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The Navi™ Needle-free Blood Collection Device attaches to a peripheral intravascular catheter (PIVC) system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins.

The Navi™ Needle-free Blood Collection Device is a sterile packaged single use product designed to be attached to an already placed peripheral intravascular catheter (PIVC) system. The device is comprised of an inner flow tube with an atraumatic tip attached to a plunger that is advanced and retracted with the use of a slider. The slider extends through the proximal end of the housing and is connected to the plunger. A male cannula is positioned at the distal end of the housing with Luer clips configured to connect to a PIVC system. The inner flow tube is intended to be advanced distally through the PIVC into a patient blood vessel establishing fluid communication between the blood vessel and the collection assembly. The inner flow tube is designed to extend beyond the distal end of the PIVC. A lateral flexible tube with a female Luer connected to the housing provides a connection point for an evacuated tube holder or syringe to obtain a blood sample. Once complete, the inner flow tube is fully retracted back into the housing, and the device is removed from the PIVC system. The device is available in three sizes (20 GA, 22 GA and 24 GA) that are compatible with the corresponding PIVC.

I am sorry, but the provided FDA 510(k) Clearance Letter for the Navi™ Needle-free Blood Collection Device (K244047) does not contain any information regarding acceptance criteria or the study data that proves the device meets specific performance criteria related to the device's efficacy in blood collection (e.g., blood volume, sample quality, success rate, etc.).

The document primarily focuses on:

• Regulatory classification and equivalence: Comparing the Navi™ device to a predicate device (PIVO™ Pro Needle-free Blood Collection Device, K230865) based on indications for use, intended use, and technological characteristics.
• Safety and basic performance testing: Listing applicable standards and types of tests performed (e.g., pressure leak, vacuum leak, kink resistance, biocompatibility, sterilization, packaging integrity) to demonstrate that the differences from the predicate device do not raise new questions of safety or effectiveness.
• Design and material comparisons: Highlighting similarities and differences in components, dimensions, and materials between the subject and predicate devices.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance, or to provide details on:

• Sample sizes used for a test set proving efficacy/performance, or data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth establishment.
• Whether MRMC or standalone (algorithm-only) studies were done, or their effect sizes.
• The type of ground truth used for performance validation.
• Sample size for the training set or how its ground truth was established, as this device is a physical medical device, not an AI/ML-based diagnostic or imaging device that typically has "training sets" and "test sets" in the context of data-driven performance validation.

The document states that "The Navi™ Needle-free Blood Collection Device was tested to demonstrate all product requirements and user needs were met." and "The test data obtained demonstrate that the Navi™ Needle-free Blood Collection Device meets requirements and user needs, and the device is substantially equivalent to the predicate device cleared under K230865." However, it does not explicitly report the quantitative results of these tests against specific numerical acceptance criteria for a "device performance" in the way you've framed the request (e.g., a specific success rate for difficult IV access, or a quantifiable improvement in blood collection efficiency). The tests mentioned (e.g., pressure leak, flow rate, hemolysis) are more fundamental engineering and safety performance tests rather than a clinical efficacy study with acceptance criteria often seen for diagnostic devices.

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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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