PSM 3-Way Silicone Foley Catheter

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September 21, 2018 Pathway, LLC David Stroup Managing Partner 8779 Cottonwood Avenue, Suite 105 Santee, CA 92071 Re: K181616 > Trade/Device Name: PSM 3-Way Silicone Foley Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: August 20, 2018 Received: August 21, 2018 Dear David Stroup: 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. 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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. # Glenn B. Bell -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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K181616 Device Name PSM 3-Way Silicone Foley Catheter Indications for Use (Describe) Urological catheter intended for drainage/irrigation of the urinary tract. Catheterization is accomplished through the urinary tract, but also suprapubic placement or by nephrostomy. Intended population is adults and pediatrics. 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. 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PSM 3-Way Silicone Foley Catheter - Pathway LLC Traditional 510(k) Premarket Notification Page 1of 1 CONFIDENTIAL {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the word "pathway" in lowercase gray letters. To the right of the word is a green graphic that looks like two stacked, rounded arrowheads pointing to the upper right. The graphic is a darker shade of green on the bottom arrowhead and a lighter shade of green on the top arrowhead. # 510(K) SUMMARY - K181616 #### Submitter Information Company Name: Pathway, LLC. Company Address: 8779 Cottonwood Avenue, Suite 105 Santee, CA 92071 Company Phone: (619) 415-0103 Contact Person: David Stroup Managing Partner dkstroup@pathwaynpi.com Date: August 20, 2018 Device Identification Device Trade Name: PSM 3-Way Silicone Foley Catheter Common Name: Foley Catheter Classification Name(s): Urological catheter and accessories Classification Regulation(s): 876.5130 Device Class: Class II Product Code(s): EZL Advisory Panel: Gastroenterology/Urology #### Identification of Predicate Devices | Device Name | Regulation No. | Product<br>Code | 510(K)<br>Number | Clearance<br>Date | |------------------------------------------------------|-------------------------------------------------|-----------------|------------------|--------------------| | 3 Way Silicone Foley Balloon Catheter<br>(MFG: Cook) | 876.5130<br>Urological catheter and accessories | EZL | K091767 | October 9,<br>2009 | #### Device Description The subject device is a single-use, latex-free, 3-way Foley catheter that is constructed of medical grade silicone. It incorporates three (3) lumens, one for inflation/deflation of the balloon, another for drainage, and the remainder for irrigation of the urinary tract. The balloon, at the distal end of the catheter, is inflated to fill volume between 10-30 ml 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 {4}------------------------------------------------ duration of the clinical application. Prior to removal, the balloon is deflated via the two-way valve connection. The drainage inlet is located distal to the catheter's balloon. The urinary bag is a standard non-interconnectable connector. The irrigation outlet is located just proximal of the catheter's balloon. It is positioned underneath a sleeve, which directs fluid in the proximal direction towards the 3-way connection. The purpose of the sleeve is to disperse the irrigation fluids gently down the urinary tract. The connector for the irrigation lumen is a standard non-interconnectable connector. #### Indications for Use Urological catheter intended for drainage/irrigation of the urinary tract. Catheterization is accomplished through the urinary tract, but also suprapubic placement or by nephrostomy. Intended population is adults and pediatrics. | Comparison Feature | PSM 3-Way Silicone Foley Catheter | Predicate Device<br>3 Way Silicone Foley Balloon Catheter | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Urological catheter intended for<br>drainage/irrigation of the urinary tract.<br>Catheterization is accomplished through<br>the urinary tract, but also suprapubic<br>placement or by nephrostomy. Intended<br>population is adults and pediatrics. | Used to provide continuous bladder<br>irrigation of fluids and drainage of urine<br>from the urinary tract. Urinary tract access<br>is generally accomplished by insertion of<br>the catheter through the urethra and into<br>the bladder but may also be accomplished<br>by suprapubic placement or by<br>Nephrostomy. | | Type | 3-way with inflation, drainage, and<br>irrigation lumens | 3-way with inflation, drainage, and<br>irrigation lumens | | Size Offering | 14, 16, 18 Fr | 16, 18, 20, 22, 24, 26 Fr | | Material | Silicone, Medical Grade | Silicone, Medical Grade | | Working Length | 36 cm | 34 cm | | Inflation Volume | 10-30 ml | 30 ml | | Performance Standard | ASTM F623 | ASTM F623 | | Indwelling Time | Up to 30 days | Up to 30 days | | Single-Use? | Yes | Yes | | Prescription Use? | Yes | Yes | | Sterile? | Yes | Yes | #### Comparison of Technological Characteristics with Predicate Device ## Summary of Testing 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) ● - . Transportation - Shelf-Life . {5}------------------------------------------------ - Performance/Functionality . Successful results were achieved with all evaluations conducted. ## Conclusion The PSM 3-Way Silicone Foley Catheter has demonstrated it is substantially equivalent to the commercially available predicate.