K Number
K073672
Device Name
SKATER BILIARY CATHETER
Manufacturer
Date Cleared
2008-01-24

(28 days)

Product Code
Regulation Number
876.5010
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Skater® Biliary Drainage Catheter is indicated for percutaneous biliary drainage.
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.
More Information

Not Found

No
The device description and performance studies focus on the physical characteristics and material properties of a drainage catheter, with no mention of AI or ML.

Yes
The device is indicated for percutaneous biliary drainage, which is a therapeutic intervention to remove fluid and relieve obstruction in the biliary system.

No

Explanation: The device is a catheter used for drainage, which is a therapeutic intervention, not a diagnostic one. Its purpose is to drain the biliary system, not to identify or characterize a disease.

No

The device description clearly outlines a physical catheter made of polyurethane with accessories like stiffening cannulas and a luer locking hub, indicating it is a hardware medical device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "percutaneous biliary drainage." This is a procedure performed directly on a patient to drain bile from the biliary system.
  • Device Description: The device is a physical catheter designed to be inserted into the body.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not perform any such analysis on specimens.

This device is a medical device used for a therapeutic procedure, not an in vitro diagnostic test.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

FGE

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Biliary system

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K070610, K050873

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 876.5010 Biliary catheter and accessories.

(a)
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.(b)
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.

0

Image /page/0/Picture/0 description: The image shows a handwritten sequence of numbers and letters. The top row appears to be "K073672", while the bottom row seems to be "163". The handwriting is somewhat stylized, with some characters being more clearly formed than others.

Attachment D

:

510(k) Summary

JAN 2 4 2008

Skater® Biliary Drainage Catheter

Section D -- 510(k) Summary

1

K0-3672

2 of 3

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: 703-673-0061

Date Prepared: December 13, 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:

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

3 of 3

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

3

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.

4

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
Other240-276-0100

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 (800) 638-2041 or (240) 276-3150 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

Page 2

5

K073672
181

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