The ConvertX Biliary Stent System with releasable drainage catheter is delivered percutaneously and is intended for internal drainage of the bile ducts, for splinting of the bile ducts during healing, or for providing bile duct patency in a stricture or past a stone while maintaining external access to the stent, as well as providing external drainage. For patients for whom external drainage is not, or no longer desirable, the releasable drainage catheter may be removed, leaving the stent to provide internal drainage from the bile duct to the duodenum.

Device Description

The ConvertX Biliary Stent System is a sterile, single-use non-vascular interventional device inserted using percutaneous access techniques to re-establish internal drainage and is intended for internal drainage of the bile ducts, for splinting of the bile ducts during healing, or for providing bile duct patency in a stricture or past a stone. The ConvertX Biliary System allows for external drainage and access as needed.

The ConvertX Biliary Stent System has two primary components: a double pigtail Biliary Stent and a Releasable Drainage Catheter with Hub.

The ConvertX Biliary Stent System is a single lumen device that has a detachable Biliary Stent with proximal and distal loops (pigtails). Both proximal and distal loops (pigtails) contain drainage holes. The proximal pigtail forms in the bile duct, while the distal pigtail forms in the duodenum. The distal pigtail has a tapered, atraumatic tip. Drainage can occur internally (from the bile duct to the duodenum) or externally (from the bile duct to the outside of the patient). A suture ("Loop Suture") is threaded through the proximal pigtail enabling the pigtail, straightened for delivery, to be closed in the bile duct.

The ConvertX Biliary Stent System's Hub has three ports which are used for both ends of the Loop Suture, external drainage of bile and the release wire. Ends of the Loop Suture and the Release Wire are connected to separate pull tabs within the Hub. The Releasable Drainage Catheter and Loop Suture may be detached from the Biliary Stent when external drainage is no longer necessary, leaving the stent in place. While still attached, the Releasable Drainage Catheter may be used to withdraw the Biliary Stent. The ConvertX Biliary Stent System is radiopaque throughout its length and has a marker on the stent between junction and proximal loop

The ConvertX Biliary Stent System is comprised of the following functional components:

. Biliary Stent
. Releasable Drainage Catheter with Hub

The ConvertX Biliary Stent System is supplied with the following accessories:

. Metal Stiffening Cannula
. Luer Cap
. Plastic Stiffening Cannula
. Loop Straightener

