SAFE MATE I.V. EXTENSION SETS

K962801 · Biological & Environmental Control Laboratories · FPA · Aug 28, 1996 · General Hospital

Device Facts

• Record ID: K962801
• Device Name: SAFE MATE I.V. EXTENSION SETS
• Applicant: Biological & Environmental Control Laboratories
• Product Code: FPA · General Hospital
• Decision Date: Aug 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The B.E.C. Safe Mate I.V. Extension Sets are intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the intravascular administration of fluids and medications. The I.V. Extension Sets provide for the entry to an intravascular administration set system without the need of a sharp needle by allowing for the penetration of a split septum injection sites or split septum Y-sites using an 11 gauge blunt plastic cannula.

Device Story

Device consists of PVC tubing set with male luer (slip, fixed, or rotating lock) at one end for catheter/needle connection and female luer/split septum needleless injection site at distal end. Used in clinical settings by healthcare providers to facilitate fluid/medication administration. Eliminates need for sharp needles by utilizing split septum sites compatible with 11-gauge blunt plastic cannulas. Includes options for standard or minibore tubing, J-loop configurations, Y-sites, and various clamps. Enhances provider safety by mitigating needlestick injury risks during IV therapy.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility testing confirms compliance with USP Class VI and Tripartite guidelines.

Technological Characteristics

Materials: Medical grade PVC tubing and components. Biocompatibility: Meets USP Class VI and Tripartite guidelines. Configuration: 4" to 36"+ lengths, standard (0.115" ID) or minibore (0.040" ID) tubing, J-loop, Y-sites, slide/clip/roller clamps. Connectivity: Male/female luer interfaces. Sterilization: Validated ethylene oxide process.

Indications for Use

Indicated for use by healthcare providers for the intravascular administration of fluids and medications, providing a needleless interface to reduce the 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 I.V. Extension Sets (K955821)
• IMED Corporation Needleless Devices (K945070)
• IMED Corporation Needleless Devices (K944320)
• IMED Corporation Needleless Devices (K931173)

Submission Summary (Full Text)

{0}

K962801

AUG 28 1996

bec Laboratories, Inc.

# 510(k) Summary

| Headquarters/Laboratory
705 front street
toledo, ohio 43605
phone: [phone]
fax: [phone] | Re: Trade Name: Safe Mate I.V. Extension Sets
Common Name: I.V. Extension Sets
Classification Name: Set, I.V. Fluid Transfer 80 LHI |
| --- | --- |
| Environmental Laboratory
1632 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 B.E.C. Safe Mate I.V. Extension Sets consist of a PVC tubing set which has a male luer (slip, fixed luer-lock, or rotating luer-lock) connector at one end intended to connect to an I.V. catheter or needle. At the distal end (or ends in the case of the bifurcated extension set or T-Connector extension set) is a female luer and/or split septum Needleless Injection Site for connection to an I.V. administration set. Extension set lengths may vary from 4" up to 36" or longer. The PVC tubing may be of standard bore (approximately 0.115" I.D.) or Minibore (approximately 0.040" I.D.) design and may be configured into a J-loop to facilitate tape fixation. Extension sets may also have one or more split septum Y-sites for the infusion of other liquid medications. Clamps (slide, clip, or roller) may also be included. |
| ) Sales Office
77 west elmwood drive
suite 123
dayton, ohio 45459
phone: [phone] | The risk to health care providers of "needlestick" injuries has become a major public health and worker safety concern. These I.V. Extension Sets are intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the intravascular administration of fluids and medications. The I.V. Extension Sets provide for the entry to an intravascular administration set system without the need of a sharp needle by allowing for the penetration of a split septum injection sites or split septum Y-sites using an 11 gauge blunt plastic cannula. |
| ) Medical Products Division
615 front street
toledo, ohio 43605
phone: [phone]
fax: [phone] | These I.V. Extension Sets utilize materials and components identical to Medical Network Associates, Incorporated's I.V. Extension Sets reviewed by FDA in 510(k) #K955821. These sets use needleless split septum |

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components identical to and found to be substantially equivalent to IMED Corporations Needleless Devices submitted under 510(k) #s K945070, K944320, and K931173. The needleless components are made of the same material by the same foreign manufacturer. Technological data and performance data were submitted for the IMED predicate devices. Tubing and standard set components are of medical grade and meet USP Class VI and/or Tripartite guideline biocompatibility requirements.

Packaging of these 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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