Percuvance Percutaneous Surgical System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a stacked format. October 12, 2018 Teleflex Medical, Inc. Kim Campbell Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560 Re: K181852 Trade/Device Name: Percuvance Percutaneous Surgical System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, GCJ, GDO Dated: September 19, 2018 Received: September 21, 2018 Dear Kim Campbell: 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. 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 located 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Long H. Chen -S 2018.10.12 10:32:25 -04'00' 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) K181852 Device Name Percuvance(TM) Percutaneous Surgical System Indications for Use (Describe) The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok® ligating clips to soft tissue during laparoscopic surgery. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | <div> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | #### 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 ## Percuvance™ Percutaneous Surgical System ## A. Name, Address, Phone, and Fax Number of Applicant Teleflex Medical, Incorporated 3015 Carrington Mill Boulevard Morrisville, NC 27560 USA Phone:919-433-4918 Fax: 919-433-4996 ## B. Contact Person Kim Campbell Regulatory Affairs Specialist ## C. Date Prepared September 19th, 2018 ## D. Device Name ## Trade Name Percuvance™ Percutaneous Surgical System ### Common Name | Primary: | Electrosurgical, Cutting and Coagulation and Accessories | |------------|---------------------------------------------------------------------| | Secondary: | Laparoscope, General and Plastic Surgery<br>Applier, Surgical, Clip | ### Classification Regulation | Primary: | 21 CFR 878.4400 | |------------|------------------------------------| | Secondary: | 21 CFR 876.1500<br>21 CFR 878.4800 | ## Product Code | Primary: | GEI | |------------|----------| | Secondary: | GCJ, GDC | {4}------------------------------------------------ ## Classification Name | Primary: | Electrosurgical Cutting and Coagulation Device and Accessories | |------------|-------------------------------------------------------------------------| | Secondary: | Endoscope and Accessories<br>Manual Surgical Instrument for General Use | ## Classification Class II ## Panel General & Plastic Surgery #### E. Device Description Teleflex Medical's Percuvance™ Percutaneous Surgical System is a micro-laparoscopic platform that comprises fourteen (14) unique components, which are combined in various configurations to create a multifunctional set of instruments for laparoscopic procedures. In accordance with IEC 60601-1:2005 (A1:2012), the Percuvance™ system is classified as a BF active accessory with a rated accessory voltage of 1000VPeak- System components include two reusable Handles (Ratcheted and Non-Ratcheted), which are manipulated by the surgeon and connect to a Shaft, which is available in two lengths (29 cm and 36 cm), affords various Tool Tips (or End Effectors) to be attached in order to perform basic surgical manipulations. The Percuvance™ Handles, Shafts, and Tool Tips are not compatible or interchangeable with components from other percutaneous systems. Initial access to the surqical site is achieved with the Introducer Tool Tip attached to the Shaft. Once inside the patient, the Introducer Tool Tip is extracorporealized through a pre-inserted, central trocar and is then exchanged for one of the other Tool Tips, which include Scissors, Gripper Grasper, Johans Grasper, Maryland Dissector, Hook Cautery, Spatula Cautery and Clip Applier. No ligating clips are provided with the Percuyance™ Percutaneous Surgical System: however, the Clip Applier Tool Tip is compatible with Teleflex M/L Hem-o-lok® ligating clip (SKU 544230). Finally, the Seal Bridge, which is available in two sizes (5 mm and 12 mm), is used to protect the trocar seal and to aid in maintaining insufflation when it used in conjunction with a trocar to facilitate the extracorporeal exchange of Tool Tips. | Model Number | Component<br>Description | Reusability<br>Status | Sterility Status | Intended to<br>Apply Monopolar<br>Energy? | |--------------|--------------------------|------------------------|----------------------------------------|-------------------------------------------| | PCVINT3 | Introducer Tool Tip | Single-Patient-<br>Use | Provided Sterile -<br>Gamma Irradiated | No | | PCVSC5 | Scissors Tool Tip | Single-Patient-<br>Use | Provided Sterile -<br>Gamma Irradiated | Yes | {5}------------------------------------------------ | Model Number | Component<br>Description | Reusability<br>Status | Sterility Status | Intended to<br>Apply Monopolar<br>Energy? | |--------------|---------------------------------------|------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------| | PCVGG5 | Traumatic Gripper<br>Grasper Tool Tip | Single-Patient-<br>Use | Provided Sterile -<br>Gamma Irradiated | Yes | | PCVJG5 | Atraumatic Johans<br>Grasper Tool Tip | Single-Patient-<br>Use | Provided Sterile -<br>Gamma Irradiated | Yes | | PCVMD5 | Maryland Dissector<br>Tool Tip | Single-Patient-<br>Use | Provided Sterile -<br>Gamma Irradiated | Yes | | PCVHK5 | Hook Cautery Tool Tip | Single-Patient-<br>Use | Provided Sterile -<br>Gamma Irradiated | Yes | | PCVSPT5 | Spatula Cautery Tool<br>Tip | Single-Patient-<br>Use | Provided Sterile -<br>Gamma Irradiated | Yes | | PCVHCA5 | Clip Applier Tool Tip | Single-Patient-<br>Use | Provided Sterile -<br>Gamma Irradiated | No | | PCVSH3 | 29 cm Shaft | Single-Patient-<br>Use | Provided Sterile -<br>Gamma Irradiated | Yes | | PCVSHL3 | 36 cm Shaft | Single-Patient-<br>Use | Provided Sterile -<br>Gamma Irradiated | Yes | | PCVNRH | Non-Ratcheted Handle | Reusable | Provided Non-Sterile -<br>Intended to be Steam<br>Sterilized by Hospital | Yes | | PCVRH | Ratcheted Handle | Reusable | Provided Non-Sterile -<br>Intended to be Steam<br>Sterilized by Hospital | Yes | | PCVSB5 | 5 mm Seal Bridge | Single-Patient-<br>Use | Provided Sterile -<br>Gamma Irradiated | N/A - Not<br>connected to the<br>Handle and Shaft<br>configuration | | PCVSB12 | 12 mm Seal Bridge | Single-Patient-<br>Use | Provided Sterile -<br>Gamma Irradiated | N/A – Not<br>connected to the<br>Handle and Shaft<br>configuration | #### Indications for Use F. The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok® ligating clips to soft tissue during laparoscopic surgery. #### Contraindications G. The following are contraindications of the Percuvance™ Percutaneous Surgical System: - . The monopolar active Tool Tips are not intended for contraceptive coagulation of fallopian tissue, but may be used to achieve hemostasis following transection of the fallopian tube. {6}------------------------------------------------ - Do not resterilize single patient use components. These components are provided sterile and are intended for use in a single procedure. Discard after use. - The device is not intended for use when endoscopic techniques are generally contraindicated. The following are contraindications of the M/L Hem-o-lok® ligating clip (SKU 544230), which is an accessory to the Percuvance™ system: - Hem-o-lok® ligating clips are not intended for use as a fallopian contraceptive tubal occlusion device. - . Hem-o-lok® ligating clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies. #### Substantial Equivalence H. The Percuvance™ Percutaneous Surgical System is substantially equivalent to the following predicate system. | Predicate Device | Manufacturer | 510(k) No. | Date Cleared | |----------------------------------------------|------------------------|------------|-----------------| | Percuvance ™ Percutaneous<br>Surgical System | Teleflex Medical, Inc. | K153063 | April 8th, 2016 | Additionally, the technology of Teleflex Medical's Percuvance™ Clip Applier Tool Tip is substantially equivalent to that of the M/L Hem-o-lok® manual, endoscopic clip appliers cleared in 510(k) K133202. Like the M/L Hem-o-lok® manual, endoscopic clip appliers, the Percuvance™ Clip Applier Tool Tip is compatible with Teleflex Medical's M/L Hem-o-lok® ligating clip (SKU 544230), which was also cleared in 510(k) K133202. | Reference (Accessory) Device | Manufacturer | 510(k) No. | Date Cleared | |---------------------------------|------------------------|------------|------------------| | Hem-o-lok® Ligating Clip System | Teleflex Medical, Inc. | K133202 | December 3, 2013 | #### l. Comparison to Predicate Device The proposed Percuvance™ Percutaneous Surgical System is substantially equivalent to the predicate system with respect to technology, intended use, indications for use and functional characteristics. The proposed modifications to Percuvance™ Percutaneous System does not introduce any new issues of safety and effectiveness. ## J. Materials All patient contacting materials are equivalent to the predicate Percuvance™ Percutaneous Surgical System and have been evaluated in accordance with ISO 10993-1:2009 (C2010) and FDA Guidance: Use of International Standard ISO 10993 (published June 16, 2016), according to their nature and duration of contact. {7}------------------------------------------------ # K. Technological Characteristics A comparison of the technological characteristics of the proposed Percuvance™ Percutaneous Surgical System and the predicate system has been performed. The results of this comparison demonstrate that the proposed system utilizes substantially equivalent technology as the predicate system. | Comparative<br>Characteristics | Predicate Device (K153063) | Proposed Device<br>Percuvance™ | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | | Percuvance™ Percutaneous Surgical System | Percutaneous<br>Surgical System | | Indications for Use | The Percutaneous Surgical System with 5mm<br>attachments is indicated for the means to<br>penetrate soft tissue to access certain areas of the<br>abdomen. The system is used to grasp,<br>manipulate, cut, cauterize and deliver Hem-o-lok®<br>ligating clips to soft tissue during laparoscopic<br>surgery. | Equivalent | | Intended Use | The Percutaneous Surgical System is a platform<br>consisting of a percutaneous surgical set and<br>accessories used as a means to penetrate soft<br>tissue to access certain areas of the abdomen.