(56 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.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device (SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing, and usually does not involve clinical studies with human patients or "AI" in the context of diagnostic algorithms. Therefore, many of the questions related to AI performance metrics (e.g., human reader improvement with AI assistance, MRMC studies, training set details, ground truth for training) are not applicable to this specific type of device and submission.
Acceptance Criteria and Device Performance Study (SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System)
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list quantitative "acceptance criteria" in the typical sense of performance metrics (e.g., sensitivity, specificity for a diagnostic device). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through a series of engineering and material characterization tests. The primary acceptance criterion is that the new device performs comparably to the predicate and does not introduce new safety concerns.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Design Equivalence: No significant differences in design compared to the predicate. | "A review of the product specifications concluded that there are no differences in design..." |
| Material Equivalence: No significant differences in materials compared to the predicate. | "...no differences in...materials..." Material characterization tests (Chemical Analysis, Raw Material Mechanical Characterization, Tensile, Rotating Beam Fatigue) were performed for both vendor-passivated and in-house passivated stents. Reported to be substantially equivalent. |
| Performance Equivalence: No significant differences in performance compared to the predicate. | "...no differences in...performance..." Bench performance testing was conducted according to various ASTM and ISO standards, and FDA guidance (e.g., "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents"). These tests covered aspects like passivation, nickel ion release, and material properties. |
| Safety and Effectiveness Equivalence: No new safety or effectiveness concerns. | "No additional safety risks were observed during testing." The overall conclusion is that the new configurations are "substantially equivalent" to the predicate, implying equivalent safety and effectiveness based on the non-inferiority demonstrated in the engineering studies. Note: Clinical data was not required for this 510(k). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a clinical "test set" for performance evaluation like diagnostic devices. The "test set" here would refer to the number of stents/delivery systems tested in various engineering studies. The document does not specify the exact number of units tested for each engineering study, but such tests typically involve a statistically relevant number of units to ensure reliability.
- Data Provenance: The studies were bench performance testing and engineering studies, not studies on human patients. The data is thus internally generated by the manufacturer (IDEV Technologies, Inc.) through laboratory experiments. No country of origin for patient data is relevant. The studies are by nature prospective in their design (i.e., experiments were designed and executed to test specific parameters).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in this context would refer to the characteristics being measured (e.g., material composition, mechanical properties). These are established by standardized physical/chemical testing methods, not by expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. There's no interpretive "ground truth" requiring adjudication by experts. The results are quantitative measurements from engineering tests.
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
No. This device is a physical medical implant (stent) and its delivery system, not a diagnostic imaging device, AI software, or a device that assists human readers. Therefore, MRMC studies and AI assistance metrics are not relevant or performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is based on engineering and material standards and specifications. This includes:
- Chemical analysis standards (e.g., ASTM A967-05)
- Mechanical property test standards (e.g., ASTM F2516-07e2, ASTM E739-91, ASTM F2129-08, ASTM F2063-05, ASTM E1447-09, ASTM E1409-08)
- Nickel ion release testing standards.
- The established design and performance characteristics of the legally marketed predicate device (SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System, K122546).
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for IDEV. The logo consists of the letters "IDEV" in a bold, sans-serif font. To the right of the letters, there are three curved lines that form a semi-circle shape. The logo is simple and modern, and the use of the curved lines gives it a sense of movement and energy.
MAY 0 2 2013
inepiration · innovation · intervention
510(k) Summary
SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System
IDEV Technologies, Inc. Submitter: 253 Medical Center Boulevard Webster, Texas 77598 281/525-2000
Contact Person: Darlene Garner Regulatory Affairs Director 281/525-2052 (phone) 281/525-2001 (fax) dgarner@idevmd.com
Date Prepared: March 4, 2013
SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Trade Name: Transhepatic Biliary System
Stent Delivery Catheter Common Name:
Classification Name: Catheter, Biliary, Diagnostic; Class II
Product Code: FGE
Predicate Devices: SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (K122546)
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
1
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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 SUPERA VERITAS® Stent Delivery System.
