IV ADMINISTRATION AND CONNECT SETS

K033301 · Codan US Corp. · FPA · Mar 4, 2004 · General Hospital

Device Facts

• Record ID: K033301
• Device Name: IV ADMINISTRATION AND CONNECT SETS
• Applicant: Codan US Corp.
• Product Code: FPA · General Hospital
• Decision Date: Mar 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CODAN IV Administration sets, In-line sets and Connect Sets are indicated for use to facilitate the continuous and bolus infusion of IV fluids, pain control includes in the systems.

Device Story

Device consists of IV administration sets, in-line sets, and connect sets used to facilitate fluid and medication delivery. Sets connect fluid containers to vascular access devices. Operated by clinicians in clinical settings to manage continuous or bolus infusions, including pain control. Provides a sterile pathway for fluid administration. Benefits include reliable delivery of IV fluids and medications to patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

IV administration, in-line, and connect sets. Sterile, single-use fluid path components. Materials and design consistent with standard intravascular administration sets regulated under 21 CFR 880.5440.

Indications for Use

Indicated for patients requiring continuous or bolus infusion of IV fluids and pain control medications.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 2004

Mr. Rohit Patel Quality Assurance Manager CODAN US Corporation 3511 West Sunflower Avenue Santa Ana, California 92704-6944

Re: K033301

Trade/Device Name: IV Administration and Connect Sets Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 8, 2004 Received: January 9, 2004

Dear Mr. Patel:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reveal yoursed yourse 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 Interstate contineree prior to thay as, been reclassified in accordance with the provisions of A. Holloments, or to act route Act (Act) that do not require approval of a premarket the Federal F 00a; Drag). You may, therefore, market the device, subject to the general af provisions of the Act. The general controls provisions of the Act include controls provins 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 (1 Nr.), it may of backed in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear no rouldish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Patel

Please be advised that FIDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements Incall that I DAY mas made a detes and regulations administered by other Federal agencies. of the Act of all y I occrat barates and set sequirements, including, but not limited to: registration 1 od intelse comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), labeling (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality by 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) I institution will anow you to organ finding of substantial equivalence of your device to a premarket notification. - The PD Presults in a classification for your device and thus, permits your device to proceed to the market.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice to: Jour de 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 may obtain 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/dsma/dsmamain.html

Sincercly 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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K033301

510(k) Submission 510(K) Submission
IV Administration set, In-line set and Connect set 2/9/04

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CODAN US IV Administration sets, In-line sets and Connect Sets Device Natile: OODAN IV Administration sets, In-line sets and Connect Sets are callulis For See.
indicated for use to facilitate the continuous and bolus infusion of IV fluids, pain control includes in the systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _