LogoFDA 510(k) Search
K Number
K970201
Device Name
GSI CANNULA WITH INTRODUCER
Manufacturer
GENERAL SURGICAL INNOVATIONS
Date Cleared
1997-04-21

(90 days)

Product Code
DYB
Regulation Number
870.1340
Type
Traditional
Panel
CV
Reference & Predicate Devices
K903078
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use of the GSI Cannula with Introducer is the same as the predicate devices (Hasson Stable Access Cannula K903078). The intended use of the predicate device and the GSI Cannula with Introducer is to provide access for surgical and diagnostic instruments for the duration of a surgical procedure.

Device Description

GSI's Cannula with Introducer is a hand held device comprised of a Cannula with an Introducer. The Cannula is comprised of a cannula body, an inflatable valve/seal and a stopcock. The inflatable valve/seal is inflated and deflated through the stopcock. The inflatable valve/seal provides a seal for surgical tools and diagnostic instruments during minimally invasive procedures using gas insufflation. The Cannula may be supplied with either a Sharp Tip or Blunt Tip Introducer. The Introducer is used for placement of the Cannula into an endoscopic or laparoscopic surgical space.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device (GSI Cannula with Introducer) and does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance.

The document discusses:

  • Device Description: A hand-held device comprising a cannula with an introducer, designed for minimally invasive procedures.
  • Intended Use: To provide access for surgical and diagnostic instruments during a surgical procedure, identical to the predicate device.
  • Comparison to Predicate Device: A table comparing the GSI Cannula with an Introducer to the Hasson Stable Access Cannula (K903078) across various design and material aspects.
  • Testing: Mentions "performance bench tests" were conducted to verify that differences from the predicate device do not affect safety or efficacy.

There is no mention of:

  • Acceptance criteria related to performance metrics for AI/ML. The document is for a physical medical device, not an AI/ML powered one.
  • Any study involving AI/ML performance.
  • Sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance related to AI/ML, nor the other requested details regarding an AI/ML study, as this information is not present in the provided text.

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).