The Nasal Pancreatic Drainage Set consists of a drainage catheter, nasal transfer tube and drainage connecting tube. The drainage catheter has flaps, side ports and a touby-borst connector. The drainage catheter flaps are located at the distal end of the catheter. The flaps help prevent migration hereby helping the drainage catheter to remain in the desired position. The side ports, also located the distal end of the drainage catheter, these help assist in drainage of pancreatic fluid. The touhy borst connector allows connection of the drainage catheter to the drainage connection tube; it also allows the drainage catheter to be flushed. The drainage connection tube allows the drainage catheter to be connected to a drainage collection bag. In the middle of the drainage connecting tube is a three way stopcock; this allows a flow through the drainage connecting tube during the procedure. The nasal transfer tube enables the drainage catheter to be threaded through the oral cavity and out through the nostril. The drainage catheter contains radiopaque material which allows the user to ensure the drainage catheter is accurately positioned using fluoroscopically.

AI/ML Overview

The provided document describes the acceptance criteria and performance data for the Cook Nasal Pancreatic Drainage Set (K171623), as determined through bench testing and biocompatibility evaluations.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Result
Biocompatibility Evaluation	Conducted in accordance with FDA's "Use of International Standard ISO 10993-1" (June 16, 2016) and ISO 10993-1:2009. Includes Cytotoxicity, Intracutaneous, Sensitization, Acute Systemic Toxicity, Systemic Toxicity, 4-week muscle implantation, Genotoxicity (Mouse Lymphoma Assay), Genotoxicity (Bacterial Reverse Mutation Study).	Successfully completed (no specific pass/fail for each individual test reported, but overall conclusion is "successfully completed").
Dimensional Verification & Simulated Use Testing (Time Zero and post-aging)	Dimensional verification as per the design parameters of the device. For simulated use testing, the device performs in line with the instructions for use.	All acceptance criteria were met. Pass
Drainage Catheter: Resistance to Collapse (Time Zero and post-aging)	Per EN 1617:1997¹. The test article does not collapse when exposed to a pressure not less than -10kPa for a period not less than 60 sec.	All acceptance criteria were met. Pass
Drainage Catheter: Flow Rate (Time Zero and post-aging)	Per EN 1618:1997². Minimum flow rate of 4 ml/min.	All acceptance criteria were met. Pass
Drainage Catheter: Tensile Testing (Time Zero and post-aging)	Per JIS T 3243³, EN 1618:1997², and EN 1617:1997¹. There shall be no breaks and cracks when subjected to a force of 4.9 N (5 Fr and 7 Fr catheters). Minimum force of 10N (7 Fr catheters).	All acceptance criteria were met. Pass
Leakage Testing	Per EN 1618:1997². At a test pressure of not less than 10kPa, there is no leakage from the test articles including their connection to a drainage collection bag.	All acceptance criteria were met. Pass
Radiopacity Testing	Per ASTM F640-12⁴. The drainage catheter is visible under fluoroscopy. Visibility of the Drainage catheter is equal to or greater than the visibility of the user-defined standard.	All acceptance criteria were met. Pass
MR Testing: Magnetically Induced Displacement Force	Per ASTM F2052-15⁵. Deflection Angle < 45°.	All acceptance criteria were met. Pass
MR Testing: Magnetically Induced Torque	Per ASTM F2213-06⁶ (2011). $\tau_{mag} < \tau_{grav}$.	All acceptance criteria were met. Pass
MR Testing: Electrical Conductivity	<1 S/m.	All acceptance criteria were met. Pass
MR Testing: MR Image Artifacts	Per ASTM F2119-07⁷ (2013). (For information only; no specific acceptance criteria given, implies it was evaluated and data collected).	All acceptance criteria were met. Pass
Sterile Barrier - Package Integrity Testing: Peel Strength (Time zero and post-aging)	Per ASTM F88/F88M-15⁸. The peel strength of the pouch seal is ≥ 1.2N/15mm seal width.	All acceptance criteria were met. Pass
Sterile Barrier - Package Integrity Testing: Bubble Leak Test (Time zero and post-aging)	Per ASTM F2096-11⁹. No stream of bubbles released from outer pouch during leak testing.	All acceptance criteria were met. Pass

2. Sample Sizes Used for the Test Set and Data Provenance

The document primarily describes bench testing and biocompatibility testing. For these types of tests, individual samples of the device components or finished product are used.

