Optilume Basic Urological Balloon Dilation Catheter

{0}------------------------------------------------ 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 2, 2020 Urotronic Inc % Ms. Ming Cheng Chew Regulatory Consultant Libra Medical Inc. 8401 73rd Ave N. Suite 63 Minneapolis, MN 55428 Re: K191061 Trade/Device Name: Optilume Basic Urological Balloon Dilation Catheter Regulation Number: 21 CFR 876.5520 Regulation Name: Urethral Dilator Regulatory Class: Class II Product Code: KOE Dated: November 22, 2019 Received: November 25, 2019 Dear Ms. Chew: 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 {1}------------------------------------------------ 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 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 medical devices and radiation-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, Jessica K. Nguyen, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecological and Urological Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191061 Device Name Optilume Basic Urological Balloon Dilation Catheter Indications for Use (Describe) The Optilume Basic Urological Balloon Dilation Catheter is indicated for the dilation of urethral strictures. 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) # 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." {3}------------------------------------------------ # 510(K) SUMMARY 1.0 #### ADMINISTRATIVE INFORMATION 1.1 #### Date of Summary Preparation: 12/31/19 #### CONTACT INFORMATION 1.1.1 | Submitter/Manufacturer | | |------------------------|-------------------------------------------------------------------------------------------------------| | | Urotronic Inc<br>2495 Xenium Lane N.<br>Minneapolis MN 55441<br>Tel:763-670-5247<br>Fax: 763-477-6357 | Primary Submission Contact Ming Cheng Chew Regulatory Consultant, Libra Medical, Inc. 8401 73rd Ave North, Suite 63 Brooklyn Park, MN 55428 Tel: 763-232-3701 Email: mcchew@libramed.com | Secondary Submission Contact | Sew-Wah Tay | |------------------------------|--------------------------------------------| | | Regulatory Consultant, Libra Medical, Inc. | | | 8401 73rd Ave North, Suite 63 | | | Brooklyn Park, MN 55428 | | | Tel: 612-801-6782 | | | Email: swtay@libramed.com | #### 1.1.2 DEVICE INFORMATION | Trade Name | Optilume Basic Urological Balloon Dilation<br>Catheter | |-----------------------|--------------------------------------------------------| | Common Name | Dilator, Urethral | | Classification Name | Urethral Dilator | | Regulation Number(s): | 876.5520 | | Class | II | | Classification Panel | Gastroenterology/Urology | | Product Code | KOE | | Previous Submission | none | There are no previous submission for the subject device. {4}------------------------------------------------ #### 1.2 PREDICATE DEVICE Boston Scientific UroMAX Ultra Balloon Dilatation Catheter (K130804) ### DEVICE DESCRIPTION OVERVIEW 1.3 The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038" (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon. The device is sterilized using ethylene oxide in a Tyvek pouch. Post sterilization the pouched catheter is sealed in a foil pouch with desiccant and contained within a single unit carton. ### 1.4 INTENDED USE The Optilume Basic Urological Balloon Dilation Catheter is intended for the dilation of the urinary tract. # 1.5 INDICATION FOR USE The Optilume Basic Urological Balloon Dilation Catheter is indicated for the dilation of urethral strictures. ### 1.6 PERFORMANCE DATA OVERVIEW The Optilume Basic Urological Balloon Dilation Catheter underwent extensive testing including: - Dimensional ● - Balloon Burst ● - Leakage Testing ● - Kink Resistance ● - Guidewire, Luer, and Cystoscope Compatibility ● - Trackability - Tensile Testing - Fatigue Testing ● - Balloon Compliance Testing - Biocompatibility Testing Cytotoxicity, Sensitization, Irritation, Systemic Toxicity ● - Packaging Testing seal strength, bubble leak, distribution ● - Accelerated aging ● A GLP animal study was performed in canines to evaluate the safety and use of the device. The device performed as intended and no device-related adverse events occurred. {5}------------------------------------------------ #### 1.7 SUBSTANTIAL EQUIVALENCE The Optilume Basic Urological Balloon Dilation Catheter is substantially equivalent to the UroMax device (K130804). It has the same intended use for the dilation of the urinary tract. The test data showed that the technological difference between the Optilume Basic Urological Balloon Dilation Catheter and its predicate do not raise safety and efficacy issues. | Characteristic | Optilume Basic | Uromax Ultra Balloon<br>Catheter | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | Intended Use | Intended for the<br>dilatation of the<br>urinary tract. | Same | | Indication for Use | The Optilume Basic<br>Urological Balloon<br>Dilation Catheter is<br>indicated for the<br>dilation of urethral<br>strictures. | Uromax Ultra TM<br>Balloon Dilatation<br>Catheters are<br>recommended for<br>dilatation of the urinary<br>tract. | | Catheter usable<br>length | 75 cm | Same | | Balloon diameters | 6 mm, 8 mm, 10 mm, | 4mm, 5mm, 6mm, 7 mm,<br>8mm, 10 mm | | Balloon lengths | 30 mm, 50 mm | 40 mm, 60 mm, 80 mm,<br>100 mm | | Rated burst pressure | 10 atm, 12 atm | 20 atm | | Guidewire<br>compatible | 0.038" (0.9652 mm) | Same | | Biocompatibility<br>compliance | ISO 10993-1 for<br>mucosal tissue | Same | | Delivery of catheter<br>to treatment site | Insert into the working<br>channel of a<br>cystoscope. | Same | | Visualization during<br>placement | Cystoscope and/or<br>fluoroscopy –<br>radiopaque marker<br>bands | Same | | Sterilization | EO, one-time use,<br>SAL 10-6 | Same | | Inflation fluid | Saline/contrast | Same | Table 1-1: Device Comparison to the Predicate Device #### CONCLUSION 1.8 Based on the test data and the same intended use, the Optilume Basic Urological Balloon Dilation Catheter is found to be substantially equivalent to its predicate.