← Product Code [FGE](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGE) · K992318 # MEDTRONIC AVE BRIDGE STENT (K992318) _Medtronic Ave, Inc. · FGE · Aug 2, 1999 · Gastroenterology, Urology · SESU_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGE/K992318 ## Device Facts - **Applicant:** Medtronic Ave, Inc. - **Product Code:** [FGE](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGE.md) - **Decision Date:** Aug 2, 1999 - **Decision:** SESU - **Submission Type:** Special - **Regulation:** 21 CFR 876.5010 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The Medtronic AVE Bridge™ Stent System (Hi-Flex) – Biliary Indication is intended to maintain patency of a bile duct which is occluded by a malignant tumor. ## Device Story Device is balloon-expandable intralumenal stent premounted on over-the-wire delivery catheter; used to maintain patency of bile ducts occluded by malignant tumors. Radiopaque platinum markers on inner shaft facilitate placement via fluoroscopy. Compatible with 0.035" guidewires; usable length 75-90cm. Operated by clinicians in clinical setting. Stent provides mechanical support to keep duct open; delivery system allows precise positioning. Benefits patient by relieving biliary obstruction. Safety/effectiveness for vascular use not established; labeling must prominently display biliary indication. ## Clinical Evidence Bench testing only. Performance testing compared subject device to predicate across multiple mechanical parameters: balloon burst, bond strength, deflation time, crossing profile, diameter vs. inflation pressure (compliance), stent free area, stent length, crush strength, recoil, and expansion. Biocompatibility testing passed. LAL testing performed for pyrogenicity. ## Technological Characteristics 316L stainless steel balloon-expandable stent; PET balloon delivery system; 5.3-5.8 F shafts; 75-90cm length; 0.035" guidewire compatibility. Radiopaque platinum markers. Sterilized via radiation per ANSI/AAMI/ISO 11137-1994 (SAL 10^-6). ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Peripheral AVE Stent Delivery System ([K983008](/device/K983008.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K992318 Page 1 of 4 ## 510(k) Summary for the Medtronic AVE Stent Delivery System | 510(k)
Summary | This summary of 510(k) safety and effectiveness information is being
submitted in accordance with the requirements of AMDA 1990 and 21 CFR
807.92. | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Identification | The assigned 510(k) number is | | Applicant: | Medtronic AVE, Inc.
Peripheral Technologies
2330A Circadian Way
Santa Rosa, California 95407
Contact: Susan L. Walton | | | Phone: (707) 591-7315 FAX: (707) 591-7406
e-mail: susan.walton@medtronic.com
Date submitted: July 9, 1999 | | Tradename: | Device Name: Medtronic AVE Stent
Model Numbers: B7080, B8080, B70100, B80100
Classification Name: Catheter, Biliary and accessories | | Section 513
Device
Classification | Classification: Class II
Classification Panel: 78FGE | | Equivalence | Medtronic AVE claims substantial equivalence to the Peripheral AVE Stent
Delivery System - For Use In Biliary Indication. | | Intended Use | The Medtronic AVE Stent Delivery System - For Use In Biliary Indication
device is intended to maintain patency of a bile duct which is occluded by a
malignant tumor. | Continued on next page {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the number K992318 written in black ink at the top. Below that, the text "Page 2 of 4" is written in cursive, also in black ink. The handwriting appears to be somewhat messy and uneven. ## 510(k) Summary for the Medtronic AVE Stent Delivery System, Continued **Description of Device** 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 imbedded on 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 75cm to 90cm. The device is provided in a sterile package. | Size range: | Diameters: 7.0 to 8.0 mm
Lengths 80 to 100 mm | |-------------|--------------------------------------------------| |-------------|--------------------------------------------------| **Comparison Table** This device is intended to maintain patency of a biliary duct which is occluded by a malignant tumor. | | Characteristic | Subject Device | Predicate Device | |--|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | | Intended Use | This device is intended to maintain patency of a bile duct which is occluded by tumor. | This device is intended to maintain patency of a biliary duct which is occluded by tumor. | | | Physical Characteristics (stent) | 316L stainless steel balloon expandable premounted stent | 316L stainless steel balloon expandable premounted stent | | | Physical Characteristics (delivery system) | Balloon delivery system | Balloon delivery system | | | Anatomical site | Biliary duct | Biliary duct | | | Target population | Patients with bile duct obstruction caused by malignant tumor. | Patients with biliary duct obstruction caused by malignant tumor. | Continued on next page {2}------------------------------------------------ ## 510(k) Summary for the Medtronic AVE Stent Delivery System, Continued | Performance
