FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Glidewire GT-R is intended to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

Device Description

The subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are both operated through a manual process. The subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are the same design and construction except for Guide wire length. The subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are constructed from the same materials. The only material difference lies in the Individual Packaging.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device called Glidewire GT-R. It focuses on demonstrating substantial equivalence to an existing predicate device rather than proving novel performance characteristics through a clinical trial or a deep-dive AI performance study.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving a device meets these criteria in the context of an AI/human-in-the-loop performance study.

Here's why and what the document does provide:

Device Type: The Glidewire GT-R is a physical medical device (a catheter guide wire), not a software device or an AI algorithm.
Purpose of 510(k): The 510(k) submission aims to show that the new device (Glidewire GT-R) is substantially equivalent to a legally marketed predicate device (Glidewire GT). This means it has the same intended use, similar technological characteristics, and performs as safely and effectively as the predicate.
Testing Focus: The "performance testing" described (Section H, Table 3) is engineering performance testing (e.g., Tensile Strength, Torqueability, Lubricity, Kink Resistance, Radiopacity). These tests ensure the physical properties and functionality of the guidewire itself meet established physical and mechanical standards and are comparable to the predicate.
No AI/Human Reader Study: Since this is a physical guidewire, there is no AI component, and thus no multi-reader multi-case (MRMC) study, human reader improvement, standalone algorithm performance, or ground truth establishment (expert consensus, pathology, outcomes data) as would be relevant for an AI diagnostic device.
"Acceptance Criteria" in this context: The acceptance criteria here refer to the passing thresholds for the physical performance tests listed in Table 3 (e.g., a certain minimum tensile strength, a maximum friction coefficient for lubricity). The document states, "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." However, it does not provide the specific numerical acceptance criteria for each test or detailed results beyond this summary statement.

To directly answer your request based on the provided text, while noting the different context:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly detailed as numerical values in the document. The document states "Performance testing met the predetermined acceptance criteria."
Reported Device Performance: The document provides a summary statement that the device met these criteria, but no specific quantitative results for each test item listed in Table 3.

Test Item	Acceptance Criteria	Reported Device Performance
Dimensional Verification	(Not specified, but assumed to be within manufacturing tolerances for guidewire dimensions.)	"met the predetermined acceptance criteria"
Visual Inspection	(Not specified, e.g., no defects, smooth coating.)	"met the predetermined acceptance criteria"
Simulated Use	(Not specified, e.g., successful navigation through a simulated vessel model without kinking or breaking.)	"met the predetermined acceptance criteria"
Tensile Strength	(Not specified, but would be a minimum force required to break/yield.)	"met the predetermined acceptance criteria"
Tip Pull	(Not specified, e.g., a minimum force to separate the tip.)	"met the predetermined acceptance criteria"
Torque Strength	(Not specified, e.g., a minimum torque before a permanent twist.)	"met the predetermined acceptance criteria"
Torqueability	(Not specified, e.g., the ability to transmit torque from the proximal to distal end smoothly.)	"met the predetermined acceptance criteria"
Lubricity and Coating Integrity	(Not specified, e.g., a coefficient of friction, or visual assessment after use.)	"met the predetermined acceptance criteria"
Particulate Evaluation	(Not specified, e.g., maximum number/size of particulates released.)	"met the predetermined acceptance criteria"
Kink Resistance	(Not specified, e.g., ability to resist kinking at certain bend radii.)	"met the predetermined acceptance criteria"
Tip Flexibility	(Not specified, e.g., ability to bend to a certain radius and return.)	"met the predetermined acceptance criteria"
Radiopacity	(Not specified, e.g., visibility under fluoroscopy to a certain standard.)	"met the predetermined acceptance criteria"
Shaping Test	(Not specified, for shapeable types, ability to hold a formed shape.)	"met the predetermined acceptance criteria"
Shape Retention	(Not specified, for shapeable types, ability to retain shape after use.)	"met the predetermined acceptance criteria"
Corrosion resistance	(Not specified, e.g., no signs of corrosion after exposure to specific solutions.)	"met the predetermined acceptance criteria"

Sample sizes used for the test set and the data provenance:
- The document does not specify the sample sizes (number of guidewires) used for each performance test.
- Data Provenance: The tests were conducted internally by Terumo Corporation (Ashitaka Factory, Japan and Terumo Medical Corporation, NJ, USA) on their manufactured devices. The data is prospective, generated specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical device, and the "ground truth" is determined by engineering measurements against pre-defined specifications, not by expert consensus on clinical images/data.
Adjudication method for the test set: Not applicable for engineering performance tests.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI or diagnostic imaging device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable.
The type of ground truth used: For the physical performance tests, the "ground truth" is based on engineering specifications and recognized industry standards (e.g., ISO, internal company standards). The predicate device and reference devices informed the establishment of these acceptance criteria.
The sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.