OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 12, 2015 Davol Incorporated Ms. Christine Lloyd Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886 Re: K142873 Trade/Device Name: OptiFix™ Absorbable Fixation System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: February 6, 2015 Received: February 9, 2015 Dear Ms. Lloyd: 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 {1}------------------------------------------------ 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 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/Resourcesfor You/Industry/default.htm. 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 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. for Sincerely yours, # David Krause -S 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K142873 Device Name OptiFix™ Absorbable Fixation System Indications for Use (Describe) The OptiFix™ Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 11pt;"> <span style="color: black;"> <span style="font-weight: bold;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 11pt;"> <span style="color: black;"> <span style="font-weight: bold;">□</span> Over-The-Counter Use (21 CFR 801 Sub </span> </span> </span> | __ 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}------------------------------------------------ # 510(k) Summary #### I. SUBMITTER Davol Inc. 100 Crossings Boulevard Warwick, RI 02886 | Contact Person: | Christine Lloyd | |-----------------|-------------------------------| | | Regulatory Affairs Specialist | | Phone: | (401) 825-8447 | | Fax: | (401) 825-8753 | | E-mail: | Christine.Lloyd@crbard.com | Date Prepared: March 12 2015 #### II. DEVICE | Name of Device: | OptiFix™ Absorbable Fixation System [product ordering codes 0113126 (deployment device contains 30 fasteners) and 0113127 (deployment device contains 15 fasteners)] | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common or Usual Name: | Staple Implantable/Implantable Staple | | Classification Name: | Implantable staple (21 CFR §878.4750) | | Regulatory Class: | II | | Product Code: | GDW | #### III. PREDICATE DEVICE OptiFixTM Absorbable Fastener System, K132134; marketed by Davol, Inc., This predicate has not been subject to a design-related recall. The reference device Davol Absorbable Fastem - SorbaFix™ (K082396) is used in this submission. #### IV. DEVICE DESCRIPTION The OptiFix™ Absorbable Fixation System is a sterile (via gamma) single use product that is comprised of a deployment component and an absorbable fastener component. Two product ordering codes are to be packaged for distribution; each contains the same ergonomically designed deployment device. The variation will be the preloaded fasteners; either 15 or 30. The shaft of the OptiFix™ Absorbable Fixation System is 39 cm in length and is designed for use with 5mm trocars. The fasteners are designed with retention features and are manufactured from Poly (D, L)-lactide. #### SECTION 7 {4}------------------------------------------------ #### V. INDICATIONS FOR USE The OptiFix™ Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair. The Indications for Use statement for the subject device is identical to the predicate device. Both the subject and predicate devices have the same intended use for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair. ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair using the mechanical actuation (trigger) force to guide the fastener and launch the implant is the principle for both the proposed and predicate devices. At a high level, the proposed and predicate devices are based on the following same elements: - Deployment component mechanical component used to guide the fastener into tissue ● - Use of a mechanical component for positioning and launching the implant ● - User-controlled mechanical trigger to guide the fastener (implant) ● - Fastener component - absorbable component based on the same material used to fixate surgical mesh to tissue At a high level, the following differences exist between the proposed and predicate devices: - The proposed deployment device has a resistive trigger and the predicate has a rotating ● trigger. - The proposed fastener component has slight differences in geometry than the predicate. ## VII. PERFORMANCE DATA The following performance data were 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. {5}------------------------------------------------ # Biocompatibility testing The biocompatibility evaluation for the OptiFix™ Absorbable Fixation System 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. Testing for the fastener included Cytotoxicity and the complete biocompatibility profile for the OptiFix fastener has been supported by full biocompatibility testing on the reference device, SorbaFix (K082396) as listed in the following. The fastener materials between the OptiFix and the reference device have been demonstrated to be substantially equivalent. - Sensitization ● - Intracutaneous Reactivity - Single-dose Systemic Toxicity ● - Rabbit Pyrogenicity - 14-Day Repeat Dose Intravenous Toxicity - Genotoxicity ● - Chronic Toxicity, 13 weeks - . Implantation. 