(73 days)
Intravascular Administration Set and Extension Set is a device used to serve as a conduit for delivery of I.V. fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Additional indications for use of this device is to provide multiple secondary sterile injection sites for other infusion fluids. The device may include a drip chamber with a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container, an infusion line filter, a 2 or 3 port manifold or I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a Y-site injection site, a PRN injection site, a Y-site with integral check valve, a Spin-Loc connector and one or more Roller/Slide/Pinch clamps.
Intravascular Administration Set/Extension Set
This document is a 510(k) clearance letter from the FDA for an "Intravascular Administration Set/Extension Set." It does not contain information about acceptance criteria, device performance studies, or details relevant to the performance evaluation of a medical device based on specific metrics like sensitivity, specificity, or accuracy.
The letter primarily:
- Confirms substantial equivalence: States that the device is substantially equivalent to legally marketed devices.
- Outlines regulatory requirements: Refers to general controls, special controls, GMP regulations, and other relevant FDA provisions.
- Approves marketing: Allows the manufacturer to begin marketing the device.
- Specifies intended use: Provides a brief description of the device's function as a conduit for IV fluids and details some of its components.
Therefore, I cannot provide a response to your request as the provided text does not contain the necessary information regarding:
- Acceptance criteria and reported device performance: No performance metrics are mentioned.
- Sample size and data provenance: No study data is presented.
- Number and qualifications of experts for ground truth: Not applicable as no ground truth was established for this type of regulatory submission.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not conducted or mentioned.
- Standalone performance: Not conducted or mentioned.
- Type of ground truth: Not applicable.
- Training set sample size: Not applicable.
- Ground truth establishment for training set: Not applicable.
This type of FDA letter is a regulatory approval, not a scientific publication detailing a device's performance study.
§ 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.