NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5

K053129 · Nexus Medical, LLC · FPA · Dec 8, 2005 · General Hospital

Device Facts

• Record ID: K053129
• Device Name: NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5
• Applicant: Nexus Medical, LLC
• Product Code: FPA · General Hospital
• Decision Date: Dec 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The NIS-5 Is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids. The NIS-5 device may aid in the prevention of needle stick injuries.

Device Story

NexusTKO Needleless Access Device (Model NIS-5) functions as an accessory to intravascular administration sets. Device facilitates needle-less delivery of drugs and fluids to patients; primary clinical benefit is reduction of needle stick injuries for healthcare providers. Device is used in clinical settings where IV access is required. Operation involves connection to standard IV administration sets to provide a closed, needle-less access point for fluid/drug infusion.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Needleless intravascular access device; functions as an accessory to IV administration sets. Class II device (Product Code FPA).

Indications for Use

Indicated for use as an intravascular administration set accessory for the delivery of drugs and fluids in patients requiring intravenous therapy. Intended to aid in the prevention of needle stick injuries.

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.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2005 DEC 8

2005

Mr. AL Boedeker Director of Quality Nexus Medical, LLC 11315 Strang Line Road Lenexa, Kansas 66215

Re: K053129

Trade/Device Name: NexusTKO Needleless Access Device, Model NIS-5 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 25, 2005 Received: November 8, 2005

Dear Mr. Boedeker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have revealy one and have determined the device is substantially cquivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of / Innendments, or to do rooms act (Act) that do not require approval of a premarket the Fought F 600; Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of a 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 MA), it may of subject to back of federal Regulations, Title 21, Parts 800 to 898. In your device ear. 80 rear over announcements concerning your device in the Ecderal Register.

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## Page 2 - Mr. Boedeker

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements modi that 1 Dr may Federal statutes and regulations administered by other Federal agencies. or the Fet of any - with all the Act's requirements, including, but not limited to: registration 1 ou Intilet compry was a 807); labeling (21 CFR Part 801); good manufacturing practice and fiscing (21 certer as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as be forth in are quartion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a premarket notification. The PDF 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), rr you desire spbeint at the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj South Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Souite y. Michie Omd

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): HO53129

Device Name: NIS-5

Indications for Use:

The NIS-5 Is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids. The NIS-5 device may aid in the prevention of needle stick injuries.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PILEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) for MD2

October 2005 Nexus Medical LLC: NIS-5 Childsion Sign-Off)
City sion of Anesthesiology, General Hos in coron Control, Danial Devices

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