(186 days)
Not Found
No
The summary describes a mechanical device (stent and delivery system) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for the palliation of malignant neoplasm in the biliary tree, which is a therapeutic intervention aimed at easing the symptoms and improving the quality of life for patients with a medical condition.
No
The device is a stent system used for palliation of malignant neoplasm, which is a treatment rather than a diagnostic function. It is a therapeutic device.
No
The device description clearly states it is a "single use only device with a stent mounted on an over-the-wire delivery system" and includes a "balloon mounted on the distal portion of the catheter," indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "palliation of malignant neoplasm in the biliary tree." This describes a therapeutic intervention performed within the body (in vivo) to alleviate symptoms, not a test performed outside the body (in vitro) on samples to diagnose or monitor a condition.
- Device Description: The description details a physical device (stent, delivery system, balloon) designed for insertion into the biliary tree. This is consistent with an implantable or interventional device, not an IVD which typically involves reagents, analyzers, or test kits for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or diagnostic testing.
Therefore, the Bridge Constant Biliary Stent System is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bridge Constant Biliary Stent System is indicated for use in the palliation of malignant neoplasm in the biliary tree.
Product codes (comma separated list FDA assigned to the subject device)
78 FGE
Device Description
The subject device is a single use only device with a stent mounted on an over-the-wire delivery system. The device is equipped with an A V100 balloon mounted on the distal portion of the catheter to facilitate the percutaneous delivery of the stent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree
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/in-vitro testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device.
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.
Bridge Extra Support (K991533), Bridge Assurant (K011817)
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
510(k) Summary for the Medtronic AVE Bridge Constant Biliary Stent System
. .
| 510(k)
Summary | This summary of 510(k) safety and effectiveness information is being
submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
807.92(a)(1) | Medtronic AVE, Inc.
Peripheral Technologies
3576 Unocal Place
Santa Rosa, California 95403 |
| Contact Person
807.92(a)(1) | Sarah Sheppard
Associate Product Regulation Manager
Phone: (707) 591-7465
Fax: (707) 591-7406
E-mail: sarah.sheppard@medtronic.com |
| Date Prepared
807.92(a)(1) | February 26, 2003 / Name change notification: April 8th, 2003 |
| Trade Name
807.92(a)(2) | Medtronic AVE Bridge Constant Biliary Stent System per 807.92 (a) (2) |
| Common Name
807.92(a)(2) | Biliary Stent and Delivery System |
| Classification Name
807.92(a)(2) | Biliary Catheter and Accessories |
| Device
Classification
807.92(a)(2) | Classification: Class II
Classification Panel: 78FGE
Regulation Number: 21 C.F.R. §876.5010 |
| Predicate Device
807.92(a)(3) | Bridge Extra Support (K991533) cleared July 29th, 1999
Bridge Assurant (K011817) cleared August 22nd, 2001 |
| Performance
Standards | Performance standards have not been established by the FDA under
section 514 of the Federal, Food, Drug and Cosmetic Act |
| Device Description
807.92(a)(4) | The subject device is a single use only device with a stent mounted on an
over-the-wire delivery system. The device is equipped with an A V100
balloon mounted on the distal portion of the catheter to facilitate the
percutaneous delivery of the stent. |
| Indications for Use
807.92(a)(5) | The Bridge Constant Biliary Stent System is indicated for use in the
palliation of malignant neoplasm in the biliary tree. |
| Technological
Characteristics
807.92(a)(6) | The Bridge Constant is substantially equivalent to the currently marketed
Bridge Extra Support (K991533) and Bridge Assurant (K011817)
devices. The subject and predicate devices are technologically similar
and are intended for palliation of malignant neoplasms in the biliary tree.
The subject and predicate devices are constructed of biocompatible
materials. The subject and predicate devices are both balloon expandable
and feature stents pre-mounted on a sheathless stent delivery system. The
subject and predicate devices are comparable and are intended to meet
clinical needs. The difference between the subject and predicate devices
are not relevant to the ability of the subject device to palliate malignant
neoplasms in the biliary tree. |
| Nonclinical
Performance
807.92(b)(1) | Preclinical/in-vitro testing was conducted to confirm the safe and
effective performance of this device as well as the biocompatibility of the
device. |
| Sterilization
807.92(b)(1) | The Bridge Constant Biliary Stent System is provided sterile. The device
is not intended for reuse or resterilization. |
| Conclusion
807.92(b)(3) | The Bridge Constant Biliary Stent System is substantially equivalent to
the currently cleared and marketed devices (Bridge Extra Support –
K991533 and Bridge Assurant – K011817) and meets the clinical needs
of the physicians. |
1
510(k) Summary for the Medtronic AVE Bridge Constant Biliary Stent System
2
Image /page/2/Picture/1 description: The image is a black and white seal. The seal is circular and contains an image of a bird with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the edge of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 2003
Ms. Sarah Sheppard Associate Product Regulation Manager Medtronic AVE 3576 Unocal Place SANTA ROSA CA 95403
Re: K030633
Trade/Device Name: Medtronic AVE Bridge Constant Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: June 3, 2003 Received: June 4, 2003
Dear Ms. Sheppard:
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 - Ms. Sarah Sheppard
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Section 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 Part 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 Part 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/dsmaldsmamain.html.
Sincerely yours,
Daniel G. Schultz, M.D.
Director Office of Device Evaluation Center for Devices and Radiological Health
4
Page _ 1 of 1
510(k) Number (if known): K030633
Device Name: Medtronic AVE Bridge Constant Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Medtronic AVE Bridge Constant Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_ 0311/2 53