BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)

K963012 · Bioject, Inc. · LHI · Oct 15, 1996 · General Hospital

Device Facts

• Record ID: K963012
• Device Name: BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)
• Applicant: Bioject, Inc.
• Product Code: LHI · General Hospital
• Decision Date: Oct 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The intended use of the Bioject Needle-Free Vial Adapter is to allow single access to 13 mm drug vials for withdrawal of medications, withdrawal and transfer of diluents, and reconstitution and withdrawal of medications, without the use of needles. The Bioject Needle-Free Vial Adapter may be used by physicians, nurses, and other practitioners who routinely administer injections, or by patients and other individuals authorized by their physicians to administer injections of prescribed medication.

Device Story

Device: single-piece polycarbonate adapter; provides needle-free access to 13 mm drug vials. Input: standard luer taper syringe connected to female luer lock fitting. Operation: shielded spike pierces vial stopper; directs fluid along vial walls to minimize foaming during reconstitution/withdrawal. Usage: clinical or home settings; operated by physicians, nurses, or patients. Output: enables safe fluid transfer/reconstitution without needles. Benefit: eliminates needle-stick risk during vial access.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established through design, material, and functional comparison to predicate devices.

Technological Characteristics

Material: Polycarbonate. Design: Single-piece adapter with female luer lock fitting and shielded spike for 13 mm vial stoppers. Sterilization: Sterile, non-pyrogenic, single-use. Connectivity: None (mechanical).

Indications for Use

Indicated for clinicians, patients, or authorized individuals requiring needle-free access to 13 mm drug vials for medication withdrawal, diluent transfer, or reconstitution.

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

• Baxter Needle*Less™ Drug Vial Adapter (K894177)
• Abbott LifeShield™ Vial Adapter (K920737)

Submission Summary (Full Text)

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*Date

OCT 15 1996

K963012

# 510(k) SUMMARY (21CFR Subpart 807.92)

(a) (1) Submitter Identification:

Bioject, Inc.
7620 SW Bridgeport Road
Portland, OR 97224
800-683-7221
503-624-9002 (fax)

Contact Person:
Jeff Snow
Regulatory Affairs & Quality Assurance

(a)(2) Device Name: Bioject Needle-Free Vial Adapter (13 mm)
Common Name: Needle-Free Fluid Transfer Device
Classification Name: Accessory to a syringe, 21 CFR 880.5860

(a)(3) Predicate Devices: Baxter Needle*Less™ Drug Vial Adapter (K894177)
Abbott LifeShield™ Vial Adapter (K920737)

(a)(4) Device Description: The Bioject Needle-Free Vial Adapter is a device which provides single access to 13 mm drug vials for withdrawal of medications, withdrawal and transfer of diluents, reconstitution and withdrawal of medications, without the use of needles. The Bioject Needle-Free Vial Adapter is a one piece, polycarbonate adapter with a standard female luer lock fitting compatible with standard luer taper syringes and a shielded spike designed to fit 13 mm outside diameter vial stopper overseas. The spike is designed to direct fluid along the drug vial walls in order to minimize foaming when used to reconstitute medications. The Bioject Needle-Free Vial Adapters are sterile, non-pyrogenic, and intended for single-use only. The adapters are individually packaged in a sterile, single-use Tyvek blister pack.

(a)(5) Intended Use / Indications For Use: The intended use of the Bioject Needle-Free Vial Adapter is to allow single access to 13 mm drug vials for withdrawal of medications, withdrawal and transfer of diluents, and reconstitution and withdrawal of medications, without the use of needles. The Bioject Needle-Free Vial Adapter may be used by physicians, nurses, and other practitioners who routinely administer injections, or by patients and other individuals authorized by their physicians to administer injections of prescribed medication.

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020

(a)(6) *Substantial Equivalence:*, The Bioject Needle-Free Vial Adapter which is the subject of this submission is substantially equivalent to the predicate Baxter Needle*Less™ Drug Vial Adapter, K894177, and predicate Abbott LifeShield™ Vial Adapter, K920737, with respect to intended use, material, design and operational principles.

The intended use of the Bioject Needle-Free Vial Adapter is for withdrawal of medications, withdrawal and transfer of diluents, and reconstitution and withdrawal of medications, without the use of needles.

Predicate Baxter Needle*Less™ Drug Vial Adapters (K894177) and LifeShield™ Vial Adapters (K9200737) may be used to allow drug vial access for fluid (medication) transfer, and reconstitution and dilution of medications.

The Bioject Needle-Free Vial Adapter has a standard female luer lock fitting compatible with standard luer taper syringes and a shielded spike end designed to fit 13 mm outside diameter vial stopper overseas. The spike is designed to direct fluid along the drug vial walls in order to minimize foaming when used to reconstitute medications.

Both predicate vial adapters have a shielded spike end to fit the vial stopper overseas. They differ at the opposite ends which have a septum or slit reseal stopper for use with other blunt cannula devices.

Bioject Needle-Free Vial Adapters are provided sterile, nonpyrogenic, and for single-use only.

The predicate devices are provided sterile, nonpyrogenic, and for single-use only.

Product design and materials for the Bioject Needle-Free Vial Adapter demonstrate functional equivalence to the predicate devices. The device is as safe and effective as the legally marketed, predicate devices, and does not raise questions of safety and efficacy different than that of the predicate.