SAFE MATE I.V. FLUID DELIVERY SETS

K962802 · Biological & Environmental Control Laboratories · FPA · Aug 28, 1996 · General Hospital

Device Facts

• Record ID: K962802
• Device Name: SAFE MATE I.V. FLUID DELIVERY 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. Fluid Delivery Sets consist of a PVC tubing set which has a male luer (slip, fixed luer-lock, or rotating luer-lock) connector or an attached schrouded plastic cannula at one end intended to connect to an I.V. catheter, needle or a split septum injection site extension set affixed to an I.V. catheter. Fluid delivery set lengths may vary from 60" up to 120" or longer. Fluid Delivery 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.

Device Story

I.V. fluid delivery set; PVC tubing; male luer connectors or shrouded plastic cannula; split septum Y-sites; slide/clip/roller clamps. Used by healthcare providers in clinical settings for intravascular fluid/medication administration. Replaces sharp needles with 11-gauge blunt plastic cannula for split septum access; reduces needlestick injury risk. Connects to I.V. catheters or extension sets. Passive safety mechanism; no active processing.

Clinical Evidence

Bench testing only. Biocompatibility testing confirms materials meet USP Class VI and/or Tripartite guidelines. Sterilization validated via ethylene oxide process.

Technological Characteristics

PVC tubing; 11-gauge blunt plastic cannula; male luer (slip, fixed, or rotating) connectors; split septum Y-sites; slide/clip/roller clamps. Materials meet USP Class VI and Tripartite biocompatibility standards. Sterilization: Ethylene oxide.

Indications for Use

Indicated for intravascular administration of fluids and medications in patients requiring I.V. therapy. Intended to provide protection against inadvertent needlestick injuries to healthcare providers by enabling needleless access to split septum injection sites or Y-sites using an 11 gauge blunt plastic cannula.

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. Fluid Delivery Sets (K955821)
• IMED Corporations Needleless Devices (K945070)
• IMED Corporations Needleless Devices (K944320)
• IMED Corporations Needleless Devices (K931173)

Submission Summary (Full Text)

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DEC Laboratories, Inc.
AUG 28 1996
K962802

# 510(k) Summary

| Headquarters/Laboratory
705 front street
toledo, ohio 43605
phone: [phone]
fax: [phone] | Re: Trade Name: Safe Mate I.V. Fluid Delivery Sets
Common Name: I.V. Fluid Delivery 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. Fluid Delivery Sets consist of a PVC tubing set which has a male luer (slip, fixed luer-lock, or rotating luer-lock) connector or an attached schrouded plastic cannula at one end intended to connect to an I.V. catheter, needle or a split septum injection site extension set affixed to an I.V. catheter. Fluid delivery set lengths may vary from 60" up to 120" or longer. Fluid Delivery 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. Fluid Delivery 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. Fluid Delivery Sets provide for the entry into an intravascular administration 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. Fluid Delivery Sets utilize materials and components identical to Medical Network Associates, Incorporated's I.V. Fluid Delivery Sets reviewed by FDA in 510(k) #K955821. These sets use needleless split septum 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. |

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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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