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K Number
K033017
Device Name
PHOENIX INFUSION CATHETER
Manufacturer
PHOENIX BIOMEDICAL
Date Cleared
2004-04-07

(194 days)

Product Code
JXG
Regulation Number
882.5550
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

These devices are intended as a means of gaining access to the cerebral ventricles or cystic tumor for the short-term (less than 30 days) injection of chemotherapeutics agents and/or radioisotopes.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter for the "Phoenix Infusor Infusion Catheter System," indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

The letter discusses:

  • The device name (Phoenix Infusor Infusion Catheter System)
  • Regulation number and name (21 CFR 882.5550, Central nervous system fluid shunt and components)
  • Regulatory class (II)
  • Product code (JXG)
  • The date of the letter and previous correspondence
  • Details about FDA regulations and responsibilities of the manufacturer
  • The "Indications for Use" statement for the device, which specifies its intended purpose: "as a means of gaining access to the cerebral ventricles or cystic tumor for the short-term (less than 30 days) injection of chemotherapeutics agents and/or radioisotopes."

There is no mention of:

  • Specific acceptance criteria (e.g., performance metrics, thresholds)
  • Any study design
  • Sample sizes for testing or training
  • Data provenance
  • Number or qualifications of experts
  • Adjudication methods
  • MRMC comparative effectiveness studies
  • Standalone algorithm performance
  • Types of ground truth
  • How ground truth was established

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).