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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:

• 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.

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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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The TFX Medical Introducer Assembly will be used to provide access to the venous system for device entry, when used in conjunction with additional percutaneous entry devices.

The TFX Medical Introducer Assembly consists of a Sheath/Dilator Assembly.

The provided text is a 510(k) summary for the TFX Medical Introducer Assembly. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or groundbreaking truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from this document. The sections you asked for, such as a table of acceptance criteria and reported device performance, sample sizes, expert details, and ground truth information, are not present in this 510(k) submission.

This type of 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device based on similar technological characteristics and intended use, rather than presenting new performance study data against acceptance criteria.

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