(15 days)
The Cook Zilver® 518 TM Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.
The Zilver® 518™ Biliary Stent with a diameter of 10 mm is a self-expanding, nitinol stent designed for superior 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® 518" Billary Stent, along with radiopaque markers on the delivery system, allow precise positioning of the stent's interconnected Zshaped seqments also keep foreshortening to a minimum.
The Zilver® 518" Biliary Stent comes preloaded in a 5 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is currently available in unrestrained outer diameters of 4, 5, 6, 7, 8, and 9mm and in lengths of 20, 30, 40, 50 and 60 mm. The 10 mm diameter stent is an addition to this product line.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Zilver® 518™ Biliary Stent.
It's important to note that this document is a 510(k) summary for a medical device (stent), not a diagnostic AI/ML device. Therefore, the concepts of "experts establishing ground truth," "adjudication methods," "MRMC studies," "standalone algorithms," "training sets," and "data provenance" (in the context of clinical images/data for AI) are not directly applicable to this type of device submission. Instead, the "acceptance criteria" here refer to engineering and performance specifications, and the "study" is a series of mechanical and physical tests demonstrating these specifications are met.
Device: Zilver® 518™ Biliary Stent
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list numerical acceptance criteria with corresponding numerical performance results in a table format. However, it indicates the types of tests performed to assure reliable design and performance. The "performance" is implicitly stated as having "conformance to the requirements for its use as a biliary stent."
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Deployment Characteristics | |
| - Profile | Conforms to specified requirements for safe and effective deployment |
| - Deployment Accuracy | Achieves precise positioning |
| - Stent length and Change due to Deployment | Minimizes foreshortening; maintains specified length post-deployment |
| - Stent Diameter | Achieves specified diameter upon deployment |
| - Uniformity of Expansion | Provides circumferential scaffolding throughout the stent's length |
| - Stent Integrity | Maintained during and after deployment |
| - Ease of Deployment | Deployed with a simple handheld device |
| Mechanical Properties | |
| - Radial Force | Provides superior radial strength |
| - Longitudinal Flexibility | Achieves optimal longitudinal flexibility |
| Structural Integrity | |
| - Finite Element Analysis | Demonstrated reliable design and performance under specified parameters |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact number of stents or test iterations used for each test. It refers to "the Zilver® 518™ Biliary Stent was subjected to the following tests."
- Data Provenance: Not applicable in the context of clinical data for AI. These are laboratory/bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" for this device is established by engineering specifications, physical measurements, and possibly simulated use, not by clinical expert consensus on interpreting images or patient conditions.
4. Adjudication method for the test set
Not applicable. This concept applies to expert review of clinical cases, not mechanical device testing.
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 a medical device (stent), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (stent), not an AI algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on engineering specifications and physical-mechanical measurements. For example, the "ground truth" for radial force would be a specific predefined value or range that the stent must demonstrate in a laboratory setting. Similarly, for deployment accuracy, the "ground truth" would be the measured deviation from the intended deployment location.
8. The sample size for the training set
Not applicable. This concept applies to AI/ML models. For medical devices, there isn't a "training set" in the computational sense, but rather a design and development process that involves iterative testing and refinement.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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510(k) Summary
001 1 - 2004
30
K042518
Page 1 of 2
Submitted By:
Leland Keyt Regulatory Affairs Coordinator Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235
September 16, 2004
Device:
| Trade Name: | Zilver® 518™ Biliary Stent |
|---|---|
| Proposed Classification: | Catheter, Biliary, Diagnostic |
Predicate Devices:
The Zilver® 518™ Biliary Stent is similar in terms of intended use, materials of constructions and technological characteristics to predicate devices reviewed as devices for palliation of malignant neoplasm in the biliary tree.
Device Description:
The Zilver® 518™ Biliary Stent with a diameter of 10 mm is a self-expanding, nitinol stent designed for superior 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® 518" Billary Stent, along with radiopaque markers on the delivery system, allow precise positioning of the stent's interconnected Zshaped seqments also keep foreshortening to a minimum.
The Zilver® 518" Biliary Stent comes preloaded in a 5 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is currently available in unrestrained outer diameters of 4, 5, 6, 7, 8, and 9mm and in lengths of 20, 30, 40, 50 and 60 mm. The 10 mm diameter stent is an addition to this product line.
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Substantial Equivalence:
31
K042518
Page 2 of 2
This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Incorporated. This device will undergo sterilization similar to the 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® 518™ 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
- a. Profile
- b. Deployment Accuracy
- c. Stent length and Change due to Deployment
- d. Stent Diameter
- e. Uniformity of expansion
- Stent Integrity ت
- g. Ease of Deployment
-
- Radial Force
-
- Finite Element Analysis
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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top and sides. Inside the circle is a stylized symbol that resembles a caduceus, with three parallel lines that curve and intersect, representing the human services aspect of the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 2004
Ms. Leland Keyt Regulatory Affairs Coordinator Cook, Incorporated 750 Daniels Way, P.O. Box 489 BLOOMINGTON IN 47402
Re: K042518
Trade/Device Name: Cook Zilver® 518™ Biliary Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: September 15, 2004 Received: September 16, 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 nrior 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. Leland Keyt
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device 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 I lease be advised mar 1211 b tabaniso ur device complies with other requirements of the Act or any FDA has made a decemination administered by other Federal agencies. You must comply with all rederal statutis and regulations administ limited to: registration and listing (21 CFR Part 807); lile Act s requirements, mendanturing practice requirements as set forth in the quality labeling (21 CFR Part 801); and if applicable, the electronic product radiation systems (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 The FDA Initing of substantial equirater and permits your device to proceed to the market. This results in a classification for 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. Flease note that the above mooning minute of in the a very of the from the device's labeling.
If you desire specific information about the application of other labeling requirements to your device IT you desire spective miorination as a ffice of Compliance at (301) 594-4616. Also, please note (21 CFR Part 0017), prease observed 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 1 ou may outlif onto gottore, 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,
Sincerely yours,
Dale R. Tiller, Ph.D.
Donna-Bea Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1 of 1
510(k) Number: K042518
Device Name: Cook Zilver® 518TM Biliary Stent
FDA's Statement of the Indications For Use for device:
The Cook Zilver® 518 TM 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 _________________________________________________________________________________________________________________________________________________________
Daniel A. Lynn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
S(k) Number K642-518
§ 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.