Parietene™ Flat Sheet Mesh

{0} FDA U.S. FOOD & DRUG ADMINISTRATION October 24, 2025 Medtronic - Sofradim Production Paula Paz Senior Regulatory Affairs Specialist 116 Avenue du Formans Trévoux, 01600 France Re: K253125 Trade/Device Name: Parietene™ Flat Sheet Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: September 25, 2025 Received: September 25, 2025 Dear Paula Paz: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253125 - Paula Paz Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K253125 - Paula Paz Page 3 assistance/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, TEK N. LAMICHHANE -S Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K253125 | | | Device Name Parietene™ Flat Sheet Mesh | | | Indications for Use (Describe) Parietene™ flat Sheet Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernias repair. | | | 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." | | {4} K253125 Page 1 of 2 510(k) Summary (K253125) Date Prepared: October 24th, 2025 Submitter: Sofradim Production (subsidiary of Covidien llc) 116, avenue du Formans 01600 Trevoux, France Telephone: +33 (0)4 74 08 90 00 Fax: +33 (0) 4 74 08 90 02 Contact: Paula Paz Regulatory Affairs Senior Specialist 116 avenue du Formans Trévoux, 01600 (France) Phone: +33 (0)4 74 08 90 00 Email: paula.paz@medtronic.com Name of device: Trade/Proprietary name: Parietene™ Flat Sheet Mesh Surgical Mesh Common name: Mesh, Surgical, Polymeric Classification name: Panel number and product code: 79 FTL Regulation number: 21 CFR 878.3300 Predicate Device: Parietene™ Flat Sheet Mesh Trade/Proprietary name: Surgical Mesh Common name: Panel number and product code: 79 FTL Classification name: Regulation number: 21 CFR 878.3300 510(k) Number: K140941 Manufacturer: Sofradim Production (subsidiary of Covidien llc) 116, avenue du Formans 01600 Trevoux, France Reason for Special 510(k) Submission: To update labeling to improve clarity only. All other performance and biocompatibility testing are leveraged from the predicate device. Device Description: Parietene™ Flat Sheet Mesh is a Monofilament polypropylene mesh. Intended Use: Parietene™ flat Sheet Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists. Indications for use: Parietene™ flat Sheet Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernias repair. {5} K253125 Page 2 of 2 Summary comparing the technological characteristics of the subject and predicate device: The modified device Parietene™ flat Sheet Mesh is substantially equivalent to the predicate device Parietene™ flat Sheet Mesh (K140941) in terms of indications and design for the following technological characteristics: - The intended use - Surgical approach - Shape and sizes - Textile design: monofilament polypropylene knitted textile - Material – polypropylene - Mechanical performance Performance data: The following performance data is provided in support of the substantial equivalence determination: - Performance testing: A summary of in-vitro (bench) tests that have been performed to evaluate the trocar compatibility of Parietene™ Flat Sheet Mesh. The results demonstrate that the subject device successfully met the established acceptance criteria and is substantially equivalent to the predicate device. As this Special 510(k) submission is intended only to update the labeling for improved clarity, most of the performance and biocompatibility testings are leveraged from its own predicate device. This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence. Conclusion: Comparison of the subject and predicate device and labeling as well as the results of performance testing demonstrates that the subject device Parietene™ Flat Sheet Mesh is substantially equivalent to the predicate device Parietene™ Flat Sheet Mesh (K140941).