(72 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects of a stent delivery system and do not mention any AI or ML components.
No
Explanation: The device is a stent delivery system intended to keep the bile duct open, which is a therapeutic function. However, the question specifically asks if the "device" is a therapeutic device, and the description clearly states it is a "stent delivery system." While it delivers a therapeutic device (the stent), the delivery system itself is not a therapeutic device.
No
The device is described as a stent delivery system intended to maintain the patency of a bile duct, which is a therapeutic function, not a diagnostic one. It does not identify or characterize diseases.
No
The device description clearly outlines physical components such as a stent, delivery catheter, balloon, and guidewires, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states that the Medtronic AVE Bridge™ FX Biliary Stent Delivery System is a device intended to be implanted within the bile duct to maintain its patency. This is an in vivo (within the living body) procedure.
- Lack of Diagnostic Testing: The device's function is mechanical (maintaining an open passage), not diagnostic (analyzing samples to identify a condition).
Therefore, based on the provided information, the Medtronic AVE Bridge™ FX Biliary Stent Delivery System is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Medtronic AVE Bridge FX Stent Delivery System is intended to maintain patency of a bile duct, which is occluded by a malignant tumor.
Product codes (comma separated list FDA assigned to the subject device)
78FGE
Device Description
The Bridge FX Stent Delivery System consists of a balloon-expandable intralumenal, 316L stainless steel stent pre-mounted onto the balloon of an over-the-wire delivery catheter. The device is available in diameters ranging from 6-10 mm and in several lengths including 20, 30, 40, and 60 mm. The delivery system has two radiopaque marker bands to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035" guidewires and has useable lengths of 80 and 130 cm. The device is provided in a sterile package.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
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)
Preclinical testing was conducted to confirm the safe and effective performance of the Bridge FX. The device passed biocompatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
This summary of 510(k) safety and effectiveness information is being 210(k) submitted in accordance with the requirements of 21 C.F.R. § 807.92. Summary Submitter Medtronic AVE, Inc. Peripheral Technologies 2170-A Northpoint Parkway Santa Rosa, California 95407 Contact Person John Riolo Vice President, Regulatory Affairs and Quality Assurance Phone: (707) 541-3271 FAX: (707) 566-1159 e-mail: john.riolo@medtronic.com June 11, 2001 Date Prepared Bridge FX Stent Delivery System Trade Name Biliary Stent and Delivery System Common Name Biliary Catheter and Accessories Classification Name Classification: Class II Device Classification Classification Panel: 78FGE Regulation Number: 21 C.F.R. §876.5010 Predicate Bridge X3 (K000744, 6/5/00) . Devices Bridge Flexible/Hi-Flex (K992569, 8/31/99; K993145, 10/21/99) ● Performance standards have not been established by the FDA under section Performance 514 of the Federal, Food, Drug and Cosmetic Act Standards
510(k) Summary for the Bridge FX Stent Delivery System
lage 1/2
1
510(k) Summary for the Bridge FX Stent Delivery System
| Device Description | The Bridge FX Stent Delivery System consists of a balloon-
expandable intralumenal, 316L stainless steel stent pre-mounted
onto the balloon of an over-the-wire delivery catheter. The
device is available in diameters ranging from 6-10 mm and in
several lengths including 20, 30, 40, and 60 mm. The delivery
system has two radiopaque marker bands to aid in the placement
of the stent during fluoroscopy. The delivery system is
compatible with 0.035" guidewires and has useable lengths of 80
and 130 cm. The device is provided in a sterile package. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Medtronic AVE Bridge FX Stent Delivery System is intended to
maintain patency of a bile duct, which is occluded by a malignant tumor. |
| Technological
Characteristics | The Medtronic AVE Bridge FX Stent Delivery System is substantially
equivalent to Medtronic AVE's previously-cleared Bridge products. The
devices have the same indications for use, intended use, and the same
fundamental scientific technology. Difference between the subject and
predicate devices are minor and are not relevant to its ability to maintain
patency of a bile duct. |
| Nonclinical
Performance | Preclinical testing was conducted to confirm the safe and effective
performance of the Bridge FX. The device passed biocompatibility
testing. |
| Sterilization | The Bridge FX is provided sterile. The device is not intended for reuse
or resterilization. |
| Conclusion | The Medtronic AVE Bridge FX Stent Delivery System is substantially
equivalent to Medtronic AVE's currently cleared and marketed Bridge
products. |
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and healing. The caduceus is depicted as a staff with two snakes coiled around it and wings at the top.
AUG 2 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin Drisko Senior Regulatory Affairs Specialist Medtronic AVE, Inc. 2170 A Northpoint Parkway SANTA ROSA CA 95407
Re: K011817
Medtronic AVE Bridge™ FX Biliary Stent Delivery System Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 20, 2001 Received: July 23, 2001
Dear Mr. Drisko:
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.
3
Page 2 - Mr. Kevin Drisko
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 remarket in pp. o taly was 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 mspoculish 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, International and Consumer 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,
Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known): K011817
Device Name: Medtronic AVE Bridge™ FX Biliary Stent Delivery System
FDA's Statement of the Indications For Use for device:
The Medtronic AVE Bridge™ FX Biliary Stent Delivery System 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
Nancy C. Bergdon
Division Sign-Off Division of Reproductive, Abd dominal. and Radiological Deyice 510(k) Number