(142 days)
CODAN US 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.
Not Found
The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to CODAN US Corporation regarding their "IV Administration and Connect Sets." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a detailed study as that information is not present in the provided 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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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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510(k) Submission 510(K) Submission
IV Administration set, In-line set and Connect set 2/9/04
Page_1 of
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 _
§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.