Sample Size: Not explicitly stated as a single number across all tests. Each test would have its own sample size, typically a small number of devices or components to demonstrate compliance with specifications. For example, "the test article" for resistance to collapse, flow rate, and leakage implies individual units were tested.
Data Provenance: The device manufacturer is Cook Ireland Ltd. The testing was performed as per Cook Ireland's design control system and in line with 21 CFR 820.30, including FDA recognized standards. This indicates the testing was conducted internally or by a contracted lab on behalf of Cook Ireland, likely in Ireland. This is prospective testing, as it's directly conducted to demonstrate the performance of the manufactured device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the type of studies described. The "ground truth" for bench tests and biocompatibility is established by objective measurements and standardized protocols (e.g., measuring force, flow rate, or observing cellular reactions), not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are not clinical trials or image interpretation studies requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not performed and is not mentioned in the document. The submission focuses on substantial equivalence based on technological characteristics and non-clinical performance data (bench and biocompatibility testing).

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not performed. This device is a physical medical device (catheter set), not an AI algorithm. Therefore, "algorithm only performance" is irrelevant.

7. Type of Ground Truth Used

Objective Measurement/Standardized Protocols: The "ground truth" for the performance criteria is defined by the objective quantitative or qualitative measurements specified in the referenced international standards (e.g., ISO, ASTM, EN, JIS) and Cook Ireland's design parameters. For biocompatibility, the ground truth is the biological response observed according to the specific test methods outlined in ISO 10993.

8. Sample Size for the Training Set

This information is not applicable. The document describes a traditional medical device (catheter set) where performance is established through physical and biological testing, not through machine learning or AI models that require training sets.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The address is likely for a specific department or office within the FDA.

July 31, 2017

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

Re: K171623

Trade/Device Name: Nasal Pancreatic Drainage Set Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE Dated: May 31, 2017 Received: June 2, 2017

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

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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.

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.

Benjamin R. Fisher -S

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) K171623

Device Name Nasal Pancreatic Drainage Set

Indications for Use (Describe)

This device is used for temporary endoscopic drainage of the pancreatic duct through the nasal passage by use of an indwelling catheter.

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: July 31, 2017

II. DEVICE

Trade Name of Device: Nasal Pancreatic Drainage Set The model numbers are NPDS-5 and NPDS-7.

Common or Usual Name: Drainage Catheter

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

Regulatory Class: II

Product Code: FGE

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III. PREDICATE DEVICE

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

Reference Device Number One: Cook Nasal Biliary Drainage Set cleared under 510(k) K896323 cleared on April 09, 1990

Reference Device Number Two: Boston Scientific Corporation, Advanix™ Pancreatic Stent and Naviflex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers cleared under 510(k) K133700 on May 14, 2014

DEVICE DESCRIPTION IV.

V. INDICATIONS FOR USE

This device is used for temporary endoscopic drainage of the pancreatic duct through the nasal passage by use of an indwelling catheter.

The indications for use statement for the subject device is not identical to the predicate 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 device have the same intended use for ductal drainage.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH A VI. PREDICATE DEVICE

The subject device is substantially equivalent to the currently marketed predicate, Cook Zimmon Endoscopic Pancreatic Stent cleared under the following 510(k): K900923 cleared on October 26, 1990.

In brief, the subject device has the same intended use and technological characteristics as the predicate, Cook Zimmon Endoscopic Pancreatic Stent with respect to the following:

Both devices have the same intended use for duct drainage. ●
. Both devices are for use in the pancreatic duct.
Both devices share diameter size.
Both devices share a material type
Both devices have anti migration features.
Both the drainage catheter of the subject device and the stent of the predicate device have side ports to assist drainage.
Both devices are visible under fluoroscopy (radiopaque).
Both devices are placed endoscopically over a wire guide.
Both sets are compatible with 0.035" wire guides.
Both devices are for professional use.
. Both devices are intended for single use only.
Both devices are supplied sterile and are sterilised using ethylene oxide. ●

The following technological differences exist between the subject device and the Cook Zimmon Endoscopic Pancreatic Stent, the predicate device:

Internal versus external drainage i)
ii) Components supplied
iii) Dimensions
iv) Features-flaps
v) Materials

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Cook's Endoscopic Nasal Biliary Drainage Set which was cleared under 510(k) K896323 on April 09, 1990 is being used as a reference device for this 510k submission (reference device number one).

The subject device and the first reference device share the following characteristics;

Both devices are used for external drainage. .
Both devices contain the following components; Drainage Catheter (with touhy-borst . connector), Nasal Transfer Tube and Drainage Connecting Tube.
Both devices share a common drainage catheter length (250cms).
Both devices share common drainage catheter diameters 5Fr and 7Fr.
Both devices share a common drainage catheter material.
Both devices have a Nasal Transfer Tube component of the same material. Both are ● 50cms in length.
Both devices share Drainage Connecting Tube material.

This legally marketed reference device provides technical information which helps address the safety and effectiveness of features which are different between the subject device and the predicate device.

Boston Scientific Corporation's Advanix™ Pancreatic Stent and Naviflex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers cleared under 510(k) K133700 on May 14, 2014 is being used as reference device number two for this 510k submission.

