(246 days)
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.
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.
This document is a 510(k) summary for the Zimmon® Pancreatic Stent/Stent sets, Geenen® Pancreatic Stent Sets, Johlin® Pancreatic Wedge Stent and Introducer, Guiding Catheter, and Pushing Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving device performance against those criteria in the way a clinical trial might.
Therefore, much of the requested information regarding acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy), sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details, is not present in this regulatory submission for a Class II medical device.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for diagnostic or clinical performance (e.g., sensitivity, specificity) because these are drainage stents, not diagnostic AI devices. Instead, it details performance testing conducted to ensure safety and effectiveness of the device itself.
| Acceptance Criterion (Type of Test) | Reported Device Performance / Evaluation |
|---|---|
| Biocompatibility | Evaluated in accordance with ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (FDA's June 16, 2016 guidance and ISO10993-1:2009). The non-clinical data supports the safety of the subject device. |
| Simulated Use | Testing was performed as per Cook Ireland's design control system. Subject device performs as intended in specified use conditions. |
| Dimensional Verification | Testing was performed as per Cook Ireland's design control system. |
| Visual Verification | Testing was performed as per Cook Ireland's design control system. |
| Flow Rate | Testing was performed as per Cook Ireland's design control system. |
| Tensile Strength | Testing was performed as per Cook Ireland's design control system. |
| Radiopacity | Testing was performed as per Cook Ireland's design control system. Stents are visible under fluoroscopy. |
| MRI Compatibility | Testing was performed as per Cook Ireland's design control system. |
| Shelf Life | Testing was performed as per Cook Ireland's design control system. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of device performance in a clinical diagnostic sense. The document refers to engineering and biocompatibility testing, not clinical trials with patient data test sets. The sample sizes for the various engineering tests (e.g., tensile, flow rate) are not specified.
- Data Provenance: Not applicable for this type of submission. The tests are described as engineering and biocompatibility evaluations performed according to Cook Ireland's design control system, implying lab-based testing rather than clinical data from specific countries.
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 stent, not an AI or diagnostic algorithm that relies on expert interpretation for ground truth. Ground truth for engineering tests is based on objective measurements against specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation in diagnostic studies with AI). This document describes objective engineering and biocompatibility tests.
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-assisted diagnostic device. It's a pancreatic stent.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical testing described, the "ground truth" would be established by:
- Biocompatibility: Adherence to established international standards (ISO 10993-1).
- Engineering Tests (Simulated use, dimensional, flow rate, tensile, radiopacity, MRI, shelf life): Objective measurements against pre-defined engineering specifications and performance requirements established internally by Cook Ireland Ltd. during their design control process.
8. The sample size for the training set
Not applicable. This refers to an AI training set, which is not relevant to this medical stent.
9. How the ground truth for the training set was established
Not applicable. This refers to an AI training set, which is not relevant to this medical stent.
Summary of Device Performance and Substantial Equivalence:
The core of this 510(k) submission is to demonstrate substantial equivalence to predicate devices (Cook Zimmon Endoscopic Pancreatic Stent K900923 and Wilson-Cook Pancreatic Wedge Stent K990130).
The "study" referenced in the document is the non-clinical performance data collected through various engineering and biocompatibility tests:
- Biocompatibility: Evaluated according to ISO 10993-1.
- Physical/Mechanical Testing: Included simulated use, dimensional and visual verification, flow rate, tensile strength, radiopacity, MRI compatibility, and shelf-life testing. These tests were performed as per Cook Ireland's design control system.
Conclusion from the document: The non-clinical data collected supports the safety and effectiveness of the subject device (the various pancreatic stents and introducers) and demonstrates that they perform as intended in the specified use conditions. This data is used to support the claim of substantial equivalence to the predicate devices. The "acceptance criteria" for these tests would be internal engineering specifications that the device must meet to function safely and effectively and to be considered similar to the predicate.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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Section 5: 510(k) Summary
I. SUBMITTER
Cook Ireland Ltd. O' Halloran Road National Technology Park Limerick Ireland
Phone: +353 61 334440 Fax: +353 61 239293
Contact Persons: Orla Gunning, Regulatory Affairs Specialist Jacinta Kilmartin, Regulatory Affairs Manager
Phone: +353 61 334440 Fax: +353 61 239293
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.
§ 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.