The Medtronic AVE Stent Delivery System - For Use In Biliary Indication device is intended to maintain patency of a biliary duct which is occluded by a malignant tumor.

Device Description

The device consists of a balloon expandable intralumenal stent premounted onto the balloon of an over-the-wire delivery catheter. The device has two radiopaque platinum markers mounted on the stent to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035inch guidewires and has a useable length of 75cm to 120cm. The device is provided in a sterile package.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Medtronic AVE Stent Delivery System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly state acceptance criteria in terms of numerical thresholds or performance targets for a device. Instead, the "acceptance criteria" are implied through the purpose of the performance testing, which is to demonstrate substantial equivalence to a predicate device. The performance is "reported" implicitly by stating that the tests were conducted and the conclusion reached was that the devices are substantially equivalent.

Therefore, the table will reflect the purpose of each test as the "acceptance criteria" (i.e., comparability to the predicate), rather than specific quantitative metrics. The "Reported Device Performance" is the stated outcome of meeting these comparative goals.

Acceptance Criteria (Purpose of Test)	Reported Device Performance (Conclusion)
Mechanical Performance (Stent Delivery System):
To compare the minimum burst pressure of the subject device and the predicate device.	Performance testing confirmed that the subject device's balloon burst pressure is comparable to the predicate device, supporting substantial equivalence.
To compare the deflation times of the subject device and the predicate device.	Performance testing confirmed that the subject device's balloon deflation times are comparable to the predicate device, supporting substantial equivalence.
To create and compare the compliance curves for the subject device and the predicate device.	Performance testing confirmed that the subject device's diameter versus inflation pressure (compliance curves) are comparable to the predicate device, supporting substantial equivalence.
To create and compare the balloon bond strength for the subject device and the predicate device.	Performance testing confirmed that the subject device's balloon bond strength is comparable to the predicate device, supporting substantial equivalence.
To create and compare the crossing profile for the subject device and the predicate device.	Performance testing confirmed that the subject device's balloon crossing profile is comparable to the predicate device, supporting substantial equivalence.
Biocompatibility:
To ensure the materials used in the device are biocompatible.	The material used in the Medtronic AVE Stent Delivery System passed all biocompatibility tests.
Sterilization:
To validate the sterilization method and achieve a Sterility Assurance Level (SAL) of 10⁻⁶.	The sterilization method aligns with ANSI/AAMI/ISO 11137 - 1994, Method I, achieving an SAL of 10⁻⁶.
To ensure the device is pyrogen-free.	The Medtronic AVE Stent Delivery System is labeled pyrogen-free, with daily LAL testing performed in compliance with FDA guidance as part of product release criteria.
Overall Equivalence:
To prove substantial equivalence to the predicate device.	The performance testing and comparison prove the two devices (subject and predicate) are substantially equivalent.

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

The document does not explicitly state the numerical sample size for each performance test (e.g., how many balloons were tested for burst pressure). It generally refers to "performance testing" being conducted. The data provenance is not specified beyond the fact that the testing was conducted by Medtronic AVE, Inc. It does not indicate the country of origin of the data or whether it was retrospective or prospective, though it's implied to be a prospective, lab-based performance study for regulatory submission.

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

This information is not applicable as the study described is a performance equivalency study for a medical device (stent delivery system), not a study involving human-in-the-loop performance, diagnostic accuracy, or clinical evaluation by experts. The "ground truth" here is based on engineering and material science standards for device functionality and safety, as compared to a predicate device.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated in point 3. There are no human judgments or diagnoses being adjudicated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This information is not applicable. The provided document describes the 510(k) summary for a stent delivery system, which is a physical medical device. It does not involve any AI or human readers for diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. The device is a physical stent delivery system, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance testing is engineering specifications, material science standards, and direct comparison to the predicate device's established performance characteristics. For biocompatibility, the ground truth is established by passing standardized biocompatibility tests. For sterilization, it's achieving specific Sterility Assurance Levels and passing pyrogenicity tests.

8. The Sample Size for the Training Set:

This information is not applicable. This is a physical device, and its approval pathway (510(k)) focuses on substantial equivalence to a predicate device based on performance testing, not on machine learning model training.

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

This information is not applicable for the reasons stated in point 8.

