The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

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.

AI/ML Overview

This document describes the marketing authorization for the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (K122546). This is a 510(k) submission, meaning the device demonstrated "substantial equivalence" to a legally marketed predicate device, rather than undergoing a de novo pathway requiring extensive clinical studies to establish safety and effectiveness from scratch. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a de novo device for performance metrics derived from clinical trials often doesn't directly apply.

Instead, for a 510(k), acceptance is based on demonstrating substantial equivalence through various means, primarily bench performance testing in this specific case, and comparison of design, materials, and intended use. The "acceptance criteria" are implicitly met by demonstrating that the modified device performs similarly or equivalently to the predicate devices across relevant engineering and performance tests.

Here's an analysis of the provided information, addressing your questions where applicable within the context of a 510(k) submission for a stent:

1. A table of acceptance criteria and the reported device performance

For this 510(k), the "acceptance criteria" are not explicitly defined as numerical thresholds in this summary. Instead, they are implied by demonstrating "substantial equivalence" to the predicate devices through bench performance testing. The reported performance is that this testing "demonstrated that the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is substantially equivalent to its predicate devices."

The specific tests performed were:

Acceptance Criterion (Implicit)	Reported Device Performance
Performance equivalent to predicate for Deployment	Verification testing included Deployment testing, demonstrating substantial equivalence.
Performance equivalent to predicate for Trackability Force Characterization	Verification testing included Trackability Force Characterization, demonstrating substantial equivalence.
Performance equivalent to predicate for Catheter Tip Integrity	Verification testing included Catheter Tip Integrity, demonstrating substantial equivalence.
Sterilization effective and equivalent to predicate	Verification testing included Sterilization Validation, demonstrating substantial equivalence.
No major differences in design, materials, or operation principles compared to predicate.	"A review of the product specifications concluded that there are no major differences in design, materials, performance, safety and product effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not specify the sample sizes (e.g., number of stents or delivery systems) for the Deployment, Trackability Force Characterization, Catheter Tip Integrity, and Sterilization Validation tests. These would typically be detailed in the full test reports, which are not included in this summary.
Data Provenance: The data is from "bench performance testing," which implies laboratory testing. No country of origin is specified for the data itself, but the submitter (IDEV Technologies, Inc.) is based in Webster, Texas, USA. This testing is inherently prospective with respect to the 510(k) submission, as it was conducted to support the submission for the modified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device received 510(k) clearance based on bench testing demonstrating substantial equivalence to predicate devices, not on a clinical trial requiring expert ground truth assessment of patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this was not a clinical study involving human assessment of outcomes or images. The "adjudication" for the bench tests would have been the objective measurements obtained during the tests themselves against predefined engineering specifications.

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), not an AI/imaging diagnostic device, and thus MRMC studies are not relevant to its clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm or software-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this 510(k) submission is the performance of the predicate devices. The modified device's performance in bench tests (Deployment, Trackability, Catheter Tip Integrity, Sterilization) was compared against the expected performance and specifications derived from the predicate devices to establish substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device submission.

Summary

{0}------------------------------------------------

K122546

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:

{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

{2}------------------------------------------------

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.

{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.

{4}------------------------------------------------

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.

{5}------------------------------------------------

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

{6}------------------------------------------------

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 _

Regulation Number and Section

§ 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.