(438 days)
No
The device description focuses on the mechanical components of a stent and delivery system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for the "palliative treatment of biliary strictures produced by malignant neoplasms," which directly addresses and alleviates a medical condition.
No
This device is a therapeutic device (stent delivery system) used for palliative treatment of biliary strictures, not for diagnosis.
No
The device description clearly details a physical medical device consisting of a stent and a delivery system with various hardware components (sheath, handle, guidewire lumen, etc.). The performance studies also focus on the physical characteristics and functionality of this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "palliative treatment of biliary strictures produced by malignant neoplasms." This describes a therapeutic intervention performed within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a stent and a delivery system designed to be implanted into the biliary system. This is consistent with a medical device used for treatment, not for in vitro diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
Therefore, the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
FGE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiopaque components for aid in proper stent positioning.
Anatomical Site
Biliary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
Key Metrics
Not Found
Predicate Device(s)
K093893, K063532, K062798, K060057, K072301
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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)
1
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).
2
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.
3
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.
4
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
5
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, and | |
| Urological Devices | |
| 510(k) Number | K111627 |
| Page 1 of 1 |