6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT

• K Number: K980127
• Device Name: 6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT
• Manufacturer: CATHETER INNOVATIONS, INC.
• Date Cleared: 1998-03-11 ( 56 days)
• Product Code: FPA
• Regulation Number: 880.5440
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

These extension sets are indicated for needle-free use in the intravenous delivery of fluids, including but not limited to, hydration fluids, chemotherapy, antibiotics, analgesics, and nutritional therapy. The sets are commonly connected to the external portion of indwelling vascular access catheters.

Device Description

Catheter Innovations, Inc. Extension Sets with PASV™ Valve

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer. It primarily confirms the substantial equivalence of the device (Catheter Innovations, Inc. Extension Sets with PASV™ Valve) to a predicate device and allows its marketing.

The document does not contain any information about:

• Acceptance criteria and reported device performance (in a table or otherwise).
• Details of any study conducted to prove the device meets acceptance criteria. This includes sample sizes, data provenance, ground truth establishment methods, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I cannot fulfill your request for this specific information based on the text provided.

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.