(21 days)
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.
Not Found
I apologize, but the provided text from the FDA 510(k) clearance letter for the CODAN IV Administration Set B400 Sp does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document is a clearance letter, confirming that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices. It discusses:
- The device name and regulation details.
- The FDA's determination of substantial equivalence.
- General controls provisions and additional controls that may apply.
- Contact information for specific advice.
- 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."
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This information would typically be found in the 510(k) summary or other supporting documentation submitted to the FDA, but it is not present in the clearance letter provided.
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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 (240) 276-0115. 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
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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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
§ 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.