V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE

K081289 · Baxter Healthcare Corp · FPA · Aug 4, 2008 · General Hospital

Device Facts

• Record ID: K081289
• Device Name: V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE
• Applicant: Baxter Healthcare Corp
• Product Code: FPA · General Hospital
• Decision Date: Aug 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

Intended for use with a vascular access device for the administration of drugs and solutions. The V-Link Antimicrobial Luer Activated Device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids. The V-Link Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may reduce the growth of microorganisms on the coated surfaces of the V-Link device. The antimicrobial agent is not intended to be used as a treatment for existing infections.

Device Story

V-Link is an in-line injection site for vascular access; connects to standard male Luer adapters (syringes/sets). Device consists of clear housing, internal gland, and center post; gland acts as valve, providing seal against Luer connector and featuring slit for activation. Hard surfaces coated with proprietary metallic silver technology to reduce microbial growth on device surfaces. Used in clinical settings for fluid administration/withdrawal. Not intended for treatment of existing infections. Supplemental submission provides additional efficacy and durability data for antimicrobial coating; no design changes from predicate.

Clinical Evidence

Bench testing only. Risk analysis and design verification tests performed to support efficacy and durability of the antimicrobial coating. No clinical data presented.

Technological Characteristics

In-line injection site; clear housing with internal gland/center post. Hard surfaces coated with proprietary metallic silver antimicrobial technology. Mechanical valve mechanism activated by male Luer connection. Non-DEHP extension sets included.

Indications for Use

Indicated for patients requiring vascular access for continuous or intermittent fluid administration or withdrawal of drugs and solutions via standard male Luer adapters.

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.

Predicate Devices

• CLEARLINK Antimicrobial Luer Activated Device and Extension Sets with CLEARLINK Antimicrobial Luer Activated Device (K072576)

Submission Summary (Full Text)

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KOR 1289 1 of 3

Section 5, 510(k) Summary

## 5. 510(k) SUMMARY

July 28, 2008

#### OWNER:

:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

# CONTACT PERSON:

Nanette Hedden Manager, Global Regulatory Affairs 1620 Waukegan Rd. MPGR-AL McGaw Park, IL 60085 Telephone: [phone] Fax: [phone]

### DEVICE NAME:

#### Trade name:

V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device

| 6N8399 | V-Link Luer Activated Device with VitalShield |
|--------|----------------------------------------------------------------------------------------------|
| 6N8378 | Non-DEHP Catheter Extension Set with<br>V-Link Luer Activated Device with VitalShield |
| 6N8374 | Non-DEHP Catheter Extension Set with<br>V-Link Luer Activated Device with VitalShield |
| 6N8377 | Non-DEHP Y-Type Catheter Extension Set with<br>V-Link Luer Activated Device with VitalShield |
| 6N8371 | Non-DEHP Y-Type Catheter Extension Set with<br>V-Link Luer Activated Device with VitalShield |

# Table 5-1. Product Codes for V-Link Antimicrobial Luer Activated Device

AUG - 4 2008

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K081287 29

Section 5, 510(k) Summary

#### Common name: IV Administration Set

### Classification name:

IV Administration Set (21 CFR 880.5440, Product Code FPA)

## PREDICATE DEVICE:

## Table 5-2. Previous 510(k)s

| Device | Company | Previous 510(k) | Clearance date |
|------------------------------------------------------------------------------------------------------------------------------|----------------------|-----------------|---------------------|
| CLEARLINK Antimicrobial Luer<br>Activated Device and Extension Sets<br>with CLEARLINK Antimicrobial Luer<br>Activated Device | Baxter<br>Healthcare | K072576 | November 6,<br>2007 |

#### DESCRIPTION OF THE DEVICE:

No design changes have been made to the V-Link Antimicrobial Luer Activated Device which was cleared on November 6, 2007. This submission adds supplemental data on the efficacy and durability of the antimicrobial coating.

The V-Link Antimicrobial Luer Activated Device consists of a clear housing encasing a gland and center post. The gland functions as the valve that provides a seal against the syringe/luer connector when the device is being used. The gland has a slit that opens when activated by the syringe/Luer connector. The gland also provides a surface that can be easily swabbed with antiseptic before each connection.

The hard surfaces of the V-Link Antimicrobial Luer Activated Device are coated with a proprietary silver technology that may reduce the growth of microorganisms on the coated surfaces of the V-Link device.

### STATEMENT OF INTENDED USE:

Intended for use with a vascular access device for the administration of drugs and solutions. The V-Link Antimicrobial Luer Activated Device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids.

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K081289 3 of 3

Section 5, 510(k) Summary

Special 510(k) Premarket Notification V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device

The V-Link Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may reduce the growth of microorganisms on the coated surfaces of the V-Link device. The antimicrobial agent is not intended to be used as a treatment for existing infections.

# TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The Baxter V-Link Antimicrobial Luer Activated Device is substantially equivalent to Baxter's current legally marketed V-Link Antimicrobial Luer Activated Device cleared November 6, 2007 (K072576).

# DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use.

# CONCLUSION:

The V-Link Antimicrobial Luer Activated Device is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. In the center of the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The overall design is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG - 4 2008

Ms. Nanette Hedden Manager, Global Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085

Re: K081289

Trade/Device Name: V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, FMG Dated: May 6, 2008 Received: May 7, 2008

Dear Ms. Hedden:

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 - Ms. Hedden

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 (OS) 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 vours.

Quts

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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#### INDICATIONS FOR USE

### 510(k) Number (if known): K081289

Device Name:

V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device

Indications for Use:

Intended for use with a vascular access device for the administration of drugs and solutions. The V-Link Antimicrobial Luer Activated Device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids.

The V-Link Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may reduce the growth of microorganisms on the coated surfaces of the V-Link device. The antimicrobial agent is not intended to be used as a treatment for existing infections.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR AND/OR AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sidn-Um) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

KO8/289 510(k) Number: _