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BNX Fine Needle Aspiration System: The device is used to sample targeted sub-mucosal and extramural gastrontestinal 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 sticks. 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.

Shark Core Fine Needle Biopsy System: The device is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adiacent to the gastrointestinal tract. The needle is designed with a passive (i.e., automatic) safety shelding feature to aid in the prevention of needle sticks.

The BNX FNA / SharkCore FNB Systems are sterile, single patient use endoscopic ultrasound aspiration needles. The devices consists of the Beacon Endoscopic Ultrasound Delivery System and either the BNX Fine Needle Aspiration Needle or the SharkCore Fine Needle Biopsy Needle which are assembled before insertion through the accessory channel of an ultrasound endoscope. The devices are offered with needle sizes of 19, 22 and 25 gauge. The BNX FNA / SharkCore FNB Systems have 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 provided document is a 510(k) summary for the BNX™ Fine Needle Aspiration System and the SharkCore™ Fine Needle Biopsy System. It describes the devices, their indications for use, and a summary of performance data. However, it does not contain the detailed information needed to construct a table of acceptance criteria and the study that proves the device meets those criteria, specifically regarding:

• Specific acceptance criteria values: The document only states that the devices "met the required specifications for completed design verifications tests." It does not provide the actual numerical or qualitative acceptance criteria for these tests (e.g., "unlocking forces must be > X N," or "sheath extension must be Y mm").
• Reported device performance values: Similarly, it states the devices "met the required specifications" but does not report the actual measured performance values (e.g., "unlocking forces measured Z N," or "sheath extension measured W mm").
• Sample sizes for test or training sets: It mentions "bench testing" but does not specify the number of units tested.
• Data provenance: No information on country of origin or retrospective/prospective nature.
• Details about experts or ground truth: Not applicable for bench testing.
• Adjudication method: Not applicable for bench testing.
• MRMC comparative effectiveness study: Not applicable, as this is bench testing, not a clinical study involving human readers.
• Standalone algorithm performance: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of ground truth, training set size, and how training ground truth was established: Not applicable for bench testing.

Therefore, I can only provide the information that is available in the document, which primarily concerns the types of tests performed and a general statement about meeting specifications.

1. Table of Acceptance Criteria and Reported Device Performance

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2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document only mentions "Bench testing has been performed."
• Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer, Covidien, LLC. This is prospective testing of manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The described testing involves bench testing of physical device attributes (forces, dimensions, durability), not human expert evaluation of data or images.

4. Adjudication method for the test set:

• Not applicable. The described testing involves bench testing of physical device attributes.

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 document pertains to the 510(k) clearance of physical aspiration/biopsy needles and does not involve AI or human image interpretation.

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

• Not applicable. This document pertains to a physical medical device, not an algorithm.

7. The type of ground truth used:

• For this bench testing, the "ground truth" would be the engineering specifications and design requirements that the device's performance characteristics (e.g., unlocking force, dimensions) were measured against.

8. The sample size for the training set:

• Not applicable. This document describes verification testing for a physical device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. No training set is involved in the context of this device's regulatory submission as described.

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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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The BNX™ Fine Needle Aspiration System is used to sample targeted sub-mucosal and extramural lesions of the gastrointestinal tract through the accessory channel of an ultrasound endoscope.

The BNXTM Fine Needle Aspiration System is a sterile, single patient use endoscopic ultrasound aspiration needle. The device consists of the BNXTM Aspiration Delivery System and BNXTM Fine Needle Aspiration Needle which are assembled before insertion through the accessory channel of an ultrasound endoscope. The needle is used to acquire aspiration samples from lesions targeted using an ultrasound endoscope. An aspiration sample is obtained by penetrating the lesions with the needle while applying suction. The device will be offered with needle sizes of 19, 22 and 25 gauge.

The provided text describes the 510(k) summary for the BNX™ Fine Needle Aspiration System, but it is a premarket notification for a medical device that does not involve AI. Therefore, most of the requested information regarding acceptance criteria, study details for AI performance, sample sizes for training and test sets, expert ground truth establishment, adjudication methods, and MRMC studies are not applicable.

The submission focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility evaluations, not through clinical efficacy studies involving diagnostic accuracy or AI performance.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for an AI device:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria with numerical performance targets typical for AI models. Instead, it describes various verification tests and their outcomes.

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

• Sample Size for Test Set: Not applicable for an AI device. The document describes bench testing performance, which involves a series of physical and mechanical tests on the device itself, not a test set of data. The number of units tested for each verification test is not specified.
• Data Provenance: Not applicable for an AI device. The testing was conducted in a laboratory/bench setting.

3. 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)

Not applicable. The "ground truth" for this device's performance is based on engineering specifications, material properties, and functional requirements, established by design and verified through laboratory testing (e.g., measuring forces, observing physical integrity). It does not involve expert clinical assessment of diagnostic output.

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

Not applicable. This concept applies to human-reviewed data for AI model evaluation. Bench testing involves direct measurement and observation against predefined engineering standards.

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. No AI component is described, and therefore no human reader assistance or MRMC study was performed. The device is a physical instrument for sample acquisition.

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

Not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's safety and effectiveness is established through adherence to engineering design specifications, biocompatibility standards, and functional performance benchmarks (e.g., a certain tensile strength, effective aspiration, visualizable echogenicity). These are verified through objective physical measurements and tests, rather than clinical outcomes or expert labels on medical data.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no training set.

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

Not applicable. There is no training set for this device.

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