CATHETER INSERTION TRAY

K962849 · Medcare Medical Group, Inc. · LJS · Oct 7, 1996 · General Hospital

Device Facts

• Record ID: K962849
• Device Name: CATHETER INSERTION TRAY
• Applicant: Medcare Medical Group, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Oct 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Intended Use

The Catheter Insertion Tray is a single patient, single use, disposable device which is intended to conveniently provide components to aid in the administration of percutaneous catheterization.

Device Story

Device is a sterile, single-use, disposable tray containing auxiliary components to facilitate percutaneous catheter insertion (TPN/CVP, PICC, Long Line). Used in clinical settings by healthcare professionals. Tray provides convenience by consolidating necessary items in one package. Subject device adds vessel dilator and guide wire to standard tray contents. Output is the physical availability of sterile components for procedural use; aids clinician workflow during catheterization; benefits patient by ensuring sterile, organized, and efficient procedural setup.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sterile, single-use, disposable tray containing auxiliary components for catheterization. Includes vessel dilator and guide wire. No electronic, software, or energy-based components.

Indications for Use

Indicated for patients requiring percutaneous catheterization, including TPN/CVP, PICC, and Long Line catheter placement.

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

• Catheter Insertion Tray (K936261)
• Prep Tray - PICC Insertion Cat No. DP2-2150

Submission Summary (Full Text)

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OCT - 7 1996
K962849

(I) **510(k) Summary:**

This summary is submitted in conformance with the format described in the 21 CFR Part 807.92 interim rule dated April 28, 1992.

(1) **Submitted By:**

MedCare Medical Group, Inc.
234 Old Homestead Highway
E. Swanzey, NH 03446

**Contact Person:**

Craig J. Bell
Director of Research and Development
[phone]

(2) **Name of Device:**

Catheter Insertion Tray

**Classification Name:**

Unknown

(3) **Identification of Predicate Devices:**

Catheter Insertion Tray (510(k) No. K936261)
Prep Tray - PICC Insertion Cat No. DP2-2150

MedCare Medical Group, Inc.
E. Swanzey, NH 03446

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(4) **Description of Device Subject to Premarket Notification:**

The Catheter Insertion Tray is intended to conveniently provide the components used to aid the insertion of percutaneous catheters such as: TPN/CVP catheters, PICC Line catheters, and Long Line catheters. The Catheter Insertion Tray provides the convenience of having these commonly used items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.

(5) **Intended Use of the Device:**

The Catheter Insertion Tray is a single patient, single use, disposable device which is intended to conveniently provide components to aid in the administration of percutaneous catheterization.

(6) **Technological Characteristics**

The MedCare Catheter Insertion Tray is similar to the predicate device in that both of the device provide a variety of auxiliary components for the convenient administration of percutaneous catheterization. Both devices provide flexibility in componentry selection for kit customization, which provides the maximum convenience for the customer. The proposed Catheter Insertion Tray will provide additional convenience by offering the inclusion of a vessel dilator and guide wire to the tray.