Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 13, 2016 C.R. Bard, Inc. Ms. Shweta Conner Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886 Re: K153236 Trade/Device Name: Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay. Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: April 12, 2016 Received: April 13, 2016 Dear Ms. Conner: 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 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 {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # David Krause -S - for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) #### K153236 Device Name PerFixTM Light Plug with HydroLight™ Onlay Indications for Use (Describe) The PerFix ™ Light Plug with HydroLight™ Onlay is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects. | Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 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." FORM FDA 3881 (8/14) Page 1 of 1 PSC Patilishing Services (301) 443-6780 EF Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ #### Section 5 510(k) Summary #### I. SUBMITTER Davol Inc. 100 Crossings Boulevard Warwick, RI 02886 | Contact Person: | Shweta Conner | |-----------------|-------------------------------| | | Regulatory Affairs Specialist | | Phone: | (401) 825-8303 | | Fax: | (401) 825-8763 | | E-mail: | shweta.conner@crbard.com | Date Prepared: May 11, 2016 #### II. DEVICE | Name of Device: | PerFix™ Light Plug with HydroLight™ Onlay | |-----------------------|-------------------------------------------| | 510(k) number: | K153236 | | Product Code | 0117450, 0117460, 0117470, 0117480 | | Common or Usual Name: | Mesh, Surgical, Polymeric/ Surgical Mesh | | Classification Name: | 21 CFR §878.3300 – Surgical Mesh | | Regulatory Class: | II | | Product Code: | FTL | #### III. PREDICATE DEVICE The predicate device for this submission is the BARD® PerFix™ Light Plug, cleared in K092032, marketed by Davol Inc., a subsidiary of CR Bard, Inc. This predicate has not been subject to a design-related recall. #### IV. DEVICE DESCRIPTION The PerFix™ Light Plug with HydroLight™ Onlay (also referenced as "PerFix™ Light Plug HL" and "PerFix™ Light HL" in the submission) is a permanent, tissue contacting implant. The PerFix™ Light Plug with HydroLight™ Onlay is comprised of two components: the BARD® PerFix™ Light Plug (hereon referred to as "plug") cleared in K092032; and the onlay, a Lightweight Large Pore Mesh (LLPM) with HydroLight™ hydrogel technology. The HydroLight™ hydrogel coating is a 90:1 mixture of polyvinylpyrrolidone (PVP) and polyethylene glycol (PEG). {4}------------------------------------------------ #### V. INDICATIONS FOR USE The PerFix™ Light Plug with HydroLight™ Onlay is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects. The Indications for Use statement for the subject PerFix™ Light Plug with HydroLight™ Onlay is identical to that of the predicate BARD® PerFix™ Light Plug. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | Device Features | Subject device<br>PerFix™ Light Plug with<br>HydroLight™ Onlay | Predicate device<br>BARD® PerFix™ Light Plug<br>(K092032) | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Identical to predicate device:<br>Indicated for reinforcement of soft<br>tissue, where weakness exists, in<br>procedures involving soft tissue repair,<br>such as groin hernia defects. | Indicated for reinforcement of soft<br>tissue, where weakness exists, in<br>procedures involving soft tissue repair,<br>such as groin hernia defects. | | Device<br>Sterilization | Identical to predicate device:<br>ETO SAL 10-6 | ETO SAL 10-6 | | Plug Material | Identical to predicate device:<br>Co-knitted using polypropylene<br>Co-knitted using polypropylene | Co-knitted using polypropylene<br>Co-knitted using polypropylene | | Onlay Material | Hydrogel coating- Blend of<br>polyvinylpyrrolidone (PVP) and<br>polyethylene glycol (PEG) | No coating | | Shape of Plug | Identical to predicate device:<br>Pre-formed cone shape<br>Available sizes- small, medium, large<br>and extra large | Pre-formed cone shape<br>Available sizes- small, medium, large<br>and extra large | | Shape of Onlay | Flat pre-shaped mesh with key hole<br>Available size- 6 x 13.5 cm | Flat pre-shaped mesh with no keyhole<br>Available size- 5.8 x 13.7 cm | | Packaging | Plug<br>Identical to predicate device:<br>Blister tray with Tyvek lid | Blister tray with Tyvek lid | | | Onlay<br>Tyvek/Mylar pouch in blister tray with<br>Tyvek lid | Blister tray with Tyvek lid | Table 5-1: Device Substantial Equivalence – General Characteristics {5}------------------------------------------------ #### VII. PERFORMANCE DATA The following performance data is provided in support of the substantial equivalence