BEC SHROUDED PLASTIC CANNULA

K961328 · Biological & Environmental Control Laboratories · FMI · May 30, 1996 · General Hospital

Device Facts

• Record ID: K961328
• Device Name: BEC SHROUDED PLASTIC CANNULA
• Applicant: Biological & Environmental Control Laboratories
• Product Code: FMI · General Hospital
• Decision Date: May 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Shrouded Plastic Cannula is intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the administration of fluids and medications. The Shrouded Plastic Cannula provides the ability to penetrate a split septum injection site or Y-site for entry into a intravascular system without the need of a sharp needle.

Device Story

Device consists of shrouded blunt tubular cannula with female luer attachment; connects to male luer lock/slip connectors on tubing sets or syringes. Used by healthcare providers to access intravascular systems via pre-slit, natural rubber septums (e.g., BEC, MED-NET, IMED injection sites). Eliminates need for sharp needles, reducing risk of accidental needlestick injuries during fluid/medication administration.

Clinical Evidence

No clinical data; bench testing only. Performance data referenced from predicate device (K945070).

Technological Characteristics

Blunt tubular cannula with female luer attachment. Materials identical to predicate. Sterilization via validated ethylene oxide process.

Indications for Use

Indicated for healthcare providers requiring needleless access to intravascular systems via pre-slit, natural rubber septums for fluid and medication administration.

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

• Medical Network Associates, Incorporated Shrouded Plastic Cannula (K952834)
• IMED Corporation Shrouded Plastic Cannula (K945070)

Submission Summary (Full Text)

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BEC laboratories, inc

K96/328

# 510(k) Summary

MAY 30 1996

| Headquarters/
Laboratory
705 front street
Toledo, Ohio 43605
phone: [phone]
fax: [phone] | Re: Trade Name: BEC Shrouded Plastic Cannula
Common Name: Shrouded Plastic Cannula
Classification Name: Needle, Aspiration & Injection, Disposable 79 GAA |
| --- | --- |
| Environmental Laboratory
1633 enterprise parkway
Twinsburg, Ohio 44087
phone: [phone]
fax: [phone] | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 and DSMA 1995. |
| Sales Office
129 dixie way south
south bend, Indiana 46637
phone: [phone] | The BEC Shrouded Plastic Cannula consists of a shrouded blunt tubular cannula at one end and a female luer attachment at the other. This luer attachment is designed to connect to a male luer lock or luer slip connector of a tubing set, syringe, or other intravascular administration device. The cannula end of the body is designed to penetrate a pre-slit, natural rubber septum and latch with the BEC, MED-NET or IMED Needleless Injection Site or Y-site. |
| Sales Office
7/ west elmwood drive
suite 123
dayton, Ohio 45459
phone: [phone] | The Shrouded Plastic Cannula is intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the administration of fluids and medications. The Shrouded Plastic Cannula provides the ability to penetrate a split septum injection site or Y-site for entry into a intravascular system without the need of a sharp needle. |
| Medical Products Division
615 front street
Toledo, Ohio 43605
phone: [phone]
fax: [phone] | This Shrouded Plastic Cannula is identical to Medical Network Associates, Incorporated's Shrouded Plastic Cannula reviewed by FDA in 510(k) #K952834 which was identical to and found to be substantially equivalent to IMED Corporations Shrouded Plastic Cannula submitted under 510(k) #K945070. These cannulas are made of the same material by the same foreign manufacturer. Technological data and performance data were submitted for the IMED predicate device. |

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# 510(k) Summary (Continued)

Packaging of the device is either performed in-house or under contract by a registered device establishment. Sterilization is performed in-house using a validated ethylene oxide process. Both packaging and sterilization procedures are consistent with those generally used by the medical device industry.

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