The Bard® E+LUMINEXX™ Biliary Stent is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding nitinol E▪LUMINEXX™ Stent preloaded on a flexible, multifunctional stent deployment system, the BARD S.A.F.E.TM Delivery System with the PerforMAXX™ Grip. It is preloaded into the delivery system and is available in two delivery system lengths, and various device diameters and lengths.

AI/ML Overview

The Bard® E•LUMINEXX™ Biliary Stent is a modified version of the predicate LUMINEXX® 3 Biliary Stent. The modification is an electropolished surface finish, which is claimed to result in an improved surface finish, smoother edges, and improved corrosion resistance. The study conducted to demonstrate the device meets acceptance criteria is a non-clinical performance data verification and validation study.

Here's the breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria for device performance. Instead, it states a general conclusion:

Acceptance Criteria (Implicit)	Reported Device Performance
Conformance to or evaluated based on FDA guidance: "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents, February 5, 1998."	"All test results confirm the modified device to be substantially equivalent to the predicate device."
Predetermined performance criteria of design verification and validation as specified by applicable standards, guidance, test protocols, and/or customer inputs.	"The Bard® E-LUMINEXX™ Biliary Stent met all the predetermined performance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." "Bard® E-LUMINEXX™ Biliary Stent is substantially equivalent to the legally marketed predicate device, the Bard® LUMINEXX® 3 Biliary Stent."

The acceptance criteria are generally framed around demonstrating substantial equivalence to the predicate device through non-clinical performance testing.

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

The document describes non-clinical performance data verification and validation. This indicates laboratory testing, not human subject testing. Therefore, there is no "test set" in the context of patient data, no country of origin for such data, and it is not retrospective or prospective patient data. The sample size would refer to the number of devices or components tested in the laboratory during design verification and validation, which is not specified in the provided text.

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

This question is not applicable. Ground truth, in the context of medical devices, usually refers to clinical outcomes or definitive diagnostic standards. Since the study was non-clinical performance testing, there were no experts establishing ground truth for a clinical test set.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, neither of which are described here for a non-clinical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical performance verification and validation study comparing the modified device to its predicate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical biliary stent, not a software algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" would be established by engineering specifications, industry standards, and the performance characteristics of the predicate device. The tests were designed to confirm that the modified device's performance aligns with these established benchmarks for safety and effectiveness.

8. The Sample Size for the Training Set

This question is not applicable. There is no training set in the context of machine learning algorithms for this physical medical device. If "training set" refers to samples used during the development of the stent or its manufacturing process, that information is not provided.

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

This question is not applicable for the same reasons as #8.

Summary

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K06 3532

Page 122

Bard® E•LUMINEXX™ Biliary Stent

510(k) Summary of Safety and Effectiveness

MAY 3 0 2008

21 CFR 807.92(a).

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (1)(3)(A) of the Food, Drug, and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based as follows:

General Information:

Submitter Name:Address:	Bard Peripheral Vascular, Inc.1625 W. Third StreetP.O. BOX 1740Tempe, AZ 85280-1740
Telephone Number:Fax Number:	(480) 894-9515(480) 449-2546
Contact Person:	Lindsay K. PackRegulatory Affairs Specialist
Device Information:
Device Trade Name:	E•LUMINEXX™ Biliary Stent

Device Trade Name:	E•LUMINEXXTM Biliary Stent
Common/Usual Name:	Biliary Stent
Classification:	Class II
Classification Panel:	Gastroenterology/Urology Devices Panel

Predicate Device:

LUMINEXX® 3 Biliary Stent (K033497 on February 4, 2004)

Summary of Change:

The modification to the E.J.UMINEXX™ Biliary Stent is an electropolished surface finish. These changes result in a subject device that has an improved surface finish, smoother edges, and improved corrosion resistance. All other aspects of the subject device remain the same as the predicate device.

Device Description:

The Bard® E+LUMINEXX™ Biliary Stent is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the

Image /page/0/Picture/19 description: The image shows the word "BARD" in a bold, outlined font. Each letter is capitalized and has a distinct, blocky design. The letters are evenly spaced and aligned horizontally, creating a clear and legible presentation of the word.

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self-expanding nitinol E▪LUMINEXX™ Stent preloaded on a flexible, multifunctional stent deployment system, the BARD S.A.F.E.TM Delivery System with the PerforMAXX™ Grip. It is preloaded into the delivery system and is available in two delivery system lengths, and various device diameters and lengths.

Intended Use of Device:

The Bard® E• LUMINEXX™ Biliary Stent is intended for palliation of malignant strictures in the biliary tree.

Technological Comparison to Predicate Device:

The technological characteristics of E·LUMINEXX™ Biliary Stent are substantially equivalent to those of the predicate LUMINEXX® 3 Biliary Stent in terms of intended use, application, patient population, basic design, performance, contraindications, materials, and sterilization method.

Non-Clinical Performance Data:

Design verification and validation of the modified device was done with conformance to or evaluated based on the following FDA quidance:

Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents, February 5, 1998.

All test results confirm the modified device to be substantially equivalent to the predicate device.

Conclusions:

The Bard® E-LUMINEXX™ Biliary Stent met all the predetermined performance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. Bard® E-LUMINEXX™ Biliary Stent is substantially equivalent to the legally marketed predicate device, the Bard® LUMINEXX® 3 Biliary Stent.

Image /page/1/Picture/15 description: The image shows the word "BARD" in a bold, outlined font. Each letter is capitalized and has a distinct, blocky design. The letters are closely spaced, creating a compact and unified appearance.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of a bird with three wing-like shapes, and the bird is facing to the right. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lindsay Pack Senior Regulatory Affairs Specialist Bard Peripheral Vascular, Inc. 1625 West 3td Street P.O. Box 1740 TEMPE ARIZONA 85280-1740

MAY 3 0 2008

Re: K063532

Trade/Device Name: Bard® E.LUMINEXX® Biliary Stent Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: March 4, 2008 Received: March 6, 2008

Dear Ms. Pack:

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 – Ms. Lindsay Pack

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.

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 described above is added to your labeling.

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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ashley B. Boan

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K063532

Device Name: Bard® E•LUMINEXX® Biliary Stem

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

The proposed device is indicated for the treatment of biliary strictures resulting from malignant neoplasms.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helu Leun

Division of Reproductive, Abdominal and
Radiological Devices

510(k) Number	K06 3532
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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.