(18 days)
Not Found
No
The device description focuses on the physical properties and deployment mechanism of a metallic stent, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also marked as "Not Found".
Yes
The device is a biliary stent intended for palliation of malignant neoplasms, which directly treats a medical condition.
No
Explanation: The device description states its purpose is to maintain patency and constant flow in the biliary duct, which is a therapeutic function, not a diagnostic one. Its intended use also indicates 'palliation of malignant neoplasms', which is treatment-oriented.
No
The device description clearly states it is a self-expandable stent made of nitinol, which is a physical hardware component. It also describes a delivery system with a handle assembly and introducer catheter assembly.
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 neoplasms in the biliary tree." This describes a therapeutic intervention within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a self-expandable stent made of nitinol, designed to be implanted in the biliary tree to maintain patency. This is a medical device used for treatment, not for analyzing biological samples.
- Input Imaging Modality: The device is placed using "fluoroscopic and percutaneous techniques," which are imaging and procedural methods used for guiding interventions within the body.
- Anatomical Site: The device is used in the "biliary tree," which is an internal anatomical structure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is clearly a therapeutic implant.
N/A
Intended Use / Indications for Use
The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Product codes (comma separated list FDA assigned to the subject device)
FGE
Device Description
The Zilver® 518 and 635TM Biliary Stent is a self-expandable stent made of nitinol. The special laser-cut pattern of the nitinol tube provides a construction with strong radial force and high flexibility. It is a slotted tube that is designed to provide support while maintaining flexibility in the duct upon deployment. Post-deployment, the stent is designed to impart an outward radial force upon the inner lumen of the duct, establishing patency in the stented region, thereby maintaining constant flow in the duct. The stent has radiopaque markers (gold rivets) at both ends to assist in fluoroscopic visualization of the stent position. The delivery system for both ZIB5 and ZIB6 devices includes a handle assembly and an introducer catheter assembly. The Zilver® 518 and 635™ Biliary Stent is mounted on the inner catheter of the delivery system and is restrained by an outer sheath. The delivery system is used to deliver the stent to the appropriate location. The stent is deployed by retracting the outer sheath while holding the central metal cannula stationary. Full deployment of the stent occurs when the distal end of the sheath has been retracted past the proximal end of the stent is placed using fluoroscopic and percutaneous techniques.
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)
There were no device changes, therefore no additional testing was required to support the determination of substantial equivalence to the predicate devices.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 16, 2018
Cook Ireland Ltd Cathrina McHale Regulatory Affairs Specialist O' Halloran Rd. National Technology Park Limerick Ireland
Re: K182980
Trade/Device Name: Zilver® 518™ Biliary Stent and Zilver® 635™ Biliary Stent Regulation Number: 21 CFR& 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE Dated: October 26, 2018 Received: October 29, 2018
Dear Cathrina McHale:
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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
1
K182980 - Cathrina McHale
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 has not been established.
Furthermore, the indication for biliary use 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.
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.
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.
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
2
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
William H. Maisel -S
William H. Maisel, MD, MPH Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K182980
Device Name
Zilver® 518TM Biliary Stent and Zilver® 635TM Biliary Stent
Indications for Use (Describe)
The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Section 7: 510(k) Summary
I. SUBMITTER
Cook Ireland Ltd. O'Halloran Road National Technology Park Limerick, Ireland
Phone: +353 61 334440 Fax: +353 61 239293
Contact Persons: Cathrina McHale, Regulatory Affairs Specialist Tracy O' Sullivan, Regulatory Affairs Manager
Phone: +353 61 334440 Fax: +353 61 239293
Date Prepared: October 26th, 2018
II. DEVICE
Trade Name of Device: Zilver® 518™ Biliary Stent Zilver® 635™ Biliary Stent
The model number is ZIB5-XX-Y.Y-ZZ and ZIB6-XX-Y.Y-ZZ where YY denotes the stent diameter and ZZ denotes the stent length. Table 7.1 details the range of Zilver® 518 and 635™ Biliary Stent sizes.
5
| Stent
Outer
| Diameter | 5 French (1.67mm) | 6 French (2.0 mm) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Delivery System 40, 80 & 125 cm | Delivery System 40, 80 & 125 cm | |||||||||
| (mm) | 20 | 30 | 40 | 60 | 80 | 20 | 30 | 40 | 60 | 80 |
| 4 | x | x | x | x | x | x | x | x | x | x |
| 5 | x | x | x | x | x | x | x | x | x | x |
| 6 | x | x | x | x | x | x | x | x | x | x |
| 7 | x | x | x | x | x | x | x | x | x | x |
| 8 | x | x | x | x | x | x | x | x | x | x |
| 9 | x | x | x | x | x | x | x | x | x | x |
| 10 | x | x | x | x | x | x | x | x | x | x |
| 12 | x | x | x | x | x | x | x | x | x | x |
| 14 | x | x | x | x | x | x | x | x | x | x |
Table 7.1: Zilver® 518 and 635™ Biliary Stent Sizes
Prefix: ZIB5 and ZIB6 Common or Usual Name: Biliary Stent Classification Name: Biliary catheter and accessories (21 CFR 876.5010) Regulatory Class: II Product Code: FGE
PREDICATE DEVICE III.
K163169, Zilver® 518™ and 635™ Biliary Stent
DEVICE DESCRIPTION IV.
The Zilver® 518 and 635TM Biliary Stent is a self-expandable stent made of nitinol. The special laser-cut pattern of the nitinol tube provides a construction with strong radial force and high flexibility. It is a slotted tube that is designed to provide support while maintaining flexibility in the duct upon deployment. Post-deployment, the stent is designed to impart an outward radial force upon the inner lumen of the duct, establishing patency in the stented region, thereby maintaining constant flow in the duct. The stent has radiopaque markers (gold rivets) at both ends to assist in fluoroscopic visualization of the stent position. The delivery system for both ZIB5
6
and ZIB6 devices includes a handle assembly and an introducer catheter assembly. The Zilver® 518 and 635™ Biliary Stent is mounted on the inner catheter of the delivery system and is restrained by an outer sheath. The delivery system is used to deliver the stent to the appropriate location. The stent is deployed by retracting the outer sheath while holding the central metal cannula stationary. Full deployment of the stent occurs when the distal end of the sheath has been retracted past the proximal end of the stent is placed using fluoroscopic and percutaneous techniques.
V. INDICATIONS FOR USE
The Zilver® 518™ and 635™ Biliary Stent are intended for palliation of malignant neoplasms in the biliary tree.
VI. COMPARISON OF TECHNOLOGICAL CHARACETERISTICS WITH A PREDICATE DEVICE
The subject device is substantially equivalent to the currently marketed device, the Zilver® 518™ and 635M Biliary Stent (ZIB5/ZIB6), cleared under K163169 on February 07th, 2017. This submission describes changes to the instructions for use only. There is no change to the indications for use, design, or materials. No additional testing was required in relation to the modifications to the Instructions for Use.
VII. PERFORMANCE DATA
There were no device changes, therefore no additional testing was required to support the determination of substantial equivalence to the predicate devices.
VIII. CONCLUSIONS
The subject device, is substantially equivalent to the predicate device, the Zilver® 518" and 635" Biliary Stent (K163169).