OptiFix Open Absorbable Fixation System - 20 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 consists of a stylized eagle or bird symbol, composed of three overlapping human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 11, 2017 C.R. Bard Incorporated Ms. Katherine Earle Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886 Re: K163698 Trade/Device Name: Optifix Open Absorbable Fixation System - 20 Absorbable Fasteners Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: December 27, 2016 Received: December 29, 2016 Dear Ms. Earle: 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 devicerelated 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. {1}------------------------------------------------ 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. # 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K163698 Device Name OptiFix™ Open Absorbable Fixation System Indications for Use (Describe) The OptiFix™ Open Absorbable Fixation System is indicated for the fixation of surgical mesh to tissues during open surgical procedures, such as hernia repair. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: overline;">X</span> 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}------------------------------------------------ #### Section 5 510(k) Summary #### I. SUBMITTER Davol Inc. 100 Crossings Boulevard Warwick, RI 02886 | Contact Person: | Katherine Earle | |-----------------|-------------------------------| | | Regulatory Affairs Specialist | | Phone: | (401) 825-8450 | | Fax: | (401) 825-8765 | | E-mail: | katherine.earle@crbard.com | Date Prepared: December 27, 2016 #### II. DEVICE | Name of Device: | OptiFix™ Open Absorbable Fixation System | |-----------------------|------------------------------------------| | Product Code: | 0113320 | | Common or Usual Name: | Implantable Staple | | Classification Name: | Implantable Staple (21 CFR §878.4750) | | Regulatory Class: | II | | Product Code: | GDW | #### III. PREDICATE DEVICE The predicate device for this submission is the OptiFix™ Absorbable Fixation System (K142873), cleared March 12, 2015; marketed by Davol, Inc. This predicate has not been subject to a design-related recall. The reference devices used in this submission are the following: - Davol Absorbable Fastener System SorbaFix™ (K082396), cleared January 2, 2009 . - OptiFix™ Absorbable Fixation System (K132134), cleared December 2, 2013 ● ## IV. DEVICE DESCRIPTION The OptiFix" Open Absorbable Fixation System, hereinafter referred to as "OptiFix" Open", is a sterile (via gamma) single use device that is comprised of a deployment component and an absorbable fastener component. The device delivers 20 synthetic absorbable fasteners via a curved shaft. The shaft of the OptiFix™ Open Absorbable Fixation System is 27cm in length. The fasteners are 6.7mm in length, are manufactured from Poly (D, L)-lactide and are dyed with D & C Violet No. 2. {4}------------------------------------------------ #### V. INDICATIONS FOR USE The OptiFix" Open Absorbable Fixation System is indicated for the fixation of surgical mesh to tissues during open surgical procedures, such as hernia repair. The Indications for Use statement for the proposed device falls within the indications for use of the predicate device. The proposed and predicate devices have the same intended use. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The fixation of surgical mesh to tissues during open surgical procedures, such as hernia repair using the mechanical actuation (trigger) force to guide the fastener and launch the implant is the operating principle for both the proposed and predicate devices. The proposed and predicate devices are based on the following similar elements: - Deployment component - mechanical component used to position and launch the fastener (implant) into tissue, consisting of a shaft connected to an ergonomic handle and integrated user-controller trigger. - Fastener component -absorbable component composed of Poly (D, L)-lactide, used to ● fixate surgical mesh to tissue. The following differences exist between the proposed and predicate devices: - The handle configuration of the proposed device is rotated 180° compared to the predicate device - The deployment shaft of the proposed device is shorter in length (27 cm) compared to the deployment shaft of the predicate device (39cm). - The deployment shaft of the proposed device has a 35° permanent angle, whereas the ● predicate device has a straight deployment shaft. ## 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 OptiFix™ Open device was conducted in accordance with FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", June 16, 2016; 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. {5}------------------------------------------------ The absorbable fasteners are determined to be long term implants (>30 days) and are supported by the biocompatibility testing listed below. - Cytotoxicity ● - Sensitization ● - Intracutaneous Reactivity ● - Single-does Systemic Toxicity ● - Rabbit Pyrogenicity - . 