INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326

K060074 · Baxter Healthcare Corp · FPA · Mar 29, 2006 · General Hospital

Device Facts

• Record ID: K060074
• Device Name: INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326
• Applicant: Baxter Healthcare Corp
• Product Code: FPA · General Hospital
• Decision Date: Mar 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

For use in neonatal population only. To be used with an indwelling catheter for the administration or withdrawal of fluids. This device may aid in the prevention of needlestick injuries.

Device Story

Interlink T-Connector Extension Set is an IV administration accessory for neonatal patients. Device consists of an Interlink injection site integrated into a T-housing, a female adapter, and a slide clamp. It connects to an indwelling catheter to facilitate fluid administration or withdrawal. The injection site is accessed via a blunt plastic cannula, reducing needlestick injury risk. The slip connection design minimizes mechanical force transmission to the catheter site compared to locking Luer devices. The device is optimized for neonates by controlling priming/residual volume and ensuring efficient flush clearance for medication and blood sampling, supporting fluid-restricted patient needs.

Clinical Evidence

Bench testing only. Testing included mechanical, biocompatibility, and microbial ingress assessments. All results met pre-defined acceptance criteria.

Technological Characteristics

Intravascular administration set; T-connector design with integrated injection site and slide clamp. Features a slip connection mechanism. Designed for low priming/residual volume. Risk management performed per ISO 14971 (2000).

Indications for Use

Indicated for neonatal patients requiring administration or withdrawal of fluids via an indwelling catheter. May aid in preventing needlestick injuries.

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

• Baxter Interlink T-Connector Extension Set (K921899)

Submission Summary (Full Text)

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MAR 2 9 2006

K060074

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### 1. 510(K) SUMMARY

#### Submitter:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

### Preparer/Contact:

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

### Date Summary was Prepared:

January 3, 2006

#### Device Name:

Trade name: Interlink T-Connector Extension Sct Common name: IV Administration Set Classification name: Intravascular Administration Set (21 CFR 880.5440, Product Code FPA)

#### Predicate Device(s):

Baxter Interlink T-Connector Extension Set cleared under premarket notification K921899, cleared April 20, 1993.

#### Device Description:

The Interlink T-Connector Extension Set consists of an Interlink injection site integrated into a T-Housing on one end of the extension set with a female adapter connected to the other end. A slide clamp is also included on the tubing. This extension set is connected to an indwelling catheter in order to administer or withdraw fluids. The injection site is accessed by a blunt plastic cannula; this allows fluid flow while aiding in the prevention of needlestick injuries.

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### Statement of Intended Use:

For use in neonatal population only. To be used with an indwelling catheter for the administration or withdrawal of fluids. This device may aid in the prevention of needlestick injuries.

## Summary of Technological Characteristics of New Device to Predicate Devices:

The technological characteristics of the Interlink T-Connector Extension Set do not differ significantly from the currently marketed Baxter Interlink Administration Sets. The T-Connector design allows for easy access to the catheter and easier tubing connection to the patient compared to standard extension sets. The slip connection provides an attachment method that is less likely to direct the forces of IV line attachment to the patient's sensitive catheter injection site as compared to locking collar type Luer devices. Also key to the intended population is the priming/residual volume and the flush clearance efficiency for infused drugs and for clearing blood from the device post blood sampling. Because the patient is small and commonly fluid restricted, control of the amount of fluid administered may be important. This includes medication as well as flushing or clearing the lines after medication administration.

### Discussion of Nonclinical Tests:

Baxter Healthcare conducts risk analyses using procedures based on ISO 14971 (2000) "Medical Devices - Application of Risk Management to Medical Devices". The risk analysis method used to assess the impact of these modifications was Failure Modes and Effects Analysis (FMEA). Design verification tests based on the results of risk analysis and design input were performed to verify those modifications. Testing of the set and components included mechanical, biocompatibility, and microbial ingress testing. All test results met the acceptance criteria.

### Conclusion:

The Interlink T-Connector Extension Set is substantially equivalent to the currently cleared Interlink T-Connector Extension Set.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2006

Baxter Healthcare Corporation C70 Ms. Nanette Hedden Specialist Global Regulatory Affairs Medication Delivery 1620 Waukegan Road McGaw Park, Illinois 60085

Re: K060074

Trade/Device Name: Interlink T-Connector Extension Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 9, 2006 Received: January 10, 2006

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 approvisions of the Act. The general controls provisions of the Act include controls provisions of a 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.

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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 and insting (s a set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as 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.

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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K 06007 4 ા ર્વ ( )

# INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Interlink T-Connector Extension Set

Indications For Use: For use in neonatal population only. To be used with an indwelling catheter for the administration or withdrawal of fluids. This device may aid in the prevention of needlestick injuries.

Prescription Use X ___________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

" nu, Ganeral Hus "