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The RUBY Intravascular Catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The RUBY Intravascular Catheter is suitable for use with power injectors.

The RUBY Intravascular Catheter is intended to be inserted in the patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously.

The RUBY Intravascular Catheter is indicated for use in pediatric patients (with body mass higher or equal to 10kg) and adults.

The RUBY™ Intravascular Catheter consists of a radiopaque catheter having a usable length of 1.30 inches in 20-gauge size. The device is a single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor pressure, or administer fluids intravenously. The RUBY™ Intravascular Catheter's hub has a blood control valve mechanism that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter is restricted immediately after needle retraction until a secure luer connection has been made. The RUBY™ Intravascular Catheter is provided with a catheter guiding element with an atraumatic tip design positioned within the formed lumen between the catheter and the needle and connected to a slider used to deploy and retract the catheter guiding element; a flashback chamber to enhance flashback visualization, and a safety container that prevents sharp injuries.

This document is an FDA Clearance Letter for a medical device (Ruby Intravascular Catheter), not a study report or clinical trial. Therefore, it does not contain the detailed information required to answer your prompt about acceptance criteria and study findings related to AI/algorithm performance.

The provided text focuses on:

• Regulatory Clearance: Explaining that the device is substantially equivalent to a predicate device, allowing it to be marketed.
• Device Description: What the Ruby Intravascular Catheter is and how it functions.
• Indications for Use: For what medical purposes the device can be used (e.g., blood sampling, fluid administration).
• Comparison to Predicate: Highlighting similarities and differences between the Ruby Catheter and a previously cleared device (AccuCath).
• Safety and Performance Tests (General): Listing the types of tests performed (e.g., performance, biocompatibility, sterilization, shelf-life and the standards they followed (e.g., ISO, ASTM).

Crucially, there is no mention of any AI, algorithm, or software component within the Ruby Intravascular Catheter. The device is a physical medical instrument (a catheter), and the testing described pertains to its physical and biological properties.

Therefore, I cannot provide a table of acceptance criteria for algorithm performance, sample sizes for an AI test set, expert qualifications for AI ground truth, or details about MRMC studies, as these concepts are not applicable to the information given in the FDA clearance letter for this specific device.

To answer your prompt with the requested details, the input would need to be a clinical study report or a 510(k) submission summary specifically for a software as a medical device (SaMD) or a device with a significant AI/algorithm component.

If you have a document related to an AI-powered medical device, please provide that, and I will do my best to extract the relevant information.

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