The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers are intended for delivery of the stent to the pancreatic duct (PD):
• Used to drain pancreatic ducts

Device Description

The Advanix™ Pancreatic Stent and NaviFlex™ RX Pancreatic Delivery System and Pushers is a plastic pancreatic stent designed for the delivery of the stent to the pancreatic duct and used to drain pancreatic ducts.

The pancreatic stents are provided in straight or single pigtail shape. The straight shape stents have trailing barbs and/or leading barbs depending on application, in rounded or tapered leading end tip to facilitate access through papilla, and a rounded trailing end or about the push catheter portion of the delivery system or stent pusher. The single pigtail stent may or may not have leading end barbs depending on application. Some stents have lateral drainage holes in the pigtails, a tapered or rounded leading end tip, and a rounded trailing end. All stents have either an endoscopic or fluoroscopic marker, or both on the trailing or leading end of the stent to assist with depth of placement in the pancreatic duct. The location and presence of an endoscopic or fluoroscopic marker is dependent on the length and diameter size of the stent. Some codes have side port holes in the body of the stent.

AI/ML Overview

I regret to inform you that the provided text is a U.S. FDA 510(k) clearance letter and summary for a medical device (Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers).

This type of document primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance bench testing and biocompatibility.

Crucially, this document does not contain information about clinical studies with human patients, nor does it establish device performance against specific acceptance criteria in a clinical setting.

Therefore, I cannot extract the information you requested regarding:

A table of acceptance criteria and the reported device performance: These are not defined in the context of clinical outcomes within this document. The "performance" mentioned refers to bench testing.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No clinical test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no clinical test set with ground truth established by experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: This device is a physical medical device (a stent and delivery system), not an AI/software device. Therefore, MRMC studies and AI assistance are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for the clinical performance criteria you are asking about. The "ground truth" for the bench tests would be the established engineering specifications and standards.
The sample size for the training set: Not applicable, as there is no training set for a clinical algorithm.
How the ground truth for the training set was established: Not applicable.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states that the submission includes Performance Bench Testing and Biocompatibility Testing. These are standard tests for physical devices to ensure their safety and physical functionality, not their clinical effectiveness in terms of patient outcomes or diagnostic accuracy.

In summary, the provided document is not a study report that demonstrates clinical performance against acceptance criteria for patient outcomes or diagnostic accuracy.

Summary

U.S. Food & Drug Administration

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov

July 3, 2025

Boston Scientific
Yanine Garcia-Quezada
Principle Regulatory Affairs Specialist
300 Boston Scientific Way
Marlborough, Massachusetts 01752

Re: K251291
Trade/Device Name: Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
Regulation Number: 21 CFR 876.5010
Regulation Name: Biliary Catheter and Accessories
Regulatory Class: Class II
Product Code: FGE
Dated: April 25, 2025
Received: April 25, 2025

Dear Yanine Garcia-Quezada:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K251291 - Yanine Garcia-Quezada Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K251291 - Yanine Garcia-Quezada Page 3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

ANTHONY LEE -S

Anthony C. Lee, Ph.D., M.B.A.
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity, and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.	K251291
Please provide the device trade name(s).

Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers

Please provide your Indications for Use below.

Please select the types of uses (select one or both, as applicable).	☒ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Page 8 of 37

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510(k) Summary

510(k) #: Prepared on: 2025-06-26

Contact Details

21 CFR 807.92(a)(1)

Applicant Name	Boston Scientific
Applicant Address	300 Boston Scientific Way Marlborough MA 01752 United States
Applicant Contact Telephone	508-382-0240
Applicant Contact	Yanine Garcia-Quezada
Applicant Contact Email	yanine.garcia-quezada@bsci.com

Device Name

21 CFR 807.92(a)(2)

Device Trade Name	Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
Common Name	Biliary catheter and accessories
Classification Name	Stents, Drains And Dilators For The Biliary Ducts
Regulation Number	21 CFR 876.5010
Product Code(s)	FGE

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K223592	Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pusher	FGE

Device Description Summary

21 CFR 807.92(a)(4)

The pancreatic stents are provided in straight or single pigtail shape. The straight shape stents have trailing barbs and/or leading barbs depending on application, in rounded or tapered leading end tip to facilitate access through papilla, and a rounded trailing end or about the push catheter portion of the delivery system or stent pusher. The single pigtail stent may or may not have leading end barbs depending on application. Some stents have lateral drainage holes in the pigtails, a tapered or rounded leading end tip, and a rounded trailing end. All stents have either an endoscopic marker, fluoroscopic marker, or both on the trailing or leading end of the stent to assist with depth of placement in the pancreatic duct. The location and presence of an endoscopic or fluoroscopic marker is dependent on the length and diameter size of the stent. Some codes have side port holes in the body of the stent.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

21 CFR 807.92(a)(5)

The indications for use of the proposed Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers device are identical to the predicate device.

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Technological Comparison

21 CFR 807.92(a)(6)

The proposed Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers is identical to the predicate's design, intended use, fundamental technology, operating principle, manufacturing process and all materials with the exception of the stent material for the 4F and 5F sizes listed in this submission.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

This 510(k) notification includes testing for the following:

-Performance Bench Testing

Stent Corrosion Testing
Stent Tensile Testing
Lumen Patency Testing
Side Drainage Hole Testing
Stent Integrity Testing
Stent Length Testing
Stent Outer Diameter Testing
Pigtail Stent Shape and Diameter Testing
Stent Endoscopic Marker Location Testing
Pusher Deployment Force Testing
Pusher Trackability Force Testing

-Biocompatibility Testing:

Cytotoxicity Testing
ISO Guinea Pig Maximization Sensitization Testing
ISO Intracutaneous Reactivity Study in Rabbits
ISO Acute Systemic Toxicity Study in Mice
USP Rabbit Pyrogen Study, Materials Mediated
Genotoxicity: Bacterial Reverse Mutation Study
Genotoxicity: Mouse Lymphoma Assay
Implantation & Systemic Toxicity
Chemical Characterization

The results of the testing listed above demonstrate that the proposed Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers is considered safe and effective for its intended use. The data also demonstrates its substantially equivalent to the predicate device (K223592).

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.