Summary

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510(k) Summary for the Medtronic AVE Stent Delivery System

510(k)Summary	This summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirements of AMDA 1990 and 21 CFR807.92.
Identification	The assigned 510(k) number is
Applicant:	Medtronic AVE, Inc.Peripheral Technologies2330A Circadian WaySanta Rosa, California 95407Contact: Susan L. WaltonPhone: (707) 591-7315 FAX: (707) 543-5454e-mail: swalton@avei.comDate submitted: April 30, 1999
Tradename:	Device Name: Medtronic AVE Stent Delivery System - For Use In BiliaryIndicationModel Numbers: TBDClassification Name: Catheter, Biliary and accessories
Section 513DeviceClassification	Classification: Class IIClassification Panel: 78FGE
Equivalence	Medtronic AVE claims substantial equivalence to the Peripheral AVE StentDelivery System - For Use In Biliary Indication.
Intended Use	The Medtronic AVE Stent Delivery System - For Use In Biliary Indicationdevice is intended to maintain patency of a biliary duct which is occluded bya malignant tumor.
	Continued on next page
Size range:	Diameters:	5.0 to 10.0 mm
	Lengths:	10.0 to 34.0 mm

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510(k) Summary for the Medtronic AVE Stent Delivery

System, Continued

The device consists of a balloon expandable intralumenal stent premounted
and the consisted and secure delivery catheter. The device has two The device consists of a balloon expandable mire delivery cather.
onto the balloon of an over-the-wire delivery catheter. The device has two
re the balloon of an and on the Description of onto the balloon of an over-the-wire denvely canced." I also end of the Device radiopaque platinum markers mounted on the stent during fluorossopy. The deliver
stent) to aid in the placement of the stent during and has a useable length a stent) to aid in the placement of the stent uning nacross and has a useable length of
system is compatible with 0.035inch guidewires and has a useable length of
the states of system is compatible with 0.055men gulder wees
75cm to 120cm. The device is provided in a sterile package.

This device is intended to maintain patency of a biliary duct which is a
re and the success the sames Comparison occluded by a malignant turnor. Table

Characteristic	Subject Device	Predicate Device
Intended Use	This device is intended to maintain patency of a biliary duct which is occluded by tumor.	This device is intended to maintain patency of a biliary duct which is occluded by tumor.
PhysicalCharacteristics(stent)	316L stainless steel balloon expandable premounted stent Diameters 5 - 10mm Lengths 10 to 34mm	316L stainless steel balloon expandable premounted stent Diameters 5 - 10mm Lengths 16 to 60mm
PhysicalCharacteristics(delivery system)	Balloon delivery system PTA catheter (AVEd) 5.3 F shafts 75 to 120cm lengths 0.035 in guidewire Ø	Balloon delivery system PTA catheter (PET) 5.3 to 5.8 F shafts 75 to 90cm lengths 0.035 in guidewire Ø
Anatomical site	Biliary duct	Biliary duct
Target population	Patients with biliary duct obstruction caused by malignant tumor.	Patients with biliary duct obstruction caused by malignant tumor.

Continued on next page

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510(k) Summary for the Medtronic AVE Stent Delivery

System, Continued

PerformanceTesting	The subject device for this 510(k) is identical to the predicate device with theexception of a new delivery system. Performance testing was conducted onthe subject device for the purpose of direct comparison to the predicatedevice. The testing was chosen to highlight any differences between thesubject device and the predicate device.
	Test	Purpose
	• Balloon Rated Burst• Balloon Deflation Time	To compare the minimum burst pressure anddeflation times of the subject device and thepredicate device. The data will support apremarket notification for the Medtronic AVEStent Delivery System - For Use In BiliaryIndication.
	• Diameter versusInflation Pressure	To create and compare the compliance curvesfor the subject device and the predicate device.The data will support a premarket notificationfor the Medtronic AVE Stent Delivery System -For Use In Biliary Indication.
	• Balloon Bond Strength	To create and compare the balloon bondstrength for the subject device and the predicatedevice. The data will support a premarketnotification for the Medtronic AVE StentDelivery System - For Use In BiliaryIndication.
	• Crossing Profile	To create and compare the crossing profile forthe subject device and the predicate device.The data will support a premarket notificationfor the Medtronic AVE Stent Delivery System -For Use In Biliary Indication.
ConclusionsAdditionalInformation	The performance testing and comparison of the Peripheral AVE StentDelivery System - For Use In Biliary Indication and the Medtronic AVE StentDelivery System - For Use In Biliary Indication prove the two devices aresubstantially equivalent.The summary includes any other information reasonably deemed necessaryby FDA.

Continued on next page

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510(k) Summary for the Medtronic AVE Stent Delivery

System, Continued

The material used in the Medtronic AVE Stent Delivery System - For Use In Biocompatibility Biliary Indication passed all biocompatibility tests. The Medtronic AVE Stent Delivery System - For Use In Biliary Indication is Sterilization provided sterile. The Medtronic AVE Stent Delivery System - For Use In Biliary Indication is not intended for sterilization or reuse/resterilization by the user. Medtronic AVE validates the sterilization method for its stent delivery systems according to the ANSI/AAMI/ISO 11137 - 1994, Method I: Sterilization of Healthcare Products - Requirements for Validation and Routine Control - Radiation Sterilization. The Sterility Assurance Level (SAL) is 10°. The Medtronic AVE Stent Delivery System - For Use In Biliary Indication is labeled pyrogen free. LAL testing is performed daily in compliance with FDA guidance on Validation of Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products and Medical Devices - Section V - 2 Inhibition and Enhancement Testing as part of Medtronic AVE's product release criteria.

