The FLUENCY® Plus Tracheobronchial Stent Graft is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures after all alternative therapies have been exhausted.
The FLUENCY® Plus Tracheobronchial Stent Graft is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Device Description

The FLUENCY® Plus Tracheobronchial Stent Graft includes a self-expanding Nitinol stent encapsulated with carbon-impregnated ePTFE pre-loaded on a flexible "pull-back" delivery system. It is a single use prosthetic device designed to maintain the patency of the tracheobronchial tree in patients with tracheobronchial strictures. Highly radiopaque tantalum markers on the stent graft ends facilitate stent graft placement. The FLUENCY® Plus Tracheobronchial Stent Graft is available in various lengths and diameters. It is preloaded into various size delivery catheters, depending on the size of the stent graft and is available in various delivery system lengths.

AI/ML Overview

The acceptance criteria for the FLUENCY® Plus Tracheobronchial Stent Graft are described and the study that proves the device meets them is detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not specify numerical acceptance criteria for the device's performance. Instead, it states that the device was evaluated based on the "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses. April 28, 1998." and that "All test results confirm the modified device to be substantially equivalent to the predicate device." The "Conclusions" section reiterates that "The FLUENCY® Plus Tracheobronchial Stent Graft met all the predetermined performance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

The primary changes described for the FLUENCY® Plus are:

Modification of the inner catheter tip.
Modification to the outer catheter material and configuration.

The reported device performance improvements due to these changes are:

Reduced deployment force.
Reduced risk of tip entanglement during withdrawal of the delivery system.
More precise stent graft placement during deployment.
More delivery system length options for physicians.

The document assesses substantial equivalence, meaning the new device performs at least as well as the predicate device (FLUENCY® Tracheobronchial Stent Graft (K031041)) in terms of safety and effectiveness, based on non-clinical data.

Based on the provided text, a direct table of acceptance criteria with specific numerical values for performance metrics cannot be generated as these are not explicitly stated. The acceptance criteria are implicitly defined by conformance to the specified FDA guidance and the demonstration of substantial equivalence to the predicate device in terms of design verification and validation.

Implied Acceptance Criteria and Reported Performance:

Acceptance Criteria Category	Specific Criteria (Implicitly from Guidance & Equivalence)	Reported Device Performance
Mechanical Performance	Reduced deployment force compared to predicate device.	Achieved reduced deployment force.
	Reduced risk of tip entanglement during withdrawal.	Achieved reduced risk of tip entanglement.
Deployment Accuracy	More precise stent graft placement.	Achieved more precise placement.
Delivery System Options	Availability of more delivery system length options.	Achieved more delivery system length options.
Biocompatibility	Maintained biocompatibility (same as predicate).	Maintained substantial equivalence in material aspects.
Sterilization	Maintained sterilization method (same as predicate).	Maintained substantial equivalence in sterilization.
Overall Equivalence	Substantial equivalence to predicate device in safety and effectiveness.	Met all predetermined performance criteria and is substantially equivalent.

2. Sample Size for the Test Set and Data Provenance

The document describes non-clinical performance data which involved design verification and validation. It does not refer to a "test set" in the context of patient data or clinical images. The data provenance is from non-clinical laboratory testing conducted by the manufacturer, Bard Peripheral Vascular, Inc., in the USA (Tempe, AZ). The studies are retrospective in the sense that they are laboratory tests performed on the device prototypes and not prospective clinical trials.

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

This information is not applicable as the studies described are non-clinical (laboratory testing) and do not involve human-interpreted test sets. No expert-established ground truth related to clinical outcomes or image interpretation is mentioned.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are non-clinical and do not involve a test set requiring adjudication by experts.

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

An MRMC study was not performed, or at least not described in the provided documentation. The submission focuses on non-clinical performance and substantial equivalence based on engineering and material changes.

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

This question is not applicable as the device is a physical medical implant (stent graft) with a delivery system, not an algorithm or AI-based system.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical performance studies would be based on engineering specifications, material properties, and physical measurements obtained during design verification and validation tests. These tests are implicitly assessing the device's conformance to its design intent and performance characteristics relative to the predicate device and relevant standards/guidance.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical medical implant and not an AI/algorithm-based system that requires a training set. The "training" for such a device would be its iterative design, prototyping, and testing phases.

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

This information is not applicable as the device is a physical medical implant and not an AI/algorithm-based system.

Summary

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K050832 pg. lot 3

JUL - 7 2005

ecial 510(k) LUENCY® Plus Tracheobronchial Stent Graft

Page 78

FLUENCY® Plus Tracheobronchial Stent Graft 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: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:	Dennis Salzmann, Ph.D.Regulatory Affairs Technical Manager

Device Information:

Device Trade Name:	FLUENCY® Plus Tracheobronchial Stent Graft
Common/Usual Name:	Tracheal Prosthesis
Classification:	Class II with Special Controls

The special controls for this device are compliant with FDA Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses. April 28, 1998.

Classification Panel: General & Plastic Surgery

Predicate Device:

FLUENCY® Tracheobronchial Stent Graft (K031041, cleared June 19, 2003)

Summary of Change:

The design modifications to the FLUENCY® Tracheobronchial Stent Graft are modification of the inner catheter tip, and modification to the outer catheter material and configuration. These changes result in a subject device that has a reduced deployment force, reduced risk of tip entanglement during withdrawal of the delivery system, allows

Bard Peripheral Vascular, Inc

TRADE SECRET/CONFIDENTIAL INFORMATIC Notify CR Bard Before Releasing this Docume

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K050832 pg 2 of 3

for more precise stent graft placement during deployment, and provides more delivery system length options for physicians. All other aspects of the subject device remain the same as the predicate device.

Device Description:

Intended Use of Device:

Technological Comparison to Predicate Device:

The technological characteristics of FLUENCY® Plus Tracheobronchial Stent Graft are substantially equivalent to those of the predicate FLUENCY® Tracheobronchial Stent Graft in terms of intended use, application, user population, basic design, performance, labeling, packaging, 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:

Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses. April 28, 1998.

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K050832 pg 3 of 3

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

Conclusions:

The FLUENCY® Plus Tracheobronchial Stent Graft met all the predetermined performance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The FLUENCY® Plus Tracheobronchial Stent Graft is substantially equivalent to the legally marketed predicate device, the FLUENCY® Trachobronchial Stent Graft.

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JAN 1 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bard Peripheral Vascular, Inc. % Mr. Joshua Smale Regulatory Affairs Specialist 1625 West 3rd Street P.O. Box 1740 Tempe, Arizona 85280

Re: K050832

Trade/Device Name: FLUENCY® Plus Tracheobronchial Stent Graft Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: June 6, 2005 Received: June 7, 2005

Dear Mr. Smale:

This letter corrects our substantially equivalent letter of July 7, 2005.

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 (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, listing 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

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Page 2 - Mr. Joshua Smale

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.

This letter will allow you to continue marketing your device as described in your Section 510(k) I mis letter will and in your he FDA finding of substantial equivalence of your device to a legally promatics noticate 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 If you a the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html

Sincerely yours,

Kio
Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K050832

Device Name: FLUENCY® Plus Tracheobronchial Stent Graft

Indications for Use:

The FLUENCY® Plus Tracheobronchial Stent Graft is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Prescription Use X (Part21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21CFR 801 Subpart C)

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

Concurrence of CORH, Office of Device Evaluation (ODE)

Signature

100-01 Division of General, Restorative, and Neurological Devices

310(k) Number /<050f32

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Regulation Number and Section

§ 878.3720 Tracheal prosthesis.

(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”