Search Results

The Biliary Pancreaticobiliary Scope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Biliary Pancreaticobiliary Scope System comprises two components: the Single-use Biliary Pancreaticobiliary Scope and the Image Processor. The Single-use Biliary Pancreaticobiliary Scope is intended to provide direct visualization, illumination and to guide accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Image Processor is intended to receive, process, and output images from the Single-use Biliary Pancreaticobiliary Scope for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

The Biliary Pancreaticobiliary Scope System comprises two components: the Single-use Biliary Pancreaticobiliary Scope (model:CL-A, CL- B), and the Image Processor (model: HUV-02). The Single-use Biliary Pancreaticobiliary Scope is a flexible scope, introduced into the pancreatico-biliary system via a duodenoscope. The Single-use Biliary Pancreaticobiliary Scope comprises a handle, an insertion tube, and a connection cable.

I am sorry, but the provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for a device to meet those criteria. The document is a 510(k) clearance letter from the FDA for a "Biliary Pancreaticobiliary Scope System."

Here's what I can tell you based on the provided text, and what is missing:

Information Present in the Document:

• Device Name: Biliary Pancreaticobiliary Scope System
• Intended Use/Indications for Use: The system is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system, including the hepatic ducts. It provides direct visualization, illumination, and guidance for accessory devices.
• Non-Clinical Tests Summary: The document lists various non-clinical tests performed, including:
  • Biocompatibility (Cytotoxicity, Intracutaneous reactivity, Sensitization, Acute systemic toxicity, Pyrogen)
  • Sterilization and shelf life testing (ISO 11135:2014, ISO 10993-7:2008, ASTM F1980-21, ISO 11607-1.2019, ASTM F 1886/F1886M-16, ASTM F88F88M-15, ASTM F 1929-15)
  • Electrical safety and electromagnetic compatibility (EMC) (IEC 60601-1, IEC60601-2-18, IEC 60601-1-2)
  • Software Verification and Validation Testing (according to FDA guidance)
  • Bench performance testing:
    • Optical performance (ISO 8600 series)
    • Color performance (color reproduction), optical performance (resolution, depth of field, image intensity uniformity), SNR, dynamic range, frame frequency, and system delay test compared with the predicate device.
    • Mechanical testing (water resistance, deflection, working channel system leakage, articulation reliability, attachment to duodenoscope reliability, irrigation pump compatibility)
  • Animal testing (referring to FDA Guidance-General Considerations for Animal Studies Intended to Evaluate Medical Devices)
• Clinical Testing: "Not Applicable." This explicitly states that clinical testing was not performed for this submission.
• Predicate Device: SpyGlass DS Direct Visualization System (K142922)

Information NOT Present in the Document (and therefore cannot be provided by me):

1. A table of acceptance criteria and the reported device performance: While various tests are listed, the document does not provide specific quantitative acceptance criteria (e.g., "resolution must be X lp/mm") or the measured performance results of the device against these criteria. It only states that the device "complies with" certain standards or that tests were "performed."
2. Sample size used for the test set and the data provenance: This information is not provided for any of the tests, nor is there a "test set" in the context of clinical or AI performance. The animal test simply states it was conducted, but no details on size or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant as no clinical or AI performance study with human expert review is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Irrelevant due to no clinical or AI performance study.
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, as this is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for the non-clinical tests described. For the animal study, the ground truth would be based on observations during the animal procedure, but no details are given.
8. The sample size for the training set: Not applicable, as this is not an AI device with a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA clearance letter focuses on establishing substantial equivalence through non-clinical performance, safety, and compatibility testing, rather than a detailed clinical effectiveness study with acceptance criteria and performance data. The phrase "Performance testing and compliance with voluntary standards demonstrate that the proposed Biliary Pancreaticobiliary Scope System is substantially equivalent to the predicate device" serves as the overall conclusion for meeting FDA's requirements for this 510(k) pathway.

Ask a specific question about this device