INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,

K103551 · Baxter Healthcare Corp · FPA · Mar 25, 2011 · General Hospital

Device Facts

• Record ID: K103551
• Device Name: INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,
• Applicant: Baxter Healthcare Corp
• Product Code: FPA · General Hospital
• Decision Date: Mar 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

The IV extension tubing kits provide the user with a "ready-to-use" set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The kits are indicated for one-time use. The IV extension tubing set is indicated for use with a vascular access device for administration and withdrawal of fluids. The Vital-Hold catheter stabilization device and the foam tape strips are indicated to provide a method for catheter securement. The APLICARE skin prep pad is indicated to prepare the skin prior to application of a dressing or bandage.

Device Story

Kit integrates intravenous extension tubing, Vital-Hold catheter stabilization device, foam tape strips, and APLICARE skin protectant prep pad into single sterile blister package. Eliminates need for separate component assembly. Tubing connects to vascular access devices for fluid administration/withdrawal. Stabilization device and tape anchor lines to patient skin. Skin prep pad applies polymer film to skin to improve adhesion and provide barrier. Used in clinical settings; operated by healthcare providers. Benefits include convenience, reduced assembly time, and standardized securement.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Kit components include IV extension tubing (various lengths/volumes), Vital-Hold catheter stabilization device, foam tape, and APLICARE skin prep pad. Materials include non-DEHP tubing and luer-activated valves (Interlink, Clearlink, V-Link). V-Link devices feature VitalShield protective coating. Sterile, single-use, ready-to-use blister pack. No electronic or software components.

Indications for Use

Indicated for patients requiring intravenous fluid administration or withdrawal via vascular access devices. Components used for catheter securement and skin preparation prior to dressing application. For one-time use.

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

• APLICARE Skin Protectant Prep Pad (K861557)
• Modified Interlink Injection Site Septum (K925126)
• Modification to Solution Administration Set with Capped Luer Activated Device (Clearlink) (K003225)
• CLEARLINK Antimicrobial Luer Activated Device and Extension Sets with CLEARLINK Antimicrobial Luer Activated Device (K072576)
• V-LINK Antimicrobial Luer Activated Device and Extension Sets with V-LINK Antimicrobial Luer Activated Device (K081289)

Submission Summary (Full Text)

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Section 5, 510(k) Summary

MAR 2 5 2011

## 5. 510(k) SUMMARY

January 12, 2010

## OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

# CONTACT PERSON:

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

#### DEVICE NAME:

Trade name: Intravenous Extension Tubing Kits

Table 5-1.

**Product Codes for Intercompany Extension Tuning & Use**

| Code number | Name |
|-------------|----------------------------------------------------------------------------------------------------------------------------------|
| 2N8220 | Clearlink System Non-DEHP Catheter Extension Set Kit, 7.7"(20.0 cm), Vol. 1.10 ml |
| 2N8221 | Interlink System Non-DEHP Catheter Extension Set Kit, 7.1"(18.0 cm), Vol. 0.85 ml |
| 2N8222 | Clearlink System Non-DEHP Catheter Extension Set Kit, 8.2"(21.0 cm), Vol. 0.57 ml |
| 2N8223 | Interlink System Non-DEHP Catheter Extension Set Kit, 7.7"(19.45 cm), Vol. 0.22 ml |
| 2N8224 | Clearlink System Non-DEHP Y-Type Catheter Extension Set Kit, 6.5"(16.45 cm), Vol. 1.2 ml |
| 2N8225 | Interlink System Non-DEHP Y-Type Catheter Extension Set Kit, 5.3"(13.4 cm), Vol. 1.21 ml |
| 2N8227 | Interlink System Non-DEHP Y-Type Catheter Extension Set Kit, 5.5"(13.9 cm), Vol. 0.85 ml |
| 6N8220 | V-Link Luer Activated Device with VitalShield Protective Coating Non-DEHP Catheter Extension Set Kit, 7.6"(19.3 cm), Vol. 1.0 ml |

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| Code number | Name |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| 6N8222 | V-Link Luer Activated Device with VitalShield Protective Coating Non-DEHP<br>Catheter Extension Set Kit, 8.2"(21.0 cm), Vol. 0.5 ml |
| 6N8224 | V-Link Luer Activated Device with VitalShield Protective Coating Non-DEHP Y-<br>Type Catheter Extension Set Kit, 5.3"(13.5 cm), Vol. 1.2 ml |

Table 5-1. Intravenous Extension Tubing Kits Product Codes

Common name: Intravenous Extension Tubing Kits

Classification name: IV Administration Set (21 CFR 880.5440, Product Code FPA), Intravenous Extension Tubing Set (21 CFR 880.5440, Product Code OJA), Intravascular Catheter Securement Device (21 CFR 880.5210, Product Code KMK), Bandage, Liquid, Skin Protectant (21 CFR 880.5090, Product Code NEC).

