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.

AI/ML Overview

The provided text describes a 510(k) submission for the "Skater® Biliary Drainage Catheter" and focuses on demonstrating its substantial equivalence to a predicate device, rather than proving it meets specific acceptance criteria through a clinical study or performance goals set for a new, non-inferiority claim.

Here's a breakdown based on the information provided, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria/Performance Goals: The document does not explicitly state quantitative "acceptance criteria" or performance goals in terms of specific metrics (e.g., accuracy, sensitivity, specificity, or success rates) for the device's clinical function. Instead, it aims to demonstrate substantial equivalence to a predicate device.

Reported Device Performance:
The document does describe the types of tests performed.

Criterion/Test Type	Reported Device Performance (Skater® Biliary Drainage Catheter)
Functional Testing	All data demonstrates comparability to the predicate device.
Leakage Testing	All data demonstrates comparability to the predicate device.
Catheter Body Tensile Strength and Elongation	All data demonstrates comparability to the predicate device.
Physical Dimensions	All data demonstrates comparability to the predicate device.
Catheter Body to Hub Tensile Strength	All data demonstrates comparability to the predicate device.
Biocompatibility Testing	Demonstrates safety and effectiveness.
Overall Safety and Effectiveness	Demonstrated through in vitro bench tests and biocompatibility testing; believed to be substantially equivalent to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "in vitro bench tests" but does not specify sample sizes for these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective) as it pertains to clinical performance data, because no clinical performance study is described. The tests conducted appear to be laboratory-based engineering and material property tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided. The device comparison is based on bench testing and material characteristics, not on interpretations by medical experts for clinical ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As no expert-based ground truth establishment or clinical performance study is detailed, no adjudication method would have been used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not done. This type of study is commonly used for diagnostic accuracy of image-based AI devices, which is not the nature of this device. The submission is for a medical catheter, and the evidence provided focuses on physical and material characteristics compared to a predicate device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study was not done. This is also relevant for AI/software devices, which this catheter is not. The performance evaluation is for the physical device itself.

7. Type of Ground Truth Used

The "ground truth" for the tests performed (functional, leakage, tensile strength, physical dimensions) would have been the engineering specifications and established testing standards for medical devices of this type, as well as comparison against the performance of the predicate device. It is not based on expert consensus, pathology, or outcomes data, as these are typically used for clinical performance evaluations.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical catheter, not an AI or machine learning algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the same reason as point 8.

Summary of the Study:

The study described is a series of in vitro bench tests and biocompatibility testing designed to demonstrate that the "Skater® Biliary Drainage Catheter" is substantially equivalent to the "Boston Scientific Corporation, Flexima™ Biliary Catheter (K023870)" predicate device. The tests covered functional performance, leakage, tensile strength and elongation of the catheter body, physical dimensions, and catheter body to hub tensile strength. The conclusion is that the new device performs "comparably" to the predicate in these areas, and that the combined results of these tests and biocompatibility testing demonstrate its safety and effectiveness. The report does not involve clinical trials, expert reviews of clinical cases, or AI performance metrics.

Summary

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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: 703.673.0061 Email: testridge@angio.com

Date Prepared: March 01, 2007

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:

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

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

Feature /TechnologicalCharacteristics	Boston ScientificCorporation, Flexima™Biliary CatheterK023870(Predicate Device)	Skater® BiliaryDrainage Catheter(New Device)
Intended Use	Designed for the external andinternal percutaneousdrainage of the biliary system	Intended for percutaneousbiliary drainage
Characteristics	Drainage catheter with metalstiffening cannula, flexiblestiffening cannula and luercap	Drainage catheter with metaland plastic stiffening cannulaand female/male luer hub(adapter)
Sizes (French)	8, 10, 12, 14	8, 10, 12
Length (cm)	35 cm from hub to proximalside of pigtail in curvedposition	40 cm from hub to distal tipin curved position
Lumens	One	One
Distal endconfiguration	12 side holes and one endhole, pigtail.	8 Fr. - 12 side drainage holesand one end drainage hole,pigtail.10 and 12 Fr. - 11 sidedrainage holes and one enddrainage hole, pigtail.
Intended anatomicallocation of distal end	Biliary system	Biliary system
Proximal endconfiguration	Standard luer locking hub andstop-cock	Female/male luer hub(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.

Image /page/3/Picture/10 description: The image is a circular logo or emblem. The central element is the acronym "FDA" in a stylized font, with the word "Centennial" written below it. Above the acronym, the years "1906-2006" are displayed, indicating a centennial celebration. The entire design is encircled by text and star symbols, forming a complete circular seal.

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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 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.