ConvertX Nephroureteral Stent System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 22, 2016 Brightwater Medical Bob Smouse CEO/ CMO 816 W. Bennett Ct. Dunlap. IL 61525 Re: K161277 Trade/Device Name: ConvertX™ Nephroureteral Stent System Regulation Number: 21 CFR 876.4620 Regulation Name: Ureteral Stent Regulatory Class: Class II Product Code: FAD Dated: October 13, 2016 Received: October 17, 2016 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 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. 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 {1}------------------------------------------------ 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 yours, For Division Douglas Silverstein -S 2016.11.22 12:05:41 -05'00' 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K161277 Device Name ConvertX Nephroureteral Stent System #### Indications for Use (Describe) The ConvertX Nephroureteral Stent System with releasable drainage catheter is delivered percutaneously and is intended to establish internal drainage from the ureteropelvic junction to the bladder 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 ureteropelvic junction to the bladder. 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for BrightWater Medical. The logo consists of a stylized water droplet made up of three curved lines in different shades of blue and green. To the right of the droplet is the text "BrightWater" in a light blue sans-serif font, with the word "Medical" below it in a smaller font size. # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS In accordance with 21 CFR §807.92 the following summary of information is provided: | Submitted By | BrightWater Medical<br>816 W. Bennett Ct.<br>Dunlap, IL 61525<br>U.S.A. | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Bob Smouse, M.D.<br>Chief Executive Officer / Chief Medical Officer<br>Phone: 1-650-210-8100<br>Email: bsmouse@brightwatermed.com | | Date Prepared | October 13, 2016 | | Proprietary Name | ConvertX™ Nephroureteral Stent System | | Common Name | Ureteral Stent | | Classification | Class II | | Regulation Number | 21 CFR 876.4620 | | Classification Panel | Gastroenterology/Urology | | Product Code | FAD | | Predicate Device | K141344, Expel Nephroureteral Stent System with Twist-Loc Hub<br>and Expel Ureteral Stent System | | Intended Use /<br>Indications for Use | The ConvertX Nephroureteral Stent System with releasable<br>drainage catheter is delivered percutaneously and is intended to<br>establish internal drainage from the ureteropelvic junction to the<br>bladder while maintaining external access to the stent, as well as<br>providing external drainage.<br>For patients for whom external drainage is not, or no longer<br>desirable, the releasable drainage catheter may be removed, leaving<br>the stent to provide internal drainage from the ureteropelvic<br>junction to the bladder. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for BrightWater Medical. The logo consists of a stylized water droplet made up of three curved lines in different shades of blue and green. To the right of the droplet are the words "BrightWater" in a light blue sans-serif font, with the word "Medical" underneath in a smaller font. ## DEVICE DESCRIPTION The ConvertX Nephroureteral Stent System is a sterile, single-use non-vascular intervention device inserted using percutaneous access techniques to re-establish internal drainage between the ureteropelvic junction and the bladder, and stent the ureter. The ConvertX System allows for external drainage and access as needed. The ConvertX Nephroureteral Stent System is a single lumen device that has a detachable ureteral stent with proximal and distal pigtails. Both proximal and distal pigtails contain drainage holes. The proximal pigtail forms in the renal pelvis, while the distal pigtail forms in the bladder. The distal pigtail has a tapered, atraumatic tip. Drainage can occur internally (from the ureteropelvic junction to the bladder) or externally (from the ureteropelvic junction to the outside of the patient). A loop suture is attached to the proximal pigtail enabling the pigtail, straightened for delivery, to be closed in the renal pelvis. The ConvertX Nephroureteral Stent System's Hub has three ports which are used for both ends of the loop suture, external drainage of urine and the ureteral stent release wire. One end of the loop suture and the release wire are connected to pull tabs. The releasable drainage catheter and loop suture may be detached from the ureteral 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 ureteral stent. The ConvertX Nephroureteral Stent System is radiopaque throughout its length. The ConvertX Nephroureteral Stent System is comprised of the following components: - Ureteral Stent ● - Releasable Drainage Catheter with Hub The following accessories are provided with the ConvertX Nephroureteral Stent System: - Metal Stiffening Cannula . - . Luer Cap ## SUMMARY OF NON-CLINICAL TESTING Design verification / performance testing for the ConvertX Nephroureteral Stent System was completed in accordance with applicable sections of ASTM F1828-97 - Standard Specification for Ureteral Stents, 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. 