Search Results

The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

Device Description

The Hydrophilic Guidewire is a stainless-steel guidewire with a radiopaque, platinum distal coil. The guidewire has a hydrophilic coating that spans the distal 170 cm. Included within the sterile pouch is a pin vise to assist in guidewire manipulation and an introducer needle to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Mirage™ Hydrophilic Guidewire and X-pedion™ Hydrophilic Guidewire. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and biocompatibility) testing, rather than a study on an AI/ML-based medical device.

Therefore, the information required to answer most of your questions about acceptance criteria for an AI/ML device, sample sizes for AI test sets, expert ground truthing, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML models is not present in this document.

However, I can extract information related to the acceptance criteria and performance data for the physical medical device as described:

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing):

The document details numerous non-clinical bench tests performed to demonstrate the safety and performance of the guidewires. The results consistently state that "The Mirage™ and X-pedion™ Hydrophilic Guidewires met the acceptance criteria for [Test Name]."

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

Test Category	Specific Test / Parameter	Acceptance Criteria (Implied by positive outcome)
Biocompatibility
Chemical Characterization (Extractables/Leachables)	No risk to the patient from Chemicals of Potential Concern (COPC).	The extractables/leachables found are acceptable.
Cytotoxicity	No evidence of cell lysis or toxicity; grade , and USP .	Met the acceptance criteria for bacterial endotoxin.
Packaging
Terminally Sterilized Medical Devices	Met criteria per ISO 11607.	Met the acceptance criteria for packaging terminally sterilized medical devices.
Performance (Bench)
Device Compatibility/Distal Access	Compatible with ancillary devices, navigates tortuous vessels.	Met the acceptance criteria for device compatibility/distal access.
Distal Flexibility	Navigates through tortuous vessels.	Met the acceptance criteria for distal flexibility.
Visual Fracture	Met criteria per ISO 10555-1 and ISO 11070.	Met the acceptance criteria for visual fracture.
Radiopacity	Clearly visible during use.	Met the acceptance criteria for radiopacity.
Tip Buckling	Withstands forces typical of clinical use.	Met the acceptance criteria for tip buckling.
Tip Retention	Satisfactory tip retention.	Met the acceptance criteria for tip retention.
Tip Shapeability	Satisfactory tip shapeability.	Met the acceptance criteria for tip shapeability.
Torque Response	Distal tip responds to proximal manipulations.	Met the acceptance criteria for torque response.
Turns to Failure	Withstands torsional forces typical of clinical use.	Met the acceptance criteria for turns to failure.
Visual Inspection and Dimensional Verification	Meets specified dimensions.	Met the acceptance criteria for visual inspection and dimensional verification.
Particulate	Meets criteria per USP for particulate counts and sizes.	Met the acceptance criteria for particulate counts and sizes.
Friction Force	Satisfactory friction force.	Met the acceptance criteria for friction force.
Flexing	Met criteria per ISO 11070.	Met the acceptance criteria for flexing.
Corrosion Resistance	Met criteria per ISO 11070.	Met the acceptance criteria for corrosion resistance.
Tensile Strength	Met criteria per ISO 11070.	Met the acceptance criteria for tensile strength.

Since this is a 510(k) submission for a non-AI/ML medical device, the following information is not applicable or not provided in the document:

Sample sizes used for the test set and the data provenance: Not an AI device, so no "test set" in the AI sense. Bench tests follow specific standards, implying sample sizes per those standards, but not explicitly stated here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth for a physical device is established via standardized physical and chemical tests, not expert human interpretation of data for AI.
Adjudication method for the test set: Not applicable for non-AI bench testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For a physical guidewire, "ground truth" is typically defined by adherence to engineering specifications, material properties, and performance under simulated clinical conditions, verified through empirical testing following established ISO and USP standards.
The sample size for the training set: Not applicable; this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable; this is not an AI/ML device.

In summary, this document is a regulatory submission for a physical medical device demonstrating substantial equivalence, not an AI/ML device requiring clinical validation for diagnostic or prognostic purposes.

Ask a Question

Ask a specific question about this device

Page 1 of 1