SimPro™ Now, GentleCath™ Hydrophilic

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May 4, 2023 Dentsply Sirona Laura Sobrin Corporate Regulatory Affairs Manager 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401 Re: K223756 Trade/Device Name: SimPro™ Now, GentleCath™ Hydrophilic Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter And Accessories Regulatory Class: II Product Code: EZD Dated: December 15, 2022 Received: April 4, 2023 Dear Laura Sobrin: 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 (21 CFR Part {1}------------------------------------------------ 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 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 K. 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 Submission Number (if known) ## K223756 Device Name SimPro™ Now GentleCath™ Hydrophilic Indications for Use (Describe) SimPro™ Now is for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder. GentleCath™ Hydrophilic is for Clean Intermittent Catheterization-ClC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying 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." {3}------------------------------------------------ ## 510(k) SUMMARY for SimPro™ Now and GentleCath™ Hydrophilic K223756 1. Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17404 Contact Person: Laura Sobrin Telephone Number: 717-849-4434 Fax number: 717-849-4343 Date Prepared: April 3, 2023 ## 2. Device Name: - Proprietary Name: SimPro™ Now and GentleCath™ Hydrophilic ● - Intermittent urinary catheter ● Common Name: - Classification Name: Urological catheter and accessories ● - CFR Number: 21 CFR 876.5130 ● - Device Class: Class II - Product Code: EZD, Catheter Straight ● ## 3. Predicate and Reference Devices: | Type | Device Name | 510(k) | Company Name | |------------------|---------------------------|---------|--------------------| | Predicate device | Hi-Slip® Plus | K062444 | OASIS MEDIKAL A.S. | | Reference device | GentleCath Glide Catheter | K161344 | ConvaTec Limited | #### 4. Description of Device: The proposed devices: SimProTM Now and GentleCath™ Hydrophilic are a range of sterile, singleuse, urinary catheters designed as an intermittent pathway for drainage of the bladder. The catheters are available in a variety of lengths and French sizes to accommodate individual anatomy of both male and female users. Both Nelaton (straight tip) and Tiemann (Coudé tip) designs are available. Each catheter is individually packaged together with a sterile water sachet (packet) and an insertion guide. The water sachet is provided for wetting of the hydrophilic surface and is to be broken immediately before use in order to soak the tubing. The insertion guide is provided to minimize touching the catheter shaft directly during insertion and retraction. {4}------------------------------------------------ #### న. Indications for Use: SimPro™ Now is for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder. GentleCath™ Hydrophilic is for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder. #### 6. Intended use population SimPro™ Now and GentleCath™ Hydrophilic catheters are intended for male, female and pediatric patients (children, adolescents and transitional adolescents B (18 years old to less than 22 years old but treated like and adult)). #### 7. Comparison of Technological Characteristics: The purpose of this Traditional 510(k) is to gain U.S. premarket clearance for the modification to the predicate device Hi-Slip® Plus (K062444). - The proposed and predicate devices have the same intended use, patient population and ● indications for use. - The proposed and predicate devices are sterile, single use, hydrophilic coated catheters, use the . same operational principle, incorporate the same basic design, and have similar materials. - . The proposed and predicate devices have similar packaging configuration and are sterilized using the same method and processes. The key differences between the predicate device (K062444) and the proposed devices are: - Additional sizes and diameters . - Addition of insertion guide for non-touch technique . - . Change in plasticizer material used in catheter body and funnel - Updates made to Instructions for Use for reduction of soaking time and other minor updates ● - Change in packaging materials supplier but similar materials and same configuration ● An overview of the similarities and differences between the proposed devices and predicate device is given in Table FS-1. #### 8. Non-Clinical Performance Data Non-clinical testing data that was submitted, referenced, or relied upon to demonstrate substantial equivalence includes: - a) Qualification of biological safety assessment according to ISO 10993-1:2018(E), Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process and FDA Guidance "Use of International Standard ISO 10993-1". Testing performed included Chemical characterization, Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Subacute Systemic Toxicity, Genotoxicity, and Pyrogenicity. {5}------------------------------------------------ - b) Test methods for confirmation of sterile barrier systems and packaging validation testing following requirements in: - . ISO 11607-1:2019, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - . ISO 