determination. #### Performance standards No performance standards have been established for this device under Section 514 of the Federal Food, Drug, and Cosmetic Act. #### Biocompatibility testing The biocompatibility evaluation for the PerFix™ Light Plug with HydroLight™ Onlay was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995; and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The following tests were conducted and the results indicate that the subject device is biocompatible per the referenced standards: - . Cytotoxicity - Sensitization ● - Irritation ● - Systemic Toxicity - Pyrogenicity - Genotoxicity - Implantation: Subcutaneous Implantation (4 week) - Implantation: Subcutaneous Implantation (8 week) - Implantation: Subcutaneous Implantation (13 week) ● - Toxicological Assessment ● #### Electrical safety and electromagnetic compatibility (EMC) The subject PerFix™ Light Plug with HydroLight™ Onlay is not an electro-mechanical medical device nor is it a medical system; therefore this section does not apply. #### Software Verification and Validation Testing The subject PerFix™ Light Plug with HydroLight™ Onlay does not contain software; therefore this section does not apply. #### Performance Testing Performance testing was completed for the subject PerFix™ Light Plug with HydroLight™ and predicate BARD® PerFix" Light Plug. In accordance with FDA's "Guidance for the {6}------------------------------------------------ Preparation of a Premarket Notification for a Surgical Mesh" published March 2, 1999, testing included the following physical and performance characteristic evaluations. Bench Testing: - . Mesh Thickness - Mesh Weave Characteristics ● - Monofilament Diameter ● - Pore Size ● - Device Weight ● - Mesh Density (Linear) . - Tensile Strength ● - Device Stiffness ● - Suture Pull Out Strength ● - Burst Strength ● - Tear Resistance ● - Material Interaction Testing ● All samples tested met the established acceptance criteria. The PerFix™ Light Plug component of the subject device is identical to that of the predicate BARD® PerFix™M Light Plug (K092032). For the HydroLight™ Onlay which is the only difference between the subject and the predicate, performance testing demonstrates that the Onlay component does not adversely affect the safety and effectiveness of the proposed device. The subject PerFix™ Light Plug with HydroLight™ Onlay passed all test requirements and demonstrated substantial equivalence to the test results of the predicate device. # Animal Study: The performance of the subject PerFix™ Light Plug with HydroLight™ Onlay was evaluated by animal study. The following in-vivo animal studies were conducted: - . Histological Characterization Comprehensive Rat GLP Study to histologically evaluate the host inflammatory/fibrotic response, and the presence or absence of hydrogel coating following subcutaneous implantation over a simulated abdominal surgical defect in the rat. - Acute GLP Porcine Study to determine tissue plane conformance and ● positioning aid properties following placement in the subcutaneous muscular abdominal tissue plane in the porcine model. All samples tested met the established acceptance criteria and demonstrated substantial equivalence to the test results of the predicate device. # Clinical Studies Clinical studies were not performed for either the subject or the predicate device, however, the following clinical data was included to support the safety and effectiveness and demonstrate substantial equivalence to the predicate BARD® PerFix™ Light Plug (K092032) {7}------------------------------------------------ - Champault G, Torcivia A, Paolino L, Chaddad W, Lacaine F, Barrat C. A self-● adhering mesh for inguinal hernia repair: preliminary results of a prospective, multicenter study. Hernia. 2011;15(6):635-41. - Tollens T, Kennes J, Vermeiren K, Aelvoet C. Prospective, Single Center, Single ● Surgeon's Experience with an Atraumatic Self-Adhering Mesh in 100 Consecutive Patients. Surgical Technology Int. 2014;(24):178-82. - . Adhesix™ Intraoperative Handling Characteristics Data from EU Clinical Experience - Testimonial of Dr. Keith Millikan, MD FACS, Surgeon & Professor, Rush ● University. - Based on his preclinical evaluation on the usability, interoperability, and o clinical utility of the coating. - VIDEO 1 "Millikan Preclinical Lab Trimming" (1:26s) o - o VIDEO 2 "Millikan Preclinical Lab Mesh Manipulation" (0:45s) - Testimonial from Dr. Timothy Tollens, MD. ● # VII. CONCLUSIONS The comparative analysis, performance testing results and clinical data demonstrate the subject PerFix™ Light Plug with HydroLight™ Onlay is substantially equivalent to the currently marketed predicate BARD® PerFix™ Light Plug (K092032).