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K Number
K042693
Device Name
IV ADMINISTRATION SET B400 SP
Manufacturer
CODAN US CORP.
Date Cleared
2004-10-21

(21 days)

Product Code
FPA
Regulation Number
880.5440
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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 Description

Not Found

AI/ML Overview

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:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for the test set and data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study details.
  6. Standalone performance details.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. 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.

§ 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.