TIO2MESH TM

{0}------------------------------------------------ K113311 # JUL 1 7 2012 Biocer Entwicklungs GmbH Traditional 510(k) Premarket Submission TiO2Mesh'" # Section 5 – 510(k) Summary for TiO2Mesh™ #### 1. Submission Sponsor Biocer Entwicklungs GmbH Address: Ludwig-Thomas Strasse 36c, Bayreuth COUNTRY: Germany Phone: 49 0 921-78-77-70-0 Fax: 49 0 921-78-77-70-79 Contact: Martina Feldmann Ph.D., Product Manager. ## 2. Submission Correspondent Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Cell Phone: Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Cheryl Fisher, Sr. QA/RA Consultant Email: project.management@emergogroup.com #### Date Prepared ന് 17 July 2012 #### 4. Device Name Trade/Proprietary Name: TiO2Mesh™ Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh Polymeric Classification Regulation: 878.3300 Surgical Mesh Classification Panel: 878 General and Plastic Surgery Product Code: OXJ, Mesh, Surgical, non-absorbable, large Abdominal Wall defects FTL, Mesh, Surgical, polymeric Device Class: 2 FDA Establishment Registration #: Not available yet. #### 5. Predicate Devices GfE Medizintechnik GmbH ; TiMeshTC Bard; SoftMesh {1}------------------------------------------------ # ા 33ના Biocer Entwicklungs GmbH Traditional 510(k) Premarket Submission TiO2Mesh™ #### 6. Device Description TiO2Mesh™ is made from a monofilament polypropylene thread and has a large-pore structure with blue orientation stripes. The surgical mesh implant has a titanium dioxide coated surface. The fabric can be stretched in both directions and is highly flexible to react to body dynamics in terms of elasticity. TiO2Mesh™ is available in different shapes and sizes (product flyer TiO2Mesh™ ). ## 7. Intended Use TiO₂Mesh™ is a surgical mesh implant specifically indicated for repair of tissue defects of the abdominal wall, where a non-reabsorbable support material is required. Relevant applications include the repair of inguinal and incisional hernia in all common surgical methods. TiO2Mesh™ can be used for both laparoscopic and other open procedures. ## 8. Technological Characteristics and Substantial Equivalence The following table compares the TiO2MeshTM to the TiMesh-TC with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. | Manufacturer | Biocer Entwicklungs<br>GmbH | GfE Medizintechnik<br>GmbH | Bard | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | TiO2 Mesh | TiMesh-TC | Soft Mesh | | 510(k) Number | Not Available yet | KO31225 | KO52155 | | Product Code | FTL | FTL | FTL | | Regulation<br>Number | 878.3300 | 878.3300 | 878.3300 | | Regulation<br>Name | Surgical mesh. | Surgical mesh.<br>The TiMESH also | Surgical mesh.<br>Bard® Large Pore | | Indications for<br>use: | TiO2Mesh™ is a<br>surgical mesh<br>implant specifically<br>indicated for repair<br>of tissue defects<br>of the abdominal<br>wall, where a non-<br>reabsorbable<br>support is<br>required. Relevant<br>applications<br>include the repair | known as TiMESH-TC,<br>along with Ethicon<br>Inc. Prolene Soft<br>Mesh, U.S.S.C.'s Non<br>Absorbable<br>Polypropylene<br>Surgical Mesh are<br>intended to be used<br>for the<br>reinforcement of<br>tissue during surgical<br>repair. Thus, the<br>TiMESH also known<br>as TiMESH-TC mesh<br>and all the predicates | Soft Mesh is<br>indicated for use in<br>the reconstruction<br>of soft tissue<br>deficiencies, such<br>as for the repair of<br>hernias and chest<br>wall defects. Bard<br>Large<br>Pore Soft Mesh<br>Pre-Shaped is<br>indicated for the<br>repair of inguinal<br>hernia defects | | TiO2Mesh™<br>Manufacturer | Biocer Entwicklungs<br>GmbH | GfE Medizintechnik<br>GmbH | Bard | | Trade Name | TiO2 Mesh | TiMesh-TC | Soft Mesh | | | of inguinal and<br>incisional hernia in<br>all common<br>surgical methods.