NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4

K041845 · Nexus Medical, LLC · FPA · Aug 24, 2004 · General Hospital

Device Facts

• Record ID: K041845
• Device Name: NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4
• Applicant: Nexus Medical, LLC
• Product Code: FPA · General Hospital
• Decision Date: Aug 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

The Nexus PAV TM Luer Lock (NIS-4) is to be used for the delivery of drugs and fluids as an accessory to intravascular administration sets. The Nexus PAV TM Luer Lock Device (NIS-4) may aid in the prevention of needle stick injuries.

Device Story

Nexus PAV Luer Lock (NIS-4) functions as an accessory to intravascular administration sets; facilitates drug and fluid delivery; incorporates design features to aid in the prevention of needle stick injuries. Used in clinical settings by healthcare professionals during standard intravenous therapy procedures. Device acts as a mechanical interface within the fluid path.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Luer lock connector; mechanical accessory for intravascular administration sets; materials and design intended for fluid path compatibility.

Indications for Use

Indicated for use as an accessory to intravascular administration sets for the delivery of drugs and fluids in patients requiring intravenous therapy.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2004

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

Re: K041845

Trade/Device Name: Nexus PAV™ Luer Lock Device (NIS-4) Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 18, 2004 Received: August 19, 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.

{1}------------------------------------------------

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 fincan that 177. Ind. mace statutes and regulations administered by other Federal agencies. or the Act of ally a oder a requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 CFR Part 807), abolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quadisation 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) This letter will anow you to overnment of your device of your device of your device to a premarket notification. - 11 your 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), If you desire specific at not 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 may obtain other generational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincercly yours,

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

{2}------------------------------------------------

KCH1745

## Indications for Use Statement

| Applicant: | Nexus Medical LLC |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K041845 |
| Device Name: | Nexus PAV ^TM Luer Lock (NIS-4) |
| Indications For Use: | The Nexus PAV ^TM Luer Lock (NIS-4) is to be used for the delivery of drugs and fluids as an accessory to intravascular administration sets. The Nexus PAV ^TM Luer Lock Device (NIS-4) may aid in the prevention of needle stick injuries. |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
| AND/OR | Over-The -Counter Use<br>(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: K041845

Page 1 of 1

.