PERIPHERALLY INSERTED MEDLINE CATHETER

K963257 · Arrow Intl., Inc. · LJS · Mar 4, 1997 · General Hospital

Device Facts

• Record ID: K963257
• Device Name: PERIPHERALLY INSERTED MEDLINE CATHETER
• Applicant: Arrow Intl., Inc.
• Product Code: LJS · General Hospital
• Decision Date: Mar 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Device Story

Arrow Peripherally Inserted Midline Catheter; polyurethane construction; single or double lumen configurations; trimmable or non-trimmable lengths; optional placement wire. Used for venous access. Clinician-operated. Provides vascular access for infusion therapy.

Clinical Evidence

Bench testing only. Results include flow rate, priming volume, flex modulus, burst pressure, and tensile strength tests. Biocompatibility requirements met.

Technological Characteristics

Polyurethane material; single/double lumen; trimmable/non-trimmable lengths; optional placement wire. Mechanical device; no software or energy source.

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

• Menlo Care Landmark Catheter

Submission Summary (Full Text)

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MAR - 4 1997

# 510(k) Summary - K963257

The Arrow Peripherally Inserted Midline Catheter is made of polyurethane material that is similar to our existing PIC catheters. The midline catheter will be available in both single and double lumen configurations, several trimmable and non-trimmable lengths, and the option of inserting with or without a placement wire.

The device has comparable technological characteristics to several predicate devices. For the purposes of this submission, the Arrow Midline Catheter is compared to the Menlo Care Landmark Catheter in terms of the following nonclinical test results:

- Flow rate test
- Priming volume test
- Flex modulus test
- Burst pressure test
- Tensile strength test

The device also meets all biocompatibility requirements.

96113

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