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Public Health Service

Image /page/4/Picture/2 description: The image shows a circular seal with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is depicted with three curved lines forming its wings and body, giving it a modern and abstract appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

UL 29 1999

Ms. Susan L. Walton Regulatory Coordinator Medtronic AVE, Peripheral Technologies 2330A Circadian Way Santa Rosa, CA 95407

K991533 Re:

K991333
Medtronic AVE Bridge™ Stent System - Biliary Indication Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: April 30, 1999 Received: May 3, 1999

Dear Ms. Walton:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 310(K) notincentially equivalent (for the indications for use above and we have determined the cevee is subscated in interstate commence
stated in the enclosure) to legally marketed prodicate devices marketed in interstate comments, or stated in the enclosure) to legally marketed preview device Amendments, or to devices that prior to May 28, 1976, the enactment date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the rederal controls provisions have been reclassified in accordance with the provisions of the general controls provisions of
Act (Act). You may, therefore, market the device, subject to the Act include Act (Act). You may, therefore, market the devices stored spovisions of the Act include the Act and the limitations described below. The general setting 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 of Device Evailation nas detecting.com the proposed labeling and that such use device will be used for an mentee and not identify and the Section 513 (i) (i) (E) of the Act, the following
could cause harm. Therefore, in accordance with and the daily of could cause harm. "Therefore, in accordently 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 Furthermore, the indication for billary use most or promotional materials, in close
pouch, box, and carton labels, instructions for use, and other promotional materials, in c pouch, box, and carton labels, hasimilar point size, and in bold print.

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Page 2 - Ms. Susan L. Walton

If your device is classified (see above) into either class II (Special Controls) on class III
ng insideration in the control and controls. Incolditional controls. Existing ma If your device is classified (see above) into entrely class in topedial only regulations.
(Premarket Approval), it may be subject to such additions Title 21, Parts 800 to 89 (Premarket Approval), it may be subject to such additions Title 21, Parts 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 8 affecting your device can be found in the ssumes compliance with the Current Grood A substantially equivalent determination assemes continues web the Manufacturing Practice requirements, as servior in the John in any of the J
Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS Medical Devices: General regulation (ZTCFK Part 620) and rifty, unco assumptions. Failure to
inspections, the Food and Drug Administration (FDA) will verify and assumptions inspections, the Food and Drug Administration (1777) will vienny butlains and publish
comply with the GMP regulation may resident in the Firster Register Please note: this comply with the GMP regulation may result in the Federal Register. Please note: this further announcements concerning your device in the regence any obligation you might have
response to your premarket notification submission does not allectronic Product Radi response to your premarket nothication submission access under the Electronic Product Radiation
under sections 531 through 542 of the Act for devices under the Electronic Pro under sections 551 through - Federal laws or regulations.

The FDA finding of substantial equivalence of your device to a legally marketed proceed to the market. This The FDA finding of substantial equivalence of your device to proceed to the market. This
results in a classification for your device and permits your device to proceed to th results in a classification for your device and perints your 510(K) premarket
letter will allow you to begin marketing your device as described letter will allow you to begin marketing your 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.
The Act. In the first to the first for any livitations are modified in any wa Please note that the above labeling innitations are required of required in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your If you desire specific information about the applied on be severing devices), please contact device (21 CFR Part 801 and additionally 807 : 0 : 0 : 2011 : 11 : 0 : gustions on the promotion and the Office of Compliance at (01) >>4-4010. Administraliance at (301) 594-4639. Also,
advertising of your device, please contact the Office of Compliance at (301) 594-4639. please note the regulation entitled, "Misbranding by reference to premarket notification"
please note the regulation entitled, "Misbranding by references tijlities under the please note the regulation entitled, "Misoration on your responsibilities under the Act may be
(21 CFR 807.97). Other general information on your responsibilities unmber (21 CFR 807.97) Other general miormation on your espance 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,

/ Susan Alpert, Ph.D., M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ I of 1

510(k) Number (if known): K991533

Device Name: Medtronic AVE Bridge™ Stent System - Biliary Indication

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

The Medtronic AVE Bridge™ Stent System – Biliary Indication is intended to maintain patency of a biliary duct which is occluded by a malignant tumor.

David H. Bowman

(Division Sign-Off) (Division Sign-OG)
Division of Repreductive, Abdominal, ENT and Radiological Devices 510(k) Number

Prescription Use V OR (Per 21 CFR 801.109)

Over-The-Counter Use_

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.