MAXCESS NEEDLE FREE CONNECTOR (8200)

K960661 · Solopak Medical Products, Inc. · FPA · Mar 21, 1996 · General Hospital

Device Facts

• Record ID: K960661
• Device Name: MAXCESS NEEDLE FREE CONNECTOR (8200)
• Applicant: Solopak Medical Products, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Mar 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Douglas Medical Products Maxcess Needlefree Connector is intended to be used as a needleless injection port that can be attached to a Luer Lock connector. It is intended for single patient use and 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

Needleless injection port; attaches to Luer Lock connectors; enables needle-free access to intravascular lines; single-patient use; swab-able; maintains line patency; used in clinical settings by healthcare providers; facilitates safe medication delivery/fluid access; reduces needlestick injury 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

One-piece Luer interfacing injection port; sterile; non-pyrogenic; packaged in Tyvek/polyethylene; sterilized per AAMI guidelines; LAL tested per USP guidelines.

Indications for Use

Indicated for use as a needleless injection port for intravascular administration sets; intended for single patient use; compatible with Luer Lock connectors.

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

• Clavem Connector (K915571)

Submission Summary (Full Text)

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K960661

Douglas Medical Products

A SoloPak® Company

MAR 21 1996

January 26, 1996

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 Connector
Common Name - Needleless Injection Port or Needlefree Injection Site
Classification Name - Intravascular Administration Set

The Douglas Medical Products Maxcess Needlefree Connector is intended to be used as a needleless injection port that can be attached to a Luer Lock connector. It is intended for single patient use and 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 Connector is a one piece design, Luer interfacing injection port. It is sterile, non-pyrogenic and packaged in a tyvek/polyethylene form, fill, and seal package. The materials used to manufacture the Douglas Medical Products Maxcess Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use. The indicated use of the Maxcess Needlefree Connector is the same or the equivalent of the predicate device named in this submission. The named predicate device in this submission is the Clavem Connector currently marketed by ICU Medical, Inc. under 510(k) #K915571. The Douglas Medical Products Maxcess Needlefree Connector 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 Connector utilizes similar and equivalent designs, and materials, as currently legally marketed products, it is safe and effective when used as intended.

Sincerely,

Ron Haselhorst
Director of RAIQA
Douglas Medical Products

1840 Industrial Drive, Suite 200, Libertyville, IL 60038 - 700-222-2222