Search Results

The introducer system is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

Device Description

The finished device is a valved tear-away introducer for use in percutaneous procedures to introduce or position catheters or other interventional devices into the peripheral vasculature. The unmodified predicate introducers are constructed using identical processes and material with the exception of the subject device was modified to add a new valve design and material. The performance characteristics to the current marketed predicate device are unchanged and are consistent with other legally marketed devices.

AI/ML Overview

The provided text is related to a medical device's 510(k) submission, specifically for the Galt Medical Corp. VTI Valved Tearaway Introducer. This document outlines the regulatory approval process and demonstrates substantial equivalence to a predicate device, focusing on functional testing rather than clinical study results involving human readers or AI.

Therefore, many of the requested categories in the prompt regarding AI, human readers, ground truth, and training data are not applicable to this type of document. The information provided is primarily about the physical and functional performance of the device itself.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to "product specifications" and "protocols based on international standards and Galt Medical requirements" but does not explicitly list the specific quantitative acceptance criteria or detailed numerical results for each test. Instead, it states that the device "met product specifications."

Acceptance Criteria (General)	Reported Device Performance (Summary)
Meet product specifications based on international standards and Galt Medical requirements for functional testing.	Device met product specifications. Substantially equivalent to predicate device.
Maintain structural and functional integrity after aging (4 years).	Device performed equivalently after 4 years of simulated aging.
Proper dilator lock function.	Successfully passed Dilator Lock Test.
Secure cap retention.	Successfully passed Cap Retention Test.
No leakage under pressure.	Successfully passed Pressure Leak Test.
No air leakage under vacuum.	Successfully passed Vacuum Leak Test.
Ease of insertion and extraction.	Successfully passed Prolonged Insertion Test and Insertion/Extraction Test.
Valve integrity (no separation).	Successfully passed Valve Separation Test.
Biocompatibility.	Additional biocompatibility testing performed for new valve material, included in submission. Previous biocompatibility (K112398) covers identical raw materials and package configuration with the exception of the new valve design.
Sterilization effectiveness.	Adopted into existing ethylene oxide sterilization cycle (K112389).
Packaging shelf life.	Previous packaging shelf life testing (K112398) applies.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated. The document mentions "Functional testing on un-aged and 4 year aged product," implying a set of physical devices were tested.
Data Provenance: Not specified, but generally, such functional and physical tests are conducted in a controlled laboratory environment by the manufacturer (Galt Medical Corp.) in the US (Garland, TX). The study is retrospective in the sense that the testing has already been completed and the results are being submitted for regulatory review, but it's a prospective test of the device's characteristics against its specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a physical device, and the "ground truth" for its performance is established by standardized functional tests and measurements, not by expert interpretation of data like in an AI or diagnostic study.

4. Adjudication method for the test set:

Not Applicable. As per point 3, there's no "adjudication" in the sense of resolving discrepancies in expert interpretations. The tests have clear pass/fail criteria based on objective measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This device is a catheter introducer, not a diagnostic AI system or a system that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

Physical device measurements and established engineering/performance standards. The "ground truth" is whether the physical device can perform its intended functions (e.g., locking, not leaking, ease of use, biocompatibility) according to predefined specifications and regulatory requirements.

8. The sample size for the training set:

Not Applicable. There is no "training set" in the context of this device's functional testing. This is not an AI/machine learning product.

9. How the ground truth for the training set was established:

Not Applicable. Same as point 8.

Ask a Question

Ask a specific question about this device

Page 1 of 1