(330 days)
This instrument has been designed to be used with Olympus endoscopes for Endoscopic Pancreatic Drainage. The Drainage Tube is not intended to be permanently implanted in the patient. The Drainage Tube is intended for short-term implantation. The Drainage Tube is also available as a kit, which includes accessories to aid in the placement of the Drainage Tube.
Pancreatic Drainage Tube has been designed to be used with Olympus endoscopes for Endoscopic Pancreatic Drainage. The instrument consists of the Drainage Tube, and Insertion Kit and Guidewire. The Drainage Tube is not intended to be permanently implanted in the patient. The drainage Tube is intended for short-term implantation.
This looks like a 510(k) premarket notification for a medical device called a "Pancreatic Drainage Tube." This type of document is a submission to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than a clinical study report with detailed performance metrics.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for an AI/CAD-like device is not applicable to this document.
Here's why and what information can be extracted:
- No AI, CAD, or similar device: The Pancreatic Drainage Tube is a physical medical instrument (a stent for drainage), not an artificial intelligence algorithm or computer-aided detection system.
- Substantial Equivalence: The primary goal of a 510(k) for this type of device is to show that it's as safe and effective as a previously cleared device. This typically involves comparisons of materials, design, intended use, and sometimes non-clinical (bench) testing, but not usually extensive clinical trials with performance metrics and ground truth establishment in the way an AI diagnostic device would.
Information Extracted from the Document (as relevant):
While I cannot provide the specific requested table and study details, I can tell you what this document does communicate about its clearance:
- Acceptance Criteria/Performance (Implied): The acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device in terms of safety and effectiveness. The reported "performance" is that the device "does not add any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness" when compared to the predicate device.
- Study Type: This is a premarket notification (510(k)) based on a comparison to predicate devices, not a clinical effectiveness study in the sense of an AI/CAD device.
- Ground Truth: For a physical device like this, "ground truth" relates to its physical properties, biocompatibility, and mechanical performance. The document states "Conclusions drawn from Non-clinical Tests" implying bench testing or material analyses were done, but no specific metrics are provided here.
- Training Set/Test Set/Experts/Adjudication/MRMC/Standalone Performance: These concepts are entirely irrelevant to a 510(k) for a physical medical instrument like a pancreatic drainage tube. There's no AI algorithm to train or test, no diagnostic interpretation to be adjudicated by experts, and no human-in-the-loop performance to measure.
Summary of Relevant Information from the Provided Text:
- Device Name: Pancreatic Drainage Tube
- Intended Use: Used with Olympus endoscopes for Endoscopic Pancreatic Drainage. Not intended for permanent implantation; intended for short-term implantation.
- Predicate Devices: Olympus PBD Stents #K933200 and Zimmon Endoscopic Pancreatic Stent (K900923 Wilson-Cook Medical, Inc.)
- Basis for Clearance: Substantial equivalence to predicate devices, indicating no significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness.
- Testing: Non-clinical tests were performed, but specific details or quantitative results are not provided in this summary. The summary only states that these tests support the conclusion of substantial equivalence.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.