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The guidewire introducer needles are intended for use as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.

The NeedleTech Guidewire Introducer Needle consists of a stainless steel cannula with an attached plastic luer lock hub on one end and a ground point or blunt tip on the other end. The device is intended to be supplied non-sterile and packaged in bulk.

The provided text is a 510(k) summary for a medical device called the "NeedleTech Guidewire Introducer Needle." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving performance against acceptance criteria in the same way a de novo or PMA submission might.

Therefore, the document does not contain the specific information requested regarding acceptance criteria studies for AI/device performance. The 510(k) summary focuses on device description, intended use, and substantial equivalence to existing predicate devices.

Here's why the requested information isn't present and what information is provided:

1. Acceptance criteria and reported device performance (Table): This document does not describe specific performance testing against acceptance criteria in the way a clinical study for a novel device would. It relies on the predicate devices to establish safety and effectiveness.
2. Sample size, data provenance (test set): Not applicable for a 510(k) summary. No test set for performance evaluation against acceptance criteria is described.
3. Number of experts, qualifications (ground truth for test set): Not applicable. No ground truth adjudication for a test set is described.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. This device is a physical introducer needle, not an AI or imaging diagnostic tool.
6. Standalone performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable. There is no AI component or "training set" for this physical device.
9. How ground truth for the training set was established: Not applicable.

What the document does provide in relation to regulatory acceptance:

• Device Name: NeedleTech Guidewire Introducer Needle
• Intended Use: The guidewire introducer needles are intended to be single-use disposable introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.
• Predicate Devices: Terumo Neolus Needle, Medtronic Disposable Hypodermic Needle Electrode, MINIRAD Light Saber Introducer Needle, Manan Blunt Needle.
• Substantial Equivalence Statement: "The NeedleTech Guidewire Introducer Needle is substantially equivalent to a combination of its predicate devices, with the exception of minor differences in size and general indications for use, which raise no new issues regarding safety of effectiveness."
• Regulatory Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed under general controls.

In summary, this 510(k) document establishes the regulatory acceptance for the "NeedleTech Guidewire Introducer Needle" based on its substantial equivalence to predicate devices, rather than a detailed study proving performance against specific acceptance criteria for a novel device or AI application.

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