(74 days)
Not Found
Not Found
No
The device description and other sections do not mention AI or ML, and the device appears to be a purely mechanical stent and delivery system.
Yes
The device is described as a "self-expanding nickel-titanium ("nitinol") stent" used to open a "constructed lumen within the biliary tree" for "palliation of malignant neoplasm", which directly targets a medical condition for therapeutic benefit.
No
The device, a self-expanding stent delivery system, is indicated for the palliation of malignant neoplasm in the biliary tree by opening a constricted lumen. This is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical stent and a delivery catheter, which are hardware components. The summary does not mention any software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Aurora is a stent and a delivery catheter used to open a constricted lumen within the biliary tree. This is a therapeutic device that is implanted directly into the body.
- Intended Use: The intended use is "palliation of malignant neoplasm in the biliary tree," which means relieving symptoms caused by a tumor. This is a therapeutic intervention, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or any other activity typically associated with IVDs.
Therefore, the Aurora device is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aurora is indicated for use in the palliation of malignant neoplasm in the biliary tree.
The Aurora Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Product codes
78 FGE
Device Description
The subject device is a system consisting of a single-lumen, tubular, self-expanding nickel-titanium ("nitinol") stent pre-loaded onto a sheathed delivery catheter. The stent design and catheter incorporate radiopaque markers to aid in stent placement during fluoroscopy. The delivery system is designed to deliver the stent to the stricture site. Once positioned at the stricture site, the sheath is withdrawn and the stent is released. Upon release, the stent's expansion results in the opening of the constructed lumen within the biliary tree.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
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 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)
Bridge Aurora
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.
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MAY 3 0 2003
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fa
510(k) Summary for the Medtronic AVE Bridge Aurora 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 | Medtronic AVE, Inc.
Peripheral Technologies
3576 Unocal Place
Santa Rosa, California 95407 |
| Contact Person | Marlene Cobb-Carlson
Associate Product Regulation Manager
Phone: (707) 541-3052
FAX: (707) 591-7758
e-mail: marlene.cobb-carlson@medtronic.com |
| Date Prepared | March 14, 2003 |
| Trade Name | Medtronic AVE Bridge™ Aurora™ Self-Expanding Biliary Stent System
( |
| Device Description | The subject device is a system consisting of a single-lumen, tubular, self-
expanding nickel-titanium ("nitinol") stent pre-loaded onto a sheathed
delivery catheter. The stent design and catheter incorporate radiopaque
markers to aid in stent placement during fluoroscopy. The delivery
system is designed to deliver the stent to the stricture site. Once
positioned at the stricture site, the sheath is withdrawn and the stent is
released. Upon release, the stent's expansion results in the opening of the
constructed lumen within the biliary tree. |
| Indications for Use | The Aurora is indicated for use in the palliation of malignant neoplasm in
the biliary tree. |
| Technological
Characteristics | The Aurora is substantially equivalent to the currently marketed
Bridge Aurora. The subject and predicate stents are technologically
similar and are intended for palliation of malignant neoplasms in the
biliary tree. The subject and predicate stents are constructed of
biocompatible materials. The subject and predicate stents are deployed
transhepatically via a sheathed delivery system. The subject device
offers a lower crossing profile. The subject and predicate stents are
comparable and are intended to meet clinical needs. The difference
between the subject and predicate devices are minor and are not
relevant to the ability of the subject device to palliate malignant
neoplasms in the biliary tree. |
| Nonclinical
Performance | Preclinical testing was conducted to confirm the safe and effective
performance of this device as well as the biocompatibility of the device. |
| Sterilization | The Aurora is provided sterile. The device is not intended for reuse or
resterilization. |
| Conclusion | The Aurora is substantially equivalent to the currently cleared and
marketed device and meets the clinical needs of the physicians. |
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Ko30839
510(k) Summary for the Medtronic AVE Bridge Polaris Biliary Stent System
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with outstretched arms, resembling a bird in flight. The figure is composed of three curved lines that create the impression of movement and dynamism. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
.
MAY 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marlene Cobb-Carlson Associate Product Regulation Manager Medtronic AVE 3576 Unocal Place SANTA ROSA CA 95403
Re: K030839
Trade/Device Name: Medtronic AVE Bridge Aurora Biliary Stent System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: May 1, 2003 Received: May 2, 2002
Dear Ms. Cobb-Carlson:
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.
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Page 2 - Ms. Cobb-Carlson
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 (QS) 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/dsma/dsmamain.html.
Sincerely yours,
Daniel G. Schultz, M.
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K030839
Device Name: Medtronic AVE Bridge Aurora Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Aurora Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use V OR (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
David A. Liguori
ictive, Abdominal,