(207 days)
The Cook Zilver® 635" Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.
The Zilver® 635" Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
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 marker at the distal end of the delivery system, allow precise positioning of 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 and 80 mm. The 100, 120, and 140 mm length stents are an addition to this product line.
The provided text is a 510(k) summary for a medical device (Zilver® 635™ Biliary Stent System), not an AI/ML device. Therefore, it does not contain information related to acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or ground truth establishment relevant to an AI/ML study.
The document discusses the substantial equivalence of the Zilver® 635™ Biliary Stent to predicate devices based on intended use, materials, and technological characteristics. It also details physical tests performed on the device to ensure reliable design and performance.
Here's an attempt to answer the questions based on the physical device testing mentioned, acknowledging that it's not an AI/ML study:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list quantitative acceptance criteria in a table format. It states that the device was subjected to tests "to assure reliable design and performance under the specified testing parameters." 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." This implies that the device met the unstated acceptance criteria for each test.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Deployment Profile met specifications | Reliable deployment profile confirmed |
| Deployment accuracy met specifications | Deployment accuracy confirmed |
| Stent length and change due to deployment met specifications | Stent length/change due to deployment confirmed as acceptable |
| Stent diameter met specifications | Stent diameter confirmed as acceptable |
| Uniformity of expansion met specifications | Uniformity of expansion confirmed |
| Stent integrity met specifications | Stent integrity confirmed |
| Radial force met specifications (sufficient for biliary stenting) | Radial force confirmed as providing reliable design and performance |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes (number of stents) used for each physical test. It only mentions "The Zilver® 635" Biliary Stent was subjected to the following tests..." This is typical for physical device testing where a sufficient number of units are tested to demonstrate consistency and compliance.
The data provenance is internal to Cook Incorporated, likely conducted in their facilities in the USA. These would be prospective physical tests, not data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to the provided document. Ground truth, in the context of AI/ML, refers to labels derived from expert review of patient data. Here, the "ground truth" would be the engineering specifications and performance requirements for the physical stent, established by Cook's engineering and quality teams, not by medical experts reviewing patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies or expert review of data. These were physical engineering tests, where results are measured against predefined specifications, not adjudicated by a panel.
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
Not applicable. This is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for these physical tests would be the engineering specifications and performance requirements set for the device. For example, a stent must deploy within a certain profile, have a specific radial force, and maintain integrity. These are not derived from expert consensus on medical images, pathology, or patient outcomes, but from design documents and industry standards for medical devices.
8. The sample size for the training set
Not applicable. There is no AI/ML model, and thus no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model, and thus no ground truth for a training set.
In summary: The provided 510(k) summary is for a physical medical device (a stent) and details physical performance tests against design specifications, not an AI/ML system's diagnostic or predictive performance. Therefore, most of the requested information regarding AI/ML study design and metrics is not present in the document.
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510(k) Summary
Submitted By:
Joey Schilling, MBA Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235
May 5, 2008
Device:
Trade Name: Proposed Classification: Zilver® 635™ Biliary Stent Catheter, Biliary, Diagnostic
Indications for Use:
The Cook Zilver® 635" Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.
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 marker at the distal end of the delivery system, allow precise positioning of 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 and 80 mm. The 100, 120, and 140 mm length stents are an addition to this product line.
AUG - 1 2008
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K080037
PAGE 2 OF 2
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 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:
- ﺎﺳﺘﻨ Deployment
- a. Profile
- b. Deployment accuracy
- Stent length and change due to deployment C.
- Stent diameter d.
- Uniformity of expansion e.
- f. Stent integrity
-
- Radial force
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a globe, signifying the department's mission to protect and enhance the health and well-being of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2008
Joey Schilling, MBA, EMT-P Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 BLOOMINGTON IN 47402-0489
K080037 Re: Trade/Device Name: Zilver® 635" Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: July 25, 2008 Received: July 28, 2008
Dear Mr. Schilling:
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 - Mr. Joey Schilling
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,
Sutte Y. Michien Dmd. FOR DR. TILLMAN
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: K080037
Device Name: Zilver® 635™ Biliary Stent System
FDA's Statement of the Indications for Use for device:
The Zilver® 635" Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
Prescription Use X (Per 21 CFR 801.109) OR
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: 1000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Over-the-Counter Use
Herbert Lewin
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 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.