BEC NEEDLELESS INJECTION SITE

K961327 · Biological & Environmental Control Laboratories · FPA · May 15, 1996 · General Hospital

Device Facts

• Record ID: K961327
• Device Name: BEC NEEDLELESS INJECTION SITE
• Applicant: Biological & Environmental Control Laboratories
• Product Code: FPA · General Hospital
• Decision Date: May 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Needleless Injection Site is intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the administration of fluids and medications. The Needleless Injection Site provides for the entry to an intravascular administration set or catheter without the need of a sharp needle by allowing for the use of a blunt cannula.

Device Story

Device consists of tubular body with male luer lock for connection to intravascular catheters/administration sets. Opposite end features enlarged section with cylindrical retaining ring compressing pre-slit natural rubber septum. Designed to receive and latch with BEC, MED-NET, or IMED shrouded plastic cannulas. Septum re-seals upon cannula removal. Used by healthcare providers in clinical settings to enable needle-free access to IV lines, replacing sharp needles with blunt cannulas to prevent accidental needlestick injuries.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established via design and material identity to predicate devices.

Technological Characteristics

Tubular body with male luer lock; natural rubber pre-slit septum; cylindrical retaining ring. Sterilization via validated ethylene oxide process.

Indications for Use

Indicated for use by healthcare providers to facilitate fluid and medication administration via intravascular sets or catheters while reducing risk of needlestick injuries.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Medical Network Associates, Incorporated Needleless Injection Site (K953343)
• IMED Corporation Needleless Injection Site (K944320)

Submission Summary (Full Text)

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K961327

bec laboratories, inc

MAY 15 1996

# 510(k) Summary

| Headquarters/Laboratory |
| --- |
| 705 front street |
| Toledo, Ohio 43605 |
| phone: [phone] |
| fax: [phone] |
| Environmental Laboratory |
| 1232 enterprise parkway |
| Twinsburg, Ohio 44087 |
| phone: [phone] |
| fax: [phone] |
| Sales Office |
| 129 dixie way south |
| south bend, indiana 46637 |
| phone: [phone] |
| Sales Office |
| West elmwood drive |
| suite 123 |
| dayton, Ohio 45459 |
| phone: [phone] |
| Medical Products Division |
| 615 front street |
| Toledo, Ohio 43605 |
| phone: [phone] |

Re: Trade Name: BEC Needleless Injection Site
Common Name: Needleless Injection Site
Classification Name: Set, Administration, Intravascular 80 FPA

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.

The BEC Needleless Injection Site consists of a tubular body with a male luer lock attachment at one end. This attachment is designed to connect to a female luer lock or luer slip connector of a catheter or other intravascular administration device. The other end of the tubular body is provided with an enlarged section adapted to receive a cylindrical retaining ring which surrounds and compresses a pre-slit, natural rubber septum. The septum retaining ring and enlarged section of the tubular body are adapted to receive and latch with the BEC, MED-NET, or IMED shrouded plastic cannula. The pre-slit septum re-seals upon removal of the cannula.

The Needleless Injection Site is intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the administration of fluids and medications. The Needleless Injection Site provides for the entry to an intravascular administration set or catheter without the need of a sharp needle by allowing for the use of a blunt cannula.

This needleless injection site is identical to Medical Network Associates, Incorporated's Needleless Injection Site reviewed by FDA in 510(k) # K953343 which was identical to and found to be substantially equivalent to IMED Corporations Needleless Injection Site submitted under 510(k) #K944320. These injection sites 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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