The AVE Bridge™ Stent System is intended for use in patients to maintain patency of a biliary duct which is occluded by tumor. The AVE Bridge™ Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant tumors. This device is not intended for intravascular use.

Device Description

The AVE Bridge™ Stent System consists of a balloon-expandable intraluminal stent premounted onto the balloon of an over-the-wire delivery catherer. The AVE Bridge™ Stent System has two radiopaque platinum markers imbedded in the inner shaft (at each end of the stent) to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035" guidewires and has a useable length of 75 cm to 90 cm. The AVE Bridge™ Stent System is provided enclosed in a sterile package.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AVE Bridge™ Stent System, focusing on demonstrating substantial equivalence to a predicate device, the PALMAZ™ Balloon-Expandable Stent. The document details performance testing conducted to support this claim, rather than establishing new acceptance criteria or proving the device meets those criteria in a de novo fashion.

Here's an analysis of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria in terms of specific thresholds for the AVE Bridge™ Stent. Instead, the "acceptance criteria" for the studies were to demonstrate substantial equivalence to the predicate device (PALMAZ™ Balloon-Expandable Stent). The reported device performance is presented as a comparison to this predicate.

Study Title	Acceptance Criteria (Implicit)	Reported Device Performance
AVE Bridge™ Stent vs JJIS Palmaz™ Balloon-Expandable Stent - Balloon Performance Study	Demonstrate substantial equivalence in minimum burst pressure and deflation times compared to PALMAZ™ Balloon.	"The test proved substantial equivalence."
AVE Bridge™ Stent vs JJIS Palmaz™ Balloon-Expandable Stent - Two Plane Crush Strength Study	Demonstrate substantial equivalence in radial strength (force to crush to 50% deployed diameter) compared to PALMAZ™ Balloon.	"The test proved substantial equivalence."
AVE Bridge™ Stent Dimensional Verification and Stent Uniformity at Nominal Deployment	Meet specified diameter and length after deployment.	"The results conclude that the stents tested meet the labeled specifications for stent diameter and stent length."

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

The document does not specify the sample sizes used for any of the non-clinical performance tests (Balloon Performance, Two Plane Crush Strength, Dimensional Verification).
The data provenance is industrial testing conducted by Arterial Vascular Engineering, Inc. and is retrospective to the submission date. There is no mention of country of origin for data; it's implied to be from the manufacturer's testing in the USA.

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

This information is not provided in the document. The studies are non-clinical, mechanical performance tests, not studies requiring expert interpretation or ground truth establishment in the medical sense (e.g., diagnosis from imaging).

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided, as the tests are non-clinical mechanical performance tests, not clinical studies requiring adjudication of outcomes or interpretations.

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

This information is not applicable and therefore not provided. The submission is for a medical device (stent) based on non-clinical performance testing for substantial equivalence, not an AI or imaging diagnostic device that would typically involve MRMC studies.

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

This information is not applicable and therefore not provided. The AVE Bridge™ Stent System is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

For the Balloon Performance Study and Two Plane Crush Strength Study, the "ground truth" was essentially the performance of the predicate device (PALMAZ™ Balloon-Expandable Stent), against which the AVE Bridge™ Stent was compared for substantial equivalence in mechanical properties.
For the Dimensional Verification and Stent Uniformity at Nominal Deployment study, the "ground truth" was the labeled specifications for stent diameter and stent length.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. As noted, this is a physical medical device, not an AI model, and therefore does not have a "training set" in the context of machine learning. The non-clinical performance studies are akin to validation/test sets for mechanical properties.

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

This information is not applicable and therefore not provided, as there is no "training set" in this context.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Arterial Vascular Engineering (AVE). The logo features the letters "AVE" in a bold, stylized font, with the "E" having a swooping extension. Below the letters, the full name "Arterial Vascular Engineering" is written in a smaller, sans-serif font.

NOV - 5 1997

K971295

AVE Bridge™ Stent System

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is bcing submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

GENERAL INFORMATION

Applicant:

Date:	2 April, 1997
Name:	Arterial Vascular Engineering, Incorporated
Address:	3576 Unocal PlaceSanta Rosa, CA 95403
Contact:	Joseph Tamayo
Phone Number:	(707) 525-0111
FAX Number:	(707) 525-0114

Trade Namc:

Device Name:	AVE Bridge™ Stent System
Model Numbers:	TBD
Classification Name:	Catheter, Biliary and accessories

Section 513 Device Classification:

Classification	Class II
Classification Panel:	78FGE

Arterial Vascular Engineoring, incorporated
AVC Dridge™- Эtен: Зуэсит - Premarket Notification КУ/1295
Additional Information Requested

3 November, 1997 Page 3 of 7

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EQUIVALENCE

Arterial Vascular Engineering, Incorporated, claims substantial equivalence to the Johnson & Johnson Interventional Systems' PALMAZ™ Balloon-Expandable Stent.

INTENDED USE

The Arterial Vascular Engineering, Incorporated (AVE) Bridge™ Stent System is intended for use in patients to maintain patency of a biliary duct which is occluded by tumor .

The AVE Bridge™ Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant rumors.

This device is not intended for intravascular use.

DEVICE DESCRIPTION

Size Range:

Diameters - 6.0 mm to 10.0 mm Lengths - 16 mm to 40 mm

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Comparison to Predicate Device:

Per 807,92(a)(6). the SIU(k) sununary of the technological characteristics of your device compared to the predicate device.

