(87 days)
Not Found
No
The device description focuses on the mechanical components of a stent system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is intended for "palliation of malignant strictures in the biliary tree," which is a therapeutic purpose.
No
The device is a biliary stent system intended for palliation of malignant strictures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details a physical stent made of L605 Cobalt Chromium and a delivery system with a balloon and catheter, indicating it is a hardware medical device, not software-only.
No, 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 Function: The Guidant HERCULINK® ELITE Biliary Stent System is a medical device designed to be implanted in the body to palliate malignant strictures in the biliary tree. It is a physical device used for treatment, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states "palliation of malignant strictures in the biliary tree," which is a therapeutic intervention, not a diagnostic test.
The description focuses on the physical components of the stent and its delivery system, how it is used to open up a blocked duct, and performance studies related to its physical properties and biocompatibility. This is consistent with a medical device, not an IVD.
N/A
Intended Use / Indications for Use
The RX HERCULINK® ELITE™ Biliary Stent System 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 RX HERCULINK ELITE Biliary Stent System features a balloon expandable stent composed of L605 Cobalt Chromium. The stent design is based upon a series of zigzaqqing rings with multiple links per ring. The stent is available in 12mm, 15mm, and 18mm lengths. The delivery system is a rapid exchange, co-axial design with a balloon at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits use of a guidewire to facilitate advancement of the catheter to and through the stricture to be dilated. The balloon has radiopaque marker(s) to aid in positioning the balloon in the stricture, and is designed to provide an expandable seament of known diameter and length at specified pressures. Markers located on the proximal outer shaft help the physician gauge the dilatation catheter position relative to the guiding catheter tip.
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)
The results of the in vitro bench tests and analyses and biocompatibility testing demonstrated the safety and effectiveness of the RX HERCULINK ELITE Biliary Stent System.
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
GUIDANT
MAR 6 2006
K053454
page 1 of 1
Appendix B 510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | Guidant Corporation |
|---|---|
| Submitter's Address: | 3200 Lakeside Drive |
| Santa Clara, CA 95054 | |
| Telephone: | 951-914-2771 |
| Fax: | 951-914-2145 |
| Contact Person: | Keith Krohn |
| Date Prepared: | December 8, 2005 |
| Device Trade Name: | RX HERCULINK® ELITE™ Biliary Stent System |
| Device Common Name: | Biliary Stent |
| Device Classification Name: | Biliary Catheter |
| Device Classification: | Class II |
Summary of Substantial Equivalence:
The RX HERCULINK® ELITE™ Biliary Stent System is substantially equivalent to: HERCULINK® PLUS Biliary Stent System (K010684, cleared 4/12/2001); and Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System, (K040413, cleared 6/21/2004)
Device Description:
The RX HERCULINK ELITE Biliary Stent System features a balloon expandable stent composed of L605 Cobalt Chromium. The stent design is based upon a series of zigzaqqing rings with multiple links per ring. The stent is available in 12mm, 15mm, and 18mm lengths. The delivery system is a rapid exchange, co-axial design with a balloon at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits use of a guidewire to facilitate advancement of the catheter to and through the stricture to be dilated. The balloon has radiopaque marker(s) to aid in positioning the balloon in the stricture, and is designed to provide an expandable seament of known diameter and length at specified pressures. Markers located on the proximal outer shaft help the physician gauge the dilatation catheter position relative to the guiding catheter tip.
Intended Use:
The RX HERCULINK ELITE Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
Performance Data:
The results of the in vitro bench tests and analyses and biocompatibility testing demonstrated the safety and effectiveness of the RX HERCULINK ELITE Biliary Stent System.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its head, symbolizing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 6 2006
Mr. Keith Krohn Manager, Regulatory Affairs Guidant Corporation 26531 Ynez Road TEMECULA CA 92591
Re: K053454
Trade/Device Name: Guidant HERCULINK® ELITE Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: February 15, 2006 Received: February 17, 2006
Dear Mr. Krohn:
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. Keith Krohn
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 labeline.
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 (301) 594-4616. 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,
Miriam C. Provost
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: K053454
Device Name: Guidant HERCULINK® ELITE Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Guidant HERCULINK® ELITE Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
David A. Ingram
(Division Sign-Off)