The Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

Device Description

The Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is a stenting system designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard® LUMINEXX™ Biliary Stent pre-loaded on a unique delivery system. This 6 Fr delivery system is compatible with a 6 Fr introducer and accepts a .035" guidewire. The stent is available in various diameters and lengths. The delivery system is available in lengths of 80cm and 135cm.

AI/ML Overview

Here's an analysis of the provided text regarding the Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System, focusing on acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Maintain patency of biliary ducts obstructed by malignant neoplasms (Intended Use)	Indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.
Functionality comparable to predicate device	Bench data indicates comparability to the predicate device.
Compatibility with 6 Fr introducer	Compatible with a 6 Fr introducer
Accepts a .035" guidewire	Accepts a .035" guidewire
Self-expanding mechanism	Stent is self-expanding
Radiopacity	Tantalum discs on each end of the stent provide enhanced radiopacity

Note: The document provided is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It does not explicitly state numerical acceptance criteria (e.g., "stent patency rate of X%"). Instead, the "acceptance criteria" are inferred from the intended use and the comparison to the predicate device. The primary performance claim is comparability to the predicate device through "bench data."

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

Sample Size: Not specified. The document only mentions "Bench data." This typically implies laboratory testing on a non-clinical sample, not patient data.
Data Provenance: Not specified. Given it's "bench data," there isn't a country of origin in the clinical sense. It's retrospective in the sense that the testing has already occurred.

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

This information is not provided. "Bench data" refers to laboratory or mechanical testing, which does not typically involve experts establishing a ground truth in the same way clinical studies do (e.g., radiologists reviewing images). The comparability assessment would likely be done by engineers or technicians.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for subjective assessments like image interpretation. "Bench data" would involve objective measurements and comparisons, not adjudication by multiple readers.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states "Bench data indicate that the Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is comparable to the predicate device." This refers to non-clinical, laboratory testing, not a clinical study involving human readers or patient outcomes, especially not one evaluating the improvement of human readers with AI assistance (as this is an actual physical stent, not an AI diagnostic tool).

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

Not applicable. This device is a physical medical implant (a stent), not an AI algorithm or diagnostic tool. Therefore, a standalone performance study in the context of AI is irrelevant.

7. Type of Ground Truth Used

The "ground truth" for the bench data would likely be established physical properties and performance metrics of the predicate device, against which the new device's performance was measured. This could include:
- Radial force
- Flexibility
- Migration resistance
- Deployment accuracy
- Radiopacity measurements
- Material properties (e.g., tensile strength, fatigue life)
This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. Sample Size for the Training Set

Not applicable. This device is a stent, not an AI model that requires a training set.

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

Not applicable. As above, no training set is relevant for this type of device.

Summary

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1020682

Bard Peripheral Technologies C.R. Bard, Inc. 13183 Harland Dr., N.E. Covington, GA 30014

APR 02 2002

510(k) SUMMARY OF SAFETY AND EFFECTIVENES INFORMATION

Submitter Information: A.
C.R. Bard, Inc., Peripheral Technologies Division Submitter's Name: Submitter's Address: 13183 Harland Drive, Covington, GA 30014 Carol Vierling Contact Person: Contact Person's Telephone Number: (770) 385-2347 Contact Person's FAX Number: (770) 385-2340 Date of Preparation: February 28, 2002
B. Device Name:
Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System
C. Predicate Devices:
Bard® LUMINEXX™ Biliary Stent and Delivery System
D. Device Description:
The Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is a stenting system designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard® LUMINEXX™ Biliary Stent pre-loaded on a unique delivery system. This 6 Fr delivery system is compatible with a 6 Fr introducer and accepts a .035" guidewire. The stent is available in various diameters and lengths. The delivery system is available in lengths of 80cm and 135cm.

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E. Intended Use:

The Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

Technological Characteristics Summary: F.

The Bard® LUMINEXX™ 6 Fr Biliary Stent is a metal mesh stent constructed of nitinol. Tantalum discs on each end of the stent provide enhanced radiopacity. The stent is self-expanding and is packaged pre-mounted on a disposable delivery system.

G. Performance Data:

Bench data indicate that the Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is comparable to the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol Vierling Director. Regulatory Affairs C.R. Bard, Inc. 13183 Harland Drive, N.E. Covington, Georgia 30014

APR 0 2 2002

Re: K020682

Trade/Device Name: Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: February 28, 2002 Received: March 4, 2002

Dear Ms. Vierling:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. Carol Vierling

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. Statland, 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): K020682

Device Name: Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System

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

The Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is indicated for use in The Burde Lonni ary strictures resulting from malignant neoplasms.

Prescription Use V OR (Per 21 CFR 801.109)

文章 1.4 At 14 - 1 - 1 - 1 - 1 - 1 - Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

	Nancy C. Brogdon
Division Sign-On
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K020682

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.