AI/ML Overview

This document is a 510(k) summary for the BrightWater Medical ConvertX Biliary Stent System. It details the device's characteristics, intended use, and a comparison to predicate devices, along with a summary of non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria	Reported Device Performance
Mechanical/Physical Performance
Stent / Catheter Dimensions	Determined by applicable standards (e.g., ASTM F1828-97, ISO 10555-1: 2013) and design specifications.	Met predetermined acceptance criteria.
Stiffener Dimensions	Determined by applicable standards and design specifications.	Met predetermined acceptance criteria.
Straightener to Stent Compatibility	Demonstrated compatibility.	Met predetermined acceptance criteria.
Guidewire Compatibility	Compatibility with 0.038" guidewire.	Met predetermined acceptance criteria.
Loop Recovery	Demonstrated adequate loop formation/recovery.	Met predetermined acceptance criteria.
Flow Recovery Post Kinking	Demonstrated adequate flow recovery after kinking.	Met predetermined acceptance criteria.
Stent-Catheter Interface Strength	Demonstrated adequate strength.	Met predetermined acceptance criteria.
Kink Resistance	Demonstrated resistance to kinking.	Met predetermined acceptance criteria.
Stent Shaft Tensile Strength	Demonstrated adequate tensile strength.	Met predetermined acceptance criteria.
Hub to Shaft Tensile Strength	Demonstrated adequate tensile strength.	Met predetermined acceptance criteria.
Hub to Stiffener Strength	Demonstrated adequate strength.	Met predetermined acceptance criteria.
Stiffener Tip Strength	Demonstrated adequate strength.	Met predetermined acceptance criteria.
Loop Retention / Removal Force	Demonstrated appropriate forces for retention and removal.	Met predetermined acceptance criteria.
Pull Wire to Pull Tab Tensile Strength	Demonstrated adequate tensile strength.	Met predetermined acceptance criteria.
Loop Suture to Pull Tab Tensile Strength	Demonstrated adequate tensile strength.	Met predetermined acceptance criteria.
Frictional Force	Demonstrated appropriate frictional forces.	Met predetermined acceptance criteria.
Loop Suture Removal Force	Demonstrated appropriate removal force.	Met predetermined acceptance criteria.
Lock Suture to Hub Tensile Strength	Demonstrated adequate tensile strength.	Met predetermined acceptance criteria.
Decoupling Force	Demonstrated appropriate decoupling force.	Met predetermined acceptance criteria.
Resistance to Deformation	Demonstrated resistance to deformation.	Met predetermined acceptance criteria.
Resistance to Liquid Leakage Under Pressure and During Aspiration/Vacuum	Demonstrated resistance to leakage.	Met predetermined acceptance criteria.
Flow Rate	Demonstrated adequate flow rate.	Met predetermined acceptance criteria.
Pouch Seal Strength	Demonstrated adequate seal strength.	Met predetermined acceptance criteria.
Material/Biocompatibility/Sterilization
Bile Compatibility (Stent & System)	Compatibility with simulated bile (e.g., ASTM F1828-97 using simulated bile, ASTM F2129-17 X2.5 Simulated Bile).	Met predetermined acceptance criteria.
Corrosion Testing	Demonstrated resistance to corrosion.	Met predetermined acceptance criteria.
Shelf Life	Demonstrated stability over shelf life.	Met predetermined acceptance criteria.
Sterilization	Demonstrated effective sterilization (EtO).	Met predetermined acceptance criteria.
Biocompatibility	Met requirements of ISO 10993.	Met predetermined acceptance criteria.
Imagery/Safety
MRI Compatibility Conditional	Evaluated according to ASTM F2182-11a, ASTM F2119-07, ASTM F2052-15, ASTM F2503-13.	Met predetermined acceptance criteria.
Radiopacity	Evaluated according to ASTM F640-12.	Met predetermined acceptance criteria.
Simulated Use
Simulated Use Testing	Performed to assess overall device function.	Met predetermined acceptance criteria.

Study Proving Device Meets Acceptance Criteria:

The document summarizes the "Summary of Non-Clinical Testing" which involved various tests based on applicable ASTM, ISO, and FDA guidance documents. The conclusion states, "The Convert X Biliary Stent System, including its packaging, met the predetermined acceptance criteria. No new safety or performance issues were raised during testing." This collective non-clinical testing served as the study proving the device met the acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It only lists the types of tests performed. The provenance of the data is not mentioned (e.g., country of origin, retrospective or prospective). This information is typically found in the full test reports, which are not included in this summary.

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)

This section is not applicable to the provided document. The listed tests are non-clinical (engineering, material, and simulated use testing), which do not involve expert interpretation or ground truth establishment by medical professionals in the context of diagnostic performance.

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

This section is not applicable to the provided document, as it describes non-clinical performance testing rather than studies involving expert adjudication of clinical outcomes or images.

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

This section is not applicable. The document describes a medical device (a biliary stent system), not an AI-powered diagnostic tool, and therefore no MRMC study or AI-related effectiveness analysis was performed.

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

This section is not applicable. The device is a physical medical stent system, not an algorithm.

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

For non-clinical testing, the "ground truth" or reference standard would be the validated testing methods and specifications defined in the relevant ASTM, ISO standards, and FDA guidance documents. For example, for tensile strength, the ground truth would be the specified force limits the device must withstand. For biocompatibility, it would be compliance with ISO 10993 requirements based on biological assays.

8. The sample size for the training set

This section is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described is for a physical medical device.

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

This section is not applicable for the reasons stated in point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 14, 2019

BrightWater Medical Bob Smouse, MD CEO/CMO 42580 Rio Nedo Road Temecula, CA 92590

Re: K181669

Trade/Device Name: ConvertX Biliary Stent System Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE Dated: February 11, 2019 Received: February 12, 2019

Dear Bob Smouse:

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 mav, 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 avare 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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,

Daniel G. Walter Jr -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K181669

Device Name ConvertX Biliary Stent System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/1 description: The image contains the logo for BrightWater Medical. The logo consists of a stylized water droplet made up of three curved lines in teal, light green, and yellow. To the right of the droplet are the words "BrightWater" in a teal sans-serif font, with the word "Medical" in a smaller font size below it.

