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K Number
K031599
Device Name
CD LEYCOM PRESSURE/VOLUME CATHETERS
Manufacturer
CD LEYCOM BV
Date Cleared
2003-12-09

(202 days)

Product Code
DQO,DRO,DXO
Regulation Number
870.1200
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Pressure, Volume and Pressure-Volume catheters are intended for use with the CFL 512 in conjunction with a pressure interface module during catheterization where the quantitative assessment of Left Ventricular function is desired. Refer to the CFL 512 User Manual for a detailed description of the need for pressure and volume measurements in the clinical setting.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA, stating that the CD Leycom 4 Fr Pressure/Volume Catheter has been found substantially equivalent to legally marketed predicate devices.

The letter discusses:

  • The device's trade name, regulation number, regulation name, regulatory class, and product code.
  • The date of receipt and review of the premarket notification.
  • The FDA's determination of substantial equivalence.
  • General controls provisions of the Act that the device must comply with.
  • Contact information for specific advice and general information.
  • The intended indications for use, stating that the catheters are "intended for use with the CFL 512 in conjunction with a pressure interface module during catheterization where the quantitative assessment of Left Ventricular function is desired."

However, it does not contain specific details about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication methods.
  5. MRMC comparative effectiveness studies.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size or ground truth establishment for a training set.

The document is primarily a regulatory clearance notification and does not include the technical study details requested.

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).