(14 days)
Not Found
Not Found
No
The description focuses on the physical characteristics and mechanical performance of a self-expanding nitinol stent, with no mention of AI or ML capabilities.
Yes.
The device is intended for "palliation of malignant neoplasms in the biliary tree," which directly addresses the management or treatment of a medical condition.
No
The device description indicates it is a self-expanding nitinol stent used for palliation of malignant neoplasms, meaning it is a therapeutic device inserted to open blockages, not to diagnose a condition.
No
The device description clearly details a physical, implantable stent made of nitinol, a delivery system, and a handheld deployment device. It does not describe software as the primary or sole component.
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 Cook Zilver® 635™ Biliary Stent is a self-expanding stent designed to be placed inside the biliary tree to palliate malignant neoplasms. This is an implantable medical device used for treatment, not for performing diagnostic tests on samples.
The information provided describes a device that is physically inserted into the body for therapeutic purposes, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cook Zilver® 635™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.
Product codes
78 FGE
Device Description
The Zilver® 635™ Biliary Stent is a self-expanding, nitinol stent designed for excellent radial strength and optimal longitudinal flexibility. Constructed from a series of interconnected Z-shaped segments, the stent conforms to the shape of the biliary system and provides circumferential scaffolding throughout the stent's length. Gold radiopaque markers on each end of the Zilver® 635™ Biliary Stent, along with one radiopaque marker at the distal end of the delivery system, allow precise positioning of the stent. The stent's interconnected Z-shaped segments also keep foreshortening to a minimum.
The Zilver® 635" Biliary Stent comes preloaded in a 6 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is available in unrestrained outer diameters of 4, 5, 6, 7, 8, 9 and 10 mm and in lengths of 20, 30, 40, 50, 60 mm. The 80 mm length stent is an addition to this product line.
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
The Zilver® 635" Biliary Stent was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Deployment 1.
- a. Profile
- b. Deployment Accuracy
- c. Stent length and Change due to Deployment
- d. Stent Diameter
- e. Uniformity of Expansion
- ﺖ Stent Integrity
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
0
DEC 2 9 2004
510(k) Summary
Submitted By:
Leland Keyt and Stephanie Roberts Requlatory Affairs Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235
December 15, 2004
Device:
| Trade Name: | Zilver® 635™ Biliary Stent |
|---|---|
| Proposed Classification: | Catheter, Biliary, Diagnostic |
Predicate Devices:
The Zilver® 635™ Biliary Stent is similar in terms of intended use, materials of construction and technological characteristics to predicate devices reviewed as devices for palliation of malignant neoplasm in the biliary tree.
Device Description:
The Zilver® 635™ Biliary Stent is a self-expanding, nitinol stent designed for excellent radial strength and optimal longitudinal flexibility. Constructed from a series of interconnected Z-shaped segments, the stent conforms to the shape of the biliary system and provides circumferential scaffolding throughout the stent's length. Gold radiopaque markers on each end of the Zilver® 635™ Biliary Stent, along with one radiopaque marker at the distal end of the delivery system, allow precise positioning of the stent. The stent's interconnected Z-shaped segments also keep foreshortening to a minimum.
The Zilver® 635" Biliary Stent comes preloaded in a 6 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is available in unrestrained outer diameters of 4, 5, 6, 7, 8, 9 and 10 mm and in lengths of 20, 30, 40, 50, 60 mm. The 80 mm length stent is an addition to this product line.
Substantial Equivalence:
This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the predicate devices currently marketed and distributed by Cook Incorporated. This 31
1
Special 510(k) Premarket Notification K INCORPORATED
device will undergo sterilization similar to the predicate devices currently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.
Test Data:
The Zilver® 635" Biliary Stent was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Deployment 1.
- a. Profile
- b. Deployment Accuracy
- c. Stent length and Change due to Deployment
- d. Stent Diameter
- e. Uniformity of Expansion
- ﺖ Stent Integrity
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent.
2
Image /page/2/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEC 2 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Ms. Leland Keyt Regulatory Affairs Coordinator Cook Incorporated 750 Daniels Way, PO Box 489 BLOOMINGTON IN 47402-0489
Re: K043481
Trade/Device Name: Cook Zilver® 635™ Biliary Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: December 14, 2004 Received: December 15, 2004
Dear Ms. Keyt:
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.
3
Page 2 - Ms. Leland Keyt
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 (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 vours,
Nancy C. Brogdon for
Dennis R. Tillman, Ph.D.
Donna-B Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: K043481
Device Name: Cook Zilver® 635™ Biliary Stent
FDA's Statement of the Indications for Use for device:
The Cook Zilver® 635™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Nancy C Brosdon
(Division Sign-Off) Division of Reproduct and Radiological Device 510(k) Number J