connector are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green).
BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon™ catheter with side holes located near the tip of the catheter which are designed to optimize power injection procedures. These devices also have a needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug. The Luer connector displays gauge-specific maximum flow rate and the maximum power injector pressure limit setting. The needle and catheter are protected by a needle cover. An end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. The stabilization platform and Luer connector are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green).
The document describes the BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems and their substantial equivalence to predicate devices, based on performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Air Leakage | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
| Liquid Leakage | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
| Fluid Leakage at Venous Pressure | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
| Septum Assembly Failure / Separation at Max Pressure | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
| Cannula / Hub Bond Strength | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
| Strength of Union between Needle Hub and Needle Tube | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
| Force to Remove Needle from Catheter System (Average System Drag) | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
| System Drag - Peak Offset Force | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each performance test. It notes that "Performance testing performed to support the design modifications included" a list of tests. The data provenance is industrial, conducted by the manufacturer (Becton Dickinson Infusion Therapy Systems Inc.) for regulatory submission to the FDA. The tests are prospective in nature, assessing the physical and mechanical characteristics of the devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This section is not applicable. The device is a physical medical device (intravascular catheter system), and its performance is evaluated based on objective physical and mechanical tests, not through human interpretation or expert ground truth establishment for a test set in the same way an AI algorithm for image analysis would be.
4. Adjudication method for the test set:
This section is not applicable for the reasons outlined in point 3. Performance is determined by meeting pre-determined objective criteria in physical tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This section is not applicable. The device is not an AI-assisted diagnostic tool or an algorithm that human readers would use. It is a medical device for vascular access.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This section is not applicable for the reasons outlined in point 5.
7. The type of ground truth used:
The "ground truth" for the performance tests are the objective engineering and regulatory standards and specifications for the physical and mechanical properties of intravascular catheter systems. These are not expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
Not applicable. This is not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML model, so there is no "training set" or ground truth establishment for it.
§ 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).