<br>TiO2Mesh™ can<br>be used for both<br>laparoscopic and<br>other open<br>procedures. | have the same<br>intended use. The<br>TiMESH is specifically<br>indicated for<br>laparoscopic and<br>open surgery for the<br>repair of direct or<br>indirect inguinal,<br>femoral, umbilical,<br>and incisional<br>hernias; rectal,<br>vaginal, and apical<br>prolapses; and<br>parietal<br>reinforcement of<br>tissues and<br>abdominal wall<br>repair. The TiMESH<br>has the same<br>indications for use as<br>a combination of the<br>predicated devices<br>TIMESH is a<br>perscriptive device<br>and should only be<br>used by a licensed<br>physician. | | | Material | PP + Titanium | PP + Titanium | PP | | Grammage | 43 | 65 | 44 | | Pore size {mm} | 2.8 | 1 | 2.5 | | Biocompatible | Yes | Yes | Yes | | Physical<br>Properties | Comparable<br>FDA Guidance<br>used | Comparable<br>FDA Guidance used | Comparable<br>(unknown whether<br>FDA Guidance was<br>used) | #### Comparison Table {2}------------------------------------------------ K113311 Biocer Entwicklungs GmbH Traditional 510(k) Premarket Submission TiO2Mesh™ ## 9. Non-Clinical Testing - a. In vitro Cytotoxicity Assay: Cell Growth Analysis via BCA-Staining with an Extract of TiO2Mesh™ - ف Irritation Test (Intracutaneous Reactivity) with TiO2Mesh™ - Test for Sensitisation (Local Lymph Node Assya LLNA) TiO2Mesh™ C. · {3}------------------------------------------------ Biocer Entwicklungs GmbH Traditional 510(k) Premarket Submission TiO2Mesh™ - Acute Systemic Toxicity in the Mouse with 4 Extracts of TiO2Mesh™ di - Test for the Local Effects after Implantation (7 days period) with TiO2Mesh™ e. - f. Test for the Local Effects after Implantation (90 days period) with TiO2Mesh™ - g. Investigation of Extractable Organic Substances (GC/MS Fingerprint) after Liquid - Extraction of a Surgical Mesh Implant h. - Test for Bacterial Endotoxins using Limulus-Amoebocyte-Lysate (LAL-Test) Kinetic i. - j. Turbidimetric Assay (KTA): Test for inhibition or enhancement with TiO2Mesh™ - k. Transport simulation and packaging of TiO2Mesh™ - Validation Report - 1. ETO Sterilization TiO2Mesh™ - Validation report #### 10. Clinical Testing There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing. The verification and validation testing of the device was found to be acceptable and supports the claims of substantial equivalence and product safety and effectiveness assuming substantially equivalent technical characteristics are the basis for the safety and effectiveness of the device. #### 11. Conclusion By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device. The TiO2Mesh™, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices. {4}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JUL 1 7 2012 Biocentw % Emergo Group Ms. Cheryl Fisher Senior QA/RA, Consultant 611 West 5th Street, 3rd Floor Austin, Texas 78701 Re: K113311 Trade/Device Name: Ti02Mesh™ Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL, OXJ Dated: June 01, 2011 Received: June 04, 2011 ## Dear Ms. Fisher: 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. 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 {5}------------------------------------------------ # Page 2 - Ms. Cheryl Fisher 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm Sincerely yours, Mark N. Melkers Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Director Enclosure {6}------------------------------------------------ Biocer Entwicklungs GmbH Traditional 510(k) Premarket Submission TiO2Mesh™ # Section 4 - Indications for Use Statement ## 510(k) Number (if known): K113311 Device Name: TiO2Mesh™ #### Indications for Use: TiO Mesh™ is a surgical mesh implant specifically indicated for repair of tissue defects of the abdominal wall, where a non-reabsorbable support material is required. Relevant applications include the repair of inguinal and incisional hernia in all common surgical methods. TiO9Mesh™ can be used for both laparoscopic and other open procedures. Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use ____________ (21 CFR 801 Subpart C) 510(k) Num (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel Knaebel MXM (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices