Advanix™ Biliary Stent with NaviFlex™ RX Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

Device Description

The Advanix™ Biliary Stent with NaviFlex™ RX Delivery System consists of biliary plastic stents and delivery system catheters. They are sold separately or in a pre-loaded configuration, in which a stent comes attached to the catheter via a suture. The system is comprised of two (2) primary components: stent and delivery catheter with a locking mechanism. The Advanix Biliary Stent allows for drainage of the biliary duct by preventing closure and maintaining the patency of the biliary duct. These biliary stents are provided in center bend and duodenal bend shapes and have leading and trailing bars, a tapered leading end tip to facilitate access through the papilla, and a rounded tailing end to match the profile of the push catheter portion of the delivery system.

AI/ML Overview

This document is a 510(k) Summary for a medical device (Advanix Biliary Stent with NaviFlex RX Delivery System) and does not describe a study involving an AI/Machine Learning device or comparative effectiveness with human readers. Therefore, many of the requested categories are not applicable.

Here's an analysis of the provided text based on the specific questions, focusing on what can be extracted:

The document is a 510(k) premarket notification for a medical device (Advanix Biliary Stent with NaviFlex RX Delivery System). It discusses the device's characteristics, indications for use, and performance data to demonstrate substantial equivalence to a predicate device (K101314).

Crucially, this is NOT a document about an AI device or a study involving AI/Machine Learning performance. Therefore, many of the questions regarding AI-specific elements (like human reader improvement with AI, standalone AI performance, ground truth for test/training sets in an ML context, sample sizes for ML sets, multi-reader multi-case studies) are not relevant to this content.

However, I can extract information related to the device's non-clinical performance and acceptance criteria.

Acceptance Criteria and Device Performance Study (Non-AI Device)

1. Table of acceptance criteria and reported device performance:

The document broadly states that "All tests met required acceptance criteria, therefore supporting a finding of substantial equivalence." However, it does not provide a specific table with numerical acceptance criteria and corresponding reported performance metrics. It lists the types of tests performed.

Test Category	Specific Test Performed	Acceptance Criteria (General Statement)	Reported Device Performance (General Statement)
Biocompatibility	MEM Elution Cytotoxicity	Aligned with ISO 10993, ISO 11135-1, ISO 10993-7, and FDA Guidance document.	Results meet requirements.
	Guinea Pig Maximization	Aligned with ISO 10993, ISO 11135-1, ISO 10993-7, and FDA Guidance document.	Results meet requirements.
	Intracutaneous Reactivity	Aligned with ISO 10993, ISO 11135-1, ISO 10993-7, and FDA Guidance document.	Results meet requirements.
	Acute Systemic Injection	Aligned with ISO 10993, ISO 11135-1, ISO 10993-7, and FDA Guidance document.	Results meet requirements.
	Implantation	Aligned with ISO 10993, ISO 11135-1, ISO 10993-7, and FDA Guidance document.	Results meet requirements.
Chemical Extractables	Studies on chemical extractables	Aligned with FDA's Guidance document, "Use of International Standard ISO 10993-1".	Results meet requirements.
Bench Testing	Drainage Lumen ID	Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions".	All tests met required acceptance criteria.
	Stent Length	Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions".	All tests met required acceptance criteria.
	Stent OD	Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions".	All tests met required acceptance criteria.
	Stent Shape	Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions".	All tests met required acceptance criteria.
	Repositionability (pre-loaded system only)	Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions".	All tests met required acceptance criteria.
	Deployment Force	Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions".	All tests met required acceptance criteria.
	Device Trackability Force	Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions".	All tests met required acceptance criteria.
	Guidewire Compatibility	Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions".	All tests met required acceptance criteria.
	Duodenoscopy Compatibility	Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions".	All tests met required acceptance criteria.
	Barb Flap Cover Compatibility	Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions".	All tests met required acceptance criteria.
	Tensile: Aged in Bile	Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions".	All tests met required acceptance criteria.
	Lumen Patency	Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions".	All tests met required acceptance criteria.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document only mentions that bench tests were performed but does not quantify the number of devices or components tested.
Data Provenance: Not specified. The tests are bench tests performed on the device itself (parts of the device).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not a study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests would be the physical properties and performance characteristics of the device measured against predetermined specifications.

