NEXUS INTRAVENOUS TUBING SETS (NIVTS)

K041861 · Nexus Medical, LLC · FPA · Nov 26, 2004 · General Hospital

Device Facts

• Record ID: K041861
• Device Name: NEXUS INTRAVENOUS TUBING SETS (NIVTS)
• Applicant: Nexus Medical, LLC
• Product Code: FPA · General Hospital
• Decision Date: Nov 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NIVTS (Nexus IV Tubing Sets) are intended for use to administer IV fluids/medication to the patients's vascular system through a needle-free system that aids in the elimination of needle-stick injury

Device Story

Nexus Intravenous Tubing Sets (NIVTS) are medical devices designed for the administration of intravenous fluids and medications. The system utilizes a needle-free interface to connect to the patient's vascular system, specifically intended to reduce the risk of needle-stick injuries to healthcare providers. The device is used in clinical settings by medical professionals. It functions as a conduit for fluid delivery, replacing traditional needle-based access points with a needle-free mechanism. The primary benefit is the enhancement of safety for clinicians during the administration of IV therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intravascular administration set; needle-free connection mechanism; class II device (21 CFR 880.5440).

Indications for Use

Indicated for patients requiring administration of IV fluids or medications via a needle-free vascular access system.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 2004

Mr. AL Boedeker Director, Regulatory Affairs/Quality Assurance Nexus Medical, LLC 11315 Strang Line Road Lenexa, Kansas 66215

Re: K041861

Trade/Device Name: Nexus Intravenous Tubing Sets Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: November 2, 2004 Received: November 3, 2004

Dear Mr. Boedeker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal 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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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 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), please contact 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

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

Enclosure

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K041861

Image /page/2/Picture/1 description: The image shows the logo for Nexus Medical. The logo features the word "NEXUS" in bold, stylized letters, with the word "MEDICAL" underneath in a smaller font. To the left of the word "NEXUS" are curved lines that resemble a circular shape. The letters are in black, and there is a trademark symbol in the upper right corner of the logo.

11315 Strang Line Road, Lenexa, KS

Responses to Reviewers Fax of 8/5/04 11/2/04 Response

Indications for Use Statement

| Applicant: | Nexus Medical LLC |
|---------------------------|-------------------------------|
| 510(k) Number (if known): | K041861 |
| Device Name: | Nexus Intravenous Tubing Sets |
| Indications For Use: | |

The NIVTS (Nexus IV Tubing Sets) are intended for use to administer IV fluids/medication to the patients's vascular system through a needle-free system that aids in the elimination of needle-stick injury

| Prescription Use | X | AND/OR | Over-The -Counter Use |
|-----------------------------|---|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

| 510(k) Number: | K041861 |
|----------------|---------|
|----------------|---------|

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