(90 days)
This instrument has been designed to be used with Olympus Endoscopes for endoscopic retrograde biliary drainage (ERBD). The stent is not intended to be permanently implanted in the patient. The stent is intended only for short-term implantation.
The subject Single Use Billary Drainage Stent V PBD-1030/ 1031/ 1032/ 1033 Stent Series, MAJ-1818/ 1819/ 1820/ 1821/ 1822 Insertion Kit Series and PBD-V630P/ V631P/ V632P Preloaded Stent Series are designed to be used with Olympus endoscopes for Endoscopic Biliary Drainage(ERBD) procedure. The subject Biliary Stent is placed into the duodenal papilla by using a Guidewire and Pusher Catheter to maintain the flow of bile by indwelling in the duodenal papilla.
This is a medical device application for a single-use biliary drainage stent. The provided document focuses primarily on establishing substantial equivalence to a predicate device through non-clinical testing, rather than reporting on a study that proves the device meets specific performance acceptance criteria in a clinical setting with human subjects. Therefore, many of the requested categories are not applicable or cannot be extracted from this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "established in-house acceptance criteria based on ISO 14971:2007" for risk analysis and "design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment." However, the specific quantitative or qualitative acceptance criteria for these tests (e.g., maximum cytotoxicity levels, minimum tensile strength, specific flexibility range) and the detailed results demonstrating the device met these specific criteria are not explicitly provided in the summary.
Instead, the document broadly states that the non-clinical tests were "performed" and that results demonstrated "stability for the stated shelf-life" and that test devices "continued to meet their specifications." This is a general statement of compliance, not a detailed reporting of criteria and performance.
| Test Category | Acceptance Criteria (Not explicitly stated in detail) | Reported Device Performance (Summary statement) |
|---|---|---|
| Biocompatibility | Established in-house criteria based on ISO 10993 series | Cytotoxicity, sensitization, intracutaneous reaction, implantation, subacute toxicity, systemic toxicity, chemistry special test, and bile solution pH tests were performed. (Specific criteria and results not provided, but implicitly met for submission.) |
| Stability | Established in-house criteria (e.g., flexibility, tensile strength, patency, compatibility with endoscope over time) | "Representative samples of devices were subjected to accelerated and real time ageing. The results of the accelerated age testing demonstrates that the device will be stable for the stated shelf-life. In addition, real time age testing will confirm the results of the accelerated age testing. The test devices were evaluated to ensure they continued to meet their specifications, including flexibility, tensile strength, tensile strength after stent placement, patency and compatibility with the endoscope." |
| Bench Testing | Established in-house criteria (e.g., flexibility characteristics) | "Bench testing was performed to compare the flexibility of the stent." (No specific criteria or comparison results are provided in the summary.) |
| Risk Analysis | Established in-house acceptance criteria based on ISO 14971:2007 | "The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment." (Results not detailed.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "Representative samples of devices" were used for stability testing and "test devices" for other non-clinical tests. However, the exact sample sizes are not specified for any of the non-clinical tests.
- Data Provenance: The tests are non-clinical (bench and lab-based testing) performed by the manufacturer, Aomori Olympus Co., Ltd. in Aomori, Japan. There is no patient data involved in the reported studies, so provenance like "country of origin of data" in terms of patient population or "retrospective/prospective" is not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies described are non-clinical, benchtop and laboratory tests. There is no "ground truth" established by human experts in the context of clinical outcomes or image interpretations. The "ground truth" for these tests would be objective measurements against defined specifications.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are non-clinical, benchtop and laboratory tests. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving expert consensus on patient data.
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
This information is not applicable. This document describes a traditional 510(k) submission for a physical medical device (biliary stent) prior to the widespread integration of AI in such devices. There is no AI component mentioned, and therefore, no MRMC study involving AI assistance for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. There is no algorithm or software component described that would operate in a standalone manner.
7. The Type of Ground Truth Used
For the non-clinical tests described:
- Biocompatibility: The ground truth is established by adherence to specified biological safety standards (e.g., ISO 10993 series) and laboratory measurements of biological responses.
- Stability: The ground truth is the device meeting its predefined engineering specifications (flexibility, tensile strength, patency, compatibility) after various aging conditions.
- Bench Testing (Flexibility): The ground truth would be objective measurements of flexibility against internal specifications or a comparison to the predicate device's flexibility.
In essence, the "ground truth" for these engineering and materials tests is the objective technical specification and standard.
8. The Sample Size for the Training Set
This information is not applicable. This is a submission for a physical medical device. There is no software algorithm that would require a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set mentioned or implied.
§ 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.