(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 <788>, AAMI TIR42).
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K 111766
Page 1 of 4
OCT 1 9 2011
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inspiration · innovation · intervention
510(k) Summary
SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System
Submitter:
IDEV Technologies, Inc. 253 Medical Center Boulevard Webster, Texas 77598 281/525-2000
Contact Person: Darlene Garner Regulatory Affairs Manager 281/525-2052 (phone) 281/525-2001 (fax) dgarner@idevmd.com
Date Prepared: June 22, 2011
SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Trade Name: Transhepatic Biliary System
Common Name: Stent Delivery Catheter
Classification Name: Catheter, Biliary, Diagnostic; Class II
Product Code: FGE
SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Predicate Devices: Transhepatic Biliary System (K093893)
Bard E-LUMINEXX® Biliary Stent (K063532)
Cordis S.M.A.R.T. ®Nitinol Stent Transhepatic Biliary System (K062798)
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Device Description:
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 table below includes the available sizes and model numbers for the 6Fr SUPERA VERITAS Stent Delivery System.
| Model No. | Stent Diameter | Stent Length | Catheter Length |
|---|---|---|---|
| S-04-040-80-6F | 4mm | 40mm | 80cm |
| S-04-060-80-6F | 4mm | 60mm | 80cm |
| S-04-080-80-6F | 4mm | 80mm | 80cm |
| S-04-100-80-6F | 4mm | 100mm | 80cm |
| S-04-120-80-6F | 4mm | 120mm | 80cm |
| S-05-040-80-6F | 5mm | 40mm | 80cm |
| S-05-060-80-6F | 5mm | 60mm | 80cm |
| S-05-080-80-6F | 5mm | 80mm | 80cm |
| S-05-100-80-6F | 5mm | 100mm | 80cm |
| S-05-120-80-6F | 5mm | 120mm | 80cm |
| S-06-040-80-6F | 6mm | 40mm | 80cm |
| S-06-060-80-6F | 6mm | 60mm | 80cm |
| S-06-080-80-6F | 6mm | 80mm | 80cm |
| S-06-100-80-6F | 6mm | 100mm | 80cm |
| S-06-120-80-6F | 6mm | 120mm | 80cm |
| S-07-040-80-6F | 7mm | 40mm | 80cm |
| S-07-060-80-6F | 7mm | 60mm | 80cm |
| S-07-080-80-6F | 7mm | 80mm | 80cm |
| S-07-100-80-6F | 7mm | 100mm | 80cm |
| S-04-040-120-6F | 4mm | 40mm | 120cm |
| S-04-060-120-6F | 4mm | 60mm | 120cm |
| S-04-080-120-6F | 4mm | 80mm | 120cm |
| S-04-100-120-6F | 4mm | 100mm | 120cm |
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| 101511-1 | t116 |
|---|---|
| ------------------------------ | -------------- |
| Model No. | Stent Diameter | Stent Length | Catheter Length |
|---|---|---|---|
| S-04-120-120-6F | 4mm | 120mm | 120cm |
| S-05-040-120-6F | 5mm | 40mm | 120cm |
| S-05-060-120-6F | 5mm | 60mm | 120cm |
| S-05-080-120-6F | 5mm | 80mm | 120cm |
| S-05-100-120-6F | 5mm | 100mm | 120cm |
| S-05-120-120-6F | 5mm | 120mm | 120cm |
| S-06-040-120-6F | 6mm | 40mm | 120cm |
| S-06-060-120-6F | 6mm | 60mm | 120cm |
| S-06-080-120-6F | 6mm | 80mm | 120cm |
| S-06-100-120-6F | 6mm | 100mm | 120cm |
| S-06-120-120-6F | 6mm | 120mm | 120cm |
| S-07-040-120-6F | 7mm | 40mm | 120cm |
| S-07-060-120-6F | 7mm | 60mm | 120cm |
| S-07-080-120-6F | 7mm | 80mm | 120cm |
| S-07-100-120-6F | 7mm | 100mm | 120cm |
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.
Intended Use:
The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
Comparison to Predicate Devices:
The 6Fr SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is substantially equivalent to the predicate devices: IDEV's 7Fr SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (K093893); the Bard E-LUMINEXX® Biliary Stent (K063532) and the Cordis S.M.A.R.T® Nitinol Stent Transhepatic Biliary System (K. 062798).
A review of the product specifications concluded that there are no major differences in design, materials, performance, safety and product effectiveness. Substantial Equivalence to the predicate devices has been demonstrated via bench performance testing.
Non-clinical Testing:
Non-clinical testing 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 1093 -International Standard for Biological Evaluation of Medical Devices". Clinical 1077yas not required in order to demonstrate safety and efficacy for the device modifications described in this 510(k).
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Biocompatibility testing included:
| Test | Results |
|---|---|
| Cytotoxicity | Pass |
| Klingman Maximization (NaCl and CSO extracts) | Pass |
| Intracutaneous Injection (NaCl and CSO extracts) | Pass |
| Systemic Injection (NaCl and CSO extracts) | Pass |
| Rabbit Pyrogen | Pass |
| Hemolysis | Pass |
| Thrombogenicity Study in Dogs | Pass |
| Complement Activation Assay (C3a and SC5b-9) | Pass |
| Unactivated Partial Thromboplastin Time (UPTT) | Pass |
All biocompatibility testing was performed under the 21 CFR, Part 58 Good Laboratory Practice for Non-Clinical Laboratory Studies. All tests passed the acceptance criteria identified in the applicable protocols.
Performance Bench Testing included:
| Test | Description of Test | Results |
|---|---|---|
| Biliary RadialForce | Comparison of the results of the SUPERA Stent deployed from a 6FrSUPERA VERITAS Stent Delivery System to the Bard E-LUMINEXX in regards to compressive force (radial stiffness andradial strength) and expansive force (radial stiffness and radialstrength. | Pass |
| Catheter TorqueStrength | Performed to characterize the torque strength of the SUPERAVERITAS Stent Delivery system when the handle was rotated on itscentral axis | Pass |
| DeploymentTesting | This following elements were assessed during deployment testing:Working length, ratchet release, Tensile, Leak, IntroducerCompatibility, Guidewire Compatibility, Pushability/Flexibility,Trackability, Torque, Distal stent deployment and Accuracy, Thumbslide deployment force, Thumb slide retraction force and Deployedstent length accuracy | Pass |
| Particulate | Performed using USP <788>, Particulate Matter in Injections andAAMI TIR42, Evaluation of Particulates Associated with VascularMedical Devices. | Pass |
Performance bench testing demonstrated that the 6Fr SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is substantially equivalent to its predicate devices. No additional safety risks were observed during testing.
Conclusion:
The 6Fr SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System demonstrated to be substantially equivalent to the predicate devices based on design specifications and characteristics, principle of operation, indications for use and performance testing.
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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a bird in flight or a human figure with outstretched arms, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Darlene Garner Regulatory Affairs Manager IDEV Technologies, Inc. 253 Medical Center Boulevard WEBSTER TX 77598
OCT 19 2011
Re: K111766
Trade/Device Name: SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System Regulation Number: 21 CFR § 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: September 29, 2011 Received: September 30, 2011
Dear Ms. Garner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device for use in the vascular system have not been established.
Furthermore, the indication for use must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
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The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (301) 796-5484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (301) 796-6926. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Christy Foreman
Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K11766
The SUPERA™ VERITAS™ Interwoven Self-Expanding Nitinol Stent Device Name: Transhepatic Biliary System
FDA's Statement of the Indications for Use for device:
The SUPERA™ VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
Prescription Use 1 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
torgn m. Wh
§ 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.