(87 days)
Peripheral AVE Stent Delivery System - For Use In Biliary Indication
Not Found
No
The device description and performance studies focus on the mechanical aspects of the stent and delivery system, with no mention of AI or ML capabilities.
Yes
The device is intended to maintain the patency of a biliary duct occluded by a malignant tumor, which is a therapeutic intervention to alleviate a medical condition.
No
The device is described as a stent delivery system intended to maintain the patency of a biliary duct occluded by a malignant tumor. Its function is interventional (to open a blocked duct), not diagnostic (to identify or characterize a disease).
No
The device description clearly outlines physical components such as a stent, delivery catheter, balloon, and radiopaque markers, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states this device is a stent delivery system intended to be used inside the body (in vivo) to maintain the patency of a biliary duct. It's a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Testing: There is no mention of analyzing biological samples or providing diagnostic information based on laboratory tests. The device's function is mechanical and interventional.
Therefore, based on the provided information, the Medtronic AVE Stent Delivery System - For Use In Biliary Indication is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
78FGE
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 fluorossopy. The deliver system is compatible with 0.035inch guidewires and has a useable length of 75cm to 120cm. The device is provided in a sterile package.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluorossopy
Anatomical Site
Biliary duct
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Study Type: Performance testing and comparison
Sample Size: Not specified
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key Results: The performance testing and comparison of the Peripheral AVE Stent Delivery System - For Use In Biliary Indication and the Medtronic AVE Stent Delivery System - For Use In Biliary Indication prove the two devices are substantially equivalent.
Key Metrics
Not Found
Predicate Device(s)
Peripheral AVE Stent Delivery System - For Use In Biliary Indication.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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) 543-5454
e-mail: swalton@avei.com
Date submitted: April 30, 1999 | |
| Tradename: | Device Name: Medtronic AVE Stent Delivery System - For Use In Biliary
Indication
Model Numbers: TBD
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 biliary duct which is occluded by
a malignant tumor. | |
| | Continued on next page | |
| Size range: | Diameters: | 5.0 to 10.0 mm |
| | Lengths: | 10.0 to 34.0 mm |
1
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. |
| Physical | ||
| Characteristics | ||
| (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 |
| Physical | ||
| Characteristics | ||
| (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
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 a new delivery system. 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. | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Test | Purpose |
| | • Balloon Rated Burst
• Balloon Deflation Time | To compare the minimum burst pressure and
deflation times of 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. |
| | • 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. |
| | • Balloon Bond Strength | To create and compare the balloon bond
strength 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. |
| | • Crossing Profile | To create and compare the crossing profile 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. |
| Conclusions
Additional
Information | The performance testing and comparison of the Peripheral AVE Stent
Delivery System - For Use In Biliary Indication and the Medtronic AVE Stent
Delivery System - For Use In Biliary Indication prove the two devices are
substantially equivalent.
The summary includes any other information reasonably deemed necessary
by FDA. | |
Continued on next page
3
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.
4
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.
5
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
6
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_