← Product Code [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA) · K962893 # INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE (K962893) _Baxter Healthcare Corp · FPA · Oct 18, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K962893 ## Device Facts - **Applicant:** Baxter Healthcare Corp - **Product Code:** [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA.md) - **Decision Date:** Oct 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for 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. ## Regulatory 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](/device/K914048.md)) - InterLink® Universal Vial Adapter ([K924064](/device/K924064.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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. s:\510k\inadpsum JUL 23 1996 42 {1} # 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. s:\510k\inadpsum JUL 23 1996 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K962893](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K962893) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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