The Zilver® 518 and 635101 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 Full deployment of the stent occurs when the distal end of the sheath has been retracted past the proximal end of the stent.

AI/ML Overview

The provided text is a 510(k) summary for the Zilver® 518 and 635TM Biliary Stent. It describes the device, its intended use, comparison to predicate devices, and performance data. However, it does not contain explicit "acceptance criteria" or a detailed "study that proves the device meets the acceptance criteria" in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, AUC, human reader studies).

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through:

Technological Characteristics Comparison: Showing the new device is identical or within the range of the predicate, with minor changes like material formulation modification, change from MR Safe to MR conditional, and consolidation of Instructions for Use.
Performance Data: This section details non-clinical testing for biocompatibility and MRI compatibility. It does not include clinical performance metrics, accuracy, or diagnostic effectiveness against a ground truth.

Therefore, many of the requested items in your prompt are not applicable or cannot be extracted from this specific document, as it pertains to a traditional medical device (biliary stent) and its 510(k) clearance process, not an AI/ML device.

Here's an attempt to answer your questions based solely on the provided text, noting where information is absent:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate devices and by meeting relevant biocompatibility and MRI safety standards. There are no performance metrics like sensitivity, specificity, F1-score, or similar clinical effectiveness measures reported for this device's function as a stent in this document.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: In accordance with ISO 10993-1: 2009.	Biocompatibility evaluation conducted and found compliant.
MRI Safety/Compatibility: Adherence to FDA guidance and ASTM standards for magnetic field interactions, radiofrequency induced heating, and magnetic resonance image artifact.	MRI testing conducted in accordance with ASTM F2052-15, ASTM F2213-06 (2011), ASTM F2182-11a, and ASTM F2119-07 (2013). Device changed from "MR Safe" to "MR Conditional".
Mechanical Performance: Non clinical joint tensile testing (as per Cook Ireland's design control system).	Performed; "no impact to the original testing conducted on the predicate device as a result of this modification."
Similar Technological Characteristics to Predicate Devices: Intended use, deployment method, materials, design, dimensions, delivery system, sterilization, etc.	Device confirmed to be identical/within the range of predicate devices for all specified characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The reported studies are non-clinical (biocompatibility, MRI safety, mechanical testing on samples of the device itself) and do not involve patient data or test sets in the context of an AI/ML device.

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)

Not applicable. This device is a physical medical device (stent), and its evaluation did not involve establishing ground truth from experts for diagnostic purposes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of device and evaluation.

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.

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 consensus, pathology, outcomes data, etc)

Not applicable. The performance data for this device focuses on physical properties, biocompatibility, and MRI compatibility rather than diagnostic accuracy against a ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, arranged in a way that they resemble a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 7, 2017

Cook Ireland Ltd. Charlene Ryan Regulatory Affairs Specialist O Halloran Road, National Technology Park Limerick Ireland

Re: K163169

Trade/Device Name: Zilver® 518 and 635TM Biliary Stent Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE Dated: November 10, 2016 Received: November 14, 2016

Dear Charlene Ryan:

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. 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.

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 device's labeling:

The safety and effectiveness of this device for use in the vascular system have not been established

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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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Image /page/2/Picture/4 description: The image shows the name "John W. Sheets Jr-S" in a simple, sans-serif font. The text is black and appears to be printed on a white background. The letters are evenly spaced and the name is presented in a straightforward manner.

John W. Sheets Jr., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163169

Device Name Zilver® 518 and 635 TM Biliary Stent

Indications for Use (Describe)

The Zilver 518 and 635 Biliary Stent are indicated for use in palliation of malignant neoplasms in the billary 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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Section 8: 510(k) Summary

SUBMITTER I.

Cook Ireland Ltd. O'Halloran Road National Technology Park Limerick, Ireland

Phone: +353 61 334440 Fax: +353 61 239293

Contact Persons: Charlene Ryan, Regulatory Affairs Specialist Tracy O' Sullivan, Regulatory Affairs Manager

Phone: +353 61 334440 Fax: +353 61 239293

Date Prepared: November 8th ,2016

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.

Prefix: ZIB5 and ZIB6

Common or Usual Name: Biliary Stent Classification Name: Stent, Metallic, Expandable, Biliary Catheters and accessories (21 CFR 876.5010)

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Regulatory Class: II

Product Code: FGE

III. PREDICATE DEVICE

Predicate: Zilver® 518™ Biliary Stent (ZIB5) cleared under the following 510(k)s:

Zilver® 518™ Biliary Stent (ZIB5):

K033348, on December 15th, 2003 K042518, on October 1st, 2004 K050698, on March 30th, 2005

Predicate: Zilver® 635™ Biliary Stent (ZIB6) cleared under the following 510(k)s: Zilver® 635™ Biliary Stent (ZIB6): K040505, on March 16th, 2004 K043481, on December 29th, 2004 K051124, on July 12th, 2005

The predicate devices detailed above have not been subject to a design related recall.

DEVICE DESCRIPTION IV.

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The stent is placed using fluoroscopic and percutaneous techniques.

V. INDICATIONS FOR USE

The Zilver® 518™ and 635™ Biliary Stent are indicated for use in palliation of malignant neoplasms in the biliary tree.

COMPARISON OF TECHNOLOGICAL CHARACETERISTICS WITH A VI. PREDICTE DEVICE

The subject device is substantially equivalent to the currently marketed device, the Zilver® 518 and 635 TM Biliary Stent (ZIB5/ZIB6), cleared under:

Zilver® 518™ Biliary Stent (ZIB5):

K033348, on December 15th, 2003 K042518, on October 18t, 2004 K050698, on March 30th, 2005

Zilver® 635™ Biliary Stent (ZIB6):

K040505, on March 16th, 2004 K043481, on December 29th, 2004 K051124, on July 12th, 2005

In brief,

The ZIB5 subject device is identical to/ within the range of the Zilver® 518™ Biliary Stent, cleared under K050698 , with respect to the following:

Both devices have the same intended use ।
Both devices are for use in the biliary tree ।
-The method of deployment for both devices is identical using a co-axial introducer system.
Both devices are supplied with the stent pre-loaded onto an introducer system. |
-The stent in both devices are placed using percutaneous and fluoroscopic techniques.
-Both devices contain radiopaque markers on the delivery system and the stent

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-The stent placement configuration for both devices allow single and overlapping placement
-The stent material of both devices is composed of Nitinol with gold radiopaque markers.
। Both devices use a laser cut and self-expanding stent design.
-The stent diameters and lengths applicable are identical to both devices.
-The delivery system lengths available are identical to both devices
Both delivery system outer diameter is 5Fr (1.67mm) -
-Both delivery systems are compatible with a 0.018" wire guide
| Both devices are intended for single use only
-Both devices are supplied with a syringe of the same volume
-Both devices are intended for permanent implantation
Both devices are supplied sterile |
The method of sterilisation is identical for both devices -

The ZIB6 subject device is identical to/ within the range of the Zilver® 635™ Biliary Stent, cleared under K051124 , with respect to the following:

। Both devices have the same intended use
। Both devices are for use in the biliary tree
The method of deployment for both devices is identical using a co-axial introducer system. -
Both devices are supplied with the stent pre-loaded onto an introducer system. ।
-The stent in both devices are placed using percutaneous and fluoroscopic techniques.
-Both devices contain radiopaque markers on the delivery system and the stent
-The stent placement configuration for both devices allow single and overlapping placement
-The stent material of both devices is composed of Nitinol with gold radiopaque markers.
Both devices use a laser cut and self-expanding stent design. |
-The stent diameters and lengths applicable are identical to both devices.
-The delivery system lengths available are identical to both devices
-Both delivery system outer diameter is 6Fr (2.0mm)
-Both delivery systems are compatible with a 0.035" wire guide
Both devices are intended for single use only |
-Both devices are supplied with a syringe of the same volume
-Both devices are intended for permanent implantation
Both devices are supplied sterile |
The method of sterilisation is identical for both devices -

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The following differences exist between the subject devices (ZIB5/ZIB6) and the predicates, K050698 and K051124 respectively:

1. Material formulation modification of Acrylonitrile Butadiene Styrene.
1. MR Safe to MR Conditional
1. Consolidation of the Instructions for Use

VII. PERFORMANCE DATA

The biocompatibility evaluation for the ZIBS and ZIB6 devices was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" as recognised by FDA and FDA's biocompatibility guidance, "Use of International Standard ISO10993, Biological evaluation of Medical Devices Part 1: Evaluation and testing (June 16, 2016)".

FDA issued guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued on December 11th, 2014 was consulted in preparation for this premarket submission. MRI testing was conducted to evaluate the magnetic field interactions, radiofrequency induced heating and magnetic resonance image artifact for the ZIB5 and ZIB6 devices in accordance with ASTM F2052-15, ASTM F2213-06 (2011), ASTM F2182-11a and ASTM F2119-07 (2013) respectively.

The device specific guidance document was consulted in preparing this premarket submission, Guidance for the content of premarket notifications for metal expandable Biliary stents. Performance testing such as non clinical joint tensile testing was performed as per Cook Ireland's design control system; there is no impact to the original testing conducted on the predicate device as a result of this modification.

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CONCLUSIONS VIII.

Non-clinical testing carried out on the device supports the substantial equivalence of the ZIB5 and ZIB6 product to the predicate device and provides a reasonable assurance of safety and effectiveness and should perform as intended in the specified use conditions.

Regulation Number and Section

§ 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.