(365 days)
The intended use of the Percutaneous Biliary Drainage Intended Use: Catheter is to treat patients with obstructive jaundice, sepsis, and hepatic decompensation and pre-operative decompression.
The proposed Percutaneous Biliary Drainage Catheter is identical to the predicate Navarre Locking Pigtail Universal Drainage Catheter in that they have identical tip-locking mechanisms. They differ only in the length of the distal ported section, catheter length, addition of a flexible cannula, number of drain holes, and the addition of a biliary septum to inject fluids into the bile duct.
The provided text describes a 510(k) summary for a medical device (Navarre Percutaneous Biliary Drainage Catheter), focusing on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study against those criteria for its own performance.
Therefore, most of the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided text.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, there are no specific, quantitative acceptance criteria defined, nor is there a direct report of the device's performance against such criteria. The submission states "Testing showed that the Percutaneous Biliary Drainage Catheter does not raise any new questions of safety and effectiveness" and "the laboratory results show that the Percutaneous Biliary Drainage Catheter design does not raise any new questions of safety and efficacy and that the Biliary Catheter is substantially equivalent to the current Locking Pigtail Universal Drainage, Navarre Universal Drainage, Cook Ultrathane™ Biliary Drainage Catheter, and the Medi-tech VTCB Biliary System."
The table below reflects what can be inferred or directly stated from the document regarding "performance" in the context of a 510(k):
| Acceptance Criteria (Inferred from 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Non-cytotoxic | Non-cytotoxic |
| Physical characteristics equivalent to predicate devices | Physical characteristics equivalent to predicate devices |
| Does not raise new questions of safety | Does not raise new questions of safety |
| Does not raise new questions of effectiveness | Does not raise new questions of effectiveness |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available in the provided text. The document mentions "Laboratory tests for cytotoxicity" and "Qualification tests" but does not specify the sample size, type of test subjects (if any, beyond materials), or data provenance.
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 available in the provided text. This submission focuses on non-clinical testing and substantial equivalence, not on clinical performance evaluation with human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not available in the provided text.
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 physical drainage catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests mentioned:
- Cytotoxicity: The ground truth would be established by standard analytical laboratory methods for assessing cell viability or metabolic activity in the presence of the device material extracts.
- Physical Characteristics: The ground truth would be established by engineering specifications, material standards, and comparison measurements against the predicate devices.
8. The sample size for the training set
Not applicable. This submission is for a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
§ 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.