The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is intended for palliation of malignant strictures in the biliary tree.
The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is indicated for the treatment of biliary strictures resulting from malignant neoplasms.

Device Description

The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Nitino! CONFORMEXX™ Stent preloaded on a flexible, multifunctional stent deployment system, the BARD S.A.F.E. ™ 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 provided document does not report any acceptance criteria or a study that proves the device meets specific acceptance criteria in the typical format of a clinical study or performance testing with quantitative metrics.

Instead, the document is a 510(k) summary for the CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than proving novel performance against predefined acceptance criteria.

Here's an breakdown of why the requested information cannot be fully provided from this document and what is stated:

Overall Summary:
The document asserts that the modified device (CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip) is substantially equivalent to its predicate device (CONFORMEXX™ Biliary Stent and Delivery System, K021994). This equivalence is based on the intended use, application, user population, basic design, performance, labeling, and sterilization method. The changes made (addition of the PerforMAXX™ Grip, an additional delivery system length, and modified packaging) are presented as not significantly altering the safety or effectiveness.

Key takeaway regarding "acceptance criteria" and "study":
The "acceptance criteria" in this context refer to the predetermined performance criteria of design verification and validation as specified by applicable standards, guidance documents (specifically, "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents, February 5, 1998"), test protocols, and customer inputs. The "study" mentioned is the non-clinical performance data (design verification and validation testing) which "confirm the modified device to be substantially equivalent to the predicate devices." No specific quantitative metrics or results from these tests are provided in this summary.

Here's an attempt to answer your questions based only on the provided text, highlighting where information is absent:

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

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to FDA Guidance for Metal Expandable Biliary Stents	Design verification and validation was done with conformance to or evaluated based on "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents, February 5, 1998."
Substantial Equivalence to Predicate Device (Bard® CONFORMEXX™ Biliary Stent and Delivery System, K021994) in terms of:	"All test results confirm the modified device to be substantially equivalent to the predicate devices." The device "met all the predetermined performance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." The device "is substantially equivalent to the legally marketed predicate device, the Bard® CONFORMEXX™ Biliary Stent and Delivery System."
- Intended Use	The technological characteristics are "substantially equivalent ... in terms of intended use."
- Application	The technological characteristics are "substantially equivalent ... in terms of application."
- User Population	The technological characteristics are "substantially equivalent ... in terms of user population."
- Basic Design	The technological characteristics are "substantially equivalent ... in terms of basic design." (Note: this refers to other aspects that remained the same, despite the stated changes like the PerforMAXX™ Grip, new delivery system length, and packaging modification.)
- Performance	The technological characteristics are "substantially equivalent ... in terms of performance."
- Labeling	The technological characteristics are "substantially equivalent ... in terms of labeling."
- Sterilization Method	The technological characteristics are "substantially equivalent ... in terms of sterilization method."

Information Not Found in the Provided Text:

Sample size used for the test set and the data provenance: This information is not provided. The document only mentions "non-clinical performance data" and "design verification and validation," which typically involve bench testing, but no details on sample sizes or data origin are given.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided. This is not a clinical study involving expert assessment of images or patient conditions.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or 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 medical imaging AI device, but a physical medical device (biliary stent).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the traditional sense. For a physical device like a stent, "ground truth" would be related to engineering specifications and functional performance (e.g., patency, deployment force, material integrity) against accepted standards. The document states "applicable standards, guidance, test protocols and/or customer inputs" were used to define performance criteria.
The sample size for the training set: Not applicable. This is not a machine learning or AI device.
How the ground truth for the training set was established: Not applicable.

Summary

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K052114
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Page 90

CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a).

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(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:	Bard Peripheral Vascular, Inc.
Address:	1625 W. Third StreetP.O. BOX 1740Tempe, AZ 85280-1740
Telephone Number:	(480) 894-9515
Fax Number:	(480) 449-2546
Contact Person:	Dennis Salzmann, Ph.D.Manager, Regulatory Affairs
Device Information:
Device Trade Name:	CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip

Common/Usual Name: Biliary Stent Class II Classification:

Classification Panel: Gastroenterology/Urology

Predicate Device:

CONFORMEXX™ Biliary Stent and Delivery System (K021994, cleared January 2, 2003)

Summary of Change:

The design modifications to the CONFORMEXX™ Biliary Stent and Delivery System are addition of the PerforMAXX™ Grip, an additional delivery system length, and modification of the packaging. These changes result in a subject device that provides more deployment methods and delivery system length options for physicians. All other aspects of the subject device remain the same as the predicate devices.

Image /page/0/Picture/14 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and prominent appearance. The font style is consistent throughout the word, creating a unified and recognizable logo or brand name.

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Device Description:

Intended Use of Device:

The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXXT™ Grip is intended for palliation of malignant strictures in the biliary tree.

Technological Comparison to Predicate Device:

The technological characteristics of the Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip are substantially equivalent to those of the predicate Bard® CONFORMEXX™ Biliary Stent and Delivery System in terms of intended use, application, user population, basic design, performance, labeling, 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 guidance document:

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 devices.

Image /page/1/Picture/15 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be outlined in black. The letter "A" is stylized with a horizontal line through the middle, resembling the Greek letter lambda.

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Conclusions:

The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip met all the predetermined performance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is substantially equivalent to the legally marketed predicate device, the Bard® CONFORMEXX™ Biliary Stent and Delivery System.

TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.

Image /page/2/Picture/7 description: The image shows the word "BARD" in a bold, outlined font. The letters are all capitalized and evenly spaced. The font is simple and geometric, with straight lines and sharp angles. The outline gives the word a three-dimensional effect.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2005

Dennis Salzmann, Ph.D. Manager, Regulatory Affairs Bard Peripheral Vascular, Inc. 1625 W. Third Street P.O. Box 1740 TEMPE AZ 85280-1740

Re: K052114 Trade/Device Name: Bard® CONFORMEXXTM Biliary Stent with the PerforMAXXTM Grip Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: August 2, 2005 Received: August 4, 2005

Dear Dr. Salzmann:

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 for use stated in the Merces, 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 and Cosmette Her (1 to) (1 to) provisions of the 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 The Office 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 - Dennis Salzmann, Ph.D.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Please note that the above labeling innitations 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 I he FDA iniding of substantial equirales is your device and permits your device to proceed to the device results in a classification for your device as described in your Section market. This letter will anow you to evigation 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), if your device is classified ($cc above) into enas regulations affecting your device can be If may be subject to additional controls. Linking majors 800 to 898. In addition, FDA may found in the Code of reactive concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dris Issualloo or our device complies with other requirements of the Act that FDA has made a decermination administered by other Federal agencies. You must of any Federal Statutes and regulations daminitives but not limited to: registration and listing (21 comply with an the Act 3 requirements, merces and manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific information about the application of other labeling requirements to your II you desire specific information accuracy as a compliance at (240) 276-0115. Also,
device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Al device (21 CFR Part 001); picuse containg by reference to premarket notification" (21) please note the regulation onlined, "Miorraneans of formation on your responsibilities under the CFK Fall 807.77). Pourmay South other gener gener gener Assistance at its Act from the Dryiblem (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

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

Enclosure

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Indications for Use

510(k) Number (if known): K052114

Device Name: Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip

Indications For Use:

The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is indicated The Bard® CONFORETER
for the treatment of biliary strictures resulting from malignant neoplasms.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive

$10(k) Number K052114

Page 1 of _1

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.