SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB

K062798 · Cordis Corp. · FGE · Feb 6, 2008 · Gastroenterology, Urology

Device Facts

Record IDK062798
Device NameSMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
ApplicantCordis Corp.
Product CodeFGE · Gastroenterology, Urology
Decision DateFeb 6, 2008
DecisionSESU
Submission TypeTraditional
Regulation21 CFR 876.5010
Device ClassClass 2
AttributesTherapeutic

Intended Use

The S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is intended for palliation of malignant strictures in the biliary tree.

Device Story

Self-expanding nitinol stent system for biliary tract; used for palliation of malignant biliary strictures. System includes 6 French delivery catheter, 0.035" guidewire lumen, and stent with tantalum micromarkers. Stent diameters 6-8 mm; lengths 120-150 mm. Delivered via transhepatic approach; intended for single use. Provides mechanical support to maintain biliary patency in patients with malignant obstructions. Physician-operated in clinical setting.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical in-vitro bench testing and animal testing (stent placement in a biliary duct).

Technological Characteristics

Self-expanding stent; Nickel-Titanium (Nitinol) alloy; tantalum micromarkers; 6 French delivery system; 120 cm usable length; 0.035" guidewire compatibility; Ethylene Oxide sterilization; single-use.

Indications for Use

Indicated for the palliation of malignant neoplasms/strictures 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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K062798 Pj. lot 2 Cordis Corporation, a Johnson & Johnson Company S.M.A.R.T. Nitinol Stent Transhepatic Biliary System FEB -- 6 2008 ## 510(k) Summary of Safety and Effectiveness General The name of the device is: Provisions Proprietary Name Common or Usual Name S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary Stent (incl. Biliary System Accessories) The device is substantially equivalent to: Name of Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent Transhepatic Biliary Predicate . Devices System (510(k) # K032457) Cordis S.M.A.R.T.® Nitinol Stent Transhepatic Biliary System . (510(k) # K003336) Cordis PRECISE™ Nitinol Stent Transhepatic Biliary System (510(k) � #K010445) ● ev3 Protégé EverFlex Self-Expanding Nitinol Stent (510(k)#K060057) Classification Class II. Performance Performance standards have not been established by the FDA under section Standards 514 of the Food, Drug and Cosmetic Act. The contents of this 510(k) premarket notification have been prepared based upon the FDA's Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents (February 5, 1998). The S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is intended for Indication for Use use in the palliation of malignant neoplasms in the biliary tree. {1}------------------------------------------------ K062798 page 22 a 510(k) Premarket Notification Cordis Corporation, a Johnson & Johnson Company S.M.A.R.T. Nitinol Stent Transhepatic Biliary System The device description of the proposed S.M.A.R.T. ® Nitinol Stent Device Description Transhepatic Biliary System is as follows. 6 French stent delivery system profile; . Stent material - Nickel Titanium alloy and tantalum . micromarkers; Expanded stent diameters: 6, 7 and 8 mm; . Stent lengths: 120 and 150 mm; . Stent delivery system usable length: 120 cm; and . Guidewire lumen 0.035" ● The S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only. Biocompatibility All materials used in the S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System are biocompatible. The S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is substantially Summary of Substantial equivalent to the predicate devices. The substantial equivalence to the Equivalence predicate devices has been demonstrated via data collected from non-clinical in-vitro bench testing and animal testing (stent placement in a biliary duct). {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol. Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 6 2008 Ms. Elena S. Jugo Regulatory Affairs Manager Cordis Corporation 14201 NW 60m Avenue MIAMI LAKES FL 33014 Re: K062798 Trade/Device Name: S.M.A.R.T. Nitinol Stent Transhepatic Biliary System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: January 18, 2008 Received: January 22, 2008 Dear Ms. Jugo: 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. {3}------------------------------------------------ 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 (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. 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. 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), please contact the Office of Compliance at (301) 594-4616. 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours. Sincerely yours, onna-Bea Tillman, Ph.D., M.P.H. Director Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page__________________________________________________________________________________________________________________________________________________________________________ 510(k) Number: K062798 Device Name: S.M.A.R.T. Nitinol Stent Transhepatic Biliary System FDA's Statement of the Indications for Use for device: The S.M.A.R.T. " Nitinol Stent Transhepatic Biliary System is intended for palliation of malignant strictures in the biliary tree. Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ Hulut lemen (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Innolitics
510(k) Summary
Decision Summary
Classification Order
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