(29 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a stent and delivery system, with no mention of AI or ML.
Yes
The device is intended to maintain the patency of a bile duct occluded by a malignant tumor, which is a therapeutic intervention.
No
Explanation: The device is a stent intended to maintain patency of a bile duct occluded by a tumor. Its purpose is therapeutic (maintaining patency), not diagnostic (identifying or characterizing a disease).
No
The device description clearly details a physical stent and delivery catheter, which are hardware components.
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 Function: The Medtronic AVE Bridge™ Stent is an implantable device designed to be placed inside the body (in vivo) to maintain the patency of a bile duct. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for maintaining patency of a bile duct occluded by a malignant tumor. This is a treatment, not a diagnostic test.
- Device Description: The description details a stent and delivery system for implantation, not equipment for analyzing biological samples.
- Input Imaging Modality: Fluoroscopy is used for guiding the placement of the device within the body, not for analyzing a specimen.
Therefore, based on the provided information, the Medtronic AVE Bridge™ Stent is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Medtronic AVE Bridge™ Stent is intended to maintain patency of a bile duct which is occluded by a malignant tumor.
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.
Product codes
78 FGE
Device Description
The Bridge™ Stent 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 120cm. The device is provided in a sterile package.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bile 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, sample size, AUC, MRMC, standalone performance, key results)
The subject device for this 510(k) is identical to the predicate device with the exception of an alternate stent segment (component) and a new stent length.
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.
Tests conducted:
- Balloon Burst
- Balloon Deflation Time
- Crossing Profile
- Diameter versus Inflation Pressure
- Stent Free Area
- Stent Length
- Stent Recoil
Results: The performance testing and comparison of the Peripheral AVE Stent Delivery System and the Medtronic AVE Bridge™ Stent prove the two devices are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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
K992569
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
2330 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 30, 1999 |
| Tradename: | Device Name: Medtronic AVE Bridge™ Stent
Model Numbers: B6028, B6028L, B7028, B7028L, B8028, B8028L, B9028,
B9028L, B10028, B10028L
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 Bridge™ Stent is intended to maintain patency of a bile
duct which is occluded by a malignant tumor. |
| | Continuad on unaret |
Continued on next page
1
510(k) Summary for the Medtronic AVE Stent Delivery
System, Continued
Description of Device
The Bridge™ Stent 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 120cm. The device is provided in a sterile package.
| Size range: | Diameters: 6.0 to 10.0 mm
Lengths 28 mm |
| ------------- | -------------------------------------------- |
|---|
Comparison Table
This device is intended to maintain patency of a bile 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 Diameters 6 - 10mmLength 28mm | 316L stainless steel balloon expandable premounted stent Diameters 5 - 10mmLengths 17 to 60mm |
| Physical Characteristics (delivery system) | Balloon delivery system PTA catheter (PET)5.3 to 5.8 F shafts75 to 120cm lengths0.035" guidewire Ø | Balloon delivery system PTA catheter (PET)5.3 to 5.8 F shafts75 to 90cm lengths0.035" guidewire Ø |
| Anatomical site | Bile 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
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 a new stent length.
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 may be either 75 cm (cleared in
K983008) or a new length, 120 cm. The manufacturing process is not
changed. | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Test | Purpose |
| | • Balloon Burst
• Balloon Deflation Time
• Crossing Profile | To compare the stent/delivery system 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. |
| | • Stent Free Area
• Stent Length
• Stent Recoil | To compare the stent dimensional data 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 | The performance testing and comparison of the Peripheral AVE Stent
Delivery System and the Medtronic AVE Bridge™ Stent prove the two
devices are substantially equivalent. | |
| Additional
Information | The summary includes any other information reasonably deemed necessary
by FDA. | |
| Biocompatibility | The materials used in the Medtronic AVE Bridge™ Stent passed all
biocompatibility tests. | |
Continued on next page
3
Kaa 2569
Page 4 of 4
510(k) Summary for the Medtronic AVE Stent Delivery
System, Continued
(
| Sterilization | The Medtronic AVE Bridge™ Stent is provided sterile.
The Medtronic AVE Bridge™ 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 10⁶.
The Medtronic AVE Bridge™ 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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized bird or human figures, with three overlapping profiles facing to the right.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 31 1999
Ms. Susan L. Walton Regulatory Coordinator Medtronic AVE, Peripheral Technologies 2330A Circadian Way Santa Rosa, CA 95407
Re: K992569
Medtronic AVE Bridge™ Stent System (Hi-Flex) - Biliary Indication Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 30, 1999 Received: August 2, 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 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.
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 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 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 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 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 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 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 vours.
Jum Cofo
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): K992569
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.
Tarind A. Styson
(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological De 510(k) Number
Prescription Use
(Per 21 CFR 801.109) OR
Over-The-Counter Use_