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510(k) Data Aggregation
(118 days)
The SUPERA™ VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker and Distal Sheath Marker embedded in the Outer Sheath to aid in proper stent positioning; a Thumb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device; a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen; a Stent Driver (ratchet) which moves the stent distally relative to the Outer Sheath; and the System Lock which eliminates the possibility of premature deployment. The working length of the delivery catheter is 80cm and 120cm. The SUPERA® Stent is housed within the SUPERA VERITAS® stent delivery catheter and is a closed end interwoven self-expanding Nitinol stent. The SUPERA® stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends. The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a sterile (via Ethylene Oxide sterilization) device and is intended for single use only.
The device is the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System, indicated for the palliative treatment of biliary strictures caused by malignant neoplasms.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied: Pass) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | ||
| Cytotoxicity | Pass | Pass |
| Klingman Maximization (NaCl and CSO extracts) | Pass | Pass |
| Intracutaneous Injection (NaCl and CSO extracts) | Pass | Pass |
| Systemic Injection (NaCl and CSO extracts) | Pass | Pass |
| Rabbit Pyrogen | Pass | Pass |
| Hemolysis | Pass | Pass |
| Thrombogenicity Study in Dogs | Pass | Pass |
| Complement Activation Assay (C3a and SC5b-9) | Pass | Pass |
| Unactivated Partial Thromboplastin Time (UPTT) | Pass | Pass |
| Performance Bench Testing | ||
| Biliary Radial Force | Pass | Pass |
| Catheter Torque Strength | Pass | Pass |
| Deployment Testing | Pass | Pass |
| Particulate | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical bench and biocompatibility testing, not a clinical study involving human patient data. Therefore, there is no "test set" in the context of clinical images or patient data.
- Test Set Sample Size: Not applicable (no human patient/image test set).
- Data Provenance: Not applicable. The testing was performed on the device itself and in animal models (Thrombogenicity Study in Dogs).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As this was non-clinical testing, there was no ground truth established by medical experts for a test set of images or clinical cases. The "ground truth" was determined by established scientific and engineering protocols and measurements.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Clinical testing was not required in order to demonstrate safety and efficacy for the device modifications described in this 510(k)." The study focused on non-clinical performance and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical device (stent delivery system), not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.
7. Type of Ground Truth Used
The "ground truth" for this non-clinical study was based on:
- Established Biocompatibility Standards: Results of biocompatibility tests were compared against predefined acceptance criteria for each specific test (e.g., cytotoxicity, pyrogenicity, hemolysis).
- Engineering Performance Specifications: Bench tests measured physical properties and performance characteristics (e.g., radial force, torque strength, deployment accuracy) against engineering specifications designed to ensure safe and effective device function, often benchmarking against predicate devices.
8. Sample Size for the Training Set
Not applicable. There was no "training set" as this was not an AI or machine learning study, nor a clinical trial that had distinct training and test patient cohorts. The non-clinical tests were performed on a sufficient number of devices/samples to yield statistically sound results for each specific test.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set. The "ground truth" for the non-clinical tests was established by adhering to recognized standards, protocols, and methods for medical device testing (e.g., 21 CFR, Part 58 Good Laboratory Practice for Non-Clinical Laboratory Studies, ISO 10555, ISO 1093, USP , AAMI TIR42).
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