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The BNX FNA System is used to sample targeted sub-mucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle stick injury. The 19Ga. and 22Ga. BNX Aspiration Needles are also intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.

The BNX Fine Needle Aspiration (FNA) System is a sterile, single patient use endoscopic ultrasound aspiration needle. The device consists of the BeaconTM Endoscopic Ultrasound Delivery System and BNXTM Fine Needle Aspiration Needle which are assembled before insertion through the accessory channel of an ultrasound endoscope. The device is offered with needle sizes of 19, 22 and 25 ga (however only the 19 and 22 gauge needles will be indicated for fiducial delivery). The BNX FNA System has an integrated needle protection shield that automatically engages over the distal end of the needle during removal to cover the needle sharp. In this manner, the needle tip is covered to help protect against inadvertent needle sticks.

The referenced BNX FNA device incorporates a long stiff metallic needle with stylet housed in a sheath with handle assembly. The handle is screwed onto the luer-lock connection of the endoscope. The needle is manipulated by a handle piston which is locked and unlocked by means of a screw to avoid advancement of the needle during introduction and withdrawal of the biopsy assembly. The tips of the Aspiration Needles are etched for enhanced ultrasonic needle visualization. The BNX FNA System is modular in design, i.e., the sheath and handle assembly are incorporated in a Delivery System as a separate component from the Aspiration Needle/stylet assembly. The modular design facilitates exchange of any size aspiration needle as the needle can be removed from the scope without requiring that the handle be disconnected. Additionally, the BNX FNA System has an integrated needle protection shield as a sharps injury protection feature that automatically engages over the distal end of the needle during removal to cover the needle sharp. In this manner, the needle tip is covered to help protect against inadvertent needle sticks. For delivery of fiducial markers the needle is loaded with the fiducial marker and fixated in place using bone wax. The fiducial marker is deployed into the target tissue by advancing the stylet.

This document describes the BNX Fine Needle Aspiration (FNA) System and its clearance through the FDA 510(k) process. It primarily establishes substantial equivalence to predicate devices and describes the device's indications for use and technological characteristics.

However, the provided text does not contain the specific details required to complete your request regarding acceptance criteria and a study proving those criteria are met.

Here’s a breakdown of what is present and what is missing based on your request:

What is available in the document:

• Device Name: BNX Fine Needle Aspiration System
• Intended Use: To sample targeted sub-mucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The 19Ga. and 22Ga. BNX Aspiration Needles are also intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
• Method of Performance Testing: "Bench and simulated use testing" was performed.
• Conclusion: The device is substantially equivalent to predicate devices for its proposed intended use.

Information NOT available in the document (and therefore cannot be provided in the requested table/description):

1. A table of acceptance criteria and the reported device performance: The document states that "bench and simulated use testing" was performed to demonstrate substantial equivalence, but it does not provide any specific quantitative acceptance criteria or the numerical performance results from these tests (e.g., success rates, precision, accuracy, force measurements, tissue sampling yield, etc.).
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as specific performance measures and ground truth establishment are not detailed.
4. Adjudication method for the test set: Not applicable.
5. 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: Not applicable. This device is a mechanical medical instrument, not an AI/imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used: Not explicitly stated for performance testing. For substantial equivalence, the ground truth is often the performance of the predicate device.
8. The sample size for the training set: Not applicable as this is a physical medical device, not a machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance and Acceptance Criteria (Based on Available Information):

Acceptance Criteria for Substantial Equivalence:

The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to existing legally marketed predicate devices. This means that the device must be as safe and effective as the predicate device(s). For this specific device, the predicate devices are:

• For Fine Needle Aspiration: BNX Fine Needle Aspiration System (K133008)
• For Fiducial Marker Delivery: Wilson-Cook Medical EchoTip Ultra Fiducial Needle (K111895)

Study Description:

The document states: "This premarket notification is supported with bench and simulated use testing. performed demonstrates that the subject device is substantially equivalent to the predicate devices for the proposed intended use."

This indicates that internal testing was conducted to show the device performed comparably to the predicate devices in a laboratory or simulated environment for its indicated uses (tissue sampling and fiducial marker implantation). No specific details on the methodology, results, or quantitative metrics of these tests are provided in this regulatory document. The specific "acceptance criteria" for these internal tests would have been developed by Covidien to ensure the device met its design specifications and performed as intended, demonstrating equivalence to the referenced predicates.

In essence, the document confirms that testing was done to support the claim of substantial equivalence, but it does not disclose the detailed results or specific acceptance metrics of that testing.

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