(80 days)
Perfudrop® Air M-P with Needle is an intravascular administration set to administer IV fluids and pharmaceuticals from a container to a patient's vascular system through a needle inserted into a vein. The administration set is for use under gravity and pressure conditions. The set is not intended nor indicated for use with blood or blood products.
The Perfudrop® Air M-P intravascular administration set (model no. 48451606) is a disposable, single-use Intravascular administration set intended for use under gravity and pressure conditions as well. The intravascular administration set uses a needle attached to the set. The design of the intravascular administration set is according to the requirements of ISO 8536-4. The design of the sterile hypodermic needle is according to the requirements of ISO 7864. The device includes a drip chamber with a 15 μm filter and a spike to penetrate and connect the tubing to an I. V. bag or other infusion fluid container, tubing, flow regulator and a connector to connect the needle to the set.
This document is a 510(k) summary for the Perfudrop® Air M-P With Needle intravascular administration set. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
The purpose of a 510(k) submission is to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics and intended use. The provided text confirms the device's substantial equivalence to the predicate "Gemini IV Administration Sets" (K022209) based on its design according to ISO 8536-4 and ISO 7864 for the needle.
Therefore, I cannot provide the requested information from the provided text for the following reasons:
- No acceptance criteria are mentioned. The document focuses on regulatory approval based on substantial equivalence, not performance criteria.
- No specific study is described. There is no mention of a performance study, clinical trial, or any other investigation designed to test the device against acceptance criteria.
- The document is a regulatory submission summary, not a study report. It outlines the device's characteristics and its comparison to a predicate device for 510(k) clearance.
To answer your request, a detailed performance study report with predefined acceptance criteria would be necessary.
§ 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.