(143 days)
CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. The device may also be used with power injector procedures up to 10mL per second of contrast media and a maximum pressure of 350psi. The device incorporates a technology that will prevent fluid displacement resulting from the following: Connection of a luer; syringe plunger compression; patient vascular pressure changes, such as coughing or sneezing; and IV solution container run-dry. The CLAVE Neutron incorporates a pre-slit septum that does not reguire the use of needles and will therefore passively aid in the reduction of needlestick injuries.
The CLAVE Neutron is a normally closed, bidirectional connector that incorporates a unique silicone valve within the fluid path. The unique valve prevents fluid displacement, both positive and negative at all times, including when the device is accessed.
Here's a breakdown of the acceptance criteria and study information for the CLAVE® Neutron™ device based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally demonstrated by the CLAVE Neutron's performance being "substantially equivalent" to predicate devices, or meeting specific physical and functional benchmarks. The table below integrates information from the "Technological Characteristics and Substantial Equivalence Table" and other sections of the summary.
| Specification/Acceptance Criteria | CLAVE® Neutron™ Reported Performance |
|---|---|
| Functional Use | Needleless connector with anti-fluid displacement and power injectable. Substantially equivalent to predicate devices for normally closed, needleless connection and fluid delivery. |
| Patient Populations | Adults, Pediatrics and Immunocompromised patients. Supported by clinical studies (Bouza 2003, Maragakis 2006) on the identical CLAVE pre-slit septum design. |
| Residual Volume | 0.14mL. Less than half of the A6 predicate (0.30mL). |
| Gravity Fluid Flow | 100mL/minute. Equivalent to the CLAVE predicate. |
| Syringe Disconnect: Fluid Displacement | Integral valve prevents displacement, both positive and negative. Substantially equivalent to fluid displacement feature of predicate devices during luer disconnection. |
| Syringe Plunger Compression: Fluid Displacement | Integral valve prevents displacement, both positive and negative. The valve operates in the identical manner as for luer disconnection, so deemed not significantly different from predicate. |
| Patient Pressure: Fluid Displacement | Integral valve prevents displacement, both positive and negative. The valve operates in the identical manner as for luer disconnection, so deemed not significantly different from predicate. |
| Bag Run-Dry: Fluid Displacement | Integral valve prevents displacement, both positive and negative. The valve operates in the identical manner as for luer disconnection, so deemed not significantly different from predicate. |
| Multiple Activations | 96 intermittent, 3 extended time. This matches predicate CLAVE and CLC2000. |
| Positive Leak Pressure | 45psig. Deemed adequate to prevent positive pressure leakage from a patient's line and therefore not significantly different from predicate devices (which had 60psig). |
| Negative Leak Pressure | -8.5psig. Matches predicate CLAVE and CLC2000. |
| Luer Retention | ISO 594-1 (5.4). Matches predicate CLAVE and CLC2000. |
| Component Assembly | >20lbf-in. (Predicates had >51bf-in or >15lbf-in, showing this is a strong assembly). |
| Chemical Compatibility | Lipids, Alcohol. Matches predicate CLAVE and CLC2000. |
| Power Injectable | 10ml/sec of contrast media and |
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.