INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE

K962893 · Baxter Healthcare Corp · FPA · Oct 18, 1996 · General Hospital

Device Facts

• Record ID: K962893
• Device Name: INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE
• Applicant: Baxter Healthcare Corp
• Product Code: FPA · General Hospital
• Decision Date: Oct 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The proposed adapter will be used to convert a conventional needle-accessed y-injection site on a Baxter or competitive solution administration set to an InterLink® injection site. This device, like other products containing the InterLink® injection site is designed to reduce the risk of accidental needle sticks when used in conjunction with the InterLink® cannula, as part of a “needless” IV access system.

Device Story

Adapter converts conventional needle-accessed Y-injection sites on IV administration sets to InterLink® needless access sites. Device features plastic spike for septum penetration and U-shaped slot for securing to Y-site arm. Operated by clinicians in clinical settings during IV therapy. Eliminates need for needles during access; reduces accidental needle stick risk. Integrates InterLink® injection site into compact housing. Compatible with various manufacturer IV sets.

Clinical Evidence

Bench testing only. Evaluated seal integrity and security of adapter on Baxter and competitive IV sets (Abbott, IMED, IVAC, Burron Medical, McGaw). Results indicate device meets or exceeds functional requirements.

Technological Characteristics

Plastic and rubber materials previously cleared for IV applications. Features plastic spike for septum penetration and U-shaped slot for mechanical attachment to Y-site arm. Compact integrated housing design. Non-powered, manual device.

Indications for Use

Indicated for patients requiring IV solution administration via conventional needle-accessed Y-sites, enabling conversion to a needless InterLink® access system to reduce accidental needle stick risks.

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

• Locking Needle Sheath with InterLink® Injection Site (K914048)
• InterLink® Universal Vial Adapter (K924064)

Submission Summary (Full Text)

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510(k) SUMMARY
OCT 18 1996
InterLink® Adapter for Conventional Y-Site
K962893

## Submitted by:

Mary Ellen Snyder
Baxter Healthcare Corporation
I.V. Systems Division
Rte. 120 and Wilson Road
Round Lake, IL 60073

## Date Prepared:

July 23, 1996

## Proposed Device:

InterLink® Adapter for Conventional Y-Site

## Predicate Devices:

Locking Needle Sheath with InterLink® Injection Site
InterLink® Universal Vial Adapter

## Proposed Device Description:

The proposed InterLink® Adapter for Conventional Y-Site is designed to convert a conventional (needle-accessed) y-injection site to an InterLink® injection site (needless access). The InterLink® injection site is incorporated into the top of the adapter to allow access to conventional injection sites with InterLink® cannulae. The adapter contains a plastic spike to pierce the conventional Y-site septum and a slot which connects to the arm of the Y-site. There are no new materials involved in the proposed adapter. All plastic and rubber materials used have been previously tested and used in other Baxter devices for similar I.V. solution administration applications.

## Statement of Intended Use:

The proposed adapter will be used to convert a conventional needle-accessed y-injection site on a Baxter or competitive solution administration set to an InterLink® injection site. This device, like other products containing the InterLink® injection site is designed to reduce the risk of accidental needle sticks when used in conjunction with the InterLink® cannula, as part of a “needless” IV access system.

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JUL 23 1996 42

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# Summary of Technological Characteristics of New Device to Predicate Devices

The proposed InterLink® Adapter for Conventional Y-Site is similar to Baxter’s Locking Needle Sheath (NeedleLock) with InterLink® Injection Site previously found substantially equivalent under K914048. Both products incorporate the Interlink® injection site into the top of the device to allow access to conventional injection sites with InterLink® cannulae. Both devices have a means for piercing the conventional y-site septum and both have a slot which connects to the arm of the Y-site.

The NeedleLock with InterLink® Injection Site consists of independent NeedleLock and injection site components bonded together. The proposed adapter differs in that the InterLink® injection site is integrated into the housing which results in a more compact component. The adapter contains a plastic spike to pierce the y-site septum whereas the NeedleLock device has a needle for septum penetration. The slot of the NeedleLock is L-shaped and is twisted to lock onto the y-arm. The adapter has a U-shaped slot which is positioned over the y-arm after spike penetration.

The proposed InterLink® Adapter for Conventional Y-Site is also similar to the InterLink® Universal Vial Adapter, covered by K924064. Both adapters incorporate the InterLink® injection site and allow standard needle-accessed components (Y-sites or vial stoppers) to be accessible with the InterLink® blunt cannula. Both adapters use a spike to pierce the Y-site or vial stopper which remains fully seated and secure after penetration without use of a locking mechanism.

# Discussion of NonClinical Tests and Referenced Studies Reported in Published Literature

Data regarding the functional performance of the proposed adapter have been generated. A description of the functional testing along with test results is provided. Testing was performed with Baxter and competitive sets including Abbott, IMED, IVAC, Burron Medical and McGaw sets. Studies evaluated the integrity of the seal between the adapter and set Y-Site and the security of the adapter on the Y-Site. The data indicate that the proposed adapter meets or exceeds all functional requirements and support its suitability for use with the intended sets.

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JUL 23 1996