510(K) SUMMARY

In accordance with 21 CFR §807.92 the following summary of information is provided:

Submitted By	BrightWater Medical42580 Rio Nedo RdTemecula, CA 92590U.S.A.
Contact Person	Bob Smouse, M.D.Chief Executive Officer / Chief Medical OfficerPhone: 1-650-210-8100Email: bsmouse@brightwatermed.com
Date Prepared	June 22, 2018
Proprietary Name	ConvertX™ Biliary Stent System
Common Name	Biliary Stent
Classification	Class II
Regulation Number	21 CFR 876.5010
Regulation Name	Biliary catheter and accessories
Classification Panel	Gastroenterology/Urology
Product Code	FGE
Predicate Devices	Boston Scientific Advanix™ Double Pigtail (K101786), Boston Scientific Expel™ Drainage Catheter (K141335)
Reference Device	BrightWater Medical ConvertX Nephroureteral Stent System (K161277)
Intended Use /Indications for Use	The ConvertX Biliary Stent System with releasable drainage catheter is delivered percutaneously and is intended for internal drainage of the bile ducts, for splinting of the bile ducts during healing, or for providing bile duct patency in a stricture or past a stone while maintaining external access to the stent, as well as providing external drainage. For patients for whom external drainage is not, or no longer desirable, the releasable drainage catheter may be removed, leaving the stent to provide internal drainage from the bile duct to the duodenum.

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Device Description

The ConvertX Biliary Stent System has two primary components: a double pigtail Biliary Stent and a Releasable Drainage Catheter with Hub.

The ConvertX Biliary Stent System is comprised of the following functional components:

. Biliary Stent
. Releasable Drainage Catheter with Hub

The ConvertX Biliary Stent System is supplied with the following accessories:

. Metal Stiffening Cannula
. Luer Cap
. Plastic Stiffening Cannula
. Loop Straightener

Summary of Non-Clinical Testing

Design verification / performance testing for the ConvertX Biliary Stent System was completed in accordance with applicable sections of ASTM F1828-97 - Standard Specification for Ureteral Stents (using simulated bile), ASTM F2129-17- "Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices": X2.5 Simulated Bile (Human Simulated Bile).

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ASTM F623-99 - Standard Performance Specification for Foley Catheters, ISO 10555-1: 2013 -Intravascular catheters - Sterile and single-use catheters, Part 1: General requirements, and the FDA Guidance for the Content of Premarket Notifications for Ureteral Stents. Biological testing was performed in accordance with applicable sections of ISO 10993 – Biological Evaluation of Medical Devices. MRI Compatibility was evaluated according to ASTM F2182-11a - Standard Test Method for Measurement of Radio Frequency Heating On or Near Passive Implants During Magnetic Resonance Imaging, ASTM F2119-07 - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, ASTM F2052-15 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, and ASTM F2503-13 - Standard Practice for Marking Medical Devices and Other Items for Safety in Magnetic Resonance Environment. Radiopacity of the predicate ConvertX Nephroureteral Stent System was evaluated in accordance with ASTM F640-12 - Standard Test Methods for Determining Radiopacity for Medical Use.

Stent / Catheter Dimensions
· Stiffener Dimensions
· Straightener to Stent Compatibility
Guidewire Compatibility
· Loop Recovery
Flow Recovery Post Kinking
· Stent-Catheter Interface Strength
· Kink Resistance
· Stent Shaft Tensile Strength
Hub to Shaft Tensile Strength
Hub to Stiffener Strength
· Stiffener Tip Strength
· Loop Retention / Removal Force
Pull Wire to Pull Tab Tensile Strength
Loop Suture to Pull Tab Tensile Strength
· Frictional Force
· Loop Suture Removal Force
Lock Suture to Hub Tensile Strength
· Decoupling Force
· Resistance to Deformation
· Bile Compatibility Stent
· Bile Compatibility- System
Resistance to Liquid Leakage Under Pressure and During Aspiration/ Vacuum
· Flow Rate
· Shelf Life
· MRI Compatibility Conditional
· Sterilization
· Biocompatibility
· Radiopacity
Pouch Seal Strength
· Corrosion Testing
· Simulated Use Testing

The Convert X Biliary Stent System, including its packaging, met the predetermined acceptance criteria. No new safety or performance issues were raised during testing.

