MAXCESS NEEDLEFREE - Y- SITE (100713)

K970800 · Solopak Medical Products, Inc. · FPA · Apr 2, 1997 · General Hospital

Device Facts

• Record ID: K970800
• Device Name: MAXCESS NEEDLEFREE - Y- SITE (100713)
• Applicant: Solopak Medical Products, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Apr 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Douglas Medical Products Maxcess™ NeedleFree Y-Site is intended for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The needlefree side port of the y-site can be swabbed and then accessed multiple times within the limits of CDC guidelines and/or institutional guidelines. The closure system has been tested and has been found to maintain line patency throughout the labeled duration of use.

Device Story

Intravascular administration set accessory; placed between primary solution source and patient vascular access device; provides unobstructed fluid flow; features needle-free side port for intermittent access; used in clinical settings; operated by healthcare professionals; maintains line patency; facilitates medication delivery or fluid administration; benefits patient by reducing needle-stick risk.

Clinical Evidence

Bench testing only. Materials tested per tripartite guidelines; sterility assurance level 10^-6 per AAMI guidelines; LAL testing per USP guidelines.

Technological Characteristics

Sterile, non-pyrogenic Y-site injection component. Materials tested per tripartite guidelines. Sterilized per AAMI guidelines to 10^-6 SAL. LAL tested per USP guidelines. Mechanical flow-through design.

Indications for Use

Indicated for single patient use as an intravascular administration set accessory for placement between a primary solution source and a patient's vascular access device to provide unobstructed fluid flow and needle-free access for intermittent injections.

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

• Maxcess™ NeedleFree Connector (K960661)

Submission Summary (Full Text)

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K970800
March 19, 1997
Summary of Safety and Effectiveness
SolePak® Medical Products
APR - 3 1997

To Whom it may concern:

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act and CFR 807.92:

Trade Name - Maxcess™ NeedleFree Y-Site
Common Name - Y-Injection Site
Classification Name - Intravascular Administration Set (accessory)

The Douglas Medical Products Maxcess™ NeedleFree Y-Site is intended for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The needlefree side port of the y-site can be swabbed and then accessed multiple times within the limits of CDC guidelines and/or institutional guidelines. The closure system has been tested and has been found to maintain line patency throughout the labeled duration of use.

The Douglas Medical Products Maxcess™ NeedleFree Y-Site is a sterile, non-pyrogenic component packaged in a tyvek/polyethylene form, fill, and seal package. The materials used to manufacture the Douglas Medical Products Maxcess™ NeedleFree Y-Site have been tested per tripartite guidelines and is safe for it's intended use. The indicated use of the Maxcess™ NeedleFree Y-Site is the same or equivalent to the predicate device named in this submission. The named predicate device in this submission is the Maxcess™ NeedleFree Connector currently marketed by Douglas Medical Products under 510(k) #K960661. The Douglas Medical Products Maxcess™ NeedleFree Y-Site is sterilized per AAMI guidelines to a $10^{-6}$ sterility assurance level. Each production lot is LAL tested per USP guidelines.

Based on the fact that the Douglas Medical Products Maxcess™ NeedleFree Y-Site utilizes similar and equivalent designs, and materials, as current legally marketed products, it is safe and effective when used as intended.

Sincerely,

Elizabeth Loya, RN
Regulatory Affairs Associate
Douglas Medical Products

1845 Tonne Road, Elk Grove Village, Illinois 60007-5125 • Telephone: [phone] • Telefax: 847-806-0087