3DMax Light Mesh

{0} [LOGO] FDA U.S. FOOD & DRUG ADMINISTRATION June 14, 2024 Davol Inc., Subsidiary of C.R. Bard, Inc. Richard Spaziano Staff Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886 Re: K241250 Trade/Device Name: 3DMax Light Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: May 2, 2024 Received: May 3, 2024 Dear Richard Spaziano: 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. 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). U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K241250 - Richard Spaziano Page 2 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. 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-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 Digitally signed by Tek N. Lamichhane -S Date: 2024.06.14 16:19:33 -04'00' 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 {2} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K241250 Device Name 3DMax Light Mesh Indications for Use (Describe) The 3DMax™ Light Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias. 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} K241250 Page 1 of 3 ### 510(k) Summary K241250 # **Submitter:** Davol Inc., Subsidiary of C.R. Bard, Inc. 100 Crossings Blvd. Warwick, RI 02886 United States Contact: Richard Spaziano Title: Staff Regulatory Affairs Specialist Email: richard.spaziano@bd.com Phone: (401) 825-8566 Date of Submission: May 3, 2024 # **Subject Device:** | Device Trade Name: | 3DMax™ Light Mesh | | --- | --- | | Common Name: | Surgical mesh | | Classification Name: | Mesh, Surgical, Polymeric | | Regulatory Class: | II | | Regulation Number: | 21 CFR 878.3300 | | Product Code: | FTL | # **Predicate Device:** | Device Trade Name: | 3DMax™ Light Mesh (K091659), cleared on August 3, 2009 | | --- | --- | | Common Name: | Surgical mesh | | Classification Name: | Mesh, Surgical, Polymeric | | Regulatory Class: | II | | Regulation Number: | 21 CFR 878.3300 | | Product Code: | FTL | # **Device Description:** The purpose of this Special 510(k) is to notify FDA of the changes to the 3DMax™ Light Mesh labeling. There are no changes to the device itself. The device description is identical to the device description for the predicate device, 3DMax™ Light Mesh (K091659). The 3DMax™ Light Mesh is designed to fit the inguinal anatomy. The device is anatomically shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 0.0048 inches in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an "M" shape to designate the medial edge of the mesh and an arrow pointing to the medial aspect. Both the arrow and "M" will aid the user during positioning and placement of the device. The orientation marker is composed of polypropylene monofilament dyed with Phthalocyaninato(2-) copper colorant. {4} K241250 Page 2 of 3 ### Indications for Use: The 3DMax™ Light Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias. ### Indications for Use Comparison to Predicate Device: The subject device and predicate device have identical intended uses, which is for use in soft tissue reinforcement where weakness exists. The subject device indications specify use in the repair of inguinal hernias while the predicate device indications are broad hernia repair indications. The differences between the subject device and predicate device indications do not constitute a new intended use, as both the subject and predicate device are indicated for the same tissue type (soft tissue) and disease entity (repair of hernias). ### Technological Comparison to Predicate Device: The subject device is identical to the predicate device in terms of design, materials, manufacturing, packaging, sterilization, biocompatibility, and shelf-life. | Device Characteristic | Subject Device: 3DMax™ Light Mesh (K241250) | | | Predicate Device: 3DMax™ Light Mesh (K091659) | | | Comparison Assessment | | --- | --- | --- | --- | --- | --- | --- | --- | | Device Classification | Class II Surgical Mesh 21 CFR 878.3300 Product Code: FTL | | | Class II Surgical Mesh 21 CFR 878.3300 Product Code: FTL | | | Same | | Intended Use | Soft tissue repair/reinforcement | | | Soft tissue repair/reinforcement | | | Same | | Indications for Use | The 3DMax™ Light Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias. | | | The 3DMax™ Light Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of hernia defects. | | | Similar | | Principles of Operation | • Insertion • Placement/Positioning | | | • Insertion • Placement/Positioning | | | Same | | Materials | **Mesh:** Polypropylene monofilament **Orientation marker:** Polypropylene monofilament with blue colorant | | | **Mesh:** Polypropylene monofilament **Orientation marker:** Polypropylene monofilament with blue colorant | | | Same | | Design | Single layer knitted 3D-shaped mesh with preformed, semi-rigid edge seal and orientation marker ("M" and arrow). | | | Single layer knitted 3D-shaped mesh with preformed, semi-rigid edge seal and orientation marker ("M" and arrow). | | | Same | | Sizes | Size | Orientations | Dimensions | Size | Orientations | Dimensions | Same | | | Medium | Left or Right | 7.9 cm x 13.4 cm (3.1" x 5.3") | Medium | Left or Right | 7.9 cm x 13.4 cm (3.1" x 5.3") | | | | Large | Left or Right | 10.3 cm x 15.7 cm (4.1" x 6.2") | Large | Left or Right | 10.3 cm x 15.7 cm (4.1" x 6.2") | | | | Extra Large | Left or Right | 12.2 cm x 17.0 cm (4.8" x 6.7") | Extra Large | Left or Right | 12.2 cm x 17.0 cm (4.8" x 6.7") | | | Sterilization Method | Ethylene oxide | | | Ethylene oxide | | | Same | The purpose of this Special 510(k) is to notify FDA of labeling updates to the 3DMax™ Light Mesh that are being made to comply with the requirements of the European medical device regulation, Regulation (EU) 2017/745, as well as to align the labeling with other hernia mesh devices across the Davol Inc. portfolio. These labeling modifications do not impact the substantial equivalence between the subject and predicate device. {5} K241250 Page 3 of 3 # Non-Clinical and/or Clinical Tests Summary & Conclusions: No non-clinical or clinical testing was provided in support of this Special 510(k). # Conclusion: The subject device and predicate device have the same intended use and technological characteristics. The only differences between the subject and predicate device are modifications to the labeling for the subject device. These labeling modifications do not impact the safety or performance of the subject device, nor do they impact the substantial equivalency between the subject and predicate devices. Therefore, the subject device, 3DMax™ Light Mesh, is substantially equivalent to the predicate device, 3DMax™ Light Mesh (K091659).