(88 days)
No
The summary describes a physical medical device (a stent and delivery catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is indicated for the "treatment of malignant biliary strictures" and "palliation of malignant strictures in the biliary tree," which are therapeutic applications.
No
The device is an endoprosthesis used for the palliation of malignant strictures in the biliary tree, which is a treatment rather than a diagnostic function.
No
The device description clearly outlines physical components: a flexible, self-expanding stent (endoprosthesis) and a delivery catheter. These are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment and palliation of malignant biliary strictures by implanting a physical device (a stent) into the biliary tract. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a physical implant (endoprosthesis) and a delivery system (catheter). It is designed to mechanically open up a narrowed passage.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
The device described is a medical device used for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The VIABIL® Biliary Endoprosthesis is indicated for the treatment of malignant biliary strictures.
The GORE VIABIL® Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree.
Product codes (comma separated list FDA assigned to the subject device)
FGE
Device Description
The VIABIL® Biliary Endoprosthesis is a flexible, self-expanding stent with an inner tubular lining that is radially compressed and secured to the distal end of a delivery catheter. The catheter provides a means for implanting the VIABIL® Biliary Endoprosthesis at the target site in the biliary tract.
There are two principle components of the device: the endoprosthesis and the delivery catheter. The endoprosthesis is available in two diameters (8 mm and 10 mm), four lengths (4 cm, 6 cm, 8 cm, and 10 cm), and is available both with and without transmural drainage holes. Two catheter lengths are available: a 40 cm working length catheter for percutaneous delivery of the endoprosthesis, and a 200-cm working length catheter for endoscopic delivery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tract, 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)
Not Found
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.
GORE VIABIL® Biliary Endoprosthesis (K041423)
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.
GORE VIABAHN Endoprosthesis (K023811)
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
| (as required by 21 CFR 807.92 (j)) | ||
|---|---|---|
| Submitter Information: | W. L. Gore and Associates Inc. | |
| 3250 W. Kiltie Lane | ||
| Flagstaff, AZ 86001 | JUL 22 2008 | |
| Contact: Michael Ivey | ||
| Phone: 928-864-3790 | ||
| Fax: 928-864-4219 | ||
| Date Prepared: | April 25, 2008 | |
| Trade or Proprietary Name: | VIABIL® Biliary Endoprosthesis | |
| Common or Usual Name: | Biliary Stent | |
| Classification Name: | Biliary Catheters | |
| Device Classification: | Class II: 21 CFR 876.5010 | |
| Device Predicate: | GORE VIABIL® Biliary Endoprosthesis (K041423) | |
| GORE VIABAHN Endoprosthesis (K023811) |
510(k) Premarket Notification Summary required by 21 CED 207 02 G
Device Description:
The VIABIL® Biliary Endoprosthesis is a flexible, self-expanding stent with an inner tubular lining that is radially compressed and secured to the distal end of a delivery catheter. The catheter provides a means for implanting the VIABIL® Biliary Endoprosthesis at the target site in the biliary tract.
There are two principle components of the device: the endoprosthesis and the delivery catheter. The endoprosthesis is available in two diameters (8 mm and 10 mm), four lengths (4 cm, 6 cm, 8 cm, and 10 cm), and is available both with and without transmural drainage holes. Two catheter lengths are available: a 40 cm working length catheter for percutaneous delivery of the endoprosthesis, and a 200-cm working length catheter for endoscopic delivery.
Statement of Intended Use:
The VIABIL® Biliary Endoprosthesis is indicated for the treatment of malignant biliary strictures.
Determination of Substantial Equivalence:
Based on a variety of tests, assessments, and comparisons of the applicant device to the predicate devices demonstrate that the VIABIL® Biliary Endoprosthesis is substantially equivalent to its predicate in terms of material composition, design, intended use, and performance attributes.
page 1 of 1
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three wing-like strokes extending upwards and to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Ivey Regulatory Affairs Medical Products Division W. L. Gore & Associates, Inc. 3250 Kiltie Lane, P.O. Box 2400 FLAGSTAFF AZ 86001
JUL 22 2008
Re: K081184
Trade/Device Name: GORE VIABIL® Biliary Endoprosthesis Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: April 25, 2008 Received: April 25, 2008
Dear Mr. Ivey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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.
2
Page 2 -- Mr. Michael Ivey
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 described above is added to your labeling.
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Sincerely yours,
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number: K081184
.....
Device Name: GORE VIABIL® Biliary Endoprosthesis
FDA's Statement of the Indications for Use for device:
The GORE VIABIL® Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree.
Prescription Use OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number