SKATER BILIARY CATHETER

K070610 · Angiotech · FGE · Jun 21, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070610
• Device Name: SKATER BILIARY CATHETER
• Applicant: Angiotech
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jun 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Skater® Biliary Drainage Catheter is indicated for percutaneous biliary drainage.

Device Story

Skater® Biliary Drainage Catheter is a hydrophilic-coated polyurethane catheter used for percutaneous biliary drainage. It features a pigtail-loop, locking-type distal end with multiple side drainage holes and one end hole. The device is provided in 8, 10, and 12 French sizes with a 40 cm length. Accessories include metal and plastic stiffening cannulas and a luer locking hub. The catheter is inserted percutaneously into the biliary system to facilitate drainage. It is intended for use by healthcare professionals in a clinical setting. The device functions similarly to existing biliary catheters, providing a pathway for bile drainage to manage biliary obstruction or related conditions, thereby benefiting the patient by relieving pressure and preventing complications associated with biliary stasis.

Clinical Evidence

Bench testing only. Testing included functional performance, leakage, catheter body tensile strength, elongation, and physical dimensions. Biocompatibility testing was also performed. All results demonstrated safety and effectiveness comparable to the predicate device.

Technological Characteristics

Hydrophilic-coated polyurethane catheter; pigtail-loop locking configuration; 8, 10, 12 French sizes; 40 cm length; includes metal and plastic stiffening cannulas and luer locking hub. Single lumen design. No electronic or software components.

Indications for Use

Indicated for percutaneous biliary drainage in patients requiring external or internal drainage of the biliary system.

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

• Boston Scientific Corporation, Flexima™ Biliary Catheter (K023870)

Submission Summary (Full Text)

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K070610 page 1 of 3

### Section 5 - 510(k) Summary

JUN 2 1 2007

### 1. Applicant Contact:

Trudy D. Estridge, PhD Director of Regulatory Affairs Angiotech Dulles Gateway Center 13921 Park Center Road, Suite 100 Herndon, VA 20171 USA CA voice: 510.742.5301 VA voice: 703.796.8927 Fax: [phone] Email: [e-mail]

Date Prepared: March 01, 2007

2. Name of Device: Skater® Biliary Drainage Catheter Common Name: Biliary Catheter Classification Name: Catheter, Biliary, Diagnostic Regulation 21 CFR 876.5010 -- Product Code FGE

### 3. Identification of device(s) to which the submitted claims equivalence:

Boston Scientific Corporation, Flexima™ Biliary Catheter, K023870

### 4. Device Description:

The Skater® Biliary Drainage Catheter is made from hydrophilic coated polyurethane. The catheter comes in a pigtail-loop, locking-type end configuration with drainage holes. The catheters are provided in 8 French, 10 French, and 12 French sizes with a length of 40 cm. Accessories include a metal stiffening cannula, a plastic stiffening cannula and a standard luer locking hub.

#### 5. Intended Use of the Device:

The Skater® Biliary Drainage Catheter is indicated for percutaneous biliary drainage.

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page 2 of 2

K07061C

# Section 5 - 510(k) Summary

6. Technological characteristics of the device in comparison to those of the predicate device(s)

| Feature /<br>Technological<br>Characteristics | Boston Scientific<br>Corporation, Flexima™<br>Biliary Catheter<br>K023870<br>(Predicate Device) | Skater® Biliary<br>Drainage Catheter<br>(New Device) |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Designed for the external and<br>internal percutaneous<br>drainage of the biliary system | Intended for percutaneous<br>biliary drainage |
| Characteristics | Drainage catheter with metal<br>stiffening cannula, flexible<br>stiffening cannula and luer<br>cap | Drainage catheter with metal<br>and plastic stiffening cannula<br>and female/male luer hub<br>(adapter) |
| Sizes (French) | 8, 10, 12, 14 | 8, 10, 12 |
| Length (cm) | 35 cm from hub to proximal<br>side of pigtail in curved<br>position | 40 cm from hub to distal tip<br>in curved position |
| Lumens | One | One |
| Distal end<br>configuration | 12 side holes and one end<br>hole, pigtail. | 8 Fr. - 12 side drainage holes<br>and one end drainage hole,<br>pigtail.<br>10 and 12 Fr. - 11 side<br>drainage holes and one end<br>drainage hole, pigtail. |
| Intended anatomical<br>location of distal end | Biliary system | Biliary system |
| Proximal end<br>configuration | Standard luer locking hub and<br>stop-cock | Female/male luer hub<br>(adapter) and clip |
| Materials | Polyurethane | Polyurethane |
| Coating | Hydrophilic | Hydrophilic |

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page 3 of 3

K070610

## Section 5 - 510(k) Summary

### 7. Safety and Performance:

The Skater® Biliary Drainage Catheter has been tested and compared to the predicate device. Testing included functional, leakage, catheter body tensile strength and elongation, physical dimensions and catheter body to hub tensile strength. All data gathered demonstrates the Skater® Biliary Drainage Catheter comparably to the predicate device.

The results of in vitro bench tests and biocompatibility testing demonstrate the safety and effectiveness of the Skater® Biliary Drainage Catheter.

#### 8. Conclusion

Based on the design, material, function and intended use discussed herein. Angiotech believes the Skater® Biliary Drainage Catheter is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

N 2 1 2007

Trudy D. Estridge, Ph.D. Director of Regulatory Affairs Angiotech® Dulles Gateway Center 13921 Park Center Road, Suite 100 HERNDON VA 20171

Re: K070610

Trade/Device Name: Skater® Biliary Drainage Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: June 7. 2007 Received: June 8, 2007

Dear Dr. Estridge:

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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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cling and Promoting

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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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4 - Indications for Use Statement

510k number if known:

KO-70610

Device Name:

Skater® Biliary Drainage Catheter

Indications for Use:

The Skater® Biliary Drainage Catheter is indicated for percutaneous biliary drainage.

Prescription Use 2 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Heal

on Sign-Off) vision of Reproductive, Abdomina and Radiological Devices 510(k) Number