(438 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 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 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 which deploys 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 120cm.
The SUPERA® stent housed within the 120cm 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.
Here's a breakdown of the acceptance criteria and the study information for the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Bond Tensile Strength | Met product specifications |
| Torque Strength | Met product specifications |
| Thumb Slide Push Force | Met product specifications |
| Deployment | Met product specifications |
| Ratchet Slippage | Met product specifications |
| Simulated Handling | Met product specifications |
| Retraction/Removal | Met product specifications |
| Radial Force Testing | Met product specifications |
| Dimensional Characterization | Met product specifications |
| Delivery | Met product specifications |
| Proximity to Target | Met product specifications |
| Deployed Stent Length | Met product specifications |
| Stent Pullback | Met product specifications |
| Stent Integrity | Met product specifications |
| Trackability | Met product specifications |
| Radiopacity | Met product specifications |
| MRI Compatibility | Met product specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Verification Bench-top Testing" and that this testing ensured the device met product specifications. However, specific sample sizes for each test are not provided in the document. The data provenance is from bench-top testing, not clinical data, and is therefore neither retrospective nor prospective in the typical clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The testing described is physical, bench-top testing of the device's mechanical properties, not an evaluation requiring expert interpretation of diagnostic output.
4. Adjudication Method for the Test Set
This information is not applicable or not provided as the testing is bench-top performance verification, not an evaluation that typically involves adjudication of results by multiple human observers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was performed or is mentioned. This device is a medical stent, not an AI diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device is a physical medical device (stent delivery system), not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance testing ("Verification Bench-top Testing") was product specifications and requirements. Each test (e.g., Bond Tensile Strength, Dimensional Characterization) would have had a predefined acceptable range or threshold set by the manufacturer against which the device's performance was measured.
8. The Sample Size for the Training Set
Not applicable. This device is a physical stent and delivery system, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the device is not an AI model, there is no training set or ground truth in that context.
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Image /page/0/Picture/1 description: The image shows the logo for IDEV, with the letters "IDEV" in a stylized font. The letters are surrounded by a series of concentric circles. Below the logo are the words "inspiration, innovation, intervention" separated by bullet points.
AUG 2 1
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 Director, Regulatory Affairs 281/525-2052 (phone) : 281/525-2001 (fax) . . dgarner@idevmd.com
Date Prepared:
February 7, 2012
Trade Name:
SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent 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 (K093893)
Bard E-LUMINEXX® Biliary Stent (K063532)
S.M.A.R.T. ®Nitinol Stent Transhepatic Biliary System (K062798)
ev3 Protégé® EverFlex® Self-Expanding Biliary Stent System (K060057 and K072301)
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Device Description:
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 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 which deploys 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 120cm.
The SUPERA® stent housed within the 120cm 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 available stent sizes for the 7Fr SUPERA VERITAS include:
4mm x 40mm, 4mm x 60mm, 4mm x 80mm, 4mm x 100mm, 4mm x 120mm, 5mm x 40mm, 5mm x 60mm, 5mm x 80mm, 5mm x 100mm, 5mm x 120mm, 6mm x 40mm, 6mm x 60mm. 6mm x 80mm. 6mm x 100mm. 6mm x 120mm. 6mm x 150mm. 7mm x 40mm, 7mm x 60mm, 7mm x 80mm, 7mm x 100mm, 8mm x 40mm, 8mm x 60mm, 8mm x 80mm, and 8mm x 100mm.
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 devices: IDEV's SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (K093893); the Bard E-LUMINEXX® Biliary Stent (K063532); the Cordis S.M.A.R.T® Nitinol Stent Transhepatic Biliary System (K062798); and the ev3 Protégé® EverFlex® Self-Expanding Biliary Stent System (K060057 and K072301).
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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.
Performance Testing:
Verification testing was performed to ensure that the 7Fr SUPERA VERITAS® stent delivery system with the proposed 150mm length stent met the product specifications and requirements. · ·
The Verification Bench-top Testing included:
- · Bond Tensile Strength
- Torque Strength
- Thumb Slide Push Force
- Deployment
- Ratchet Slippage
- Simulated Handling
- Retraction/Removal
- · Radial Force Testing
- Dimensional Characterization
- Delivery.
- Proximity to Target
- Deployed Stent Length
- Stent Pullback
- Stent Integrity
- Trackability
- Radiopacity
- · MRI Compatibility
Conclusion:
The 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 2 1 2012
Ms. Darlene Garner Regulatory Affairs Manager IDEV Technologies, Inc. 253 Medical Center Blvd. WEBSTER TX 77598
Re: K111627
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: August 14, 2012 Received: August 15, 2012
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 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.
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Page 2 - Ms. Darlene Garner
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
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,
Jonetta)
Image /page/4/Picture/9 description: The image shows a handwritten signature. The signature is in black ink and appears to be cursive. The signature is relatively short and simple, with a few loops and curves.
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): K111627
Device Name: SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System
The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Indications For Use: Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
Prescription Use X (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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Gastro-Renal, andUrological Devices | |
| 510(k) Number | K111627 |
| 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.