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The Howell Biliary Introducer Needle is used for aspiration biopsy in the biliary system.

The Howell Biliary Introducer Needle is a modification to the Wilson-Cook Aspiration Biopsy Needle cleared to market via 510(k) K961897. The modified Howell Biliary Introducer Needle is a sterile, single use device that consists of a luer slip handle, outer catheter sheath, inner catheter with needle, stylet, syringe with stopcock, and MLLA hub. The Howell Biliary Introducer Needle is 200 cm long. The Howell Biliary Introducer Needle is introduced to the biopsy site through the Howell Biliary Introducer, covered by K961897. There have been no modifications to the Howell Biliary Introducer.

This document is a 510(k) premarket notification for a medical device, specifically the Howell Biliary Introducer Needle. It does not contain information about software or AI-enabled devices. Therefore, it does not have the kind of acceptance criteria or study details (like sample size, ground truth, expert qualifications, MRMC studies, or training sets) that would be relevant to an AI/ML-driven device.

The document discusses the substantial equivalence of modifications made to an existing predicate device (Wilson-Cook Aspiration Biopsy Needle). The performance data cited is related to design verification and validation testing, which is typical for hardware medical devices, not software performance.

Here's a breakdown based on the information provided, noting the absence of AI-specific details:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics for device performance (e.g., sensitivity, specificity, or accuracy targets) as would be seen for an AI device. Instead, the "acceptance criteria" are implied by the substantial equivalence determination process for medical devices, which focuses on demonstrating that modifications do not raise new questions of safety or effectiveness compared to a predicate device.

• Reported Device Performance:

  • The document states that "Design verification and/or validation testing was performed as a result of this risk analysis assessment."
  • "Results from design validation and/or verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness."

  Note: This is a general statement about traditional medical device testing, not a report of specific performance metrics like those for an AI algorithm. The performance is deemed acceptable if it does not introduce new risks/issues compared to the predicate.

2. Sample Size for the Test Set and Data Provenance:

• Not applicable/Not provided. The document refers to "design verification and/or validation testing" for a physical medical device, not a test set for an algorithm. There is no data provenance information as it's not a data-driven study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable/Not provided. There is no "ground truth" establishment in the context of an AI algorithm's performance for this type of device submission.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No. This is a hardware device submission, not an AI device.

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

• No. This is a hardware device submission.

7. The Type of Ground Truth Used:

• Not applicable/Not provided.

8. The Sample Size for the Training Set:

• Not applicable/Not provided. There is no training set for a physical medical device.

9. How the Ground Truth for the Training Set was Established:

• Not applicable/Not provided.

Summary based on the provided document:

The document focuses on demonstrating substantial equivalence for the Howell Biliary Introducer Needle, a physical aspiration biopsy needle, to a legally marketed predicate device (Wilson-Cook Aspiration Biopsy Needle). The "acceptance criteria" are implicitly met by showing that minor design changes (material change for stylet, addition of syringe with stopcock, change in expiry date) do not negatively impact safety or effectiveness. This is confirmed through standard risk analysis (DFMEA) and design verification/validation testing appropriate for a hardware medical device. The document does not contain any information pertaining to AI or software-based performance studies.

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