NEXUS I.V. FLUID TRANSFER DEVICE

K080976 · Nexus Medical, LLC · LHI · Nov 10, 2008 · General Hospital

Device Facts

• Record ID: K080976
• Device Name: NEXUS I.V. FLUID TRANSFER DEVICE
• Applicant: Nexus Medical, LLC
• Product Code: LHI · General Hospital
• Decision Date: Nov 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Nexus I.V. Vial Access Device is intended for use to aid healthcare professionals in mixing and transferring I.V. fluids / medication from a rubber-stopper medication vial to another device, through a needle-free system that aids in the elimination of needle stick injuries.

Device Story

Nexus I.V. Vial Access Device is a needle-free fluid transfer accessory. It connects to rubber-stoppered medication vials to facilitate mixing and transfer of I.V. fluids/medications to other devices. Used by healthcare professionals in clinical settings. Primary benefit is the elimination of needle stick injuries during fluid handling. Device operates as a mechanical interface between the vial and the delivery system.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Needle-free fluid transfer device; mechanical interface for rubber-stoppered vials; designed for I.V. administration sets. No software or electronic components.

Indications for Use

Indicated for healthcare professionals to facilitate the mixing and transfer of I.V. fluids or medications from rubber-stoppered vials to other devices using a needle-free system to reduce 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 0 2008

Mr. Larry Smith Director of Manufacturing Nexus Medical, LLC 11315 Strang Line Road Lenexa, Kansas 66215

Rc: K080976

Trade/Device Name: I.V. Vial Access Device Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: October 23, 2008 Received: October 31, 2008

Dear Mr. Smith:

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 Federal Register.

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Page 2 - Mr. Smith

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours.

Sayle H. Mckinzie Dmd.

Chiu S. Lin, Ph. D Division 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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## Indications for Use

510(k) Number (if known): K080976

Device Name: I.V. Vial Access Device

Indications for Use:

The Nexus I.V. Vial Access Device is intended for use to aid healthcare professionals in mixing and transferring I.V. fluids / medication from a rubber-stopper medication vial to another device, through a needle-free system that aids in the elimination of needle stick injuries.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

wision Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices 3-2

October 2008 Nexus Medical LLC: Fluid Transfer Device

> 1 0804 1 510(k) Number: