(56 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and delivery system of a stent, with no mention of AI or ML capabilities.
Yes
The device is indicated for the "palliative treatment of biliary strictures produced by malignant neoplasms," which describes a medical treatment for a disease.
No
Explanation: The "Intended Use / Indications for Use" states that the device is "indicated for palliative treatment of biliary strictures produced by malignant neoplasms," which describes a therapeutic rather than a diagnostic function.
No
The device description clearly details a physical medical device consisting of a stent and a delivery system with various hardware components. There is no mention of software as the primary or sole component.
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 samples taken from the body.
- Device Description: The description details a stent and a delivery system designed to be implanted in the biliary system. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific 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 diagnostic, monitoring, or compatibility purposes. This device is a therapeutic implant.
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 (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary strictures
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)
Engineering studies were performed per the FDA's "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; ISO 10993 - International 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 included:
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-House Passivation
Raw Material Mechanical Characterization, Nitinol Wire Tension and Rotating Beat Fatigue
Material Characterization SUPERA Stent Chemical Analysis
Raw Material Mechanical Properties Characterization, Nitinol Wire Tensile and Rotating 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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. 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
1
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
3
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-House |
| Passivation |
| Raw Material Mechanical Characterization, Nitinol Wire Tension and Rotating |
| Beam Fatigue |
| Material Characterization SUPERA Stent Chemical Analysis |
| Raw Material Mechanical Properties Characterization, Nitinol Wire Tensile and |
| Rotating 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.
6
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
7
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 __
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