(291 days)
This device is used in palliation of malignant neoplasms in the biliary tree.
Stent Description: This flexible, self-expanding stent is constructed of nitinol wire with a radiopaque core. Both ends of the stent have an increased diameter called flanges intended to provide resistance to migration. The total length of the stent in its collapsed state is indicated by radiopaque markers on the inner catheter assembly. The stent is provided in either of two body diameters 8mm or 10mm and in the following lengths 4, 6, 8 or 10cm.
Stent Delivery System Description: The stent is mounted on an inner catheter, which accepts a 0.035" wire guide and is constrained by an outer sheath. A pistol-grip delivery handle allows stent deployment or recapture. The introducer sheath diameter is 8.5Fr and the working length is 200cm.
The provided text describes the Cook Ireland Evolution® Biliary Stent System. Here's an analysis of the provided information concerning acceptance criteria and supporting studies, formatted as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in Bench Testing) | Reported Device Performance (Summary from study) |
|---|---|---|
| Mechanical Performance | Deployment functionality | Successfully completed |
| Expansion force | Successfully completed | |
| Compression force | Successfully completed | |
| Dimensions ( соответствие спецификациям ) | Successfully completed | |
| Joint strength | Successfully completed | |
| Material Properties | Corrosion resistance | Successfully completed |
| Biocompatibility | Compliance with ISO 10993-1 | Supports safety of the Evolution® Biliary Stent System |
| Shelf Life | Maintenance of device integrity over time | Successfully completed |
| MRI Compatibility | Compatibility with MRI environments | Successfully completed |
| Equivalence to Predicates | Shares many technological characteristics with predicate devices (materials, stent type, preloaded on delivery system, fluoroscopy visualization, dimensions, permanent implantation, expanded stent ends, delivery system functionality, wire guide compatibility, recapture capability, single use, sterile) | Substantially equivalent to predicate devices (Boston Scientific Wallflex™ Biliary RX Stent System and Wallstent™ RX Biliary Endoprosthesis Stent System) |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "Performance (bench) testing" which was "successfully completed." However, it does not specify the sample size used for the test sets for any of the individual bench tests (deployment, expansion force, etc.).
The data provenance is laboratory bench testing, presumably conducted by or for Cook Ireland Ltd. The country of origin for the data is not explicitly stated beyond Cook Ireland Ltd.'s address in Limerick, Ireland. The study is a retrospective evaluation of device characteristics against pre-defined engineering and regulatory standards, rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Bench testing typically relies on engineers and technicians to execute tests and interpret results against established specifications, rather than clinical experts establishing a "ground truth" in the same way it would be done for diagnostic AI.
4. Adjudication Method for the Test Set
This information is not provided. Bench testing is usually less about adjudication and more about objective measurements against pre-defined pass/fail criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (a stent and its delivery system), not an AI algorithm. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm or AI was not done. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the bench testing, the "ground truth" was established by predetermined technical specifications, engineering standards (e.g., ASTM standards), and regulatory guidance (FDA's Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents). The device's performance was measured against these objective, quantitative criteria.
8. The Sample Size for the Training Set
This information is not applicable/not provided. There is no mention of a "training set" as this is a physical medical device and not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as point 8.
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Cook Ireland Evolution® Biliary Stent System
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Page 8 of 87
Section 5.0 510(k) Summary
| Name: | Cook Ireland Ltd | MAR 1 2013 | |
|---|---|---|---|
| Address: | O'Halloran RoadNational Technology ParkLimerick, Ireland | ||
| Phone: | 011 353 61 334440 | ||
| Fax: | 011 353 61 239293 | ||
| Contact Persons: | Jacinta Kilmartin, Regulatory Affairs SpecialistSinead Burke, Regulatory Affairs Manager | ||
| Date: | May 11, 2012 | ||
| Trade Name: | Evolution® Biliary Stent System | ||
| Common Name: | Biliary Stent System | ||
| Classification Name: | Catheter, biliary, diagnostic (21 CFR 876.5010, ProductCode: FGE) | ||
| Predicate Devices: | Boston Scientific Wallflex™ Biliary RX Stent System(Uncovered) (K061231 and K081733) and the Wallstent™RX Biliary Endoprosthesis Stent System (Uncovered)(K012752 and K030107). | ||
| Description of theDevice: | Stent Description:This flexible, self-expanding stent is constructed of nitinol wirewith a radiopaque core. Both ends of the stent have an increaseddiameter called flanges intended to provide resistance tomigration. The total length of the stent in its collapsed state isindicated by radiopaque markers on the inner catheter assembly.The stent is provided in either of two body diameters 8mm or10mm and in the following lengths 4, 6, 8 or 10cm |
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| Stent Delivery System Description: | The stent is mounted on an inner catheter, which accepts a0.035" wire guide and is constrained by an outer sheath. Apistol-grip delivery handle allows stent deployment or recapture.The introducer sheath diameter is 8.5Fr and the working lengthis 200cm. |
|---|---|
| Indications for use: | This device is used in palliation of malignant neoplasms inthe biliary tree. |
| Comparison ofCharacteristics: | The Evolution® Biliary Stent System is substantiallyequivalent to the currently marketed predicate devices, BostonScientific Wallflex™ Biliary RX Stent System (Uncovered)(K061231 and K081733) and the Wallstent™ RX BiliaryEndoprosthesis Stent System (Uncovered) (K012752 andK030107).The proposed device shares many technologicalcharacteristics with at least one of the predicate devices (orfall within the range of predicates) in terms of the following:Stents: Materials, Stent type, Stents supplied preloaded on the stent delivery system, Ability to be visualised under fluoroscopy, Dimensions, Intended for permanent implantation, Expanded stent ends. Stent Delivery System: Allows placement using fluoroscopic and endoscopic techniques, Allows deployment using a coaxial catheter system, Wire guide port on outer sheath, Compatibility with 0.035" wire guides, Allows stent recapture during the deployment process. Intended Use. All are intended for single use only and are supplied sterile |
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Differences include different stent delivery system materials and dimensions.
Performance Data: Performance (bench) testing was carried out to determine the equivalence of the Evolution® Biliary Stent System to the predicate devices and to verify the safety and effectiveness of the device.
Performance Testing-Bench:
The bench testing was conducted in accordance with various applicable ASTM standards and in accordance with FDA's Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents. The following bench tests were carried out: deployment, expansion force, compression force, dimensions, corrosion, joint strength, MRI and shelf life testing. The bench testing was successfully completed. Results of the testing provide reasonable assurance that the Evolution® Biliary Stent System will function as intended. Biocompatibility:
Biocompatibility testing in compliance with ISO 10993-1 and FDA's Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents supports the safety of the Evolution® Biliary Stent System.
K121430
pg 3 of 3
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Image /page/3/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 eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2013
Cook Ireland, Ltd. % Ms. Jacinta Kilmartin, Regulatory Affairs Specialist O'Halloran Road National Technology Park LIMERICK IRELAND
Re: K121430
Trade/Device Name: Evolution® Biliary Stent System Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: February 22, 2013 Received: February 25, 2013
Dear Ms. Kilmartin:
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.
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Page 2 - Ms. Jacinta Kilmartin
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Christy L. Foreman
Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K121430
Device Name: Evolution® Biliary Stent System
Indications For Use: This device is used in palliation of malignant neoplasms in the biliary tree
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin F 2013.02.26 18 :46:00 -05'00'
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and | |
| Urological Devices | |
| 510(k) Number | K121430 |
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.