(88 days)
The Flexima™ Nasobiliary Catheter is indicated for prolonged access to the biliary ductal system via the nose, including:
- Decompression of an obstructed bile duct in acute suppurative cholangitis.
- Temporary or short-term decompression of the common bile duct, similar to that which follows unsuccessful stone extraction after endoscopic sphincterotomy.
- Prevention of stone impaction after endoscopic sphincterotomy.
- Infusion of contrast medium for repeat cholangiography.
- Instillation of various therapeutic solutions, including antibiotics (for acute bacterial cholangitis) or saline (to flush sludge or small stones after endoscopic sphincterotomy).
- Preoperative biliary decompression to decrease jaundice (thereby decreasing perioperative complications) in patients undergoing elective biliary tract surgery.
- Temporary biliary decompression in patients who are septic or who have severe coagulopathy. Once infection has been controlled or coagulopathy corrected, sphincterotomy can be performed, and a large stent can be inserted for long-term therapy.
- Access for intraluminal irradiation therapy, using iridium.
- Aspiration of bile for chemical and bacteriologic studies (e.g., to identify causative agents in bacterial cholangitis or to determine the lithogenicity of bile in patients with cholestasis).
- Facilitating the healing process in traumatic or surgical biliary fistulae.
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The provided text describes a 510(k) premarket notification for the Flexima™ Nasobiliary Catheter. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a new performance study to establish specific acceptance criteria for the device's diagnostic performance (e.g., sensitivity, specificity for an AI algorithm).
The "Performance Characteristics" section explicitly states: "Laboratory testing regarding characteristics was performed on Flexima™ Nasobiliary Catheter to verify its safety and performance." and "A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Flexima™ Nasobiliary Catheter with satisfactory results."
This indicates that the "acceptance criteria" and "device performance" relate to the physical and material characteristics of the catheter (e.g., integrity, flow rates, material safety, sterility) and not to a diagnostic accuracy or AI software performance as would be relevant to the questions posed.
Therefore, most of the requested information regarding sample size, data provenance, ground truth, expert opinions, MRMC studies, or standalone algorithm performance is not applicable to this submission, as it is a device (catheter) and not an AI/diagnostic software.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance for Flexima™ Nasobiliary Catheter
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Safety | Biocompatibility: Satisfactory results |
| Performance | Laboratory testing verified safety and performance |
| Packaging | Packaged in Tyvek® and extrusion coated-polyethylene on polyester |
| Sterilization | Sterilized using ethylene oxide gas (AAMI protocol) |
| Pyrogenicity | Periodic testing to monitor bacterial endotoxin levels |
Additional Information Relevant to AI/Diagnostic Studies (Not Applicable to this Device)
- Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device (catheter), not a diagnostic algorithm that would use a test set of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic ground truth was established for this device.
- Adjudication method for the test set: Not applicable.
- 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 is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a physical device like this relates to its physical and material properties meeting specifications.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
Conclusion from document: The submission for the Flexima™ Nasobiliary Catheter primarily relies on demonstrating substantial equivalence to existing predicate devices and providing evidence of the device's safety (biocompatibility, sterility, pyrogenicity) and physical performance through laboratory testing. It does not involve diagnostic performance metrics or AI algorithm evaluation.
§ 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.