IV ADMINISTRATION SET B400 SP

K042693 · Codan US Corp. · FPA · Oct 21, 2004 · General Hospital

Device Facts

• Record ID: K042693
• Device Name: IV ADMINISTRATION SET B400 SP
• Applicant: Codan US Corp.
• Product Code: FPA · General Hospital
• Decision Date: Oct 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The CODAN IV Administration Set B400 Sp is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container, into the patient.

Device Story

CODAN IV Administration Set B400 Sp facilitates delivery of IV fluids from plastic bags or solution containers to patients. Device consists of tubing and connectors; operates via gravity or pump-assisted flow. Used in clinical settings by healthcare professionals. Output is fluid delivery to patient venous system. Benefits include reliable, sterile fluid administration.

Clinical Evidence

Bench testing only.

Technological Characteristics

Intravascular administration set; plastic tubing and connectors; sterile; single-use; gravity or pump-compatible flow path.

Indications for Use

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

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 representation of three human figures, possibly symbolizing health, family, and community.

OCT 2 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

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

Re: K042693

Trade/Device Name: CODAN IV Administration Set B400 Sp Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 28, 2004 Received: September 30, 2004

Dear Mr. Patel:

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 - Mr. Patel

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be auvribed that 12 a determination that your device complies with other requirements nical that 127 may made statutes and regulations administered by other Federal agencies. of the Act of ally I outstal but its requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF RT Far 807), abality systems (QS) regulation (21 CFR Part 820); and if requirences as bet form in alle quadily ion 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 mis lotter while and in your finding of substantial equivalence of your device to a premainer noticated 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), 11 you dealte specifical 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 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

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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K042693

510(k) Submission IV Administration Sets B400 Sp 9/28/04

> Page _ 1 of

510(k) Number (if known): ___Unassigned at this time

Device Name: Intravascular Administration Set

Indications For Use: The CODAN IV Administration Set B400 Sp is indicated to

facilitate the infusion of IV fluids from a plastic bag or solution container, into the patient.

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

RaullSofuet for Anthony Watson 10-21-04

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

510(k) Number: K042693