### PREDICATE DEVICES:

| Device | Company | Previous<br>510(k) | Clearance date |
|------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------------|------------------|
| APLICARE Skin Protectant Prep Pad | APLICARE,<br>Inc. | K861557 | July 11, 1986 |
| Modified Interlink Injection Site Septum | Baxter<br>Healthcare | K925126 | July 18, 1993 |
| Modification to Solution Administration Set<br>with Capped Luer Activated Device<br>(Clearlink). | Baxter<br>Healthcare | K003225 | October 19, 2000 |
| CLEARLINK Antimicrobial Luer Activated<br>Device and Extension Sets with<br>CLEARLINK Antimicrobial Luer Activated<br>Device | Baxter<br>Healthcare | K072576 | November 6, 2007 |
| V-LINK Antimicrobial Luer Activated<br>Device and Extension Sets with V-LINK<br>Antimicrobial Luer Activated Device | Baxter<br>Healthcare | K081289 | August 4, 2008 |

Table 5-2. Previous 510(k)s

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### DESCRIPTION OF THE DEVICE:

The intravenous extension tubing kits will consist of an intravenous extension tubing set, a Vital-Hold catheter stabilization device, two foam tape strips and an APLICARE skin protectant prep pad. The intravenous extension sets may contain any of Baxter's cleared access ports (e.g., Interlink Injection Site, Clearlink Luer Activated Valve or V-Link Luer Activated Valve).

The IV extension tubing set is used with a vascular access device for administration and withdrawal of fluids.

The Vital-Hold catheter stabilization device is used to help anchor medical intravenous tubes and lines requiring mechanical stability while installed on the skin surface of a patient.

The two foam tape strips with release liners are used to assist with line stabilization.

The APLICARE skin protectant prep pad is a sterile pad saturated in skin prep solution. The prep solution prepares the skin prior to application of a dressing or bandage. When dry, the prep agent leaves a thin polymer film on the skin surface providing a clean surface for adhesion and a barrier to the natural body oils that can affect adhesion.

The IV extension tubing set, the Vital-Hold catheter stabilization device, the two foam tape strips and the APLICARE skin protectant prep pad will be integrated into one sterile unit blister package to provide the user with a "ready-to-use" set up avoiding the need to acquire/assemble components from various manufacturers) 4 home and comments and

#### STATEMENT OF INTENDED USE:

The IV extension tubing kits provide the user with a "ready-to-use" set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The kits are indicated for one-time use.

The IV extension tubing set is indicated for use with a vascular access device for administration and withdrawal of fluids.

The Vital-Hold catheter stabilization device and the foam tape strips are indicated to provide a method for catheter securement.

The APLICARE skin prep pad is indicated to prepare the skin prior to application of a dressing or bandage.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle or bird with three lines forming its body and wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird.

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

C/O Ms. Nanette Hedden Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085

APR - 5 2011

Re: K103551

Trade/Device Name: Intravenous Extension Tubing Kits Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 28, 2011 Received: March 1, 2011

Dear Ms. Hedden:

This letter corrects our substantially equivalent letter of March 25, 2011.

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 (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 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 sequirements of the Act or any Federal statutes and regulations administered by other Federal squareins. 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/ucm 115809.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-fire number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Howad Bolstead

for

FD

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

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#### INDICATIONS FOR USE .

510(k) Number (if known): k103551

Device Name:

Intravenous Extension Tubing Kits

Indications for Use:

The IV extension tubing kits provide the user with a "ready-to-use" set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The kits are indicated for one-time use.

The IV extension tubing set is indicated for use with a vascular access device for administration and withdrawal of fluids.

The Vital-Hold catheter stabilization device and the foam tape strips are indicated to provide a method for catheter securement.

The APLICARE skin prep pad is indicated to prepare the skin prior to application of a dressing or bandage.

Prescription Use X AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

1

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

3/24/4

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103551