(112 days)
The Smartport CT MPPort Access System is indicated for any adult patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.
The Smartport CT MP port can accommodate a 3 ml/sec injection rate of contrast agent when used with a 19 or 20 gauge power injectable infusion set.
The 19 or 20 gauge LifeGuard Infusion Set can accommodate power injection when used with Smartport CT ports.
The LifeGuard® CT Safety Infusion Set is indicated for use in the access of implanted vascular ports for the administration of fluids and drugs, as well as blood sampling.
The 20ga and 19ga LifeGuard® CT Safety Infusion Sets are also indicated for power injection of contrast media when used with Smartport CT power injectable port access systems.
Not Found
The provided text is a 510(k) summary for a medical device (Smartport CT MP Port Access System and LifeGuard® CT Safety Infusion Set) and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The document primarily focuses on:
- Device Identification: Proprietary and common names, classification, product codes, regulatory class.
- Legally Marketed Predicate Devices: Devices to which equivalence is claimed.
- Intended Use / Indications: What the device is designed for.
- FDA Communication: The clearance letter from the FDA confirming substantial equivalence to predicate devices.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
§ 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.