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K Number
K041345
Device Name
PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES
Manufacturer
MEDIX, INC.
Date Cleared
2004-07-22

(63 days)

Product Code
FOZ
Regulation Number
880.5200
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

A properly placed I.V. catheter provides access to a vein or artery. TThe I.V. catheter system is designed for single use and has a needlestick protection feature. The needle guard that automatically locks over the needle as the catheter is threaded into the vessel reduces the risk of accidental needlesticks. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. 16 to 24 gauge catheters may be used with power injectors up to 300 psi.

Device Description

Protectiv® Jelco® Safety I.V. Catheter

AI/ML Overview

The provided document is a 510(k) premarket notification letter for a medical device called the "Protectiv® Jelco® Safety I.V. Catheter". It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain information regarding:

  • Specific acceptance criteria for device performance.
  • A study that proves the device meets acceptance criteria.
  • Reported device performance metrics (e.g., sensitivity, specificity, accuracy).
  • Sample sizes for test sets or training sets.
  • Data provenance, expert qualifications, or adjudication methods.
  • Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
  • The type of ground truth used.

Therefore, I cannot provide the requested information based solely on the text provided. The letter is a regulatory approval document confirming substantial equivalence, not a detailed technical report of device testing or performance.

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).