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K Number
K192625
Device Name
PG Pro Microcatheter
Manufacturer
MicroVention, Inc., A Terumo Group Company
Date Cleared
2019-11-21

(59 days)

Product Code
DQY,KRA
Regulation Number
870.1250
Type
Traditional
Panel
CV
Reference & Predicate Devices
K101542,K142449
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PG Pro microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.

Device Description

The PG Pro Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the catheter hub is used for the attachment of accessories.

AI/ML Overview

The provided text is for a 510(k) premarket notification for the "PG Pro Microcatheter". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria for an AI/ML type of medical device through a clinical study.

Therefore, the text does not contain the information requested regarding:

  1. A table of acceptance criteria and reported device performance for an AI/ML device.
  2. Sample size and data provenance for a test set.
  3. Number of experts and their qualifications for ground truth establishment.
  4. Adjudication method for a test set.
  5. MRMC comparative effectiveness study results.
  6. Standalone performance of an algorithm.
  7. Type of ground truth used (expert consensus, pathology, outcomes data).
  8. Sample size for a training set.
  9. How ground truth for the training set was established.

Instead, the document describes:

  • Device Description: The PG Pro Microcatheter is a single lumen catheter designed for introducing over a guidewire to access small, tortuous vasculature for infusing diagnostic and therapeutic agents in the peripheral vasculature.
  • Predicate Device: Headway 27 Microcatheter (K142449). A reference device (Headway 17 Microcatheter, K101542) is also listed.
  • Comparisons: The document includes a detailed "TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE" (Table 1) comparing the PG Pro Microcatheter to its predicate and reference devices across properties like Indications For Use, Principle of Operation, Material(s), Proximal ID/OD, Distal ID/OD, Number of Marker bands, Coating, Effective Length, Tip Configuration, Guidewire Compatibility, Method of Supply, and Accessories. The table highlights differences such as the PG Pro being intended only for peripheral vasculature, using a Tungsten coil vs. stainless steel, having a different range of effective lengths, being straight configuration only, being compatible with larger guidewires, and not including a shaping mandrel.
  • Performance Data (Non-Clinical):
    • Biocompatibility testing: Conducted according to ISO10993-1, including cytotoxicity, sensitization, irritation, acute systemic toxicity, and hemocompatibility, as it is considered a limited (

§ 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).