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K Number
K211134
Device Name
BIB Stent Placement Catheter
Manufacturer
NuMED, Inc
Date Cleared
2021-05-27

(41 days)

Product Code
NVM
Regulation Number
870.1250
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text does not contain information about acceptance criteria or a study proving device performance for the "BIB Stent Placement Catheter." This document is a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices.

The letter details:

  • The device name and applicant.
  • The FDA regulation number, name, and product code.
  • The date of the clearance.
  • A brief statement about the substantial equivalence determination.
  • Information regarding general controls and other FDA regulations that apply to the device.
  • Contact information for FDA resources.
  • The "Indications for Use" for the BIB Stent Placement Catheter, which states it is "Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter."

It does not include:

  1. A table of acceptance criteria or reported device performance.
  2. Details on sample sizes or data provenance for any studies.
  3. Information about experts or ground truth establishment.
  4. Adjudication methods.
  5. Multi-reader multi-case comparative effectiveness study results.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Training set sample size or how its ground truth was established.

Therefore, I cannot fulfill your request for this information based on the provided text.

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).