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K Number
K190489
Device Name
Elcam Stopcocks and Manifolds
Manufacturer
Elcam Medical ACAL
Date Cleared
2019-04-23

(54 days)

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

Elcam Stopcocks and Manifolds are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Device Description

Elcam Stopcocks and Manifolds (*including MRVLS, Closed Stopcock and S2R)

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) clearance letter for "Elcam Stopcocks and Manifolds" (K190489) does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details related to AI/MRMC studies.

The document is a standard FDA clearance letter, primarily confirming substantial equivalence to a predicate device and outlining regulatory information. It describes the device's indications for use but does not delve into the specific technical studies or performance data typically associated with software-as-a-medical-device (SaMD) or AI-powered devices.

Therefore, I cannot fulfill your request for:

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

§ 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.