MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY

K014136 · Sulzer Intratherapeutics, Inc. · FGE · Jan 17, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K014136
• Device Name: MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
• Applicant: Sulzer Intratherapeutics, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jan 17, 2002
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Protégé™ Self-Expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication) is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Device Story

Self-expanding nitinol stent designed for biliary duct patency; palliative treatment for malignant neoplasms. Stent premounted on over-the-wire delivery catheter (80 or 120 cm length). Deployment via StarPort™ delivery system featuring inner/outer sheath with safety lock. Upon deployment, stent expands to predetermined diameter, exerting constant outward force. Used in clinical setting by physicians. Stent provides mechanical support to biliary ducts to maintain patency.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance testing.

Technological Characteristics

Self-expanding nitinol (nickel-titanium alloy) stent; electropolished. Lengths 20-80 mm; diameters 6-12 mm. Delivery system: over-the-wire catheter with inner/outer sheath and safety lock. Mechanical expansion principle.

Indications for Use

Indicated for palliative treatment of malignant neoplasms in the biliary tree. Prescription use only.

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

• Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (K012066)
• Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (K012347)

Submission Summary (Full Text)

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## Premarket Notification (510(k)) Summary

| 510(k) Number: | K014136 |
|---------------------------|------------------------------------------------------------------------------------------------|
| Product Name: | Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication) |
| Common Name: | biliary stent |
| Class: | Class II, 21 CFR 876.5010 |
| Submitter's Name: | Sulzer IntraTherapeutics Inc.<br>651 Campus Drive<br>St. Paul, MN 55112 |
| Official Contact: | Maria E. Brittle<br>Regulatory Affairs Manager<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | December 14, 2001 |

This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission for a modification to the Protégé™ Self-expanding Nitinol StarPort™ Delivery Technology.

The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.

The Protégé™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20 - 80 mm) and diameters (6 - 10 mm). The stent is electropolished. The stent is premounted on an 80 or 120 cm working length, 0.035" over-the-wire delivery catheter designed promountou on an over of Ipon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock.

The modified Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is substantially equivalent to the currently marketed Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (K012066, K012347) in intended use, materials, technological characteristics and performance. A 12 mm stent diameter has been added to further expand the product offering.

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Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the caduceus.

## JAN 1 7 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Maria E. Brittle Regulatory Affairs Manager SULZERMEDICA Sulzer IntraTherapeutics, Inc. 651 Campus Drive St. Paul, Minnesota 55112

Re: K014136

Trade/Device Name: Protégé™ Self-Expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication) Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: December 14, 2001 Received: December 17, 2001

Dear Ms. Brittle:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. Maria E. Brittle

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your dovieo to additional controls. Existing major regulations affecting your device can be may of subjoct to additions, 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 r rouse of action and a determination that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or uny 1 odolar bakated and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Far 607); adoming (21 CFR Part 820); and if applicable, the electronic forth in and quality by signs (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. I herefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your 11 you desire specific morand additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, 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). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Bernard F. Statland, M.D., Ph.D.

Bernard E. Statland, Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K014136

## Device Name: Protégé™ Self-Expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication)

FDA's Statement of the Indications For Use for device:

The Protégé™ Self-Expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication) is intended as a palliative treatment of malignant neoplasms in the biliary tree.

| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---------------------------------------|---|
| Over-The-Counter Use | |

Nancy C. Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

K014136