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510(k) Data Aggregation
(179 days)
This device is used to dilate strictures in the pancreatobiliary systems and to dilate openings via the transgastric or transduodenal wall. This device is indicated for adult use only.
The Tornus ES is a rotary-operated dilator designed for use in bile duct/pancreatic duct strictures and via transgastric/transduodenal dilation of openings. The Tornus ES is comprised of stainless-steel coils and polymeric materials. The Dilation and Shaft segments are composed of coils materials that are welded together. The Tornus ES is available for prescription use only.
The provided text describes the performance data for the Tornus ES device, specifically focusing on non-clinical testing and biocompatibility assessments. It does not detail a study involving human subjects or AI assistance, which would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or reader performance metrics. Therefore, several points of your request cannot be fulfilled as they are not applicable to the information provided.
Based on the provided text, primarily pages 8 and 9, here's the information regarding the device's acceptance criteria and the study that proves it meets those criteria:
1. A table of acceptance criteria and the reported device performance
The document provides acceptance criteria specifically for biocompatibility testing, and a general "Pass" for non-clinical performance tests.
Table 1: Non-Clinical Testing Performance
| Test Item | Reported Device Performance |
|---|---|
| Appearance | Pass |
| Tensile strength | Pass |
| Guidewire pass-through ability | Pass |
| Dilation ability | Pass |
| Slide durability | Pass |
| Radio-detectability | Pass |
| Corrosion resistance | Pass |
| Polyurethane strength | Pass |
| Guide wire trackability | Pass |
| Kink resistance | Pass |
| Dimension measurement | Pass |
| Simulated use and (torsional strength) | Pass |
Table 2: Biocompatibility Testing Acceptance Criteria and Results
| Test Method | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity MEM Elution Test | ISO 10993-5 (No deviations) | The test system is considered suitable if no signs of cellular reactivity (Grade 0) are noted for both the negative control article and the medium control. | Non-cytotoxic |
| Sensitization KLIGMAN Maximization Test | ISO 10993-10 (No deviations) | The extracts should show no evidence of causing delayed dermal contact sensitization in the guinea pig. | Non-Sensitizing |
| Irritation Intracutaneous Injection Test | ISO 10993-10 (No deviations) | The test extract and the negative control must exhibit similar edema and erythema scores. | Non-Irritant |
| Systemic Toxicity Acute System Toxicity Test | ISO 10993-11 (No deviations) | The test article must not show significantly greater biological activity than the control. | Non-toxic |
| Systemic Toxicity Rabbit Pyrogen Test (material mediated) | ISO 10993-11 (No deviations) | The test article should not increase the rectal temperature of any of the animals by more than 0.5 degrees Celsius. | Non-pyrogenic |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "Non clinical laboratory testing" and "in vitro bench tests". This indicates that the testing was performed on units of the device itself and not on patient data. No specific sample sizes for these tests are provided, nor is the country of origin of the data or whether it was retrospective or prospective, as these terms are generally applicable to clinical trials or studies involving patient data, which is not the case here.
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 applicable. The testing was non-clinical and benchtop, not requiring human expert interpretation or ground truth establishment in the context of imaging or clinical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to adjudication of ground truth in clinical data, not bench testing.
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 document describes a medical device (a catheter) and its non-clinical performance and biocompatibility. It does not involve AI or human image readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards established for the device. For biocompatibility, the ground truth is established by the methods and criteria defined in the ISO 10993 series of standards.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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(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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