SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908

• K Number: K961155
• Device Name: SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908
• Manufacturer: DOUGLAS MEDICAL PRODUCTS CORP.
• Date Cleared: 1996-06-18 ( 88 days)
• Product Code: LJS
• Regulation Number: 880.5970
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: K932211
• Predicate For: N/A

Intended Use

The SoloPak Peripheral Intravenous Catheter Insertion Kits are intended to be used for the placement of a peripheral catheter.

Device Description

The SoloPak Peripheral Intravenous Catheter Insertion Kits include a single lumen catheter, introducer, and the necessary accessories to perform the placement.

AI/ML Overview

This document, K961155, is a 510(k) premarket notification for the SoloPak Peripheral Intravenous Catheter Insertion Tray. It does not contain any information regarding acceptance criteria, device performance studies, or AI/algorithm-based assessments.

The document is a submission stating that the SoloPak Peripheral Intravenous Catheter Insertion Kits are substantially equivalent to predicate devices (Clinicathr Procedural Tray and Per-Q-Cath Tray). The safety and effectiveness are based on the kits utilizing similar and equivalent designs, materials, and components as legally marketed products, and sterilization according to AAMI guidelines.

Therefore, I cannot provide the requested information. The document does not describe:

• Acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods for a test set.
• MRMC comparative effectiveness studies or human reader improvement data.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size or how its ground truth was established.

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”