52 weeks Testing for the new materials within the deployment device included Cytotoxicity, Sensitization, Intracutaneous Reactivity, and Single-dose Systemic Toxicity. The deployment component of the proposed OptiFix™ Absorbable Fixation System is determined to be tissue contacting for duration of less than 24 hours, while the absorbable fasteners are determined to be permanent implants. # Testing The following non-clinical tests were completed for the proposed and predicate device. The OptiFix™ Absorbable Fixation System passed all the test requirements and demonstrated substantial equivalence to the test results of the predicate device. - Performance and Functional testing of the OptiFix™ Absorbable Fixation System-● deployment device and fastener - Actuation (trigger) torque . - . Fastener deployment - . Fastener gap height - . Ball burst testing - Mesh compatibility testing of the OptiFix™ Absorbable Fixation System - Resorption profile of the fastener All samples tested met the established acceptance criteria. #### SECTION 7 {6}------------------------------------------------ # Animal Study Animal studies were not performed on the proposed device for this submission. Based on identical materials and comparable mechanical strengths measured at the bench level, the in vivo safety and performance of the proposed device was evaluated via the animal and histological studies conducted on the reference device, the SorbaFix Fixation Device. ## Clinical Studies Clinical studies were not performed for the submission of this device nor were clinical studies performed for the predicate device. | Device Features | Proposed device<br>OptiFix™ | Predicate device<br>OptiFix™ (K132134) | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Soft tissue fixation | Soft tissue fixation | | Indication For use | Indicated for the approximation<br>of soft tissue and fixation of<br>surgical mesh to tissues during<br>open or laparoscopic surgical<br>procedures, such as hernia repair. | Indicated for the approximation of<br>soft tissue and fixation of surgical<br>mesh to tissues during open or<br>laparoscopic surgical procedures,<br>such as hernia repair. | | Fastener Material | Poly (D,L) Lactide | Poly (D,L) Lactide | | Fastener Violet Dye | D & C Violet No. 2<br>conforms to 21 CFR §74.3602 | D & C Violet No. 2<br>conforms to 21 CFR §74.3602 | | Fastener Body<br>Contact | Long term implant (>30 days)<br>contacting tissue and/or bone | Long term implant (>30 days)<br>contacting tissue and/or bone | | Fastener<br>Shape/Design | Push Tack with retention features<br>on end | Push Tack with retention features<br>on end | | Fastener Dimensions | 6.7 mm overall fastener length<br>Fastener head: 3.7 mm length; 3.5<br>mm thickness | 6.7 mm overall fastener length<br>Fastener head: 3.7 mm length; 3.5<br>mm thickness | | Fastener<br>Manufacturing<br>Method | Injection-Molded | Injection-Molded | | Fastener Absorption<br>Time | 360 days | 360 days | | Fastener Quantity<br>per Device | 15 & 30 fasteners | 15 & 30 fasteners | # Table 7-1: Device Substantial Equivalence – General Characteristics #### Premarket Notification for OptiFix™ Absorbable Fixation System {7}------------------------------------------------ | Device Features | Proposed device<br>OptiFix™ | Predicate device<br>OptiFix™ (K132134) | |----------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------| | Fastener Delivery<br>System | Push - Impact tube pushes<br>fasteners forward over a straight<br>guidewire | Push – Impact tube pushes<br>fasteners forward over a straight<br>guidewire | | Deployment Device<br>Handle design | Pistol/Gun shape | Pistol/Gun shape | | Deployment Device<br>Shaft Nominal<br>Length | 39 cm in length | 39 cm in length | | Deployment Device<br>Trigger | Resistive trigger | Rotating trigger | | Deployment Device<br>Trigger Stroke | Swift and full | Slow and progressive | | Deployment Device<br>Guidewire | Moveable | Stationary | | Device Sterilization | Gamma Irradiation<br>(25 - 40 kGy) | Gamma Irradiation<br>(25 - 40 kGy) | ## VIII. CONCLUSIONS The OptiFix™ Absorbable Fixation System is substantially equivalent to the legally marketed predicate device for the following reasons: - A) The same intended use and indications for use as the predicate device. - B) Both devices use a similar fixation technology to deliver the fasteners by compressing a trigger. - C) Both devices house similar synthetic absorbable fastener with retention head design. - D) Identical materials with long history of biocompatible use in medical instrumentation and implantation. - E) Identical technological characteristics to the predicate devices such as: Fastener dimensions trigger handle, penetration depth, and shaft length. - F) Same principle of operation. The comparative analysis as well as the bench and preclinical testing results demonstrated that the OptiFix™ Absorbable Fixation System should perform as safe, and as effective, as the predicate device that is currently marketed for the same intended use. #### SECTION 7