NAC PRN NEEDLELESS ACCESS CONNECTOR

• K Number: K992268
• Device Name: NAC PRN NEEDLELESS ACCESS CONNECTOR
• Manufacturer: THE KIPP GROUP
• Date Cleared: 1999-09-15 ( 71 days)
• Product Code: FPA
• Regulation Number: 880.5440
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

The NAC PRN Needleless Access Connector is an accessory to an Intravascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called the "NAC PRN Needleless Access Connector." While it confirms the device's substantial equivalence to a predicate device and its regulatory classification, it does not contain any information about acceptance criteria for device performance or any studies that demonstrate the device meets such criteria.

The letter is a regulatory approval document, not a scientific study report. Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from this text.

Regulation Number and Section

§ 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.