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K Number
K963659
Device Name
EXEL I.V. ADMINISTRATION SET
Manufacturer
EXEL INTL.
Date Cleared
1997-12-16

(469 days)

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

THIS DEVICE IS ESED FOR IMPUSION OF SOLUTIONS AND MEDICATION INTRAVENOUSLY INTO THE PATIENT.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the necessary information to describe the acceptance criteria, the study details, or the device performance as requested. The document is a 510(k) clearance letter from the FDA for an "Exel I.V. Administration Set," indicating that the device has been deemed substantially equivalent to a predicate device.

The letter discusses regulatory aspects, such as:

  1. Device Type: Exel I.V. Administration Set.
  2. Regulatory Class: II.
  3. Product Code: FPA.
  4. Indications For Use: "THIS DEVICE IS USED FOR INFUSION OF SOLUTIONS AND MEDICATION INTRAVENOUSLY INTO THE PATIENT."
  5. FDA Clearance Date: December 18, 1997.

However, it does not include:

  • A table of acceptance criteria or reported device performance.
  • Details about sample sizes, data provenance, or ground truth establishment for any studies.
  • Information on expert usage, adjudication methods, or MRMC comparative effectiveness studies.
  • Specifics on standalone algorithm performance or training set details.

This document is a regulatory approval, not a scientific study report. Therefore, I cannot fulfill your request based solely on the provided text.

§ 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.