BULLSEYE BILIARY STENT SYSTEM
Device Facts
| Record ID | K082093 |
|---|---|
| Device Name | BULLSEYE BILIARY STENT SYSTEM |
| Applicant | Squareone |
| Product Code | FGE · Gastroenterology, Urology |
| Decision Date | Jul 29, 2009 |
| Decision | SESU |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5010 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The BullsEye Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
Device Story
BullsEye Biliary Stent System is a 316L stainless steel, balloon-expandable stent; designed for biliary duct scaffolding to restore/maintain bile flow. Stent features distal cylindrical segment for structural support and proximal conformable flare segment to prevent migration. Pre-mounted on dual-balloon, monorail delivery system (80cm working length); compatible with 0.014" guidewires and catheters/sheaths with minimum 0.081" inner diameter. Radiopaque marker bands facilitate positioning. Used by clinicians in interventional procedures to palliate malignant biliary obstructions. Device provides mechanical support to duct walls; benefits patient by relieving biliary obstruction caused by neoplasms.
Clinical Evidence
bench testing only
Technological Characteristics
316L stainless steel; balloon-expandable stent; 6.2mm diameter, 15mm length (unexpanded); 3.7mm proximal flare; dual-balloon monorail delivery system; radiopaque marker bands; mechanical scaffolding principle.
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 PALMAZ GENESIS Transhepatic Billiary Stent and Delivery System (K010411)
- Bard LUMINEXX 3 Biliary Stent and Delivery System (K033497)
Submission Summary (Full Text)
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CONFIDENTIAL
SquareOne, Inc. 510(k) Application BullsEye Billiary Stent System
## 510(k) Summary of Safety and Effectiveness
# JUL 2 9 2009
Dril 093
11
:
| Submitter: | SquareOne, Inc. 510 Clyde Avenue Mountain View, CA 94043 |
|----------------|------------------------------------------------------------|
| Telephone: | 650-967-9424 |
| Fax: | 650-967-9421 |
| Contact: | Eric Ankerud; EVP, Regulatory & Quality |
| Date Prepared: | July 22, 2008 |
| Trade Name: | BullsEye Biliary Stent System |
|------------------------|-------------------------------|
| Common Name: | Biliary stent |
| Classification Name: | Biliary catheter |
| Device Classification: | Class II, per 21 CFR 876.5010 |
## Summary of Substantial Equivalence:
A variety of tests, assessments, and comparisons demonstrate that the BullEye Biliary Stent System is substantially equivalent to the Cordis PALMAZ GENESIS Transhepatic Billiary Stent and Delivery System (K010411) and the Bard LUMINEXX 3 Biliary Stent and Delivery System (K033497) in terms of composition, design, intended use, and performance attributes.
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CONFIDENTIAL
K082093
pg 2 of 2
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# BullsEye Biliary Stent System
SquareOne, Inc. 510(k) Application
#### Device Description:
The BullsEye Biliary Stent System is a 316L stainless steel, balloon-expandable stent design with a 6.2mm diameter and 15mm length (unexpanded). The stent is comprised of a distal cylindrical segment, which provides permanent structural support and subsequently restores and maintains bile flow by scaffolding the duct wall, and a 3.7mm proximal conformable flare segment, which helps to prevent post deployment stent migration and dislocation. The stent is pre-mounted on a dual-balloon, monorail, delivery device with 80cm working length and a crossing profile compatible with guide catheters/introducer sheaths with a minimum inner diameter of 0.081". The system is also compatible with standard 0.014″ guidewires. Two radiopaque marker bands aid in positioning of the stent during the delivery procedure.
## Intended Use:
The BullsEye Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# JUL 2 9 2009
Eric P. Ankerud, J.D. Executive Vice President, Regulatory and Quality SquareOne, Inc. 510 Clyde Avenue MOUNTAIN VIEW CA 94043
Re: K082093
Device Name: BullsEye Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: November 21, 2008 Received: November 24, 2008
Dear Mr. Ankerud:
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 - Mr. Eric Ankerud
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 (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.
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) 796-5484. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known): _ K082093
Device Name: BullsEye Biliary Stent System
Indications For Use: BullsEye Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use (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)
Raunty Reaves
(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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