Search Results

The Modified TFX Medical Safety Needle with Introducer is intended to be used for guidewire introduction during gastrointestinal procedures such as PEG (Percutaneous Endoscopic Gastrostomy), PEJ (Percutaneous Endoscopic Jejunostomy) or other endoscopic gastrointestinal procedures requiring placement of a guidewire.

This device, with the exception of length, is identical to the TFX Medical Safety Needle with Introducer cleared by the FDA in K000665. The working length of the needle has been increased, due to the intended gastrointestinal use, and will be available in 2F - 6F sizes with lengths ranging between 2.50″ - 4.0″. The Modified TFX Medical Safety Needle with Introducer will allow placement of guidewires ranging from 0.015″ - 0.052″. The variance in sizes and lengths is due to specific procedure, physician preference and patient body type.

This product consists of two components:

• Safety Needle (Needle with Passive Sharps Protection)
• Peelable Splitable Introducer

The provided text is a 510(k) summary for a medical device (Modified TFX Medical Safety Needle with Introducer) and a determination letter from the FDA. It does not contain information about acceptance criteria, study methodologies, or test performance data for this device.

The document states that the device is "substantially equivalent in design and materials" to previously cleared devices and mentions the use of a "guidance document, 'Supplementary Guidance on the Content of Premarket Notification Submissions for Medical Devices with Sharps (510 (k) | Injury Protection Features)', was used in the design and verification of the function of the Safety Needle." However, it does not detail the specific acceptance criteria or the results of any testing done to prove the device meets them.

Therefore, I cannot provide the requested information from the given input. The requested details would typically be found in a more comprehensive study report or a different section of a 510(k) submission that elaborates on design verification and validation testing.

Ask a specific question about this device