S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

K993646 · Cordis Corp. · FGE · Nov 28, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K993646
• Device Name: S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
• Applicant: Cordis Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Nov 28, 1999
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Device Story

The Cordis S.M.A.R.T. .018" Nitinol Stent Transhepatic Biliary System is a self-expanding, open-mesh nitinol stent preloaded onto a sheathed delivery catheter. Used in clinical settings for transhepatic biliary procedures, the device is operated by a physician. The delivery system is inserted to reach the stricture site; the sheath is then withdrawn to release the stent. Upon release, the stent expands to conform to the inner lumen of the biliary duct, providing palliation for malignant neoplasms. The device is intended for prescription use only.

Clinical Evidence

No clinical data; equivalence confirmed through pre-clinical testing.

Technological Characteristics

Self-expanding, open-mesh nitinol stent; preloaded on a sheathed delivery catheter; transhepatic delivery mechanism; biocompatible materials.

Indications for Use

Indicated for the palliation of malignant neoplasms in the biliary tree.

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

• Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System

Submission Summary (Full Text)

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K993646

Attachment 4

## Summary of Safety and Effectiveness

| General<br>Provisions | The name of the device is: | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | Proprietary Name | Common or Usual Name |
| | Cordis S.M.A.R.T. ^TM .018" Nitinol Stent<br>Transhepatic Biliary System | Biliary Stent |
| Name of<br>Predicate<br>Devices | The device is substantially equivalent to:<br>• Cordis S.M.A.R.T. ^TM Nitinol Stent Transhepatic Biliary System | |
| Classification | Class II. | |
| Performance<br>Standards | Performance standards have not been established by the FDA under section<br>514 of the Food, Drug and Cosmetic Act. | |
| Indications for<br>Use | The Cordis S.M.A.R.T. ^TM .018" Nitinol Stent Transhepatic Biliary<br>System is intended for use in the palliation of malignant neoplasms in the<br>biliary tree. | |
| Device<br>Description | The Cordis S.M.A.R.T. ^TM .018" Nitinol Stent Transhepatic Biliary<br>System is a system consisting of a self-expanding, open mesh, nitinol stent<br>preloaded onto a sheathed delivery catheter. The delivery system is designed<br>to deliver the stent to the stricture site via transhepatic access. Once<br>positioned at the stricture site, the sheath is withdrawn and the stent is<br>released. Upon release, the stent expands and conforms to the inner lumen of<br>the biliary duct. | |
| Biocompatibility | All materials used in the Cordis S.M.A.R.T. ^TM .018" Nitinol Stent<br>Transhepatic Biliary System are biocompatible. | |

Continued on next page

Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System Special 510(k) October, 1999

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Summary of Substantial Equivalence

The Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System is substantially equivalent to the predicate device. The equivalence was confirmed through pre-clinical testing.

Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System Special 510(k) October, 1999

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Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with outstretched wings, symbolizing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle. The logo is simple, clean, and easily recognizable.

NOV 28 1999

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elena S. Jugo, R.A.C. Manager, Regulatory Affairs Cordis Corporation P.O. Box 025700 Miami, FL 33102-5700

Re: K993646

Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: October 28, 1999 Received: October 29, 1999

Dear Ms. Jugo:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have roviewed your becally be is substantially equivalent (for the indications for use above into we nave acterine as a 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 Costisions of the Act and the limitations described below. The general controls provisions of the provisions of the 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. Elema S. Jugo

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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. Therefore, 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 device (21 CFR Part 801 and additionally 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Daniel W. Frye

David W. Feigal Ar., M.D. Acting Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K993646

Device Name: Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System

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

The Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

David A. Segner

(Division Sign-Off) Division of Reproductive, Abdominal, B and Radiological Devi 510(k) Number

Prescription Use OR
(Per 21 CFR 801.109)

Over-The-Counter Use