EZ-CONNECT

K061771 · Vidacare Corporation · FPA · Jul 10, 2006 · General Hospital

Device Facts

• Record ID: K061771
• Device Name: EZ-CONNECT
• Applicant: Vidacare Corporation
• Product Code: FPA · General Hospital
• Decision Date: Jul 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The EZ-Connect Extension Set is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container into the patient.

Device Story

EZ-Connect is an intravascular extension set used to facilitate fluid delivery from a solution container to a patient. The device consists of 150 mm of tubing, a right-angle luer lock connector with a cap, a standard straight luer lock connected to a needleless connector, and a central pinch clamp. It is intended for use in clinical settings to connect IV fluid sources to patient access points. The device functions as a passive conduit for fluid administration.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of technological characteristics.

Technological Characteristics

Intravascular administration set; 150 mm tubing; right-angle luer lock connector; straight luer lock; needleless connector; pinch clamp. Passive fluid delivery system. No electronic components or software.

Indications for Use

Indicated for patients requiring infusion of IV fluids from a plastic bag or solution container.

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

• EXTENSION SET LIGHT-SAFE, MODEL BC565 (K021480)

Submission Summary (Full Text)

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6. 510(k) Summar

JUL 1 0 2006

722-A Isom Road San ruitonio. TX 78216 :10-375-8500

### SUMMARY

Submitter's name: Address:

Phone:

Fax number:

VidaCare Corporation 722-A Isom Road San Antonio, TX 78216 210-375-8500 210-375-8537

Name of contact person: Grace Holland Requlatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] fax: [phone]

Date the summary was prepared: June 21, 2006

Name of the device: Trade or proprietary name: Common or usual name: Classification name: Class: Product code: 21 CFR Reference:

EZ-Connect EZ-Connect Extension Set Set. Administration, Intravascular II FPA 880.5440

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:

Applicant: Codan US Corp Device: EXTENSION SET LIGHT-SAFE, MODEL BC565 510(k): K021480

Description of the device:

The EZ-Connect is an extension set comprised of 150 mm of tubing with a right angle luer lock connector and cap on one end, a standard straight luer lock connected to a needleless connector on the other end and a pinch clamp in the middle.

REGULATORY SPECIALISTS, INC.

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Indications for Use:

The EZ-Connect Extension Set is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container into the patient.

Summary of substantial equivalence:

The EZ-Connect was compared in the following areas and found to have similar technological characteristics and to be equivalent to the predicate.

- Biocompatibility Design features Indications for use Standards met Sterility Target population Where used
Conclusion:

The EZ-Connect Extension Set meets the functional claims and intended use as described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicate Codan Extension Set Light-Safe Model BC 565.

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Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is written around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 0 2006

VidaCare Corporation C/O Ms. Grace Holland Regulatory Specialists, Incorporated 3722 Avenue Sausalito Irvine, California 92606

Re: K061771

Trade/Device Name: EZ-Connect Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 21, 2006 Received: June 26, 2006

Dear Ms. Holland:

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. Holland

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.

Sylette Y. Michael Oms.

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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# 5. Indications for Use Statement Indications for Use

510(k) Number (if known): __

Device Name: EZ-Connect ___________________________________________________________________________________________________________________________________________________________________ Indications for Use:

The EZ-Connect is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container into the patient.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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REGULATORY SPECIALISTS, INC.

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