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portion of the SafeLine Multidose Vial Adapter is inserted into the drug vial solid stopper and the drug solution is withdrawn using a blunt plastic cannula connected to a syringe. The fluid is withdrawn into the syringe through the blunt plastic cannula inserted into the injection site portion of the SafeLine Multidose Vial Adapter.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 Description

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.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (SafeLine™ Multidose Vial Adapter), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies or training set details) is not applicable to this document.

The document describes a conventional medical device and focuses on demonstrating substantial equivalence to a predicate device based on material composition, functional performance, and microbiological challenge testing.

Summary

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McGaw, Inc. 510(k) Notification
December 7, 1995

MAR - 6 1996

K 955595

ATTACHMENT 7

510(k) Summary

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McGaw, Inc.

2525 McGaw Avenue California 92713-9791 hone: 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:

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

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2525 McGaw Avenue Fax: 714 660 2700

5) Intended Use of the Subject Device

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

Diane Geist for J. D. Angel
Signature

Signature

12-7-95

Date

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.