The subject device and the second reference device share the following characteristic;

Anti-migration features; both devices have flap features to help prevent migration.

This legally marketed reference device provides technical information which helps address the safety and effectiveness of a feature which is different between the subject device and the predicate device.

VII. PERFORMANCE DATA

The biocompatibility evaluation for the Nasal Pancreatic Drainage Set was conducted in accordance with the FDA's Use of International Standard ISO 10993-1," Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16,

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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).

The following biocompatibility testing was successfully completed;

Cytotoxicity
Intracutaneous
Sensitization ●
Acute Systemic Toxicity ●
Systemic Toxicity
o 4 week muscle implantation
Genotoxicity - Mouse Lymphoma Assay
Genotoxicity Bacterial Reverse Mutation Study o

A summary of the bench testing completed is detailed in Table 5.1.

Testing was successfully performed as per Cook Ireland's design control system in line with 21 CFR 820.30 including FDA recognised standards where relevant. The results from performance testing demonstrated that the subject device will remain sterile and will perform as intended for its 3 year shelf life.

Test	Acceptance Criteria	Result
Dimensional Verificationand Simulated UseTesting (Simulated use -Time Zero and post aging)	Dimensional verification as per the designparameters of the device.For simulated use testing the deviceperforms in line with the instructions foruse.	All acceptancecriteria were met.Pass
Drainage Catheter:Resistance to collapse,flow rate and tensiletesting, (Time Zero andpost aging)	Resistance to CollapseTesting Per EN 1617:1997¹.The test article does not collapse whenexposed to a pressure not less than -10kPafor a period not less than 60 sec.Flow Rate	All acceptancecriteria were met.Pass
Test	Acceptance Criteria	Result
	Testing per EN 1618:19972.
	Minimum flow rate of 4 ml/min.
	Tensile TestingTesting per JIS T 32433, EN 1618:19972and per EN 1617:19971.
	There shall no breaks and cracks whensubjected to a force of 4.9 N (5 Fr and 7 Frcatheters).
	Minimum force of 10N (7 Fr catheters).
Leakage Testing	Testing per EN 1618:19972.At a test pressure of not less than 10kPathere is no leakage from the test articlesincluding their connection to a drainagecollection bag.	All acceptancecriteria were met.Pass
Radiopacity Testing	Testing Per ASTM F640-124The drainage catheter is visible underfluoroscopy.Visibility of the Drainage catheter is equalto or greater than the visibility of the user-defined standard.	All acceptancecriteria were met.Pass
MR Testing	Magnetically Induced DisplacementForceTesting per ASTM F2052-155Deflection Angle < 45°Magnetically Induced TorqueTesting per ASTM F2213-066 (2011)$\tau_{mag} < \tau_{grav}$Electrical Conductivity<1 S/m	All acceptancecriteria were met.Pass
Test	Acceptance Criteria	Result
Sterile Barrier - PackageIntegrity Testing(Time zero and postaging)	MR Image ArtifactsTesting per ASTM F2119-077 (2013)For information only.Peel StrengthTested as per ASTM F88/F88M-158.The peel strength of the pouch seal is ≥1.2N/15mm seal width.Bubble Leak TestTesting as per ASTM F2096-119.No stream of bubbles released from outerpouch during leak testing.	All acceptancecriteria were met.Pass

Table 5.1: Summary of the Bench Testing Performed

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CONCLUSIONS VIII.

Performance testing results (including bench, biocompatibility, packaging integrity and shelf life testing) meet the relevant test criteria as per the testing/standards listed above.

The non-clinical data obtained from performance testing supports the safety and efficacy of the subject device. It demonstrates that subject device will perform as intended in line with the instructions for use. The test methods used for evaluating different characteristics' effects on safety and effectiveness are acceptable; FDA recognised standards were referenced where relevant. The performance data supports the substantial equivalence of the Nasal Pancreatic Drainage Set to the predicate device.

1 EN 1617:1997, Sterile drainage catheters and accessory devices for single use

2 EN 1618:1997, Catheters other than intravascular catheters - Test methods for common properties

3 JIS T 3243:2011, Catheters and tubes designed for the biliary tract

4 ASTM F640-12 Standard Test Methods for Determining Radiopacity for Medical Use

5 ASTM F2052-15 Standard test method for measurement of magnetically induced devices in the manetic resomance every many

6 ASTM F2213-06 (2011) Standard test method for menetically induced torque on passive implants in the magnetic resonance environment

7 ASTM F2119-07 (2013) Standard test method for evaluation of MR image artifacts from passive implants.

8 ASTM F88/F88M-15 Standard test method for seal strength of flexile barrier materials.

9 ASTM F2096-11, Standard test method for detecting gross leaks in packaging by internal pressurization (bubble leak test)

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.