INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET

K123868 · Baxter Healthcare Corp · FPA · Jan 8, 2013 · General Hospital

Device Facts

• Record ID: K123868
• Device Name: INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET
• Applicant: Baxter Healthcare Corp
• Product Code: FPA · General Hospital
• Decision Date: Jan 8, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the administration of fluids from a container to the patient through a vascular access device. The Interlink Lever Lock Cannula is indicated to function exclusively with the Interlink Injection Site as a fluid path injection device.

Device Story

Interlink System comprises Lever Lock Cannula, solution sets, secondary medication sets, and CONTINU-FLO sets; single-use disposable devices for IV fluid administration. Lever Lock Cannula functions exclusively with Interlink Injection Site as fluid path injection device; female Luer connects syringe or secondary medication set to injection site. CONTINU-FLO sets include injection site and check valve to prevent backflow during secondary medication administration. Used in clinical settings for gravity or pump infusion; operated by healthcare professionals. Modification involves replacing solvent carrier in silicone lubrication process of Lever Lock Cannula. System facilitates fluid delivery from container to patient vascular system via needle or catheter.

Clinical Evidence

Bench testing only. Performance assessment included insertion force, removal force, tip protector removal force, lever arm integrity, ISO Luer tests, lipid resistance, and flow tests.

Technological Characteristics

Single-use disposable IV administration sets. Components include Lever Lock Cannula, solution sets, and check valves. Materials include silicone lubricant. Connectivity: mechanical Luer lock. Sterilization: not specified. No software or electronic components.

Indications for Use

Indicated for patients requiring continuous or intermittent fluid administration via vascular access device. Used for gravity or pump infusion of I.V. fluids.

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

• SafeSite TM Injection Site and SafeSite TM Blunt Cannula (K883638)

Reference Devices

• K925126
• K940697

Submission Summary (Full Text)

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K123868

Special 510(k) Premarket Notification Interlink System

Section 5, 510(k) Summary Page 1 of 3

# 5. 510(k) SUMMARY

December 14, 2012

# OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

# CONTACT PERSON:

Gary Chumbimune Manager, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: [phone] Fax: [phone]

# DEVICE NAME:

Trade name: Interlink System ·

| Code number | Name |
|-------------|-------------------------------------------------------|
| 2C9292 | INTERLINK System Lever Lock Cannula with Check Valve |
| 2H7452 | Non-DEHP Secondary Medication Set with DUO-VENT Spike |
| 2C6402 | INTERLINK System Solution Set |
| 2H6537 | Non-DEHP CONTINU-FLO Solution Set |
| 1C8533 | INTERLINK System Vented CONTINU-FLO Solution Set |
| 1C8669 | INTERLINK System CONTINU-FLO Solution Set |

Table 5-1. Representative Product Codes for the Interlink System

JAN 0 8 2013

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Special 510(k) Premarket Notification Interlink System

Common name: Interlink Lever Lock Cannula, Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink Continu-Flo Sets.

Classification name: IV Administration Set: 21 CFR 880.5440

#### PREDICATE DEVICE:

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

| Device | Company | Previous 510(k) | Clearance date |
|-------------------------------------------------------------|-------------------|-----------------|--------------------|
| SafeSite TM Injection Site and SafeSite TM Blunt<br>Cannula | Baxter Healthcare | K883638 | September 23, 1988 |

#### DESCRIPTION OF THE DEVICE:

The proposed devices, which are the subject of this Special 510(k) Premarket Notification, consist of the Interlink Lever Lock Cannula, Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink CONTINU-FLO Sets. They are single use disposable devices intended for use with a vascular device for continuous or intermittent fluid administration. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notifications K883638 (cleared on September 23, 1988), K925126 (cleared on June 18, 1993), and K940697 (cleared on August 30, 1994).

The Interlink Lever Lock Cannula is intended to function exclusively with the Interlink Injection Site as a fluid path injection device. It has a female Luer that allows the connection of a svringe or the distal end of an Interlink Secondary Medication Set to an Interlink injection site of an Interlink solution set or an Interlink CONTINU-FLO set.

The Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink CONTINU-FLO Sets are used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They can be used for gravity or pump infusion of I.V. fluids. Interlink CONTINU-FLO Sets contain the Interlink Injection Site that can be used for the administration of secondary medication. They also contain a check valve which prevents blackflow of solution from the secondary medication container into the primary container during the administration of secondary medication. Interlink Secondary Medication Sets are used in conjunction with Interlink CONTINU-FLO sets to administer intermittent fluids to the patient.

The basis for this premarket notification is a modification to the Interlink Lever Lock Cannula, which is an integral part of the Interlink System. The modification consists of replacing the

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solvent carrier used in the silicone lubrication process of the Interlink Lever Lock Cannula. The product labels are also being updated to add the indications for use statement of the device and clarify their use to comply with Baxter's labeling standards.

## STATEMENT OF INTENDED USE:

For the administration of fluids from a container to the patient through a vascular access device. The Interlink Lever Lock Cannula is indicated to function exclusively with the Interlink Injection Site as a fluid path injection device.

## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The proposed devices consist of the Interlink Lever Lock Cannula, Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink CONTINU-FLO Sets. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notifications K883638 (cleared on September 23, 1988), K925126 (cleared on June 18, 1993), and K940697 (cleared on August 30, 1994). A minor modification will be made to the silicone lubrication process of the Interlink Lever Lock Cannula. The intended use, the basic design, function and the materials for the proposed device are equivalent to the predicate device.

## DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. Below is a summary of the performance assessment of the Interlink Lever Lock Cannula conducted to show that it is suitable for its intended use:

- · Insertion force test
- · Removal force test
- · Tip protector removal force test
- · Lever arm maximum activation integrity test
- · ISO Luer tests on female Luer lock connector
- · Lipid resistance test
- · Lever lock flow test

## CONCLUSION:

The proposed devices are substantially equivalent to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Januarv 8, 2013

Mr. Gary Chumbimune Manager, Global Regulatory Affairs Baxter Healthcare Corporation 32650 North Wilson Road ROUND LAKE IL 60073

Re: K123868

Trade/Device Name: Interlink System Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 14, 2012 Received: December 17, 2012

Dear Mr. Chumbimune:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

#### Public Health Service

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

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA bas 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); 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/ucm115809.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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthong Lo m

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, 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:

Interlink System

Indications for Use:

For the administration of fluids from a container to the patient through a vascular access device. The Interlink Lever Lock Cannula is indicated to function exclusively with the Interlink Injection Site as a fluid path injection device.

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

(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)

Digitally signed by Richard C. Chapman Date: 2013.01.09 10:40:59 -05'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: