Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set

K172057 · Cook Ireland, Ltd. · FGE · Mar 9, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K172057
• Device Name: Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
• Applicant: Cook Ireland, Ltd.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Mar 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stents: Zimmon® Pancreatic Stent/Stent Sets, Geenen® Pancreatic Stent/Stent Sets and Johlin® Pancreatic Wedge Stent and Introducer. This device is used to drain obstructed pancreatic ducts. Stent Introducers: Guiding Catheter and Pushing Catheter. This device is used for endoscopic pancreatic stent placement.

Device Story

Polymeric pancreatic stents and introducer systems (guiding/pushing catheters) used for endoscopic drainage of obstructed pancreatic ducts. Stents feature anti-migration designs (pigtails, flaps, bends), side-ports for drainage, and radiopaque markers. Introducers facilitate placement over a wire guide under fluoroscopic and endoscopic monitoring. Used by physicians in clinical settings for short-term indwell (up to 3 months). Stents are deployed to relieve obstruction, improving ductal drainage and patient outcomes. Components include flap protectors for endoscope insertion. Devices are single-use and sterile.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993-1), simulated use, dimensional/visual verification, flow rate, tensile strength, radiopacity, MRI compatibility, and shelf-life testing.

Technological Characteristics

Polymeric pancreatic stents and catheters. Sizes: 3Fr to 11.5Fr; lengths: 2cm to 25cm. Features: anti-migration (pigtails, flaps, bends), side-ports, radiopaque bands, tapered/buffed tips. Sterile, single-use. Deployment: endoscopic over wire guide under fluoroscopy. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients requiring drainage of obstructed pancreatic ducts. For professional use only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Cook Zimmon Endoscopic Pancreatic Stent (K900923)
• Wilson-Cook Pancreatic Wedge Stent (K990130)

Submission Summary (Full Text)

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March 9, 2018

Cook Ireland Ltd. Orla Gunning Regulatory Affairs Specialist O' Halloran Road, National Technology Park, Limerick Ireland

Re: K172057

> Trade/Device Name: Zimmon® Pancreatic Stent/Stent sets, Geenen® Pancreatic Stent Sets, Johlin® Pancreatic Wedge Stent and Introducer, Guiding Catheter and Pushing Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE Dated: February 22, 2018 Received: February 26, 2018

Dear Orla Gunning:

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. 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.

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.

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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); 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.

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.

For comprehensive regulatory information about medical devices and radiation-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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Charles Viviano -S

For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172057

### Device Name

Zimmon® Pancreatic Stent/Stent sets, Geents/ Stents/ Stent Sets, Johlin® Pancreatic Wedge Stent and Introducer, Guiding Catheter and Pushing Catheter

Indications for Use (Describe)

Stents: Zimmon® Pancreatic Stent/Stent Sets, Geenen® Pancreatic Stent/Stent Sets and Johlin® Pancreatic Wedge Stent and Introducer.

This device is used to drain obstructed pancreatic ducts.

Stent Introducers: Guiding Catheter and Pushing Catheter. This device is used for endoscopic pancreatic stent placement.

| 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# Section 5: 510(k) Summary

#### I. SUBMITTER

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

Phone: [phone] Fax: [phone]

Contact Persons: Orla Gunning, Regulatory Affairs Specialist Jacinta Kilmartin, Regulatory Affairs Manager

Phone: [phone] Fax: [phone]

Date Prepared: March 06, 2018

#### II. DEVICE

Trade Name of Device: Zimmon® Pancreatic Stents/Stent sets, Geenen® Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin® Pancreatic Wedge Stent and Introducer

The model numbers are GEPD, GPDS, GPSO, GPSOS, GPSO-SF, GPSOS-SF, JPWS, SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS, GC and PC.

Common or Usual Name: Drainage Catheter

Classification Name: Biliary, Catheter and Accessories (21 CFR 876.5010)

Regulatory Class: II

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K172057 Page 2 of 4

Product Code: FGE

#### III. PREDICATE DEVICE

Cook Zimmon Endoscopic Pancreatic Stent cleared under 510(k): K900923 cleared on October 26. 1990

Wilson-Cook Pancreatic Wedge Stent (K990130 - cleared on February 12, 1999)

### IV. DEVICE DESCRIPTION

The intended use of all Cook pancreatic stents is to drain obstructed pancreatic ducts. A variety of stents in different sizes are available across the device range to accommodate various patient anatomies, the size and location of the obstruction and physician preference. They are offered in French sizes of between 3Fr and 11.5Fr, and in labelled lengths of between 2cm and 25cm.The subject devices and their components can be supplied as stent only, introducer only (guiding or pushing catheter) or as stent sets combining stent and introducers/introducer systems.

The stent sets can contain one or several of the following stent placement components; a flap protector, a guiding catheter, a pushing catheter or a dedicated introducer system. The flap protector is provided with stents that have duodenal flap-type anti-migration features, and is used to collapse the flap(s) on the device as it is introduced into the working channel of the endoscope. The function of the guiding catheter is to guide the pancreatic stent as part of its introduction to its intended location. The guiding catheter also has a Hub that allows for contrast injection. The function of the Pushing Catheter is to advance the stent, over a prepositioned wire guide or Guiding Catheter, to its intended location within the anatomy, and to maintain the position of the Stent as it being deployed. The stents are polymeric and some of the stents have radiopaque bands. The stent designs include anti-migrational features such as duodenal pigtails, duodenal bends and ductal and duodenal flaps. To facilitate stent insertion and removal the stent ends are tapered or buffed. Side-ports on the pancreatic stents assist in drainage. All stents are deployed endoscopically over a guide wire in the same manner under fluoroscopic and endoscopic monitoring.

These Cook pancreatic stents are all for professional use and are provided sterile. They are all intended for short-term use and have an indicated indwell of up to 3 months.

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### V. INDICATIONS FOR USE

Stents: Zimmon® Pancreatic Stent/Stent Sets. Geenen® Pancreatic Stent/Stent Sets and Johlin® Pancreatic Wedge Stent and Introducer.

This device is used to drain obstructed pancreatic ducts.

Stent Introducers: Guiding Catheter and Pushing Catheter. This device is used for endoscopic pancreatic stent placement.

There are minor differences in the indications for use statement compared to the subject device: however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. The subject and predicate devices have the same intended use for drainage of obstructed pancreatic duct.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH A VI. PREDICATE DEVICE

# The similarities between the predicate devices and subject devices can be summarized as follows:

- -Both the subject devices and predicates share stent set components
- Both the subject device and predicates share stent dimensions -
- -Both the subject devices and predicates share design features such as anti migration and side ports
- -Both the subject devices and predicates share stent and introducer material types.
- -Both the subject devices and predicates share introduction system dimensions
- Both subject devices and predicates have the same regulation number, regulation description, FDA classification code and class
- Both the subject devices and predicates have the same intended use -
- -Both subject devices and predicates are used in the same anatomical site
- -Both subject devices and predicates devices are sterile
- Both subject devices and predicates devices have the same sterilization method -
- Both subject stents are visible under fluoroscopy -
- -Both subject devices and predicates devices have an atraumatic tip design
- Both subject devices and predicates devices are for professional use -
- Both subject devices and predicate devices are single use -

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- -Both subject devices and predicate devices have the similar or the same method of placement and deployment
# The differences between the predicate devices and subject devices can be summarized as follows:

- Components Supplied -
- -Stent Dimensions
- -Introducer Dimensions
- Anti-migration features -
- Atraumatic tip -
- -Side ports
- -Stent Materials
- -Introducer Materials

#### VII. PERFORMANCE DATA

The biocompatibility evaluation for the Cook Pancreatic Stents, Introducers and Sets was conducted in accordance with the FDA's Use of International ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16, 2016 and International Standard ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (ISO10993-1:2009).

Testing performed included simulated use, dimensional and visual verification, flow rate, tensile, radiopacity, MRI and shelf life testing. Testing was performed as per Cook Ireland's design control system.

#### CONCLUSIONS VIII.

The non-clinical data supports the safety of the subject device and demonstrates that the Pancreatic stents. Introducers and sets are safe and effective and perform as intended in the specified use conditions. This non-clinical data supports the substantial equivalence of Cook Pancreatic Stents, Introducers and Sets to the predicate devices.