(108 days)
No
The device description focuses on the mechanical components of a stent and delivery system, with no mention of AI or ML capabilities. The performance studies are bench tests, not related to algorithmic performance.
Yes
The device is used for the "palliative treatment of biliary strictures produced by malignant neoplasms," which describes a medical intervention to treat a condition.
No
The device is a stent delivery system used for the treatment of biliary strictures, not for diagnosis. Its intended use is palliative treatment, which is a therapeutic intervention.
No
The device description clearly outlines a physical medical device consisting of a stent and a delivery system with various hardware components (catheter, guidewire lumen, flush ports, etc.). There is no mention of software being the primary or sole component of the device.
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 test performed on a sample taken from the body.
- Device Description: The device is a stent and a delivery system designed to be implanted in the biliary system. This is a medical device used for treatment, not for diagnosing a condition by analyzing a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to physically treat a condition within the body.
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 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.
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
Not Found
Anatomical Site
biliary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification testing for the device modification included Deployment testing, Trackability Force Characterization, Catheter Tip Integrity, and Sterilization Validation. Clinical data was not required in order to demonstrate safety and efficacy for the device modifications described in this 510(k). Bench performance testing demonstrated that the 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 a logo with the letters "IDEV" in a stylized font. The letters are outlined in black, and the "I" is a solid black bar. To the right of the letters, there are three concentric circles that form a partial globe shape. The logo has a registered trademark symbol in the upper right corner.
DEC 7 2012 -
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 |
Darlene Garner Contact Person: Regulatory Affairs Director 281/525-2052 (phone) 281/525-2001 (fax) dgamer(@idevmd.com
Date Prepared: August 20. 2012
SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Trade Name: Transhepatic Biliary System
Stent Delivery Catheter Common Name:
Classification Name: Catheter, Biliary, Diagnostic; Class II
FGE Product Code:
SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Predicate Devices: Transhepatic Biliary System (K093893)
SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (K111766)
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
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1
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. 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 |
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| Model No. | Stent Diameter | Stent Length | Catheter Length |
|---|---|---|---|
| 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 |
| 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-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 devices: IDEV's SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (K093893 and K111766).
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.
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3
Performance Testing:
Verification testing for the device modification included Deployment testing, Trackability Force Characterization, Catheter Tip Integrity, and Sterilization Validation. Clinical data was not required in order to demonstrate safety and efficacy for the device modifications described in this 510(k). Bench performance testing demonstrated that the 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 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/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is arranged so that "DEPARTMENT OF HEALTH & HUMAN SERVICES" is on the left side of the circle, and "USA" is on the right side.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
DEC - 7 2012
IDEV Technologies, Inc. % Ms. Darlene Garner Regulatory Affairs Director 253 Medical Center Blvd. WEBSTER TX 77598
Re: K122546
Trade/Device Name: The 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: November 20, 2012 Received: November 21, 2012
Dear Ms. Garner:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o na re ro rowed your ve 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 and 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, r attremore, the marcanonations 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 J
A Christy Foreman
Director
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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Page 3 – Ms. Darlene Garner
Indications for Use
510(k) Number (if known): K122546
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.
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)
Herbert P. Lerner 2012.12.03 16:30:42 -05'00'
Page 1 of 1
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122546 510(k) Number _