14-Day Repeat Dose Intravenous Toxicity - Genotoxicity - . Chronic Toxicity, 13 weeks - Implantation, 4 weeks - . Implantation, 8 weeks - Implantation, 12 weeks - Implantation, 26 weeks - Implantation, 52 weeks ● The deployment component of the proposed OptiFix™ Open device is determined to be tissue contacting for a duration of less than 24 hours, and has been supported by the biocompatibility testing as listed below. - Cytotoxicity ● All samples tested met the acceptance criteria and the proposed OptiFix™ Open device is biocompatible for its intended use. ## Electrical safety and electromagnetic compatibility (EMC) The proposed OptiFix "Open device 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 proposed OptiFix" Open device does not contain software; therefore this section does not apply. ## Product Testing The following non-clinical tests were completed for the proposed and predicate device. The OptiFix "Open device passed all the test requirements and demonstrated substantial equivalence to the test results of the predicate device. - · Performance and Functional testing of the OptiFix™ Open device - Actuation (trigger) Torque ● - Fastener Deployment - Fastener Gap Height - Ball Burst Testing - Single Fastener Pullout (Pluck) Force {6}------------------------------------------------ - · Resorption Profile Assessment of the OptiFix™ Open fastener - Physical Properties - Mechanical Shear Force All samples tested met the established acceptance criteria. #### Animal Study Animal studies were not performed on the proposed device for this submission. Based on identical materials and substantially equivalent 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 devices: Davol Absorbable Fastener System - SorbaFix" (K082396) and OptiFix " Absorbable Fixation System (K132134), which were used to support the predicate OptiFix " Absorbable Fixation System (K142873). #### Clinical Studies Clinical studies were not performed for the submission of this proposed device nor were clinical studies performed for the predicate device. ## VIII. CONCLUSIONS The proposed OptiFix™ Open device is substantially equivalent to the legally marketed predicate device for the following reasons: - A) The same intended use as the predicate device. - B) Similar technological characteristics as the predicate device such as: the fastener delivery system, deployment device trigger, and the fastener dimensions, shape/design and material. - C) The same principle of operation. The comparative analysis, see Table 5-1 below, as well as the bench and preclinical testing results demonstrate that the proposed OptiFix™ Open device performs as intended and is substantially equivalent to the predicate device that is currently marketed for the same intended use. | Device<br>Features | Proposed device<br>OptiFix™ Open | Predicate device<br>OptiFix™ (K142873) | |-----------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Same as predicate | Soft tissue fixation | | Indication for<br>Use | Indicated for the fixation of<br>surgical mesh to tissues during<br>open surgical procedures, such as<br>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 | | Table 5-1: Device Substantial Equivalence - General Characteristics | | | |---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device<br>Features | Proposed deviceTM<br>OptiFixTM Open | Predicate deviceTM<br>OptiFixTM (K142873) | | Fastener<br>Material | Same as predicate | Poly (D,L) – Lactide | | Fastener Violet<br>Dye | Same as predicate | D & C Violet No. 2 conforms to 21<br>CFR § 74.1602(a)(1) and (b) | | Fastener Body<br>Contact | Same as predicate | Long term implant (>30 days)<br>contacting tissue and/or bone | | Fastener<br>Shape/Design | Same as predicate<br>Image: Purple fastener pointing down | Push Tack with retention features<br>on end<br>Image: Purple fastener pointing down | | Overall<br>Fastener<br>Dimensions | Same as predicate | 6.7mm overall fastener length<br>Fastener head: 3.7 mm length; 3.5<br>mm thickness | | Fastener<br>Manufacturing<br>Method | Same as predicate | Injection - Molded | | Fastener<br>Absorption<br>Time | Same as predicate | 360 days | | Fastener<br>Quantity per<br>Device | 20 fasteners | 15 & 30 fasteners | | Fastener<br>Delivery<br>System | Same as predicate | Push – Impact tube pushes<br>fasteners forward over a guidewire | | Deployment<br>Component<br>Configuration | Image: Deployment Component Configuration | Image: Deployment Component Configuration | | Deployment<br>Component<br>Shaft Length | 27cm in length | 39cm in length | | Deployment<br>Component<br>Shaft Angle | 35° | None | | Deployment<br>Component<br>Body Contact | Same as predicate | Transient use – Less than 24 hour<br>duration | | Device<br>Sterilization | Same as predicate | Gamma Irradiation<br>(25 - 40 kGy) | | Device<br>Features | Proposed device<br>OptiFix™ Open | Predicate device<br>OptiFix™ (K142873) | | Device<br>Packaging | Device is placed into a PETG<br>(Polyethylene terephthalate<br>Glycol-modified) thermoformed<br>tray which is inserted into a foil<br>pouch, sealed and placed into an<br>SBS (Solid Bleached Sulfate)<br>paperboard printed shelf carton. | Device is placed into an SBS<br>(Solid Bleached Sulfate) cardboard<br>insert which is inserted into a foil<br>pouch, sealed and then placed into<br>an SBS (Solid Bleached Sulfate)<br>paperboard printed shelf carton. | {7}------------------------------------------------ {8}------------------------------------------------