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K Number
K041420
Device Name
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
Manufacturer
ANGIODYNAMICS, INC.
Date Cleared
2004-07-26

(59 days)

Product Code
LJS
Regulation Number
880.5970
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The AngioDynamics, Inc. Morpheus™ CT PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections term penpherar aboob to the ocharing, infusion, or therapy use a 4 French or larger catheter.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.

The document is a 510(k) clearance letter from the FDA for a medical device (AngioDynamics, Incorporated Morpheus™ CT PICC and Procedure Kit). This type of document primarily confirms that the FDA has determined the device is substantially equivalent to a legally marketed predicate device.

It does not contain:

  1. A table of acceptance criteria or reported device performance.
  2. Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
  3. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
  4. Information about the type of ground truth used, or the sample size and ground truth establishment for a training set.

The letter focuses on regulatory compliance and the determination of substantial equivalence, not on the specific performance study details that would be found in a clinical study report or a more detailed technical submission.

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”