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 Intended Use of the Modified Safety Needle with Introducer device is identical to the Modified TFX Medical Safety Needle with Introducer cleared by the FDA in K021034. In order to provide a more robust design, the material of construction has been changed from High Density Polyethylene to Polypropylene. An increase in the outer diameter has also been implemented to add additional rigidity to the cannula sheath.

The Modified TFX Medical Safety Needle with Introducer will continue to allow placement of guidewires ranging from 0.015" - 0.052". The variance in sizes and lengths is due to the specific procedure, physician preference and patient body type.

This product consists of the following two components:

• Safety Needle (Needle with Passive Sharps Protection)- The Safety Needle, has the 1. same blunter technology as the Bio-Plexus, Punctur-Guard Blood Collection needle (K895024).
• Sheath Introducer- The functionality of the peelable, splitable introducer is identical 2. to the existing introducer sold by TFX Medical, which was initially cleared under K920908 and subsequently cleared under K021034 to be used for guidewire introduction during gastrointestinal procedures.

The sheath will also be made available in a non-peelable configuration.

The provided text describes a 510(k) submission for a Modified TFX Medical Safety Needle with Introducer. This submission is for a medical device and not an AI/ML algorithm, therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The submission relies on substantial equivalence to predicate devices, rather than establishing new performance criteria through clinical studies with acceptance criteria. The acceptance criteria for the material and design changes are inferred to be successful performance in the identified performance testing and conformance with voluntary performance standards.

1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document does not mention the specific sample size used for performance testing, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This is not applicable as the submission is for a physical medical device, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth from a test set. Substantial equivalence is based on engineering and material characteristics, and conformance to standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This is not applicable for a physical medical device submission of this nature.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This is not applicable. The device is a safety needle and introducer, not an imaging analysis or diagnostic AI tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not applicable. The submission is for a physical medical device.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the material and design changes, the "ground truth" is based on established engineering principles, material science properties, and adherence to recognized performance standards (e.g., ISO 10993-1 for biocompatibility). The performance testing would have compared the device's characteristics against these established benchmarks or against the predicate device's measured performance. No clinical "outcomes data" or "expert consensus" for diagnostic accuracy are mentioned beyond the device's intended function.

7. The sample size for the training set

• This is not applicable. The submission does not involve an AI/ML algorithm or a "training set" in that context.

8. How the ground truth for the training set was established

• This is not applicable.

Ask a specific question about this device

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

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.

Ask a specific question about this device

Ask a specific question about this device