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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: 1. Safety Needle (Needle with Passive Sharps Protection) - The Safety Needle, which has the same blunter technology as the Bio-Plexus, Punctur-Guard® Blood Collection needle, is manufactured under the QSR Design Control requirements. The guidance document, "Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Protection Features", was used in the design and verification of the function of the Safety Needle. 2. Peelable Splitable Introducer - This introducer is identical to the existing introducer sold by TFX Medical, which was cleared under K920908.

This 510(k) summary describes a medical device, the "Modified TFX Medical Safety Needle with Introducer," and claims substantial equivalence to other legally marketed devices. However, it does not include any acceptance criteria or a study proving the device meets specific performance criteria.

The document focuses on:

• Device Description: Highlighting that the new device is almost identical to a previously cleared device (K000665) but with an increased working length for gastrointestinal use and the addition of a safety feature to prevent needle sticks.
• Intended Use: Specifying its application in guidewire introduction during gastrointestinal procedures.
• Technological Characteristics: Emphasizing the added anti-stick safety feature as the primary reason for the submission.
• Substantial Equivalence: Listing several predicate devices to which the new device is claimed to be substantially equivalent.
• FDA Clearance Letter: Confirming that the FDA has reviewed the submission and determined the device to be substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than presenting detailed performance study data against specific acceptance criteria.

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