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 ConvertX {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for BrightWater Medical. The logo consists of a stylized water droplet made up of three concentric lines in teal, light green, and teal again. To the right of the droplet is the text "BrightWater" in a teal sans-serif font, with the word "Medical" in a smaller font size directly below it. 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 - · Urine Compatibility Stent - · Urine Compatibility -System - Resistance to Liquid Leakage Under Pressure and During Aspiration/ Vacuum - Flow Rate - · Shelf Life - MRI Compatibility Conditional - · Sterilization - · Non-pyrogenic LAL Kinetic Chromogenic - · Biocompatibility - · Radiopacity - · Pouch Seal Strength The ConvertX Nephroureteral Stent System, including its packaging, met the predetermined acceptance criteria. No new safety or performance issues were raised during testing. | Performance /<br>Technological<br>Characteristic | Convert X<br>Nephroureteral Stent<br>System | Expel Nephroureteral<br>Stent System Twist Loc<br>Hub (K141344) | Expel Ureteral Stent<br>System (K141344) | |---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The ConvertX<br>Nephroureteral Stent<br>System with releasable<br>drainage catheter is<br>delivered percutaneously<br>and is intended to<br>establish internal<br>drainage from the<br>ureteropelvic junction to<br>the bladder while<br>maintaining external<br>access to the stent, as<br>well as providing<br>external drainage. | The Expel Nephroureteral<br>Stents are delivered<br>percutaneously and are<br>intended to establish<br>internal drainage from the<br>ureteropelvic junction to<br>the bladder while<br>maintaining external<br>access to the stent, as<br>well as providing external<br>drainage. | The Expel Ureteral Stent<br>System is delivered<br>percutaneously and is<br>intended to establish<br>drainage from the<br>ureteropelvic junction to<br>the bladder and stenting<br>of the ureter for all<br>patients in whom it is<br>desirable to place a drain<br>which does not extend<br>externally. | | Performance /<br>Technological<br>Characteristic | Convert X<br>Nephroureteral Stent<br>System | Expel Nephroureteral<br>Stent System Twist Loc<br>Hub (K141344) | Expel Ureteral Stent<br>System (K141344) | | | For patients for whom<br>external drainage is not,<br>or no longer desirable,<br>the releasable drainage<br>catheter may be<br>removed, leaving the<br>stent to provide internal<br>drainage from the<br>ureteropelvic junction to<br>the bladder. | | | | Common Name | Ureteral Stent | Ureteral Stent | Ureteral Stent | | Classification | Class II, Performance<br>Standards | Class II, Performance<br>Standards | Class II, Performance<br>Standards | | Regulation Number | 21 CFR 876.4620 | 21 CFR 876.4620 | 21 CFR 876.4620 | | Product Code | FAD | FAD | FAD | | Single Use Only | Yes | Yes | Yes | | Provided Sterile | Yes | Yes | Yes | | Sterilization Method | EtO | EtO | EtO | | Diameters | 10.3 French | 8.3 and 10.3 French | 8.3 and 10.3 French | | Stent Lengths | 20, 22, 24, 26, 28 cm | 22, 24, 26, 28 cm | 22, 24, 26, 28 cm | | Guidewire<br>Compatibility | 0.038" | 0.038" | 0.038" | | Stent Material | Polyurethane | Polyurethane | Polyurethane | | Drainage Catheter<br>Material | Polyurethane | Polyurethane | NA | | Loop Suture Material | Polyethelyne | Nylon | Nylon | | Tapered Stent Tip | Yes | Yes | Yes | | Radiopaque | Yes | Yes | Yes | | MRI Compatible | Yes | Yes | Yes | | Urine Compatible | Yes | Yes | Yes | | Maximum Indwelling<br>Time | Not to exceed 30-days | Not to exceed 30-days | Not to exceed 90-days | | Delivery Method | Percutaneous | Percutaneous | Percutaneous | | Method of<br>conversion from<br>nephroureteral stent<br>to ureteral stent | Disconnect | Removal / Exchange | NA | | Performance<br>Technological<br>Characteristic | Convert X<br>Nephroureteral Stent<br>System | Expel Nephroureteral<br>Stent System Twist Loc<br>Hub (K141344) | Expel Ureteral Stent<br>System (K141344) | | Biocompatibility | Meets requirements of<br>10993-1 | Meets requirements of<br>10993-1 | Meets requirements of<br>10993-1 | | Accessory Devices | Stiffening Cannula<br>Luer Cap | Cannulas, Plug/Cap,<br>Stabilizer, Pigtail<br>Straightener | Cannulas, Stabilizer,<br>Pigtail Straightener | ## PREDICATE DEVICE COMPARISON {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for BrightWater Medical. The logo consists of a stylized water droplet made up of three curved lines in different shades of blue and green. To the right of the droplet is the text "BrightWater" in a sans-serif font, with the word "Medical" in a smaller font size below it. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for BrightWater Medical. The logo consists of a stylized water droplet symbol on the left, composed of three concentric lines in shades of blue and green. To the right of the symbol, the text "BrightWater" is displayed in a light blue sans-serif font, with the word "Medical" appearing below it in a smaller font size and the same color. # CONCLUSION The ConvertX™ Nephroureteral Stent System has the same intended use and similar technological characteristics as the Expel Nephroureteral Stent System with Twist-Loc Hub and Expel Ureteral Stent System (K141344) marketed by Boston Scientific Corporation. 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 Nephroureteral Stent System is substantially equivalent to the predicate devices.