NFC NEEDLEFREE CONNECTOR MODEL 69900

K981548 · Filtertek, Inc. · FPA · Jun 18, 1998 · General Hospital

Device Facts

• Record ID: K981548
• Device Name: NFC NEEDLEFREE CONNECTOR MODEL 69900
• Applicant: Filtertek, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jun 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

This device is intended to be used as a needless injection port that can be attre hed to any standard luer connector. It is a single patient use device that has an access port that can be swabbed and accessed multiple times.

Device Story

Filtertek NFC Needlefree Connector is a one-piece, luer-interfacing injection port. Device attaches to standard luer lock connectors to provide a needleless access point for fluid administration. Designed for single-patient use; port surface is swab-able for multiple access events. Maintains line patency during use. Used in clinical settings to facilitate safe intravenous access without needles. Benefits include reduced risk of needlestick injuries and maintenance of closed system integrity.

Clinical Evidence

Bench testing only. Materials tested per tripartite guidelines. Sterility verified per AAMI guidelines to 10-6 SAL. Production lots undergo LAL testing per USP guidelines.

Technological Characteristics

One-piece luer-interfacing design. Materials tested per tripartite guidelines. Sterilization via AAMI guidelines to 10-6 sterility assurance level. LAL testing per USP guidelines. Standalone mechanical device.

Indications for Use

Indicated for use as a needleless injection port for attachment to standard luer connectors for single patient use, allowing for multiple access events.

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™ Connector (K960661)
• Clave™ Connector (K915571)

Submission Summary (Full Text)

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JUN 1 8 1998

## June 11, 1998

## SUMMARY OF SAFETY AND EFFECTIVENESS

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: NFC Needlefree Connector Common Name: Needless injection port or needlefree injection site Classification Name: Intravascular Administration Set

The Filtertek NFC 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. The closure has been tested and has been found to maintain line patency throughout the labeled duration of use.

The Filtertek NFC Needlefree Connector is a one-piece design. luer interfacing injection port. It is sterile, nonpyroqenic and packaged in a Tyvek/polyethylene form, fill, and seal package. The materials used to manufacture the Filtertek NFC Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use. The indicated use of the NFC Needlefree Connector is the same or the equivalent of the predicate device named in this submission. The named predicate devices in this submission are Douglas Medical products Maxcess™ Connector currently marketed by Douglas Medical Products under 510(k) #K960661, and the Clave™ Connector currently marketed by ICU Medical, Inc under 510(k) #K915571. The Filtertek NFC Needlefree Connector is sterilized per AAMI quidelines to a 108 sterility assurance level. Each production lot is LAL tested per USP guidelines.

Based on the fact that the Filtertek NFC Connector utilizes similar and equivalent designs and materials as currently legally marketed products, it is safe and effective when used as intended.

By:

Larry Larkin Requlatory Affairs Administrator

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 1998

Mr. Larry Larkin 'Requlatory Affairs Administrator Filtertek, Incorporated 11411 Price Road P.O. Box 310 Hebron, Illinois 60034

K981548 Re : Trade Name: NFC Needlefree Connector Model 69960 Regulatory Class: II Product Code: FPA Dated: April 17, 1998 Received: April 30, 1998

Dear Mr. Larkin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Larkin

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known): To be assigned

Device Name: NFC Needlefree Connector

Indications For Use:

This device is intended to be used as a needless injection port that can be attre hed to any standard luer connector. It is a single patient use device that has an access port that can be swabbed and accessed multiple times.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device evaluation (ODE)

(Division Sign-Off) 3. Both Division of Dental, Infection of Dental, Infection Control, and General Hospital Devices 510(k) Number_K9Q154 Y

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)