The subject device is a system consisting of a single-lumen, tubular, self-expanding nickel-titanium ("nitinol") stent pre-loaded onto a sheathed delivery catheter. The delivery system is designed to deliver the stent to the stricture site via transhepatic access. Once positioned at the stricture site, the sheath is withdrawn and the stent is released. Upon release, the stent expands and conforms to the inner lumen of the biliary duct. The device has two radiopaque markers to aid in stent placement during fluoroscopy.

AI/ML Overview

The provided document is a 510(k) summary for the Bridge SE Biliary Self-Expanding Stent Delivery System. This type of regulatory submission establishes substantial equivalence to a predicate device, rather than performing a de novo clinical study with specific acceptance criteria or an MRMC study. Therefore, the information requested about acceptance criteria, specific study details, and AI-related metrics is not directly applicable or available in this document.

However, I can extract information regarding the device description, indications for use, and technological characteristics to explain how the device is considered to meet substantial equivalence criteria without the detailed study information you requested.

Here's an analysis based on the provided text, addressing only the applicable points:

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

The concept of explicit "acceptance criteria" and "reported device performance" in the context of a de novo clinical trial is not present here because this is a 510(k) submission. Instead, the "acceptance criteria" for a 510(k) submission are met by demonstrating substantial equivalence to a legally marketed predicate device. The "performance" is demonstrated through nonclinical testing and comparison to the predicate.

Acceptance Criteria (for 510(k) Substantial Equivalence without explicit performance metrics)	Reported Device Performance (based on substantial equivalence narrative)
Intended Use: Device is for the same intended use as the predicate.	Palliation of malignant neoplasm in the biliary tree.
Technological Characteristics: Device has similar technological characteristics to the predicate.	Same materials (nitinol), same delivery method (sheathed delivery catheter via transhepatic access). Minor differences (additional stent sizes, longer catheter) are not considered to impact safety or effectiveness.
Safety and Effectiveness: Differences in technological characteristics do not raise new questions of safety or effectiveness.	Preclinical testing conducted to confirm safe and effective performance and biocompatibility.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. A 510(k) summary primarily focuses on demonstrating substantial equivalence through comparison to a predicate device and often relies on bench testing and existing knowledge of similar devices, rather than a prospective clinical trial with a defined test set of patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as this document does not describe a clinical study involving human readers or expert-established ground truth in the way a diagnostic algorithm study would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there is no described clinical study in the document that would require an adjudication method for a test set.

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

An MRMC comparative effectiveness study was not performed or described in this 510(k) summary. This document pertains to a medical device (stent and delivery system), not an AI-assisted diagnostic tool or an imaging modality requiring a reader study.

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

This concept is not applicable to the Bridge SE Biliary Self-Expanding Stent Delivery System, as it is a physical medical device (stent) and not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" in the context of diagnostic accuracy for an algorithm is not applicable here. The assessment for this device relies on preclinical testing to confirm performance and biocompatibility, and the comparison to an already cleared predicate device. For stent efficacy, "outcomes data" or clinical follow-up would typically be part of a full clinical trial, but this 510(k) relies on the established safety and efficacy of the predicate device for its substantial equivalence claim.

8. The sample size for the training set

This information is not provided as this is not a study involving a training set for an algorithm.

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

This information is not provided as this is not a study involving a training set for an algorithm.

Summary

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510(k) Summary for the Bridge SE Biliary Self-Expanding Stent Delivery System

JAN 1 4 2002
510(k)Summary	This summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirements of 21 C.F.R. § 807.92.
Submitter	Medtronic AVE, Inc., Peripheral Technologies2170-A Northpoint ParkwaySanta Rosa, California 95407
Contact Person	John RioloVice President, Regulatory Affairs and Quality AssurancePhone: (707) 541-3271FAX: (707) 566-1159e-mail: john.riolo@medtronic.com
Date Prepared	December 20, 2001
Trade Name	Bridge SE Biliary Self-Expanding Stent Delivery System ("Bridge SE")
CommonName	Biliary Stent and Delivery System
ClassificationName	Biliary Catheter and Accessories
DeviceClassification	Classification: Class IIClassification Panel: 78FGERegulation Number: 21 C.F.R. §876.5010
PredicateDevice	Bridge SE Biliary Self-Expanding Stent Delivery SystemK011080; cleared 10/11/2001
PerformanceStandards	Performance standards have not been established by the FDA under section514 of the Federal, Food, Drug and Cosmetic Act
Device Description	The subject device is a system consisting of a single-lumen, tubular, self-expanding nickel-titanium ("nitinol") stent pre-loaded onto a sheatheddelivery catheter. The delivery system is designed to deliver the stent tothe stricture site via transhepatic access. Once positioned at the stricturesite, the sheath is withdrawn and the stent is released. Upon release, thestent expands and conforms to the inner lumen of the biliary duct. Thedevice has two radiopaque markers to aid in stent placement duringfluoroscopy.
Indications for Use	The Bridge SE Biliary Self-Expanding Stent Delivery System isindicated for use in the palliation of malignant neoplasm in the biliarytree.
TechnologicalCharacteristics	The Bridge SE Biliary Self-Expanding Stent Delivery System ("BridgeSE") is substantially equivalent to the currently marketed Bridge SEBiliary Self-Expanding Stent Delivery System. The subject and predicatestents are technologically similar and are intended for palliation ofmalignant neoplasms in the biliary tree. The subject and predicate stentsare constructed of biocompatible materials. The subject and predicatestents are delivered percutaneously via sheathed delivery systems. Thesubject device offers additional stent sizes and a longer catheter length.The subject and predicate stents are comparable and are intended to meetclinical needs. The difference between the subject and predicate devicesare minor and are not relevant to the ability of the subject device topalliate malignant neoplasms in the biliary tree.
NonclinicalPerformance	Preclinical testing was conducted to confirm the safe and effectiveperformance of the Bridge SE Biliary Self-Expanding Stent DeliverySystem as well as the biocompatibility of the device.
Sterilization	The Bridge SE Biliary Self-Expanding Stent Delivery System is providedsterile. The device is not intended for reuse or resterilization.
Conclusion	The Bridge SE Biliary Self-Expanding Stent Delivery System issubstantially equivalent to the currently cleared and marketed device andmeets the clinical needs of the physicians.

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510(k) Summary for the Bridge SE Biliary Self-Expanding Stent Delivery System

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2002

Mr. Kevin Drisko Regulatory Affairs Manager Medtronic AVE, Inc. Medtronic Peripheral Technologies 2170-A Northpoint Parkway Santa Rosa, California 95407

Re: K014205

Trade/Device Name: Medtronic AVE Bridge SE Biliary Self-Expanding Stent Delivery System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: December 20, 2001 Received: December 21, 2001

Dear Mr. Drisko:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for use in the vascular system have not been established.

Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

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Page 2 – Mr. Kevin Drisko

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.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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,

Bernard E. Statland, M.D., Ph.D.

Bernard E tatland, M.D., Ph.D Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K014205

Device Name: Medtronic AVE Bridge SE Biliary Self-Expanding Stent Delivery System

FDA's Statement of the Indications For Use for device:

The Medtronic AVE Bridge SE Biliary Self-Expanding Stent Delivery System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Prescription Use \✓ OR Over-The-Counter Use _
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number: K014205

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.