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.

AI/ML Overview

This document is a 510(k) Summary for the Skater® Biliary Drainage Catheter, detailing its regulatory submission to the FDA. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a performance study with detailed acceptance criteria and expert reviews in the way typically found for AI/ML-driven diagnostic devices.

Therefore, the requested information, particularly regarding specific acceptance criteria, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment in the context of a performance study, is largely not present in this document. The document describes product characteristics and safety/performance testing, which are manufacturing and preclinical assessments, not clinical performance studies for diagnostic accuracy.

Here's a breakdown of what can be gleaned from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from "Safety and Performance" Section)	Reported Device Performance
Comparability to predicate device	"[A]ll data gathered demonstrates that the Skater® Biliary Drainage Catheter is comparable to the predicate devices."
Dimensional Inspection	Tested and presumably met internal specifications.
Process Performance Qualification	Tested and presumably met internal specifications.
Biocompatibility	Tested and presumably met biocompatibility standards.
Aging (Shelf-life)	Tested and presumably met stability standards.
LAL (Limulus Amebocyte Lysate - Endotoxin test)	Tested and presumably met endotoxin limits.
Bioburden (Sterilization)	Tested and presumably met sterilization standards.
EO/EC Residual (Ethylene Oxide/Epichlorohydrin - Sterilization residuals)	Tested and presumably met residual limits.
In vitro bench tests for safety and effectiveness	"The results of in vitro bench tests and biocompatibility testing demonstrate the safety and effectiveness of the Skater® Biliary Drainage Catheter."

2. Sample size used for the test set and the data provenance

Not explicitly stated for a clinical performance study. The document refers to "in vitro bench tests" and "biocompatibility testing," which are typically laboratory-based assessments, not clinical trials with human subjects or large datasets. No specific sample sizes for these tests are provided.
Data Provenance: Not applicable in the context of a clinical performance study. The tests mentioned are laboratory/bench tests, not trials with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This information is relevant for diagnostic accuracy studies involving expert human review of images or data to establish a ground truth. The document describes bench and biocompatibility testing, which do not involve expert human interpretation for ground truth.

4. Adjudication method

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert human interpretation, which is not described as part of the testing here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This type of study is for evaluating AI-assisted diagnostic performance. The Skater® Biliary Drainage Catheter is a medical device (catheter) and not an AI-powered diagnostic tool, so an MRMC study is not relevant to its regulatory submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This concept is for AI algorithms. The device itself is a physical medical instrument.

7. The type of ground truth used

Benchmarking/Standard Measurements: For dimensional inspection, LAL, bioburden, EO/EC residual, and potentially other in vitro tests, the "ground truth" would be established by industry standards, validated measurement methods, and predefined acceptance limits (e.g., a specific dimension, a maximum endotoxin level, sterility).
Biocompatibility Standards: For biocompatibility, the ground truth is established by recognized international standards (e.g., ISO 10993 series) and specific in vitro/in vivo tests designed to evaluate potential adverse biological reactions.

8. The sample size for the training set

Not applicable. There is no "training set" for this type of medical device submission, as it does not involve machine learning or AI models. The device is evaluated through engineering, chemical, and biological testing, not by training an algorithm.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, this question is not relevant.

In summary: This 510(k) submission confirms that the Skater® Biliary Drainage Catheter underwent various safety and performance tests (dimensional, process, biocompatibility, aging, LAL, bioburden, EO/EC residual) and was found comparable to its predicate devices. However, it does not involve the type of clinical performance study details (e.g., test set, expert review, AI accuracy metrics) that would be pertinent to AI/ML diagnostic tools.

Summary

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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: 703-673-0061

Date Prepared: December 13, 2007

2. Name of Device:	Skater® Biliary Drainage Catheter
Common Name:	Biliary Catheter
Classification Name:	Catheter, Biliary, DiagnosticRegulation 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:

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/ TechnologicalCharacteristics	Skater® Biliary DrainageCatheter(Predicate Device)K070610	Canalizer HydrophilicGuide Wire*K050873	Skater® Biliary DrainageCatheter (New Device)
Intended Use	Intended for percutaneousbiliary drainage.	N/A*	Intended for percutaneousbiliary drainage.
Characteristics	Drainage catheter withmetal and plastic stiffeningcannula and female/maleluer hub (adapter)	N/A*	Drainage catheter withmetal and plastic stiffeningcannula and female/maleluer hub (adapter). Thetubing has the option ofhaving a radiopaquemarker band.
Sizes (French)	8, 10, 12	N/A*	8, 10, 12
Length (cm)	40 cm from hub to distaltip in curved position	N/A*	40 cm from hub to distaltip in curved position
Lumens	One	N/A*	One
Distal End Configuration	8 Fr. - 12 side drainageholes and one enddrainage hole, pigtail.10 and 12 Fr. - 11 sidedrainage holes and one enddrainage hole, pigtail.	N/A*	8 Fr. - 12 side drainageholes and one enddrainage hole, pigtail.10 and 12 Fr. - 11 sidedrainage holes and one enddrainage hole, pigtail.
Intended anatomicallocation of distal end	Biliary system	N/A*	Biliary system
Proximal endconfiguration	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.

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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 (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

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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)

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

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.