SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

K093893 · Idev Technologies, Inc. · FGE · Oct 5, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K093893
• Device Name: SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
• Applicant: Idev Technologies, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Oct 5, 2010
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The SUPERA VERITAS is a 7Fr, 120cm delivery system for a self-expanding Nitinol stent. The system includes a handle, outer sheath, and internal stent driver. The stent consists of 6 interwoven Nitinol wires joined by proprietary welded couplers. The device is used by physicians in a clinical setting to treat biliary strictures. The operator uses a thumb slide to advance the stent while the outer sheath retracts, allowing the stent to expand into the stricture. Radiopaque markers on the catheter tip and sheath aid in positioning. A deployment lock prevents premature deployment. The device is sterile, single-use, and delivered via Ethylene Oxide. It provides mechanical support to maintain biliary patency in malignant cases.

Clinical Evidence

No clinical data was required. Safety and efficacy were demonstrated through bench and animal performance testing, including compliance with ISO 10555 (sterile, single-use intravascular catheters) and ISO 10993 (biological evaluation).

Technological Characteristics

7Fr delivery system; 120cm working length; 0.014" or 0.018" guidewire compatible. Stent material: Nitinol (6 interwoven wires with welded couplers). Self-expanding mechanism. Radiopaque markers. Ethylene Oxide sterilization. No software or electronic components.

Indications for Use

Indicated for palliative treatment of biliary strictures caused by malignant neoplasms in patients requiring biliary stenting.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• SureSave™ Interwoven Self-Expanding Biliary Nitinol Stent System (K060557)
• SUPERA® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (K071646)
• Bard E-Luminexx® Biliary Stent (K063532)

Submission Summary (Full Text)

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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 cm<br>Stent Delivery<br>Catheter | 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 |
| Stent<br>Diameter<br>(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 [phone]. 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 [phone] or [phone] 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

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