CharacteristicCompared	AVE Bridge™ Stent System	PALMAZ™ Balloon-ExpandableStent
Intended Use:	The AVE Bridge™ Stent System isintended for use in patients to maintainpatency of a biliary duct which isoccluded by tumor.The AVE Bridge™ Stent System isindicated for palliative treatment ofbiliary duct strictures caused bymalignant tumors.	The device is a permanent implantintended to maintain patency of a bile ductwhich is obstructed by scar tissue or tumor.
PhysicalCharacteristics(Stent):	316L stainless steel balloonexpandable stent - premounted Diameters - 6 mm to 10 mm Lengths - 16 mm to 40 mm	316L stainless steel balloon expandablestent - premounted or unmounted Diameters - 4 mm to 12 mm Lengths - 9 mm to 40 mm
PhysicalCharacteristics(Delivery catheter):	balloon delivery system - PTA catheter 5.3 F shaft size 75 cm to 90 cm length 0.035 in. Guidewire diameter	balloon delivery system - PTA catheter 5 F to 7 F shaft size 75 cm length 0.035 in. Guidewire diameter for unmounted stents - Medi-tech PE-MT™PTA balloon catheters 5 F to 9 F shaft size 60 cm to 120 cm length 0.035 in. Guidewire diameter
Anatomical Sites:	Biliary Ducts	Biliary Ducts
Target Population:	Patients with biliary duct obstructioncaused by malignant tumor	Patients with biliary duct obstructioncaused by tumor or scar tissue

3/5

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Performance Testing:

Per 807.92(b)(1) If the determination of substuntial equivalence is also based on un assessment of performance data, the summary includes a brief discussion of the non clinical less and how their results support a decemination of substantial cquivalence

1. AVE Bridge™ Stent vs JJIS Palmaz™ Balloon-Expandable Stent - Balloon Performance Study

Purpose:

To compare the minimum burst pressure and deflation times of the AVE Bridge™ Stent balloons to the PALMAZ™ Balloon-Expandable Stent balloons. The data gathered will support a premarket notification for the AVE Bridge™ Stent System.

Results:

The test proved substantial equivalence.

2. AVE Bridge™ Stent vs JJIS Palmaz™ Balloon-Expandable Stent - Two Plane Crush Strength Study

Purpose:

To determine and compare the radial strengths of the AVE Bridge™ Stent and the PALMAZ™ Balloon-Expandable Stent by graphically representing the amount of force required to crush a stent to fifty percent (50%) of its deployed diameter. The data gathered will support a premarket notification for the AVE Bridge™ Stent System.

Results:

The test proved substantial equivalence.

3. AVE Bridge™ Stent Dimensional Verification and Stent Uniformity at Nominal Deployment

Purpose:

To verify that processed AVE Bridge™ Stents meet diameter and length specifications after deployment. The data gathered will support a premarket notification for the AVE Bridge™ Stent System.

Results:

The results conclude that the stents tested meet the labeled specifications for stent diameter and stent length.

Page 415

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CONCLUSIONS:

The AVE Bridge™ Steut vs the JJIS Palmaz™ Balloon-Fxpandable Stent performance testing results prove that the Bridge™ Stent is substantially equivalent to the JJS Palmaz™ Balloon-Expandable Stent

Additional Information:

Per 807.92(d), the summary includes any other information reasonably decreed neicasaly by FDA.

BIOCOMPATIBILITY

The materials cmployed in the AVE Bridge™ Stent Delivery System passed all biocompatibility tests.

STERILIZATION INFORMATION

The AVE Bridge 2M Stent System is provided sterile.

The AVE Bridge™ Stem is not intended for sterilization or reuse/ resterilization by the user.

Validation

Arterial Vascular Engineering, Incorporated validates the sterilization method, for its stent delivery system products, quarterly each year according to the ANSI/ AAMI/ ISO 11137 - 1994, Method I. Sterilization of Healthcare Products - Requirements for Validation and Routine Control - Radiation Sterilization.

Sterility Assurance Lovel (SAL)

The Sterility Assurance Level or SAL for the validated AVE stent systems is 10 .

Pyrogen Testing

The AVE Bridge™ Stent System is labeled "pyrogen free". LAL testing is performed datty, in compliance with FDA guidcline on Validation of Limulus Amebocyte I yeate Test as an End Product Endotoxin Test for IIuman and Animal Parenteral Drugs, Biological Products, and Medical Devices - Section V - 2 Inlibition and Enhancement Testing, as part of AVE's product release critcria.

5 November, 1997
Page 7 of 7

Arterial Vascular Engineering, Incorporatod AVF Bridge™ Stent Syctom - Promarket Notification K971295 Additional Information Requested

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Image /page/5/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is a stylized caduceus, a symbol often associated with healthcare. The text "AN SERVICES - USA" is also included in the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 1997

Mr. Joseph.Tamayo Regulatory Affairs Specialist Arterial Vascular Engineering, Inc. 3576 Unocal Place Santa Rosa, California 95403

Re: K971295

AVE Bridge™ Stent System Dated: August 12, 1997 Received: August 13, 1997 Regulatory class: II 21 CFR §876.5010/Product code: 78 FGE

Dear Mr. Tamayo:

We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 III (Premarket Aproval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation wititled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours

William Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number: K971295 AVE Bridge™ Stent System Device Name:

Indications For Use:

The AVE Bridge™ Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant tumors.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Robert
Sign-Oling /
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971295

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.