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K Number
K030260
Device Name
GELBFISH FLEX VASCULAR DILATOR
Manufacturer
VASCUMETRIX, LLC
Date Cleared
2003-02-20

(27 days)

Product Code
DRE
Regulation Number
870.1310
Type
Special
Panel
CV
Reference & Predicate Devices
K012256
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

These devices are intended to be used over a guidewire to dilate or calibrate blood vessels.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, I cannot provide details on the acceptance criteria and the study that proves the device meets those criteria. The document describes a 510(k) submission for a medical device (Gelbfish Flex Vascular Dilator) and its substantial equivalence to a predicate device.

The provided text focuses on:

  • Device Identification: Proprietary and generic names, classification, product code, and intended use.
  • Predicate Device: Identification of the predicate device.
  • Comparison to Predicate Device: Highlights two differences: the shaft material (polyurethane vs. stainless steel) and the bonding method for the tip (medical grade adhesive vs. laser welding).
  • Conclusion: States that the modified device is substantially equivalent to the predicate device and has no additional safety issues, based on physical properties, performance characteristics, and intended use.
  • FDA Communication: The FDA's letter granting substantial equivalence based on the submitted information.

There is no information in the provided text regarding:

  1. A table of acceptance criteria or reported device performance.
  2. Sample sizes used for test sets or data provenance.
  3. Number of experts or their qualifications for establishing ground truth.
  4. Adjudication methods.
  5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
  6. Standalone algorithm performance.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This type of information is typically detailed in the full 510(k) submission, specifically in sections related to performance testing and clinical data, which are not included in this summary. The current text primarily addresses the regulatory path for a modified device claiming substantial equivalence to an existing one.

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).