Predicate Device Comparison

Performance /TechnologicalCharacteristic	Convert X BiliaryStent SystemSubmitted	BostonScientificAdvanix™Double PigtailK101786	Boston ScientificExpel DrainageCatheterK141335	ConvertXNephroureteralStent SystemK161277(Reference Device)
Indications for Use	The ConvertX BiliaryStent System with	Advanix DoublePigtail Biliary	The drainagecatheter is intended	The ConvertXNephroureteral Stent
	releasable drainagecatheter is deliveredpercutaneously and isintended for internaldrainage of bile ducts,for splinting of the bileducts during healing,or for providing bileduct patency in astricture or past a stonewhile maintainingexternal access to thestent, as well asproviding externaldrainage.For patients for whomexternal drainage isnot, or no longerdesirable, thereleasable drainagecatheter may beremoved, leaving thestent to provideinternal drainage fromthe bile duct to theduodenum	Stent is intendedfor drainage of thebile ducts, forsplinting of a bileduct duringhealing, or forproviding bileduct patency in astricture or past astone.	to providepercutaneousdrainage of abscessfluid and biliarycollections	System withreleasable drainagecatheter is deliveredpercutaneously and isintended to establishinternal drainage fromthe ureteropelvicjunction to the bladderwhile maintainingexternal access to thestent, as well asproviding externaldrainage.For patients for whomexternal drainage isnot, or no longerdesirable, thereleasable drainagecatheter may beremoved, leaving thestent to provideinternal drainage fromthe ureteropelvicjunction to thebladder.
Common Name	Biliary Stent	Biliary Stent	Biliary Catheter	Ureteral Stent
Classification	Class II, PerformanceStandards	Class II,PerformanceStandards	Class II,PerformanceStandards	Class II, PerformanceStandards
RegulationNumber	21 CFR 876.5010	21 CFR 876.5010	21 CFR 876.5010	21 CFR 876.5010
Product Code	FGE	FGE	FGE	FAD
Single Use Only	Yes	Yes	Yes	Yes
Provided Sterile	Yes	Yes	Yes	Yes
SterilizationMethod	EtO	EtO	EtO	EtO
Diameters	10.3 F	7, 8.5 & 10F	8F to 14F	10.3F
Stent Lengths	5,7,10, and 15 cm	3 cm to 15 cm	20 to 40 cm	20 to 28 cm
GuidewireCompatibility	0.038

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Radiopaque	Yes	Yes	Yes	Yes
MRI Compatible	Yes	Yes	Yes	Yes
Bile Compatible	Yes	Yes	Yes	Yes
MaximumIndwelling Time	Catheter: Not toexceed 30-daysStent: Not to exceed90-days	Not to exceed 90-days	Not to exceed 90-days	Not to exceed 30-days
Delivery Method	Percutaneous	Percutaneous	Percutaneous	Percutaneous
Method ofconversion to stent	Disconnect	N/A	N/A	Disconnect
Biocompatibility	Meets requirements of10993-1	Meetsrequirements of10993-1	Meets requirementsof 10993-1	Meets requirements of10993-1
Accessory Devices	Metal StiffeningCannulaPlastic StiffeningCannulaLoop StraightenerLuer Cap	NaviFlex™RXDelivery System	CannulasTrocarsConnecting TubesPlugs / CapsPigtail StraightenerFacial DilatorsGuidewiresDressingCatheter CuffIntroducers	Stiffening CannulaLuer Cap

Conclusion

The ConvertX™ Biliary Stent System has the same intended use and similar technological characteristics as the Advanix Double Pigtail Stent System and Expel Drainage Catheter marketed by Boston Scientific. Moreover, performance testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the ConvertX Biliary Stent System is substantially equivalent to the predicate devices.

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.