11607-2:2019, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - ASTM F 1929-15, Standard test method for detecting seal leaks in porous medical packaging by . dye penetration. - ASTM D4169-22, Standard Practice for Performance Testing of Shipping Containers and ● Systems - ASTM D4332-14, Standard Practice for Conditioning Containers Packages or Packaging Components for Testing - ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials ● - EN 868-5:2018, Packaging for terminally sterilized medical devices Part 5- Sealable pouches ● and reels of porous materials and plastic film construction – Requirements and test methods. - c) Sterilization validation was performed according to - . ISO 11137-1:2006/(R)2015, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - ISO 11137-2:2013, Sterilization of health care products Radiation Part 2: Establishing the . sterilization dose. - ISO 11135:2014. Sterilization of health-care products Ethylene oxide Requirements for the . development validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] - ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide . sterilization residuals. - d) Shelf life and Performance bench testing was performed per applicable sections of ISO 20696:2018. Sterile urethral catheters for single use, and internal test methods to document the following properties of the catheters: - Flow rate was verified by the test method in Annex E of ISO 20696:2018. . - Peak tensile force was verified by the test method in Annex H of ISO 20696:2018. . - Connector security was verified by internal test method. ● - Kink stability was verified by internal test method. ● - Friction was verified by internal test method. ● - Water retention was verified by internal test method. ● - . Coefficient of friction was verified by internal test method. - Packaging sterile integrity was verified by internal test method. ● - Primary package seal strength was verified by internal test method. - Catheter soaking time prior to use according to the Instructions for Use was verified by internal test method. All tests met the pre-determined acceptance criteria. {6}------------------------------------------------ The results of the testing show substantial equivalence in performance of the proposed device when compared to the predicate device (K062444) and reference device (K161344). ### 9. Clinical Performance Data No data from human clinical studies has been included to support the substantial equivalence of the proposed SimPro™ Now and GentleCath™ Hydrophilic. #### 10. Conclusion The proposed devices and the predicate device (K062444) have the same intended use and indications for use, are sterile, single use catheters, incorporate the same basic design, incorporate the same or very similar materials, and have similar packaging configuration. Performance data are included to address the safety and effectiveness of the proposed devices. The results of non-clinical bench testing, combined with the design, biocompatibility, and intended use comparison to the predicate device (K062444) demonstrate that the proposed devices are as safe, as effective and perform as well as the legally marketed device. {7}------------------------------------------------ | | Proposed Devices | | Predicate Device | Reference Device | Discussion | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Element | SimPro™ Now | GentleCath™<br>Hydrophilic | Hi-Slip® Plus (K062444) | GentleCath Glide<br>Intermittent Catheter<br>(K161344) | | | Product Code | EZD | EZD | EZD | GBM | Same as predicate device | | Device for<br>Prescription use | Yes | Yes | Yes | Yes | Same | | Indications for Use | SimPro™ Now is for Clean<br>Intermittent Catheterization-CIC<br>treatment and is indicated for use by<br>patients with chronic urine retention.<br>The catheter is inserted into the<br>bladder through the urethra for<br>emptying the bladder. | GentleCath™ Hydrophilic is for<br>Clean Intermittent Catheterization-<br>CIC treatment and is indicated for use<br>by patients with chronic urine<br>retention. The catheter is inserted into<br>the bladder through the urethra for<br>emptying the bladder. | Hi-Slip® Plus is launched for<br>Clean Intermittent<br>Catheterization-CIC treatment<br>and is indicated for use by<br>patients with chronic urine<br>retention. The catheter is<br>inserted into the bladder through<br>the urethra for emptying the<br>bladder. | Intermittent catheters are<br>indicated for routine<br>transient intermittent<br>drainage of the bladder.<br>The catheter is inserted<br>through the urethra.