2-Way 100% Silicone Cleartract Catheter

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December 1, 2022 SILQ Technologies, Corp. % Aaron Rogers Director of Regulatory and Quality Pathway LLC 8779 Cottonwood Ave, Suite 105 Santee, California 92071 Re: K222118 > Trade/Device Name: 2-Way 100% Silicone Cleartract Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: October 25, 2022 Received: October 25, 2022 Dear Aaron Rogers: 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 {1}------------------------------------------------ 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 (OS) 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, # Jessica K. Nguyen -S Jessica Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology 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) K222118 Device Name 2-Way 100% Silicone Cleartract Catheter #### Indications for Use (Describe) The 2-Way 100% Silicone ClearTract Catheter is intended for drainage of the urinary tract. Catheterization is generally accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic placement or other placement of the catheter, such as nephrostomy tract. Intended population is adults and pediatrics. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:16px">☐</span> 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 DATE PREPARED December 1, 2022 # 1. SUBMITTER INFORMATION #### APPLICANT SILQ Technologies, Corporation 323 Sunny Isles Blvd., 7th Floor Sunny Isles Beach, FL 33160 | OFFICIAL CORRESPONDENT | Aaron Rogers<br>Pathway, LLC.<br>8779 Cottonwood Ave., Suite 105<br>Santee, CA 92071<br>619-415-0103 x704<br>arogers@pathwaynpi.com | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------| |------------------------|-------------------------------------------------------------------------------------------------------------------------------------| ## 2. SUBJECT DEVICE INFORMATION | DEVICE TRADE NAME | 2-Way 100% Silicone ClearTract Catheter | |-----------------------|-----------------------------------------| | COMMON NAME | Foley Catheter | | CLASSIFICATION NUMBER | 21 CFR §876.5130 | | CLASSIFICATION NAME | Urological Catheter and Accessories | | PRODUCT CODE | EZL | | PRODUCT CODE NAME | Catheter, Retention Type, Balloon | | REGULATORY CLASS | II | # 3. PREDICATE DEVICE INFORMATION | PREDICATE DEVICE | 2-Way 100% Silicone ClearTract Catheter (K221625) | |------------------|---------------------------------------------------| | IDENTIFICATION | | {4}------------------------------------------------ REFERENCE DEVICE PSM 3-Way Silicone Foley Catheter (K181616) IDENTIFICATION ## 4. DESCRIPTION OF SUBJECT DEVICE The 2-Way 100% Silicone ClearTract Catheter is a standard single-use 2-way Foley catheter that is constructed of medical grade silicone with a surface modification. It incorporates two (2) lumens, one for inflation/deflation of the balloon and the other for drainage of the urinary tract. The drainage inlet is located distal to the catheter's balloon. The connection to the urinary bag is a standard noninterconnectable connector. The objective of this 510(k) was only to update the indications for use (IFU) statement to include bladder urine drainage by either suprapubic or nephrostomy in addition through the urethra. No changes were made to the device design, manufacture or any of its physical attributes when compared to the predicate device. ## 5. INDICATIONS FOR USE The 2-Way 100% Silicone ClearTract Catheter is intended for drainage of the urinary tract. Catheterization is generally accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic placement or other placement of the catheter, such as nephrostomy tract. Intended population is adults and pediatrics. | Comparison Item | Subject Device:<br>2-Way 100% Silicone<br>ClearTract Catheter | Predicate Device:<br>2-Way 100% Silicone<br>ClearTract Catheter | Reference Device:<br>PSM 3-Way Silicone Foley<br>Catheter | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K222118 | K221625 | K181616 | | Indications for Use | The 2-Way 100% Silicone<br>ClearTract Catheter is<br>intended for drainage of the<br>urinary tract. Catheterization<br>is generally accomplished by<br>inserting the catheter through<br>the urethra and into the<br>bladder. However, drainage<br>is sometimes accomplished<br>by suprapubic placement or<br>other placement of the<br>catheter, such as<br>nephrostomy tract. Intended<br>population is adults and<br>pediatrics. | The 2-Way 100% Silicone<br>ClearTract Catheter is<br>intended for drainage of the<br>urinary tract. Catheterization<br>is accomplished by inserting<br>the catheter through the<br>urethra and into the bladder.<br>Intended population is adults<br>and pediatrics. | Urological catheter intended<br>for drainage/irrigation of the<br>urinary tract. Catheterization<br>is accomplished through the<br>urinary tract, but also<br>suprapubic placement or by<br>nephrostomy. Intended<br>population is adults and<br>pediatrics. | | Design Features | | | | | Type | Same as Predicate | 2-Way Foley Catheter with<br>inflation and drainage<br>lumens | 3-Way Foley Catheter with<br>inflation, drainage and<br>irrigation lumens | | Size/Balloon | Same as Predicate | 14Fr/10cc<br>16Fr/5cc<br>18Fr/10cc | 14Fr/10cc - 30cc<br>16Fr/10cc-30cc<br>18Fr/10cc-30cc | | Materials of Construction | Same as Predicate | Silicone, Medical Grade | Silicone, Medical Grade | ### 6. TECHNOLOGICAL CHARACTERISTICS COMPARISON {5}------------------------------------------------ | Comparison Item | Subject Device:<br>2-Way 100% Silicone<br>ClearTract Catheter | Predicate Device:<br>2-Way 100% Silicone<br>ClearTract Catheter | Reference Device:<br>PSM 3-Way Silicone Foley<br>Catheter | |----------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------| | Zwitterionic Polymer<br>Surface Modification | Same as Predicate | Yes | No | | Performance Standard | Same as Predicate | ASTM F623 | ASTM F623 | | Indwelling Time | Same as Predicate | Up to 30 days | Up to 30 days | | Single Use? | Same as Predicate | Yes | Yes | | Prescription Use? | Same as Predicate | Yes | Yes | | Sterile? | Same as Predicate | Yes | Yes | | Sterilization Method | Same as Predicate | Ethylene Oxide Gas | Ethylene Oxide Gas | ## 7. SUMMARY OF NON-CLINICAL TESTING The following testing was performed to support the additional indications for use. - . Biocompatibility Genotoxicity Study per 10993-3:2014, Biological Evaluation of Medical Devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. - Bacterial Endotoxins Test (BET) / Limulus amebocyte lysate (LAL) test per USP <85>. #### 8. CONCLUSIONS All changes were made in compliance with 21 CFR 820.30 for design controls. Based on a risk assessment, the proposed additions to the indications for use do not change or add new risks to the ClearTract catheter All testing was successfully completed and provided objective evidence to demonstrate the ClearTract catheter is substantially equivalent to the predicate device.