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The Nexus TKO®-6 is a luer-activated, normally closed, bi-directional, anti-reflux device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients. The Nexus TKO®-6 incorporates anti-reflux technology which prevents blood reflux resulting from the following conditions: bag run-dry, connection and disconnection of luer lock devices, syringe plunger compression and patient vascular changes, such as coughing or sneezing. The Nexus TKO®6 has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.

The Nexus TKO®-6 is a luer-activated, normally closed, bi-directional, anti-reflux device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients. The Nexus TKO®-6 incorporates anti-reflux technology which prevents blood reflux resulting from the following conditions: bag run-dry, connection and disconnection of luer lock devices, syringe plunger compression and patient vascular changes, such as coughing or sneezing. The Nexus TKO®6 has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.

This document is a 510(k) premarket notification approval letter from the FDA for a medical device called the "Nexus Luer-Activated Device, Nexus TKO®-6." It confirms that the FDA has found the device to be substantially equivalent to a legally marketed predicate device.

However, this document does not contain information about acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study report proving a device meets acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This means the device met the requirements for 510(k) clearance, which is primarily about demonstrating substantial equivalence, not necessarily meeting a predefined set of performance acceptance criteria through clinical studies detailed in the provided text.

Therefore,Based on the provided FDA 510(k) clearance letter, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. This document is an approval letter, not a study report. It states that the device is "substantially equivalent" to a predicate device, which is the basis for its clearance, rather than detailing a specific study with acceptance criteria and performance metrics.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information about standalone (algorithm only) performance.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Therefore, I am unable to provide the requested information from the given text.

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