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510(k) Data Aggregation
(108 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 6 Fr delivery catheter is 80cm and 120cm. The working length of the 7Fr delivery catheter is 120 cm. 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.
This document describes the marketing authorization for the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (K122546). This is a 510(k) submission, meaning the device demonstrated "substantial equivalence" to a legally marketed predicate device, rather than undergoing a de novo pathway requiring extensive clinical studies to establish safety and effectiveness from scratch. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a de novo device for performance metrics derived from clinical trials often doesn't directly apply.
Instead, for a 510(k), acceptance is based on demonstrating substantial equivalence through various means, primarily bench performance testing in this specific case, and comparison of design, materials, and intended use. The "acceptance criteria" are implicitly met by demonstrating that the modified device performs similarly or equivalently to the predicate devices across relevant engineering and performance tests.
Here's an analysis of the provided information, addressing your questions where applicable within the context of a 510(k) submission for a stent:
1. A table of acceptance criteria and the reported device performance
For this 510(k), the "acceptance criteria" are not explicitly defined as numerical thresholds in this summary. Instead, they are implied by demonstrating "substantial equivalence" to the predicate devices through bench performance testing. The reported performance is that this testing "demonstrated that the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is substantially equivalent to its predicate devices."
The specific tests performed were:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Performance equivalent to predicate for Deployment | Verification testing included Deployment testing, demonstrating substantial equivalence. |
| Performance equivalent to predicate for Trackability Force Characterization | Verification testing included Trackability Force Characterization, demonstrating substantial equivalence. |
| Performance equivalent to predicate for Catheter Tip Integrity | Verification testing included Catheter Tip Integrity, demonstrating substantial equivalence. |
| Sterilization effective and equivalent to predicate | Verification testing included Sterilization Validation, demonstrating substantial equivalence. |
| No major differences in design, materials, or operation principles compared to predicate. | "A review of the product specifications concluded that there are no major differences in design, materials, performance, safety and product effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the sample sizes (e.g., number of stents or delivery systems) for the Deployment, Trackability Force Characterization, Catheter Tip Integrity, and Sterilization Validation tests. These would typically be detailed in the full test reports, which are not included in this summary.
- Data Provenance: The data is from "bench performance testing," which implies laboratory testing. No country of origin is specified for the data itself, but the submitter (IDEV Technologies, Inc.) is based in Webster, Texas, USA. This testing is inherently prospective with respect to the 510(k) submission, as it was conducted to support the submission for the modified device.
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. This device received 510(k) clearance based on bench testing demonstrating substantial equivalence to predicate devices, not on a clinical trial requiring expert ground truth assessment of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this was not a clinical study involving human assessment of outcomes or images. The "adjudication" for the bench tests would have been the objective measurements obtained during the tests themselves against predefined engineering specifications.
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 is a medical device (stent and delivery system), not an AI/imaging diagnostic device, and thus MRMC studies are not relevant to its clearance.
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 or software-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this 510(k) submission is the performance of the predicate devices. The modified device's performance in bench tests (Deployment, Trackability, Catheter Tip Integrity, Sterilization) was compared against the expected performance and specifications derived from the predicate devices to establish substantial equivalence.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
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(291 days)
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 7Fr, 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system comprised of a Handle and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker Band and Distal Sheath Marker Band embedded in the Outer Sheath to aid in proper stent positioning; a Thurnb 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 which deploys the stent distally relative to the Outer Sheath; the System Lock which eliminates the possibility of premature deployment. The working length of the delivery catheter is 120cm.
The SUPERA® Stent housed within the SUPERA VERITAS" stent delivery catheter 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 provided text describes the 510(k) summary for the SUPERA VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. It details the device, its intended use, comparison to predicate devices, and the performance testing conducted.
Here's the information extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "Engineering studies were performed per the FDA's 'Guidance of Premarket notification 510(k) Submissions for Short Term and Long Term Intravascular Catheters'; the Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; ISO 10555 - Sterile, Single-use Intravascular Catheters; and ISO 10993 - International Standard for 'Biological Evaluation of Medical Devices.'"
While specific quantitative acceptance criteria and their corresponding reported device performance values are not explicitly listed in a detailed table within this summary, the overall acceptance criterion was demonstrating substantial equivalence to predicate devices. The reported device performance, in this context, is that the device met this criterion.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Compliance with FDA Guidances for Premarket Notification for Intravascular Catheters and Metal Expandable Biliary Stents (regarding design, materials, performance, safety, and effectiveness). | Achieved through bench and animal performance testing, demonstrating no major differences in design, materials, performance, safety, and product effectiveness compared to predicate devices. |
| Compliance with ISO 10555 (Sterile, Single-use Intravascular Catheters). | Achieved through engineering studies. |
| Compliance with ISO 10993 (Biological Evaluation of Medical Devices). | Achieved through engineering studies. |
| Substantial equivalence to predicate devices (IDEV's SureSave™ Biliary Stent System (K060557), IDEV's SUPERA® Biliary Stent System (K071646), and Bard E-Luminexx® Biliary Stent (K060557)) based on design specifications, characteristics, principle of operation, indications for use, and performance testing, with no additional safety risks observed. | Demonstrated through bench and animal performance testing, with the device also offering improvements in ease-of-use, ergonomics, and manufacturability. |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not explicitly stated. The document mentions "bench and animal performance testing" but does not provide details on the number of units tested or animals used.
- Data provenance: Not explicitly stated, but given it's a 510(k) submission to the FDA, it is expected to be from studies conducted by the manufacturer (IDEV Technologies, Inc.) or contracted labs. The studies appear to be prospective in nature, as they were conducted to support the 510(k) submission. No country of origin for the data is specified, but the submitter is a US-based company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission relies on engineering and animal testing, not human expert interpretation of data or images to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This study does not involve human interpretation or adjudication of results to establish ground truth.
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 is a medical device (stent and delivery system) submission, not an AI/software-as-a-medical-device (SaMD) submission. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance testing was based on engineering measurements and observations from bench testing (e.g., mechanical properties, deployment characteristics, material integrity) and physiological and safety outcomes in animal models (e.g., biocompatibility, deployment success, patency).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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