CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED

K072576 · Baxter Healthcare Corp · FPA · Nov 6, 2007 · General Hospital

Device Facts

• Record ID: K072576
• Device Name: CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED
• Applicant: Baxter Healthcare Corp
• Product Code: FPA · General Hospital
• Decision Date: Nov 6, 2007
• 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 CLEARLINK 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 CLEARLINK Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may inhibit the growth of microorganisms on the coated surfaces of the CLEARLINK device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially contaminated. The antimicrobial agent is not intended to be used as a treatment for existing infections.

Device Story

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, opening upon activation by Luer connector. Hard surfaces coated with proprietary metallic silver technology to inhibit microbial growth on device surfaces; reduces risk of microbial contamination. Used in clinical settings for fluid administration/withdrawal. Healthcare providers swab surface with antiseptic before connection. Benefits patient by reducing potential for device-related microbial colonization.

Clinical Evidence

Bench testing only. Risk analyses and design verification tests were conducted to support substantial equivalence. No clinical data provided.

Technological Characteristics

Luer-activated valve with clear housing, internal gland, and center post. Hard surfaces coated with metallic silver antimicrobial agent. Mechanical valve actuation via standard male Luer connector. Non-DEHP extension sets available. Sterilization method not specified.

Indications for Use

Indicated for use with vascular access devices for continuous or intermittent fluid administration or withdrawal of fluids in patients requiring IV access. Not indicated for treatment of existing infections.

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

• ON-Q Silver Soaker Antimicrobial Catheter (K051401)
• Modification to Solution Administration Set with Capped Luer Activated Device (K003225)
• NP Medical Capless Luer Activated Valve (K973916)
• Elcam Antimicrobial Stopcock (K053405)

Submission Summary (Full Text)

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K072576

### 5. 510(k) SUMMARY

October 18, 2007

### OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

NOV 0 6 2007

## 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:

CLEARLINK Antimicrobial Luer Activated Device and Extension Sets with CLEARLINK Antimicrobial Luer Activated Device

| 6N8399 | Luer Activated System1<br>Luer Activated Device with Silver for IV Access | |
|--------|---------------------------------------------------------------------------|--|
| 6N8378 | Luer Activated System<br>Non-DEHP Catheter Extension Set | |
| 6N8374 | Luer Activated System<br>Non-DEHP Catheter Extension Set | |
| 6N8377 | Luer Activated System<br>Non-DEHP Y-Type Catheter Extension Set | |
| 6N8371 | Luer Activated System<br>Non-DEHP Y-Type Catheter Extension Set | |

## Table 5-1. Product Codes for CLEARLINK Antimicrobial Lucr Activated Device

^&#x27; Clearlink is a trademark of Baxter, Intl., Inc.

Other trademarks are the properties of their respective owners.

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1 Baxter Healthcare Corporation will be applying a brand name to replace Luer Activated System for the antimicrobial product prior to market release.

#### Common name: 1V Administration Set

______________________________________________________________________________________________________________________________________________________________________________

#### Classification name:

1V Administration Set (21 CFR 880.5440. Product Code FPA)

#### PREDICATE DEVICE(S):

| Device | Company | Previous 510(k) | Clearance date |
|-------------------------------------------------------------------------------------------|-------------------|-----------------|-------------------|
| ON-Q Silver Soaker<br>Antimicrobial<br>Catheter (Coating) | I-Flow | K051401 | November 30, 2005 |
| Modification to<br>Solution<br>Administration Set<br>with Capped Luer<br>Activated Device | Baxter Healthcare | K003225 | October 19, 2000 |
| NP Medical Capless<br>Luer Activated<br>Valve | NP Medical | K973916 | March 9, 1998 |
| Elcam<br>Antimicrobial<br>Stopcock (or<br>Manifold) (Coating) | Elcam Medical | K053405 | May 11, 2006 |

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

## DESCRIPTION OF THE DEVICE:

The CLEARLINK 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 syringefluer 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 antiscptic before each connection.

The hard surfaces of the CLEARLINK Antimicrobial Luer Activated Device are coated with a proprietary silver technology that may destroy or inhibit the growth of

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microorganisms on the coated surfaces of the CLEARLINK device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially compromised.

## STATEMENT OF INTENDED USE:

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Intended for use with a vascular access device for the administration of drugs and solutions. The CLEARLINK 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 CLEARLINK Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may inhibit the growth of microorganisms on the coated surfaces of the CLEARLINK device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially contaminated. The antimicrobial agent is not intended to be used as a treatment for existing infections.

## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The Baxter CLEARLINK Antimicrobial Luer Activated Device is substantially equivalent to Baxter's current legally marketed CLEARLINK Luer Activated Device cleared by 510(k) K003225 and NP Medical's 510(k) K973916. Baxter's current CLEARI.INK Luer Activated Device does not include the antimicrobial feature. The CLEARLINK Antimicrobial Luer Activated Device utilizes an antimicrobial agent equivalent to the coating in the 510(k) cleared on the I-Flow ON-Q SilverSoaker Catheter (K051401) and is similar to the antimicrobial agent (silver ions) used in Elcam Medical's Antimicrobial Stopcock (K053405).

# 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 CLEARLINK Antimicrobial Luer Activated Device is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 0 6 2007

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

Re: K072576

Trade/Device Name: CLEARLINK Antimicrobial Luer Activated Device and Extension Sets with CLEARLINK Antimicrobial Luer Activated Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 12, 2007 Received: September 14, 2007

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 (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/industry/support/index.html.

Sincerely 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

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#### INDICATIONS FOR USE

510(k) Number (if known);

Device Name: CLEARLINK Antimicrobial Luer Activated Device and Extension Sets with CLEARLINK Antimicrobial Luer Activated Device

Indications for Use:

Intended for use with a vascular access device for the administration of drugs and solutions. The CLEARLINK 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 CLEARLINK Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may inhibit the growth of microorganisms on the coated surfaces of the CLEARLINK device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially contaminated. The antimicrobial agent is not intended to be used as a treatment for existing infections.

Prescription Use __ X ________________________________________________________________________________________________________________________________________________________ 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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

| 510(k) Number: | K472516 |
|----------------|---------|
|----------------|---------|