The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system. The major components of the Flexima Biliary Catheter are the drainage catheter, metal stiffening cannula, flexible stiffening cannula and luer cap.

AI/ML Overview

The provided text is a summary of a 510(k) premarket notification for the Flexima™ Biliary Catheter.

This document DOES NOT contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or any comparative effectiveness study (MRMC or standalone AI performance).

The document focuses on demonstrating substantial equivalence to a predicate device. This typically involves performance testing to show the new device functions similarly to the existing device, but it doesn't usually include the kind of detailed clinical study information (like ground truth establishment, expert adjudication, or AI performance metrics) requested in your prompt, especially for a non-AI medical device like a biliary catheter.

Therefore, I cannot fulfill your request for the specific details you've asked for, as they are not present in the provided text.

Here's an explanation of why the requested information is absent based on the document:

Type of Device: The Flexima Biliary Catheter is a physical medical device for drainage, not an AI or imaging-based diagnostic tool. The performance criteria for such devices typically revolve around mechanical properties, biocompatibility, and functional equivalence, rather than diagnostic accuracy metrics.
Regulatory Pathway (510(k)): The 510(k) pathway, particularly a Special 510(k) in this case, primarily aims to demonstrate "substantial equivalence" to a legally marketed predicate device. This often involves bench testing, limited animal studies, or comparison of design specifications, rather than large-scale human clinical trials or complex AI performance evaluations.
Content of the Summary: The provided text is a "Summary of Safety and Effectiveness" which briefly outlines the device, its intended use, and states that "All data gathered demonstrate this device as substantially equivalent." It does not elaborate on the specific tests or their results.

To directly address your prompt points, given the provided text, I can only state that this information is not available:

A table of acceptance criteria and the reported device performance: Not provided. The document generally states "All data gathered demonstrate this device as substantially equivalent," but no specific performance criteria or results are listed.
Sample size used for the test set and the data provenance: Not provided. The type of testing and sample sizes are not detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth in this context (for a physical catheter) would likely relate to objective measurements of device properties rather than expert consensus on diagnostic images.
Adjudication method: Not applicable/Not provided.
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: Not applicable. This is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used: Not applicable/Not provided.
The sample size for the training set: Not applicable. This is not an AI device.
How the ground truth for the training set was established: Not applicable. This is not an AI device.

Summary

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Special 510(k) Flexima™ Biliary Catheter Boston Scientific Corporation

DEC 2 0 2002

Summary of Safety and Effectiveness

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

GeneralInformation	Submitter: Boston Scientific Corporation780 Brookside DriveSpencer, IN 47460Contact Person: Nicholas Condakes
GeneralProvisions	Trade Name: Flexima Biliary CatheterClassification Name: Biliary Catheter and Accessories
Name ofPredicateDevices	Flexima Biliary Catheter
Classification	Class II
PerformanceStandards	Performance Standards have not been established by FDA under Section 514of the Food, Drug and Cosmetic Act
Intended Useand DeviceDescription	TheFlexima Biliary Catheter is designed for external and internalpercutaneous drainage of the biliary system. The major components of theFlexima Biliary Catheter are the drainage catheter, metal stiffening cannula,flexible stiffening cannula and luer cap.
Summary ofSubstantialEquivalence	The Flexima Biliary Catheters have been tested and compared to the predicatedevice. All data gathered demonstrate this device as substantially equivalent.No new issues of safety or efficacy have been raised.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping profiles, suggesting a sense of community and service.

Public Health Service

DEC 2 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Nicholas Condakes Regulatory Affairs Specialist II Boston Scientific Medi-Tech® Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537

Re: K023870

Trade/Device Name: Flexima™ Biliary Drainage Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: November 19, 2002 Received: November 20, 2002

Dear Mr. Condakes:

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. Iisting 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 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.

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.

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This letter will allow you to begin marketing your device as described in your 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:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

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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Special 510(k) Flexima™ Biliary Catheter Boston Scientific Corporation

K023870 0-0 0 0 6 3

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Indications For Use

510(k) Number (if known)
Device Name:	Flexima™ Biliary Catheter
Indications for Use	The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	OR Over-The Counter Use (Optional Format 1-2-96)
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(Division Sign Off)

Division of Reproductive, Abdominal,

and Peripheral Devices

510(k) Number	K023870
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Confidential

Boston Scientific Corporation

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.