MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA

K960982 · Sherwood Medical Co. · FMI · Dec 23, 1996 · General Hospital

Device Facts

• Record ID: K960982
• Device Name: MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA
• Applicant: Sherwood Medical Co.
• Product Code: FMI · General Hospital
• Decision Date: Dec 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Monoject™ Blunt I.V. Access Cannula is a sterile, lubricated plastic cannula with a female luer hub. It is used to provide access to pre-pierced IV line injection sites and pre-pierced medication vials.

Device Story

Sterile, lubricated plastic cannula with female luer hub; used for accessing pre-pierced IV injection sites and medication vials; available as individual cannula or pre-attached to 3ml, 6ml, or 12ml piston syringes; operated by clinicians; facilitates needle-free access to IV systems; reduces risk of needlestick injuries.

Clinical Evidence

Bench testing only. Comparative performance testing included insertion force, bend test, and break resistance. Biocompatibility testing included cytotoxicity, intracutaneous irritation, acute systemic toxicity, sensitization, hemolysis, subchronic toxicity, and drug compatibility.

Technological Characteristics

Plastic cannula; female luer hub; sterile; lubricated; available as standalone or pre-attached to piston syringes (3ml, 6ml, 12ml).

Indications for Use

Indicated for accessing pre-pierced IV line injection sites and pre-pierced medication vials in clinical settings.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• B-D Interlink Syringe Cannula
• Monoject Lifeshield Blunt Cannula
• Monoject Lifeshield Blood Collection Device

Submission Summary (Full Text)

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ATTACHMENT #1
K960982

THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF SMDA 1990.

510(k) Summary of Safety & Effectiveness
Monoject™ Blunt I.V. Access Cannula

Submitted By: Sherwood Medical Co., 1915 Olive St., St. Louis, MO 63103, [phone]
Contact: Cheryl Winters-Heard, Manager, Regulatory Affairs
Date Prepared: March 6, 1996

DEC 23 1996

The Monoject™ Blunt I.V. Access Cannula is a Class II device per 21 CFR 880.5860, General Hospital Devices Panel 80, Procode FMF.

The Monoject™ Blunt I.V. Access Cannula is a sterile, lubricated plastic cannula with a female luer hub. It is used to provide access to pre-pierced IV line injection sites and pre-pierced medication vials.

The Monoject™ Blunt I.V. Access Cannula will be available in the following configurations: Individual Blunt Cannula; Blunt I.V. Access Cannula attached to piston syringe of 3 ml, 6ml and 12 ml sizes.

The Monoject™ Blunt I.V. Access Cannula is substantially equivalent in its intended use and function to the following currently marketed devices: B-D Interlink Syringe Cannula, Monoject Lifeshield Blunt Cannula, Monoject Lifeshield Blood Collection Device.

The Monoject™ Blunt I.V. Access Cannula and SE devices have undergone the following comparative testing:
- Insertion Force Test
- Bend Test
- Break Resistance and Resilience Test

In addition, the following testing will be performed to confirm that no issues of biological safety or effectiveness are raised.
- Cytotoxicity
- Intracutaneous Irritation
- Acute Systemic Toxicity
- Sensitization
- Hemolysis
- Subchronic Toxicity
- Drug Compatibility Testing.

The results of this testing will indicate that the Monoject™ Pointless Blunt I.V. Access Cannula perform equivalently to or better than the B-D Interlink Cannula product. No new issues relating to safety or efficacy were raised.

The Monoject™ Blunt I.V. Access Cannula will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.