Testing | The subject device for this 510(k) is identical to the predicate device with the
exception of an alternate stent segment (component) and extended stent
lengths. The flexible Medtronic AVE Stent was found to be substantially
equivalent in K983008 approved November 25, 1998. Performance testing
was conducted on the subject device for the purpose of direct comparison to
the predicate device. The testing was chosen to highlight any differences
between the subject device and the predicate device. The balloon materials
have not been changed. The useable catheter length is not changed. The
manufacturing process is not changed. | | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Test | Purpose | | | • Balloon Burst | To compare the stent/delivery system of the
subject device and the predicate device. The | | | • Bond Strength | subject device and the predicate device. The | | | • Balloon Deflation Time | data will support a premarket notification for | | | • Crossing Profile | the Medtronic AVE Stent Delivery System -
For Use In Biliary Indication. | | | • Diameter versus
Inflation Pressure | To create and compare the compliance curves
for the subject device and the predicate device.
The data will support a premarket notification
for the Medtronic AVE Stent Delivery System -
For Use In Biliary Indication. | | | • Stent Free Area | To compare the stent dimensional data for the
subject device and the predicate device. The | | | • Stent Length | subject device and the predicate device. The | | | • Crush Strength
• Stent Recoil
• Stent Expansion | data will support a premarket notification for
the Medtronic AVE Stent Delivery System -
For Use In Biliary Indication. | | Conclusions | The performance testing and comparison of the Peripheral AVE Stent
Delivery System - For Use In Biliary Indication and the Medtronic AVE Stent
Diameter versus Inflation Pressure prove the two devices are substantially
equivalent. | | | Additional
Information | The summary includes any other information reasonably deemed necessary
by FDA. | | | Biocompatibility | The material used in the Medtronic AVE Stent passed all biocompatibility
tests. | | Continued on next page {3}------------------------------------------------ K992318 Page 4 of 4 ## 510(k) Summary for the Medtronic AVE Stent Delivery System, Continued | Sterilization | The Medtronic AVE Stent is provided sterile. | |---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The Medtronic AVE Stent 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 10-6. | | | The Medtronic AVE Stent 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. | - {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three horizontal lines above it, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white. 2 1999 Alle Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Susan L. Walton Regulatory Coordinator Medtronic AVE, Peripheral Technologies 2330A Circadian Way Santa Rosa, CA 95407 K992318 Re: > Medtronic AVE Bridge™ Stent System (Hi-Flex) - Biliary Indication Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 10, 1999 Received: July 12, 1999 Dear Ms. Walton: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 scction 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. {5}------------------------------------------------ Page 2 -- Ms. Susan L. Walton If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 renamed in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 mspotions) the Food and Diam 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations. The FDA finding of substantial equivalence of your device to a legally marketed predicate device The I Dri mainig of sacctantial equice and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement 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. 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "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/dsma/dsmamain.html" . Sincerely yours, Sincerely yours, Susan Alpert, Ph.D., M.D. Susan Alpert, Ph.D., M.D. Director Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Page _ 1 of 1 510(k) Number (if known): K992318 Device Name: _Medtronic AVE Bridge™ Stent System (Hi-Flex) - Biliary Indication FDA's Statement of the Indications For Use for device: The Medtronic AVE Bridge™ Stent System (Hi-Flex) – Biliary Indication is intended to maintain patency of a bile duct which is occluded by a malignant tumor. Prescription Use」 OR (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Girard W. Seaymore Division Sign Off eproductive, Abdominal, E 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGE/K992318](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGE/K992318) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com