iTind System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 25, 2021 Medi-Tate Ltd. % Janice M. Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103 Re: K210138 Trade/Device Name: iTind System Regulation Number: 21 CFR§ 876.5510 Regulation Name: Temporarily-placed Urethral Opening System for Symptoms of Benign Prostatic Hyperplasia Regulatory Class: II Product Code: OKA Dated: May 20, 2021 Received: May 20, 2021 Dear Janice M. Hogan: 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. {1}------------------------------------------------ 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 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-regulatoryinformation/postmarketing-safety-reporting-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-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, Mark J. Antonino, M.S. 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K210138 Device Name #### iTind System Indications for Use (Describe) The iTind System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above. Type of Use (Select one or both, as applicable) 区 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.qov "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}------------------------------------------------ # K210138 510(k) SUMMARY Medi-Tate Ltd.'s iTind ## Submitter Medi-Tate Ltd. 17 Hauman St. Hadera, Israel, 3850169 Phone: +972-77-700-6745 Facsimile: +972-4-770-1838 Contact Person: Lihi Liviatan Date Prepared: June 24, 2021 Name of Device: iTind system ## Regulation Name: Temporarily-placed Urethral Opening System for Symptoms of Benign Prostatic Hyperplasia Regulation Number: 21 CFR 876.5510 Regulatory Class: II Product Code: QKA Predicate Device: DEN190020 - Medi-Tate's iTind ### Device Description The iTind System is a prescription temporary implantable transprostatic tissue retractor system and consists of the iTind System and a Retrieval Kit. The iTind System consists of an implant and a delivery system. The iTind implant is pre-mounted on a dedicated guide wire. The iTind implant is made of nitinol super elastic shape memory alloy (SMA), and biocompatible material widely used in the manufacture of medical devices. When in its folded configuration, the device is inserted through a sheath and deployed within the bladder neck and prostatic urethra where it assumes its expanded configuration at a maximum diameter of 33 mm and a length of 50 mm. When in expanded configuration, the struts of the iTind implant exert radial force outwardly on the bladder neck and prostatic urethra to push obstructive tissue away from the urinary path. The implant is designed to cover the entire length of the prostatic urethra, from the bladder neck to a point proximal to the external urinary sphincter. The iTind implant is left in position for 5–7 days. The device is subsequently removed using a sheath. The deployment and removal of the iTind implant should follow the Instructions For Use supplied by Medi-Tate and should only be attempted after the operator has been appropriately trained. The device is compatible with commercially available cystoscopes at least 19Fr in diameter. {4}------------------------------------------------ ## Indications for Use The iTind System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to beniqn prostatic hyperplasia (BPH) in men age 50 and above. ## Summary of Technological Characteristics Several components of the device are being modified to use different materials of construction and to add visual markers to improve ease of use. In addition, the shelf-life was extended to 3 years. These changes do not raise different types of safety or efficacy questions. ## Performance Data - EN ISO 10993 -1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, 2-258 - ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for ● genotoxicity, carcinogenicity and reproductive toxicity, 2-228 - . ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, 2-245 - ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation, 2-247 - . ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals, 14-408 - . ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, 2-174 - . ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity, 2-255 - . EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, 15-530 - EN ISO 11607-2:2019 Packaging for terminally sterilized medical devices Part 2: ● Validation requirements for forming, sealing and assembly processes, 15-531 - . ASTM F2096-11 Standard test method for detecting gross leaks in packaging by internal pressurization - bubble test, 14-359 - . ASTMF1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, 14-497 ## Conclusions The subject iTind is as safe and effective as the predicate iTind. The subject iTind has the same intended use, indications, and principles of operation and similar technological characteristics as its predicate device. The minor technological differences between the iTind and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the iTind is as safe and effective as the predicate iTind. Thus, the subject device is substantially equivalent.