| Model No. | Stent Diameter | Stent Length | Catheter Length |
|---|---|---|---|
| 6Fr System | |||
| 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 |
| 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 |
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K130591 PAGE 3 OF 4
| Model No. | Stent Diameter | Stent Length | Catheter Length |
|---|---|---|---|
| S-07-100-120-6F | 7mm | 100mm | 120cm |
| 7Fr System | |||
| S-04-040-120-G3 | 4mm | 40mm | 120cm |
| S-04-060-120-G3 | 4mm | 60mm | 120cm |
| S-04-080-120-G3 | 4mm | 80mm | 120cm |
| S-04-100-120-G3 | 4mm | 100mm | 120cm |
| S-04-120-120-G3 | 4mm | 120mm | 120cm |
| S-05-040-120-G3 | 5mm | 40mm | 120cm |
| S-05-060-120-G3 | 5mm | 60mm | 120cm |
| S-05-080-120-G3 | 5mm | 80mm | 120cm |
| S-05-100-120-G3 | 5mm | 100mm | 120cm |
| S-05-120-120-G3 | 5mm | 120mm | 120cm |
| S-06-040-120-G3 | 6mm | 40mm | 120cm |
| S-06-060-120-G3 | 6mm | 60mm | 120cm |
| S-06-080-120-G3 | 6mm | 80mm | 120cm |
| S-06-100-120-G3 | 6mm | 100mm | 120cm |
| S-06-120-120-G3 | 6mm | 120mm | 120cm |
| S-06-150-120-G3 | 6mm | 150mm | 120cm |
| S-07-040-120-G3 | 7mm | 40mm | 120cm |
| S-07-060-120-G3 | 7mm | 60mm | 120cm |
| S-07-080-120-G3 | 7mm | 80mm | 120cm |
| S-07-100-120-G3 | 7mm | 100mm | 120cm |
| S-08-040-120-G3 | 8mm | 40mm | 120cm |
| S-08-060-120-G3 | 8mm | 60mm | 120cm |
| S-08-080-120-G3 | 8mm | 80mm | 120cm |
| S-08-100-120-G3 | 8mm | 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 SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is substantially equivalent to the predicate device, IDEV's SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (K122546).
A review of the product specifications concluded that there are no differences in design, materials, performance, safety and product effectiveness. Substantial Equivalence to the predicate devices has been demonstrated via bench performance testing.
Testing:
Engineering studies were performed per the FDA's "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; ISO 10993 - International
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Standard for Biological Evaluation of Medical Devices". Additionally, testing was conducted per ASTM F2516-07e2; ASTM E739-91; ASTM A967-05; ASTM F2129-08; ASTM F2063-05; ASTM E1447-09; ASTM E1409-08; Clinical data was not required in order to demonstrate safety and efficacy for the device modifications described in this 510(k).
| Testing |
|---|
| Engineering Study, SUPERA Stent In-house Passivation Process |
| In-House Passivation Process Validation (IQ and OQ) |
| Engineering Study, Nickel Ion Release Testing, Vendor Passivated Stent |
| Nickel Ion Release Testing, In House Passivation |
| Material Characterization SUPERA Stent Chemical Analysis - In-HousePassivation |
| Raw Material Mechanical Characterization, Nitinol Wire Tension and RotatingBeam Fatigue |
| Material Characterization SUPERA Stent Chemical Analysis |
| Raw Material Mechanical Properties Characterization, Nitinol Wire Tensile andRotating Beam Fatigue Test - In-House Passivation |
Testing of the In-house passivated stent verified that the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is substantially equivalent to its predicate device. No additional safety risks were observed during testing.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2, 2013
IDEV Technologies, Inc. % Ms. Darlene Garner Regulatory Affairs Director 253 Medical Center Blvd. WEBSTER TX 77598
Re: K130591
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: March 5, 2013 Received: March 7, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
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Page 2 - Ms. Darlene Garner
Furthermore, the indication for biliary 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.
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 vour 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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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Page 3 – Ms. Darlene Garner
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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Christy L. Foreman -S
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): K130591
Device Name: SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System
Indications for Use:
The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
X Prescription Use (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)
HerbertPLerner-S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130591 510(k) Number __
Page 1 of 1
§ 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.