DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010
Device Facts
| Record ID | K021824 |
|---|---|
| Device Name | DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010 |
| Applicant | Guidant Corp. |
| Product Code | FGE · Gastroenterology, Urology |
| Decision Date | Jul 2, 2002 |
| Decision | SESU |
| Submission Type | Special |
| Regulation | 21 CFR 876.5010 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The DYNALINK™ .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.
Device Story
The DYNALINK™ .035 Biliary Self-Expanding Stent System is a catheter-based delivery system for a self-expanding Nitinol stent. The device is used in the biliary tree to treat malignant strictures. The delivery system consists of a coaxial catheter with an inner member compatible with 0.035" guide wires and an outer member featuring a distal sheath that constrains the stent. A proximal pull-back handle allows the physician to retract the sheath, deploying the stent. The stent is laser-cut from superelastic Nitinol, electropolished, and features radio-opaque markers for visualization. The device is intended for use by clinicians. The stent provides mechanical support to maintain patency in the biliary duct, offering palliation for patients with malignant obstructions.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Stent material: superelastic nickel-titanium (Nitinol). Surface finish: electropolished with titanium oxide layer. Delivery system: coaxial catheter, 0.035" guide wire compatible, 7F sheath and 9F guiding catheter compatibility. Stent diameters: 12 mm and 14 mm. Stent lengths: 38, 56, and 80 mm. System lengths: 55, 80, and 120 cm. Deployment: mechanical retraction of outer sheath. Radio-opaque markers included.
Indications for Use
Indicated for palliation of malignant 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
- DYNALINK .018 Biliary Self-Expanding Stent System (K014007)
Submission Summary (Full Text)
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# (JUL) = 2 2002
K021824
## 510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | Guidant Corporation |
|-----------------------------|----------------------------------------------------|
| Submitter's Address: | 3200 Lakeside Drive<br>Santa Clara, CA 95052 |
| Telephone:<br>Fax: | 650-470-6278<br>650-617-5024 |
| Contact Person: | Martha Murari, Ph.D. |
| Date Prepared: | June 3, 2002 |
| Device Trade Name: | DYNALINK™ .035 Biliary Self-Expanding Stent System |
| Device Common Name: | Biliary Stent |
| Device Classification Name: | Biliary Catheter |
| Device Classification: | Class II |
Summary of Substantial Equivalence:
The design, materials, method of delivery and intended use features of 12 mm and 14 mm DYNALINKIN Stem Systems are substantially equivalent with regard to these features in the predicate device, the DYNALINK ,018 Biliary Self-Expanding Steat System (K014007, January 7, 2002). The 12 mm and 14 mm DYNALINK To Stent Systems will be marketed as part of the DYNALINK . 035 Biliary Self-Expanding Stem System product line.
### Device Description:
The 12 mm and 14 mm DYNALINKING Stent Systems are catherers designed to deploy a selfexpanding nickel titanium (Nitinol) stent into the biliary tree.
The catherer body is constructed from two coaxial members. The inner member (IM) is comparible with a 0.035" guide wire in an over the wire configuration. The outer member (OM) is composed of a distal sheath that constrains the unexpanded stent, an outer shaft over most of the catheter length, and a proximal handle used to retract the assembly,
The distal end of the delivery system includes either the 12 mm or the 14 mm DYNALINK™ Stent held in its constrained state by the stem-restraining sheath, a soft, low profile tip, and two
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radio-opaque markers to indicate the proximal and distal ends of the stent. At the proximal end of the delivery system. the user interface is composed of a pull-back handle attached to the OM, a shaped housing that allows the handle to slide axially, and a luer firting that is rigidly fixed to the shaped housing.
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The 12 mm and 14 mm DYNALINK™ Stents are fabricated from superclastic nickel-titanium (niunol) in a series of serpentine rings that are aligned along a common longitudinal axis.
The stent is laser cut from a tube of superelastic minnol. All of the stent diameters are cut with similar stent patterns, and the stent is expanded and heat-treated to be stable at the desired final diamerer. The stens are electropolished to obtain a smooth finish with a thin layer of itanium oxide on the surface.
#### Indications for Use:
The DYNALINK . 018 Biliary Self-Expanding Stent System and the DYNALINK™ .035 Biliary Self-Expanding Stent System are intended for palliation of malignant strictures in the biliary tree.
#### Technological Characteristics:
Comparisons of the new and predicate devices show that technological characterissics such as materials, biocompatibility, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate device. The design modifications of the new biliary stent systems compared to that of the predicate biliary stent system is the diameter of the stent, a system length of 55 cm, and dimensional changes to the delivery catheter. Manufacturing process changes, including a modification to a material coating, have also been made. These devices will be available in stent diamerers of 12 mm with stent lengths of 38, 56, and 80 mm for system lengths of 55, 80, and 120 cm and will have compatibility with 7F sheaths and 9F guiding catherers.
#### Performance Data:
The safery and effectiveness of the 12 mm and 14 mm DYNALINK™ Stent Systems have been demonstrated through data collected from in vitro bench tests and analyses.
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Public Health Service
JUL - 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Martha Murari, Ph.D. Senior Regulatory Affairs Associate Guidant Corporation 1525 O'Brien Drive MENLO PARK CA 94025
K021824 Re:
Trade/Device Name: DYNALINK™ .035 Biliary Self-Expanding Stent System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: June 3, 2002 Received: June 4, 2002
Dear Dr. Murari:
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 - Dr. Martha Murari
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 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 Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Bernard F. Statland, M.D., Ph.D.
Bernard E. Statland, M.D., Ph. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K021824
Device Name: DYNALINK™ .035 Biliary Self-Expanding Stent System
FDA's Statement of the Indications For Use for device:
The DYNALINK™ .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.
Prescription Use ✓ OR
(Per 21 CFR 801.109)
- ﺗ
Over-The-Counter Use
Nancy C. Brogdon
