SKATER BILIARY CATHETER

K073672 · Angiotech · FGE · Jan 24, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K073672
• Device Name: SKATER BILIARY CATHETER
• Applicant: Angiotech
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jan 24, 2008
• Decision: SESE
• Submission Type: Special
• 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 polyurethane catheter designed for percutaneous biliary drainage. Device features pigtail-loop, locking-type configuration with drainage holes; includes metal/plastic stiffening cannulas and standard luer locking hub. Optional radiopaque marker band available. Used by clinicians in clinical settings to facilitate drainage from the biliary system. Operates via percutaneous insertion; provides drainage path for bile. Benefits include effective biliary decompression. No software or complex algorithms involved.

Clinical Evidence

Bench testing only. Testing included dimensional inspection, process performance qualification, biocompatibility, aging, LAL (Limulus Amebocyte Lysate) testing, bioburden, and EO/EC residual analysis. Results demonstrate safety and effectiveness comparable to predicate devices.

Technological Characteristics

Polyurethane catheter; 8, 10, 12 French sizes; 40 cm length. Features SLIP-COAT™ hydrophilic coating, pigtail-loop locking configuration, and drainage holes. Includes metal/plastic stiffening cannulas and luer locking hub. Optional radiopaque marker band. Sterilization via ethylene oxide (EO).

Indications for Use

Indicated for percutaneous biliary drainage in patients requiring biliary system access.

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

• Skater® Biliary Drainage Catheter (K070610)
• CanaliZer Hydrophilic Guide Wire (K050873)

Submission Summary (Full Text)

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# Attachment D

:

# 510(k) Summary

JAN 2 4 2008

Skater® Biliary Drainage Catheter

Section D -- 510(k) Summary

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K0-3672

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#### 510(k) Summary

#### 1. Applicant Contact:

Trudy D. Estridge, PhD Director, 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]

Date Prepared: December 13, 2007

| 2. Name of Device: | Skater® Biliary Drainage Catheter |
|----------------------|--------------------------------------------------------------------------------|
| Common Name: | Biliary Catheter |
| Classification Name: | Catheter, Biliary, Diagnostic<br>Regulation 21 CFR 876.5010 - Product code FGE |

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

Angiotech, Skater® Biliary Drainage Catheter, K070610 is being referred to as the predicate device for the intended use of the device.

Medical Device Technologies, Inc., CanaliZer Hydrophilic Guide Wire, K050873 is being referred to as the predicate for the use of only the coating.

#### 4. Device Description:

The Skater® Biliary Drainage Catheter is a polyurethane catheter with SLIP-COAT™, a lubricious hydrophilic coating.. 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 Device:

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

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K073672

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| Feature/ Technological<br>Characteristics | Skater® Biliary Drainage<br>Catheter<br>(Predicate Device)<br>K070610 | Canalizer Hydrophilic<br>Guide Wire*<br>K050873 | Skater® Biliary Drainage<br>Catheter (New Device) |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for percutaneous<br>biliary drainage. | N/A* | Intended for percutaneous<br>biliary drainage. |
| Characteristics | Drainage catheter with<br>metal and plastic stiffening<br>cannula and female/male<br>luer hub (adapter) | N/A* | Drainage catheter with<br>metal and plastic stiffening<br>cannula and female/male<br>luer hub (adapter). The<br>tubing has the option of<br>having a radiopaque<br>marker band. |
| Sizes (French) | 8, 10, 12 | N/A* | 8, 10, 12 |
| Length (cm) | 40 cm from hub to distal<br>tip in curved position | N/A* | 40 cm from hub to distal<br>tip in curved position |
| Lumens | One | N/A* | One |
| Distal End Configuration | 8 Fr. - 12 side drainage<br>holes and one end<br>drainage hole, pigtail.<br>10 and 12 Fr. - 11 side<br>drainage holes and one end<br>drainage hole, pigtail. | N/A* | 8 Fr. - 12 side drainage<br>holes and one end<br>drainage hole, 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 | N/A* | Biliary system |
| Proximal end<br>configuration | Female/male luer hub<br>(adapter) and clip | N/A* | Female/male luer hub<br>(adapter) and clip |
| Materials | Polyurethane | Polyurethane | Polyurethane |
| Coating | Hydrophilic | Hydrophilic | Hydrophilic |

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

*Predicate is only for slip coat being applied to polyurethane material. It is not applicable to form, fit or function of the device. This is an acceptable coating.

#### 7. Safety and Performance:

The Skater® Biliary Drainage Catheter has been tested and compared to the predicate device. Testing included dimensional inspection, process performance qualification, biocompatibility, aging, LAL, bioburden, and EO/EC residual. All data gathered demonstrates that the Skater® Biliary Drainage Catheter is comparable to the predicate devices.

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing its wings.

JAN 2 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Trudy D. Estridge, Ph.D. Director of Regulatory Affairs Angiotech 13921 Park Center Road, STE 100 HERNDON VA 21071

K073672 Re:

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: December 13, 2007 Received: December 27, 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 (PMA), 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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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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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

Final report

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K073672
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### Attachment B

### Indications for Use Statement

510(k) Number (if known):

K073672

Device Name: Skater® Biliary Drainage Catheter

Indications for Use:

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

### (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use X (Part 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Haber Henson

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K013672

Attachment B - Indications for Use Page 1 of 1

Skater Biliary Drainage Catheter