The PROTÉGÉ® EverFlex™ Self-Expanding Biliary Stent System is a self-expanding nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (nitinol) and comes pre-mounted on a 6F, 0.035" overthe-wire delivery system. The stent is cut from a nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Protégé® EverFlex™ Self-Expanding Biliary Stent System, focusing on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, the device's acceptance criteria and performance are primarily established through substantial equivalence to predicate devices rather than explicit, quantitative acceptance criteria for clinical outcomes or device functionality. The summary describes general performance categories rather than specific metrics with defined pass/fail points.

Acceptance Criteria Category	Reported Device Performance (Summary of Testing)
Biocompatibility	Assessed and tested in accordance with ISO 10993 Part 1, "Biological Evaluation of Medical Devices," 1997(E) and FDA Memorandum #G95-1, "Biological Evaluation of Medical Devices." (Implies satisfactory results to meet these standards)
Performance Characteristics (Bench Testing)	Bench testing pertaining to performance characteristics was conducted on the 5mm Protégé EverFlex Self-Expanding Biliary Stent System and compared to predicate device testing to demonstrate equivalency. (Implies the device performed similarly to predicates in bench tests.)
Substantial Equivalence	Stated as substantially equivalent to the Protégé® EverFlex Self-Expanding Biliary Stent System (K060057) and other listed predicate devices (Bard® LUMINEXX™, Abbott Xpert™, Abbott DYNALNK™). This is the overarching "acceptance criterion" for regulatory approval by the FDA.

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

Sample Size for Test Set: Not explicitly stated in the provided document. The summary focuses on bench testing rather than human clinical trials. For bench tests, "sample size" would refer to the number of stents or components tested. This information is not detailed.
Data Provenance: The data provenance is from bench testing. The document does not specify the country of origin of this testing data. It is retrospective in the sense that it likely compares the new device's bench test results to existing data from predicate devices. There is no mention of prospective clinical trial data.

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

Not applicable. The "ground truth" for this submission is based on engineering specifications, material science, and performance measurements from bench testing, and comparison to predicate devices, not on expert consensus from clinical image interpretation or patient outcomes directly relevant to establishing "ground truth" for a test set in the conventional sense (e.g., for an AI device).

4. Adjudication Method for the Test Set

Not applicable. There's no mention of a human test set requiring adjudication. The assessment is based on physical and mechanical properties measured during bench testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (stent), not a diagnostic AI algorithm. The study described is focused on physical and mechanical performance and comparison to predicate devices for regulatory substantial equivalence.

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

Not applicable. The Protégé® EverFlex™ Self-Expanding Biliary Stent System is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

Engineering specifications and standards: Compliance with ISO 10993 Part 1 for biocompatibility.
Bench test results: Measured physical and mechanical performance characteristics of the stent (e.g., expansion force, fatigue resistance, radiopacity, etc., though specific details are not provided).
Predicate device data: The performance of the new device is compared to the established performance of legally marketed predicate devices to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary

{0}------------------------------------------------

510(k) Summary Protégé® EverFlex™ Self-Expanding Biliary Stent System

MAR 1 8 2008

510(k) Number: Y072301

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 8807.92.

Submitter/Contact Person:
Applicant(Manufacturer)	ev34600 Nathan Lane NorthPlymouth, MN 55442Tel: (763) 398-7000Fax: (763) 398-7200
Submitter's Name:	ev39600 Nathan Lane NorthPlymouth, MN 55442Tel: (763) 398-7000Fax: (763) 398-7200
Official Contact:	Bruce BacklundSr. Regulatory Affairs Specialistev34600 Nathan Lane NorthPlymouth, MN 55442Tel: (763) 398-7612Fax: (763) 398-7200bbacklund@ev3.net
Summary Preparation Date:	August 15, 2007
Device Name and Classification:
Trade Name:	Protégé® EverFlex™
	Self-Expanding Biliary Stent System
Common Name/Usual Name:	Biliary Stent
Classification Name:	Biliary Catheter
Class:	Class II, 21 CFR 876.5010

Predicate Devices:

Protégé® EverFlex™ Self-Expanding Biliary Stent System (K060057)

Abbott Xpert™ Self-Expanding Transhepatic Biliary Stent System (K033537)

{1}------------------------------------------------

Bard® LUMINEXX™ Biliary Stent System (K003793)

Boston Scientific Sentinol TM (K032025)

DYNALINK™ Biliary Self-Expanding Stent System (K002143)

This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission.

Device Description:

Summary of Testing:

Biocompatibility: Biocompatibility was assessed and tested in accordance with ISO 10993 Part 1, "Biological Evaluation of Medical Devices," 1997(E) and FDA Memorandum #G95-1, "Biological Evaluation of Medical Devices".

Performance Data: Bench testing pertaining to performance characteristics was conducted on the 5mm Protégé EverFlex Self-Expanding Biliary Stent System and compared to the predicate device testing to demonstrate equivalency.

Statement of Equivalence:

The 5mm Protégé EverFlex Self-Expanding Biliary Stent System is substantially equivalent to the Protégé® EverFlex "Self-Expanding Biliary Stent System (K060057). Bard® LUMINEXX™ Biliary Stent System (K003793), Abbott Xpert™ Self-Expanding Transhepatic Biliary Stent System (K033537) and Abbott DYNALNK™ Biliary Self-Expanding Stent System (K002143)

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

MAR 1 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

David Worrell, MS, RAC Director, Regulatory Affairs ev36 Inc. 9600 54th Avenue North PLYMOUTH MN 55442-2111

Re: K072301

Trade/Device Name: Protégé® EverFlex™ Self-Expanding Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: December 14, 2007 Received: December 17, 2007

Dear Mr. Worrell:

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.

{3}------------------------------------------------

Page 2 - Mr. David Worrell

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 described above is added to your labeling.

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), 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K0723d/

Device Name: Protégé® EverFlex™ Self-Expanding Biliary Stent System

Indications for Use:

The Protégé® EverFlex™ Self-Expanding Biliary Stent System

: 上一篇:

is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Prescription Use(Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
-------------------------------------------------	---	--------	------------------------------------------------	--

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Page 1 of 1
Division Sign-off
Division of Abdominal,
510(k) Number	K072301

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.