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

Not applicable. This concept is for clinical or radiological studies with expert review.

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 a traditional medical device (biliary stent), not an AI diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This refers to AI algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For biocompatibility: Ground truth is established by adherence to international standards (ISO 10993, ISO 11135-1, ISO 10993-7) and FDA guidance for biological evaluation and sterilization residuals.
For bench testing: Ground truth is implicitly defined by the specified engineering and performance requirements for the device, and adherence to FDA guidance for non-clinical bench performance testing.

8. The sample size for the training set:

Not applicable. This is not an AI/Machine Learning device, so there is no training set in that context.

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

Not applicable. No training set for an AI model.

Summary

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December 18, 2020

Boston Scientific Corporation Elena Hennessey Fellow, Regulatory Affairs Specialist 100 Boston Scientific Wav Marlborough, MA 01752

Re: K203162

Trade/Device Name: Advanix Biliary Stent with NaviFlex RX Delivery System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: FGE Dated: October 21, 2020 Received: October 23, 2020

Dear Elena Hennessey:

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. 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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

For Thelma I. Valdes, Ph.D. Acting 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

510(k) Number (if known)

K203162

Device Name

Advanix™ Biliary Stent with NaviFlex™ RX Delivery System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CER 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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K203162 Page 1 of 2

SECTION 5 510(K) SUMMARY

510(k) SUMMARY

Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Contact: Elena Hennessev Fellow Regulatory Affairs Specialist Tel: 508-683-4347 Date Prepared: December 15, 2020

2. Proposed Device:

Trade Name: Advanix™ Biliary Stent with NaviFlex™ RX Delivery System Common Name: Stents, Drains And Dilators For The Biliary Ducts Regulation Name: Biliary Catheters and Accessories Regulation Number: 876.5010 Product Code: FGE Classification: Class II

3. Predicate Device:

Predicate Device:

4. Device Description:

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	Advanix Biliary Stent
Shape	• Center Bend
	• Duodenal Bend
Sizes (Fr)	• 7F
	• 8.5F
Lengths (cm)	• 5cm
	• 7cm
	• 9cm
	• 12cm
	• 15cm
	• 18cm
Single or Stent Set	• Center Bend Single Stent (no delivery system)
	• Duodenal Bend Single Stent (no delivery system)
	• Center Bend Pre-loaded (stent and delivery system)
	• Duodenal Bend Pre-loaded (stent and delivery system)

Table 4-1 - Advanix Biliary Stent Material Change Stent Configurations:

5. Indications for Use:

The proposed Advanix™ Biliary Stent with NaviFlex™ RX Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

6. Technological Characteristics:

The proposed Advanix™ Biliary Stent with NaviFlex™ RX Delivery System is identical to the predicates in design, intended use and all materials with the exception of the stent material.

7. Performance Data:

The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a risk management process", ISO 11135-1 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices -Part 7: ethylene oxide sterilization residuals".

The following Biocompatibility tests were performed on the Advanix™ Biliary Stent with NaviFlex™ RX Delivery System: MEM Elution Cytotoxicity; Guinea Pig Maximization; Intracutaneous Reactivity; Acute Systemic Injection; and Implantation. In addition, the results of chemical extractable studies are provided which meet FDA's Guidance document, entitled, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process."

The proposed device bench testing is in alignment with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". The following bench tests were performed on the Advanix™ Biliary Stent with NaviFlex™ RX Delivery System: Drainage Lumen ID; Stent Length; Stent OD; Stent Shape; Repositionability (pre-loaded system only); Deployment Force; Device Trackability Force; Guidewire Compatibility; Duodenoscopy Compatibility; Barb Flap Cover Compatibility; Tensile: Aged in Bile; and Lumen Patency. All tests met required acceptance criteria, therefore supporting a finding of substantial equivalence.

8. Conclusion:

The information Boston Scientific Corporation provided in this submission demonstrates that the proposed Advanix Biliary Stent with NaviFlex RX Delivery System is substantially equivalent to the currently cleared Advanix Biliary Stent with NaviFlex RX Delivery System (K101314).

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.