NEXUS TKO-6, LUER-ACTIVATED DEVICE

K113398 · Nexus Medical, LLC · FPA · Apr 18, 2012 · General Hospital

Device Facts

• Record ID: K113398
• Device Name: NEXUS TKO-6, LUER-ACTIVATED DEVICE
• Applicant: Nexus Medical, LLC
• Product Code: FPA · General Hospital
• Decision Date: Apr 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nexus TKO®-6 is a luer-activated, normally closed, bi-directional, anti-reflux device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients. The Nexus TKO®-6 incorporates anti-reflux technology which prevents blood reflux resulting from the following conditions: bag run-dry, connection and disconnection of luer lock devices, syringe plunger compression and patient vascular changes, such as coughing or sneezing. The Nexus TKO®6 has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.

Device Story

Nexus TKO-6 is a luer-activated, normally closed, bi-directional, anti-reflux valve; functions as an accessory to IV catheters. Device prevents blood reflux caused by bag run-dry, luer connection/disconnection, syringe plunger compression, and patient vascular pressure changes (e.g., coughing/sneezing). Features pre-slit septum for needle-free access, reducing needlestick injury risk. Used in clinical settings by healthcare providers for IV therapy administration. Mechanical design provides passive anti-reflux protection without active electronic components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Luer-activated, normally closed, bi-directional, anti-reflux valve. Features pre-slit septum for needle-free access. Mechanical design; no electronic components or software.

Indications for Use

Indicated for use as an accessory to IV catheters in veins or arteries for administration of blood, IV drugs, and IV fluids. Patient population includes neonates, pediatric, and immunocompromised patients.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Heather Turner Director of Quality and Regulatory Nexus Medical, LLC 11315 Strang Line Road Lenexa, Kansas 66215

APR 18 2012

Re: K113398

Trade/Device Name: Nexus Luer-Activated Device, Nexus TKO®-6 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: March 22, 2012 Received: March 23, 2012

Dear Ms. Turner:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Turner

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem /default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. 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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Premarket Notification 510(k) Traditional

## 004.0 Indications for Use Statement

Indications for Use

510(k) Number (if known): _

Device Name: Nexus Luer-Activated Device, Nexus TKO®-6

Indications for Use:

The Nexus TKO®-6 is a luer-activated, normally closed, bi-directional, anti-reflux device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients.

The Nexus TKO®-6 incorporates anti-reflux technology which prevents blood reflux resulting from the following conditions: bag run-dry, connection and disconnection of luer lock devices, syringe plunger compression and patient vascular changes, such as coughing or sneezing.

The Nexus TKO®6 has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.

X Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (6) livision Sign-Off) Jivision of Anesthesiology, General Hospital 004-1 Nexus Medical LLC: TKO-6 intection Control, Dental Devices 510(k) Number.