(291 days)
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 Thurnb 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; 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 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 provided text describes the 510(k) summary for the SUPERA VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. It details the device, its intended use, comparison to predicate devices, and the performance testing conducted.
Here's the information extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "Engineering studies were performed per the FDA's 'Guidance of Premarket notification 510(k) Submissions for Short Term and Long Term Intravascular Catheters'; the Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; ISO 10555 - Sterile, Single-use Intravascular Catheters; and ISO 10993 - International Standard for 'Biological Evaluation of Medical Devices.'"
While specific quantitative acceptance criteria and their corresponding reported device performance values are not explicitly listed in a detailed table within this summary, the overall acceptance criterion was demonstrating substantial equivalence to predicate devices. The reported device performance, in this context, is that the device met this criterion.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Compliance with FDA Guidances for Premarket Notification for Intravascular Catheters and Metal Expandable Biliary Stents (regarding design, materials, performance, safety, and effectiveness). | Achieved through bench and animal performance testing, demonstrating no major differences in design, materials, performance, safety, and product effectiveness compared to predicate devices. |
| Compliance with ISO 10555 (Sterile, Single-use Intravascular Catheters). | Achieved through engineering studies. |
| Compliance with ISO 10993 (Biological Evaluation of Medical Devices). | Achieved through engineering studies. |
| Substantial equivalence to predicate devices (IDEV's SureSave™ Biliary Stent System (K060557), IDEV's SUPERA® Biliary Stent System (K071646), and Bard E-Luminexx® Biliary Stent (K060557)) based on design specifications, characteristics, principle of operation, indications for use, and performance testing, with no additional safety risks observed. | Demonstrated through bench and animal performance testing, with the device also offering improvements in ease-of-use, ergonomics, and manufacturability. |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not explicitly stated. The document mentions "bench and animal performance testing" but does not provide details on the number of units tested or animals used.
- Data provenance: Not explicitly stated, but given it's a 510(k) submission to the FDA, it is expected to be from studies conducted by the manufacturer (IDEV Technologies, Inc.) or contracted labs. The studies appear to be prospective in nature, as they were conducted to support the 510(k) submission. No country of origin for the data is specified, but the submitter is a US-based company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission relies on engineering and animal testing, not human expert interpretation of data or images to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This study does not involve human interpretation or adjudication of results to establish ground truth.
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
Not applicable. This is a medical device (stent and delivery system) submission, not an AI/software-as-a-medical-device (SaMD) submission. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance testing was based on engineering measurements and observations from bench testing (e.g., mechanical properties, deployment characteristics, material integrity) and physiological and safety outcomes in animal models (e.g., biocompatibility, deployment success, patency).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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K093893
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OCT - 5 2010
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
Contact Person: Darlene Garner Regulatory Affairs Manager 281/525-2052 (phone) 281/525-2001 (fax) dgarner(@idevmd.com
Date Prepared: October 4, 2010
SUPERA VERITAS™ Interwoven Self-Expanding Nitinol Stent Trade Name: Transhepatic Biliary System
Common Name: Stent Delivery Catheter
Classification Name: Catheter, Biliary, Diagnostic; Class II
Product Code: FGE
SureSave™ Interwoven Self-Expanding Biliary Nitinol Stent Predicate Devices: System (K060557)
SUPERA® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (K071646)
Bard E-Luminexx® Biliary Stent (K063532)
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
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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 Thurnb 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; 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 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 table below includes the available sizes and model numbers for the SUPERA® stent.
| 120 cmStent DeliveryCatheter | Stent Length (mm) | |||||
|---|---|---|---|---|---|---|
| 40 | 60 | 80 | 100 | 120 | ||
| 4 | S-04-040-120-G3 | S-04-060-120-G3 | S-04-080-120-G3 | S-04-100-120-G3 | S-04-120-120-G3 | |
| StentDiameter(mm) | 5 | S-05-040-120-G3 | S-05-060-120-G3 | S-05-080-120-G3 | S-05-100-120-G3 | S-05-120-120-G3 |
| 6 | S-06-040-120-G3 | S-06-060-120-G3 | S-06-080-120-G3 | S-06-100-120-G3 | S-06-120-120-G3 | |
| 7 | S-07-040-120-G3 | S-07-060-120-G3 | S-07-080-120-G3 | S-07-100-120-G3 | ||
| 8 | S-08-040-120-G3 | S-08-060-120-G3 | S-08-080-120-G3 | S-08-100-120-G3 | ||
| 8 | S-08-040-120-G3 | S-08-060-120-G3 | S-08-080-120-G3 | S-08-100-120-G3 |
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 SureSave™ Interwoven Self-Expanding Biliary Nitinol Stent System (K060557); IDEV's SUPERA® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (K071646); and the Bard E-Luminexx® Biliary Stent (K060557).
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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 and animal performance testing.
Performance Testing:
Engineering studies were performed per the FDA's "Guidance of Premarket notification 510(k) Submissions for Short Term and Long Term Intravascular Cathetens''; the Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; ISO 10555 - Sterile, Single-use Intravascular Catheters; and ISO 10993 -International Standard for "Biological Evaluation of Medical Devices. Clinical data was not required in order to demonstrate safety and efficacy for the device modifications described in this 510(k). Bench and animal performance testing demonstrated that the SUPERA VERITAS" Interwoven Self-Expanding Nitinol Stent Transhepatic Billiary System is substantially equivalent to its predicate devices. Additionally, the UPERA VERITAS" Interwoven Self-Expanding Nitinol Stent Transhepatic Billiary System appears to offer improvements in regards to the ease-of-use, ergonomics and manufacturability of the product. No additional safety risks were observed dring 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/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Ms. Darlene Garner Regulatory Affairs Manager IDEV Technologies, Inc. 253 Medical Center Boulevard WEBSTER TX 77598
OCT 5 2010
Re: K093893 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 19, 2010 Received: August 20, 2010
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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (301) 796-5484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 796-5857 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Christy Foreman
Christy Foreman Acting Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
OCT - 5 2010
510(k) Number (if known): K093893
Device Name: SUPERA VERITAS" Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System
Indications For Use: 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)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K093893
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.