← Product Code [LHI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI) · K955595 # SAFELINE MULTIDOSE VIAL ADAPTER (K955595) _Mcgaw, Inc. · LHI · Mar 6, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K955595 ## Device Facts - **Applicant:** Mcgaw, Inc. - **Product Code:** [LHI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI.md) - **Decision Date:** Mar 6, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The SafeLine Multidose Vial Adapter is intended for multiple withdrawals of drug solution from standard size drug vial solid stoppers. The spike portion of the SafeLine Multidose Vial Adapter is inserted into the drug vial solid stopper and the drug solution is withdrawn using a blunt plastic cannula connected to a syringe. The fluid is withdrawn into the syringe through the blunt plastic cannula inserted into the injection site portion of the SafeLine Multidose Vial Adapter. The drug solution in the syringe can then be transferred to an I.V. administration set with a pre-slit septum injection site for administration of the drug solution to the patient. The SafeLine Multidose Vial Adapter replaces use of a traditional metal hypodermic needle to provide needlefree access to drug vials. Thus, eliminating the potential for accidental needlestick injury. ## Device Story SafeLine Multidose Vial Adapter is a sterile plastic accessory for drug vials; features pre-slit rubber septum injection site and drug vial spike. Device enables needlefree drug withdrawal; user inserts spike into vial stopper; withdraws solution via blunt plastic cannula attached to syringe. Used in clinical settings to transfer medication to I.V. administration sets. Replaces traditional metal hypodermic needles; eliminates accidental needlestick injury risk. Green tint signifies needlefree SafeLine product compatibility. ## Clinical Evidence Bench testing only. Evidence includes functional performance testing and microbiological challenge testing comparing the subject device to the predicate. ## Technological Characteristics Single sterile plastic device; includes pre-slit rubber septum injection site and drug vial spike. Green-tinted plastic construction. Designed for needlefree access to standard drug vials. ## 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 - Baxter InterLink® System Universal Vial Adapter ## 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} McGaw, Inc. 510(k) Notification December 7, 1995 MAR - 6 1996 K 955595 ATTACHMENT 7 510(k) Summary 40 {1} McGaw, Inc. 2525 McGaw Avenue P.O. Box 19791 Irvine, California 92713-9791 Telephone: 714.660 2000 Fax: 714.660 2700 # 510(k) Summary "This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92." "The assigned 510(k) number is: 4955595." ## 1) Submitter Information McGaw, Inc. 2525 McGaw Avenue P.O. Box 19791 Irvine, California 92713-9791 Contact Person: John G. D'Angelo, M.S., R.Ph. Director, Regulatory Affairs Phone: (714) 660-2517 FAX: (714) 66-3293 ## 2) Name of Device Trade/Proprietary Name: SafeLine™ Multidose Vial Adapter Common/Usual Name: I.V. Fluid Transfer Set Classification Name: Set, Intravascular, Administration ## 3) Predicate Device The currently marketed Baxter InterLink® System Universal Vial Adapter is the predicate used for the substantial equivalence claim. ## 4) Description of the Subject Device The SafeLine™ Multidose Vial Adapter is an additional accessory device for use with McGaw’s SafeLine System. It is a single sterile plastic device composed of a pre-slit rubber septum injection site, a standard drug vial spike and a plastic spike tip protector. The SafeLine Multidose Vial Adapter is designed to withdraw drug solution from the solid stopper of standard size drug vials using a blunt plastic cannula attached to a syringe. Thus providing needlefree access of drug vials. As with all of the currently marketed SafeLine devices, the new SafeLine Multidose Vial Adapter is tinted green to signify a needle free SafeLine product. 41 {2} McGaw, Inc. 2525 McGaw Avenue P.O. Box 19791 Irvine, California 92713-9791 Telephone: 714.660.2000 Fax: 714.660.2700 ## 5) Intended Use of the Subject Device The SafeLine Multidose Vial Adapter is intended for multiple withdrawals of drug solution from standard size drug vial solid stoppers. The spike portion of the SafeLine Multidose Vial Adapter is inserted into the drug vial solid stopper and the drug solution is withdrawn using a blunt plastic cannula connected to a syringe. The fluid is withdrawn into the syringe through the blunt plastic cannula inserted into the injection site portion of the SafeLine Multidose Vial Adapter. The drug solution in the syringe can then be transferred to an I.V. administration set with a pre-slit septum injection site for administration of the drug solution to the patient. The SafeLine Multidose Vial Adapter replaces use of a traditional metal hypodermic needle to provide needlefree access to drug vials. Thus, eliminating the potential for accidental needlestick injury. ## 6) Technological Characteristics of the Subject Device The subject device, the SafeLine™ Multidose Vial Adapter, is substantially equivalent to the predicate device, the Baxter InterLink® System Universal Vial Adapter. There are technological differences between the subject device and the predicate device. However, these technological differences do not raise any different questions of safety and efficacy. The substantial equivalence claim is supported by the information presented in this 510(k) submission. This information is contained in Attachments 1 through 6 and includes the following: - Description and intended use of the subject device and the predicate device - Comparison of the attributes of the subject device with the attributes of the predicate device - Material composition of the subject device components - Drawing of the subject device - Functional performance and comparison testing of the subject device and the predicate device - Microbiological challenge testing comparing the subject device and the predicate device - Draft labeling of the subject device and the predicate device current labeling The conclusions drawn from the information listed above support that the new SafeLine Multidose Vial Adapter is substantially equivalent to the Baxter InterLink System Universal Vial Adapter. ## 7) Signature of Applicant: McGaw, Inc. John G. D’Angelo, M.S., R.Ph. Director Regulatory Affairs Signature Diane Gernot for J.D’Angelo Date 12-7-95 42 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K955595](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K955595) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com