<br>GentleCath Glide<br>intermittent catheter is<br>intended for adult use<br>only. | Same as predicate device | | Anatomical site | Bladder through the Urethra | | Bladder through the Urethra | Bladder through the<br>Urethra | Same | | Patient population | Intended for male, female and<br>pediatric patients (children,<br>adolescents and transitional<br>adolescents B (18 years old to less<br>than 22 years old but treated like and<br>adult)). | | Intended for male, female and<br>pediatric patients (children,<br>adolescents and transitional<br>adolescents B (18 years old to<br>less than 22 years old but treated<br>like and adult)). | Intended for male and<br>female patients | Same as predicate device | | Principal of<br>operation | • Squeeze water pocket<br>• Peel pack open<br>• Insert catheter<br>• Empty bladder<br>• Withdraw catheter | • Squeeze water pocket<br>• Peel pack open<br>• Insert catheter<br>• Empty bladder<br>• Withdraw catheter | • Squeeze water pocket<br>• Peel pack open<br>• Insert catheter<br>• Empty bladder<br>• Withdraw catheter | • Squeeze water<br>pocket<br>• Peel pack open<br>• Insert catheter<br>• Empty bladder<br>• Withdraw catheter | Same | | | Proposed Devices | | Predicate Device | Reference Device | Discussion | | Element | SimPro™ Now | GentleCath™<br>Hydrophilic | Hi-Slip® Plus (K062444) | GentleCath Glide<br>Intermittent Catheter<br>(K161344) | | | | • Dispose device | | • Dispose device | • Dispose device | | | Catheter tip<br>Configuration | Nelaton (Straight) tip &<br>Tiemann (Coudé tip) tip | | Nelaton (Straight) tip &<br>Tiemann (Coudé tip) tip | Nelaton (Straight) tip &<br>Tiemann (Coudé tip) tip | Same | | Type/Sizes | Nelaton<br>CH.8, 10, 12, 14,<br>16 & 18<br>in 15cm length<br>Nelaton<br>CH.6, 8, 10, 12,<br>14, 16 & 18<br>in 20cm length<br>Nelaton<br>CH.6, 8 & 10<br>in 30cm length<br>Nelaton<br>CH.8, 10, 12, 14,<br>16, 18, 20 & 22<br>in 40cm length | Nelaton<br>CH.8, 10, 12,<br>14 & 16<br>in 20cm length<br>Nelaton<br>CH.8, 10, 12,<br>14, 16 & 18<br>in 40cm length | Nelaton<br>CH.6, 8, 10, 12, 14, 16 & 18<br>in 20cm length<br>Nelaton<br>CH.6, 8 & 10<br>in 30cm length<br>Nelaton<br>CH.8, 10, 12, 14, 16, 18, 20, 22<br>& 24<br>in 40cm length | Nelaton<br>CH.8, 10, 12, 14, 16<br>in 15cm length<br>Nelaton<br>CH.8, 10, 12, 14, 16 &<br>18<br>in 20cm length | Similar<br>To facilitate handling by female<br>users, a shorter catheter (15cm)<br>has been added to the proposed<br>SimPro™ Now.<br>With the exception of the 40cm<br>Tiemann tip catheter which has<br>been expanded to include an<br>additional diameter of CH20,<br>all other sizes are within the<br>range of predicate device Hi-<br>Slip Plus (K062444). | | | Tiemann<br>CH.10, 12, 14, 16,<br>18 & 20<br>in 40cm length | Tiemann<br>CH.10, 12, 14,<br>16 &18<br>in 40cm length | Tiemann<br>CH.10, 12, 14, 16 &18<br>in 40cm length | Tiemann<br>CH.8, 10, 12, 14, 16<br>&18<br>in 40cm length | | | Catheter tube<br>Material | Polyvinylchloride (PVC) +<br>Dioctyl terephthalate (DEHT) | | Polyvinylchloride (PVC) +<br>Di(2-ethylhexyl) (DEHP) | Polyolefin Based<br>Synthetic Thermoplastic<br>Elastomer (POBE) | Same base material, different<br>plasticizer as predicate device<br>The proposed device is<br>composed of identical base<br>material (PVC) with a non- | | | Proposed Devices | | Predicate Device | Reference Device | Discussion | | Element | SimPro™ Now | GentleCath™<br>Hydrophilic | Hi-Slip® Plus (K062444) | GentleCath Glide<br>Intermittent Catheter<br>(K161344) | | | | | | | | phthalate plasticizer (DEHT).<br>Biocompatibility testing was<br>performed to address material<br>formulation differences<br>between the proposed and<br>predicate device in support of<br>substantial equivalence. | | Hydrophilic surface<br>coating | Polyvinylpyrrolidone (PVP) & NaCl | | Polyvinylpyrrolidone (PVP) &<br>NaCl | Hydrophilic additive<br>within the base material<br>(unknown) | Same as predicate device | | Hydrophilic coating<br>activation | Integrated water sachet with sterile<br>water | | Integrated water sachet with<br>sterile water | Integrated water sachet<br>with sterile water | Same | | Catheter funnel | Color coded end-funnel with<br>insertion guide | | Color coded end-funnel<br>No insertion guide | Color coded end-funnel<br>with insertion sleeve | Similar to predicate and<br>reference devices<br>The proposed devices are<br>provided with insertion guide to<br>minimize touching the catheter<br>shaft directly during insertion<br>and retraction. This has the<br>same functionality as the<br>insertion sleeve in the reference<br>device.<br>Both predicate and proposed<br>devices are composed of the<br>same base material for the<br>catheter funnel. The proposed<br>funnel material contains a non-<br>phthalate plasticizer. | | Single Package | Paper and film peel pack | | Paper and film peel pack | Paper and film peel pack | Similar<br>Same packaging configuration<br>and similar materials.<br>Packaging testing has been<br>conducted and included to<br>address material formulation | | Element | Proposed Devices | | Predicate Device | Reference Device | Discussion | | | SimPro™ Now | GentleCath™ Hydrophilic | Hi-Slip® Plus (K062444) | GentleCath Glide Intermittent Catheter (K161344) | | | | | | | | and sterility integrity in support<br>of substantial equivalence. | | Sterilization method | Ethylene Oxide &<br>gamma irradiation (water sachet) | Ethylene Oxide &<br>gamma irradiation (water sachet) | Ethylene Oxide | Same as predicate device | | | Condition of Use | Single Use | Single Use | Single Use | Same | | | Shelf Life | 3 years | 3 years | 18 months | Same as predicate device | | ## Table FS-1: Comparison of technological characteristics between proposed, predicate, and reference devices {8}------------------------------------------------ {9}------------------------------------------------ # K223756 Page 7 of 8 {10}------------------------------------------------ K223756 Page 8 of 8