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K Number
K182660
Device Name
GaltTWS
Manufacturer
Galt Medical Corp.
Date Cleared
2019-05-30

(247 days)

Product Code
DRB,DQX,DTL
Regulation Number
870.1380
Type
Traditional
Panel
CV
Reference & Predicate Devices
K152528,K992664,K982559
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The GaltTWS Stylet is a percutaneous catheter stylet placed inside a catheter, lead, or cannula to stiffen the device for placement or extraction.

Device Description

The GaltTWS stylet is comprised of a stainless steel twisted/braided wire of varying diameters (0.012-0.015 inch), and varying length (30-72cm). The GaltTWS stylet can be configured as a Twisted/Braided wire bonded to a hub, flushable hub, or connected to a flushable adjustable hub using the Galt Gateway Hemostasis Valve (K152528).

AI/ML Overview

This document is a 510(k) premarket notification decision letter for a medical device called the "GaltTWS Stylet." As such, it does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML-based medical device.

The requested information (acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc.) is specific to studies proving the performance of AI/ML algorithms. This FDA letter pertains to a non-AI medical device (a catheter stylet) and focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility.

Therefore, I cannot fulfill the request using the provided text. The document describes:

  • Device: GaltTWS Stylet (a percutaneous catheter stylet)
  • Purpose: Stiffen a catheter, lead, or cannula for placement or extraction.
  • Regulatory Pathway: 510(k) for substantial equivalence.
  • Testing: Bench testing (Particulate, Mechanical Properties, Leak, Tortuous Path) and Biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemolysis, Pyrogen, EO Residuals).
  • Conclusion: Device is substantially equivalent to marketed predicate devices.

This information is relevant to traditional medical device clearance, not the evaluation of AI/ML performance.

§ 870.1380 Catheter stylet.

(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).