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510(k) Data Aggregation
(143 days)
Endoscopic biliary stent placement for biliary drainage of obstructed ducts that could be caused by common bile duct stones, malignant biliary obstruction, benign or malignant strictures or other obstructed biliary conditions requiring drainage.
The Compass BDS® Biliary Stent includes double pigtails with double radiopaque marker bands. Compass BDS® Biliary Stents are recommended for use with Cook stent introducers (PC-7, PC-7E, and FS-PC-7). The product code for Compass BDS® Biliary Stent is CBBSO-X-Y (CBBSO-7-5, CBBSO-7-10, CBBSO-7-15), where X denotes French size (Fr) and Y denotes the length in centimeters (cm). This product contains a stent and a pigtail straightener. The stent design allows the stent to be introduced on either side and the double-pigtails minimize migration, while side holes enhance biliary fluid drainage. It also has a tapered tip at both ends to facilitate smooth cannulation. The stent has two radiopaque bands on both ends for fluoroscopic visibility.
This application is for a medical device (Compass BDS Biliary Stent), not an AI/ML powered device. Therefore, the requested information regarding AI/ML powered device acceptance criteria and study details are not applicable here.
However, based on the provided document, here's what can be extracted about the device's performance data and substantial equivalence to a predicate device:
The acceptance criteria for the Compass BDS Biliary Stent are implicitly met through a comparison to a predicate device and a series of non-clinical performance tests. The study's conclusion is that the device is substantially equivalent to the predicate device and meets its design input requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests/Characteristics | Reported Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | Performed; results intended to demonstrate compliance with ISO 10993-1:2018 and FDA guidance. |
| Irritation | Performed; results intended to demonstrate compliance with ISO 10993-1:2018 and FDA guidance. | |
| Sensitization | Performed; results intended to demonstrate compliance with ISO 10993-1:2018 and FDA guidance. | |
| Acute Systemic Toxicity | Performed; results intended to demonstrate compliance with ISO 10993-1:2018 and FDA guidance. | |
| Systemic Toxicity (13 Week Subcutaneous Implantation) | Performed; results intended to demonstrate compliance with ISO 10993-1:2018 and FDA guidance. | |
| Muscle Implantation (4 Week) | Performed; results intended to demonstrate compliance with ISO 10993-1:2018 and FDA guidance. | |
| Muscle Implantation (13 Week) | Performed; results intended to demonstrate compliance with ISO 10993-1:2018 and FDA guidance. | |
| Mouse Lymphoma Assay | Performed; results intended to demonstrate compliance with ISO 10993-1:2018 and FDA guidance. | |
| Material Mediated USP Rabbit Pyrogen Study | Performed; results intended to demonstrate compliance with ISO 10993-1:2018 and FDA guidance. | |
| Bacterial Reverse Mutation Study | Performed; results intended to demonstrate compliance with ISO 10993-1:2018 and FDA guidance. | |
| Device Performance | Simulated Use | Testing completed to Cook Ireland's design control system. Demonstrates the device meets design input requirements. |
| Dimensional Testing | Testing completed to Cook Ireland's design control system. Demonstrates the device meets design input requirements. | |
| Visual Testing | Testing completed to Cook Ireland's design control system. Demonstrates the device meets design input requirements. | |
| Tensile Strength Testing | Testing completed to Cook Ireland's design control system. Demonstrates the device meets design input requirements. | |
| MRI Conditional Testing | Testing completed to Cook Ireland's design control system. Demonstrates the device meets design input requirements. | |
| Radiopacity | Testing completed to Cook Ireland's design control system. Demonstrates the device meets design input requirements. | |
| Flow Rate | Testing completed to Cook Ireland's design control system. Demonstrates the device meets design input requirements. | |
| Shelf-Life Testing | Testing completed to Cook Ireland's design control system. Demonstrates the device meets design input requirements. | |
| Substantial Equivalence | Comparison to Predicate Device (K172044) | The subject device shares the same intended use, technological characteristics (e.g., use in biliary duct, single use, sterile, EO sterilization, professional use only, requires 0.035" wire guide and endoscope, endoscopic placement with fluoroscopic monitoring, supplied as stent only with pigtail straightener, double pigtail, made from Ethylene-Vinyl-Acetate (EVA) co-polymer, multiple side ports with no flaps). Differences (stent marker bands, additional sideports, bidirectional stent ends) are addressed by performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify sample sizes for the performance tests. The data provenance is Cook Ireland Ltd.'s internal design control system. It does not mention country of origin or whether the studies were retrospective or prospective, but given it's a premarket notification for a device, the tests are primarily non-clinical and conducted by the manufacturer.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable as the studies described are non-clinical (biocompatibility and performance testing) of a physical device, not an AI/ML algorithm requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This is not applicable for the non-clinical testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This is not applicable as the application is for a physical medical device, not an AI/ML system, and no human reader studies are mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the application is for a physical medical device, not an AI/ML algorithm.
7. The Type of Ground Truth Used
For biocompatibility, the ground truth is established by adherence to recognized international standards (ISO 10993-1:2018) and FDA guidance for biological evaluation. For device performance testing, the ground truth is established by the predefined design input requirements for the device.
8. The Sample Size for the Training Set
This is not applicable as there is no mention of a training set for an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no mention of a training set for an AI/ML algorithm.
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