SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908

K961155 · Douglas Medical Products Corp. · LJS · Jun 18, 1996 · General Hospital

Device Facts

• Record ID: K961155
• Device Name: SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908
• Applicant: Douglas Medical Products Corp.
• Product Code: LJS · General Hospital
• Decision Date: Jun 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SoloPak Peripheral Intravenous Catheter Insertion Kits are intended to be used for the placement of a peripheral catheter. The SoloPak Peripheral Intravenous Catheter Insertion Kits include a single lumen catheter, introducer, and the necessary accessories to perform the placement.

Device Story

Procedural tray for peripheral intravenous catheter placement; contains single lumen catheter, introducer, and accessories. Used by clinicians in clinical settings to facilitate vascular access. Device components and materials equivalent to predicate procedural trays. Sterilized to 10^-6 sterility assurance level per AAMI guidelines.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established via comparison of materials, components, and manufacturing processes to predicate devices.

Technological Characteristics

Procedural tray containing single lumen catheter, introducer, and accessories. Sterilization: AAMI guidelines, 10^-6 sterility assurance level.

Indications for Use

Indicated for use in the placement of a peripheral intravenous catheter in patients requiring peripheral vascular access.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• Clinicath™ Procedural Tray (K932211)
• Per-Q-Cath Tray (K83145)

Submission Summary (Full Text)

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K961155

Douglas Medical Products
A SoloPak® Company

March 19, 1996

To Whom it may concern:

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act and CFR 807.92:

Trade Name - SoloPak Peripheral Intravenous Catheter Insertion Tray
Common Name - PICC Placement Tray, PICC Procedural Tray
Classification Name - Percutaneous Intravascular Catheter Accessory

The SoloPak Peripheral Intravenous Catheter Insertion Kits are intended to be used for the placement of a peripheral catheter. The SoloPak Peripheral Intravenous Catheter Insertion Kits include a single lumen catheter, introducer, and the necessary accessories to perform the placement.

The components, processes and materials used to manufacture the SoloPak Peripheral Intravenous Catheter Insertion Kits are the same or the equivalent of the predicate devices named in this submission. The named predicate devices in this submission were the Clinicath™ Procedural Tray (K932211) marketed by SIMS Deltec, Inc. and the Per-Q-Cath Tray (K83145) marketed by Gesco Intl., Inc. The SoloPak Peripheral Intravenous Catheter Insertion Kits are sterilized per AAMI guidelines to a 10 -s sterility assurance level.

Based on the fact that the SoloPak Peripheral Intravenous Catheter Insertion Kits utilize similar and equivalent designs, materials, and components as currently legally marketed products, these products are safe and effective when used as intended.

Sincerely,
Ron Haselhorst
Director of RA\QA
Douglas Medical Products

1840 Industrial Drive, Suite 200, Libertyville, IL 60048 • Telephone: [phone] • Telefax: 708-949-7388