HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue. April 21, 2020 Pathway, LLC Aaron Rogers Director of Regulatory and Quality 8779 Cottonwood Avenue, Suite 105 Santee, CA 92071 Re: K192034 Trade/Device Name: HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: March 19, 2020 Received: March 23, 2020 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling {1}------------------------------------------------ (21 CFR Part 801); medical device reporting (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-safetyreporting-combination-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-devices/medical-device-safety/medical-devicereporting-mdr-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, Purva Pandya Acting 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) K192034 Device Name HYDROPHILIX 100% Silicone 2-Way Foley Catheter, 14Fr/10cc HYDROPHILIX 100% Silicone 2-Way Foley Catheter, 16Fr/5cc HYDROPHILIX 100% Silicone 2-Way Foley Catheter, 18Fr/10cc Indications for Use (Describe) Urological catheter is intended for drainary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder. Intended population is adults and pediatrics. 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. 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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}------------------------------------------------ K192034 page 1 of 3 Image /page/3/Picture/1 description: The image contains the logo for Hydrophilix. On the left is a blue hexagon shape with a circular design in the middle. To the right of the shape is the company name, HYDROPHILIX, in blue font. Image /page/3/Picture/2 description: The image shows the word "pathway" in lowercase letters, with a stylized logo to the right of the word. The logo consists of two curved shapes, one above the other, forming a diamond-like shape. The text and logo are in a gray color. The image appears to be a logo or branding element. # 510(K) SUMMARY - K192034 ## Submitter Information | Company Name: | Hydrophilix, Inc. | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company Address: | 12100 Wilshire Blvd<br>Suite 800<br>Los Angeles, CA 90025 | | Contact Person: | Aaron Rogers<br>Pathway, LLC.<br>Director of Regulatory & Quality<br>(619) 415-0103<br>arogers@pathwaynpi.com | | Date: | April 21, 2020 | | Device Identification | | | Device Trade Name: | HYDROPHILIX 100% Silicone 2-Way Foley<br>Catheter, 14Fr/10cc<br>HYDROPHILIX 100% Silicone 2-Way Foley<br>Catheter, 16Fr/5cc<br>HYDROPHILIX 100% Silicone 2-Way Foley<br>Catheter, 18Fr/10cc | | Common Name: | Foley Catheter | | Classification Name: | Urological catheter and accessories | | Classification Number: | 876.5130 | | Regulatory Class: | Class II | | Product Code(s): | EZL | | Product Code Name: | Catheter, Retention Type, Balloon | | Advisory Panel: | Gastroenterology/Urology | # Identification of Predicate Device | Predicate Device | | | | | |--------------------------------|------------------------------------------------|--------------|---------------|------------------| | Device Name | Regulation No. | Product Code | 510(K) Number | Clearance Date | | Bardex Lubi-Sil Foley Catheter | 876.5130 - Urological catheter and accessories | EZL | K984084 | February 1, 1999 | # Device Description The Subject Device is a single-use, 2-way Foley catheter that is constructed of medical grade silicone. It incorporates two (2) lumens, one for inflation/deflation of the other for drainage of the urinary tract. {4}------------------------------------------------ The balloon, at the distal end of the catheter, is inflated to the labeled fill volume and remains inflated via the incorporated two-way valve in the connector at the proximal end of the inflation lumen. The connector engages with slip/taper luer connection that is standard on syringes. With the balloon inflated, the catheter maintains position in the urinary tract for the duration of the clinical application. Prior to removal, the balloon is deflated via the 2-way valve connection. The drainage inlet is located distal to the catheter's balloon. The urinary bag is a standard non-interconnectable connector. The Subiect Device is packaged inside a perforated plastic sleeve that is inserted into a sterile barrier pouch. Ten (10) units are packaged into a carton, which is the saleable unit. The Subject Device is terminally sterilized via Ethylene Oxide (EO). The Subject Device will be initially offered in 14. 16. 18Fr sizes. The entire length of the Subject Device is disposable. The Subject Device is not sold as a set, there are no accessories or components included. #### Indications for Use Urological catheter intended for drainage of the urinary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder. Intended population is adults and pediatrics. | Comparison Table - Subject and Predicate Devices | | | |--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison<br>Feature | Subject Device | Predicate Device | | Indications for Use | Urological catheter intended for drainage of<br>the urinary tract. Catheterization is<br>accomplished through the urinary tract.<br>Intended population is adults and pediatrics. | Used in the drainage and/or collection<br>and/or measurement of urine. Generally,<br>drainage is accomplished by inserting the<br>catheter through the urethra and into the<br>bladder. However, drainage is sometimes<br>accomplished by suprapubic or other<br>placement of the catheter, such as a<br>nephrostomy tract. | | Type | 2-way with inflation and drainage lumens | 2-way with inflation and drainage lumens | | Size/Balloon Size | 14Fr/10cc | 8, 10Fr/3cc Balloon | | | 16Fr/5cc | 12-24Fr, even sizes/5cc Balloon | | | 18Fr/10cc | 16-24Fr, even sizes/30cc Balloon | | Material | Silicone, Medical Grade | Silicone, High Grade | | Performance<br>Standard | ASTM F623 | ASTM F623 | | Single-Use? | Yes | Yes | | Prescription Use? | Yes | Yes | | Sterile? | Yes | Yes | ## Comparison of Technological Characteristics with Predicate Device ## Summary of Evaluations Performed The test program was performed in accordance to FDA guidance and recognized performance states, which includes the following: - Biocompatibility - Sterilization - Packaging Integrity (i.e., Sterile Barrier) ● {5}------------------------------------------------ K192034 page 3 of 3 - Transportation . - Performance/Functionality . Successful results were achieved with all evaluations conducted. # Conclusion The Subject Device has demonstrated it is substantially equivalent to the commercially available predicate.