<br>The devices' Tool Tips or attachments are<br>provided separately from the percutaneous Shaft<br>and are introduced to the site via a traditional<br>conduit such as a trocar once they are attached<br>extracorporeally to the Shaft tip. A Seal Bridge is<br>used in conjunction with the trocar to maintain<br>insufflation during extracorporeally exchange.<br>Once inside the abdomen, the surgical set is used<br>to grasp, manipulate, cut, cauterize, and deliver<br>Hem-o-lok® ligating clips to soft tissues during<br>laparoscopic surgery. | Equivalent | | Contraindications | The monopolar active Tool Tips are not intended<br>for contraceptive coagulation of fallopian tissue,<br>but may be used to achieve hemostasis following<br>transection of the fallopian tube. (system<br>contraindication)<br>Do not resterilize single patient use components.<br>These components are provided sterile and are<br>intended for use in a single procedure. Discard<br>after use. (system contraindication)<br>The device is not intended for use when<br>endoscopic techniques are generally<br>contraindicated. (system contraindication) | Equivalent | | Comparative<br>Characteristics | Predicate Device (K153063)<br>Percuvance™ Percutaneous Surgical System | Proposed Device<br>Percuvance™<br>Percutaneous<br>Surgical System | | | Hem-o-lok® ligating clips are not intended for use<br>as a fallopian contraceptive tubal occlusion device.<br>(accessory ligating clip contraindication) | | | | Hem-o-lok® ligating clips are contraindicated for<br>use in ligating the renal artery during laparoscopic<br>donor nephrectomies. (accessory ligating clip<br>contraindication) | | | Intended Procedure | Laparoscopic | Equivalent | | Reusability Status | Handles are reusable; All other components are<br>single patient use and disposable | Equivalent | | Sterility Status | Handles are provided non-sterile and are intended<br>to be sterilized by end user prior to use; All other<br>components are provided sterile | Equivalent | | Sterilization Method | Non-sterile (reusable) components to be steam<br>sterilized by end user; Sterile components<br>sterilized by gamma irradiation using method<br>VDmax | Equivalent | | Energy | Monopolar | Equivalent | | Rated Accessory<br>Voltage | 1000 VPeak | Equivalent | | Connector Type | Handle Post | Equivalent | | Electrosurgical<br>Testing | CB Scheme (in compliance with IEC 60601-1<br>series 2nd and 3.1 Editions) | Equivalent | | Handle | Yes | Equivalent | | Shaft | Yes (2.9 mm) | Equivalent | | Introducer Tip | Yes | Equivalent | | Tool Tips | Yes (5 mm) | Equivalent | | Graspers | Yes | Equivalent | | Maryland<br>Dissectors | Yes | Equivalent | | Scissors | Yes | Equivalent | | Cautery Tips | Yes (Spatula and Hook) | Equivalent | | Clip Applier | Yes | Equivalent | | Seal Bridges | Yes | Equivalent | | Exchange<br>Technology | Exchanged extracorporeally | Equivalent | {8}------------------------------------------------ {9}------------------------------------------------ ## L. Performance Data Comprehensive bench testing was completed on the modifications identified below to ensure the system performed equivalently (or better) to the predicate system. Existing design, usability validations and packaging (ship) testing, performed on the predicate device still adequately covers the proposed device. Stability testing was repeated on the sterile components and their packaging to support the legacy extended 3 year shelf life according to aging methods and test methods previously submitted in the predicate 510(k) in support of the initial 1 year shelf life. Though the majority of the electrosurgical safety testing submitted for the system is still valid, certain electrosurgical safety tests were repeated at a third party test house to support the Shaft metal lock tube change. Biocompatibility data submitted for the Percuvance system still adequately represents the proposed system, as no new patient contacting materials were introduced. However, as a result of Shaft's green ink band modification, which is pad printed on the Shaft's proximal knob, a full biocompatibility panel was completed. Additionally, cytotoxicity testing was performed on the Shaft metal lock tube change. The additional biocompatibility and cytotoxicity tests were performed as a conservative measure, as both modifications impacted parts of the device that are not intended to have any patient contact. ## M. Conclusion Based upon the testing presented throughout the submission and in this 510(k) Summary, Teleflex Medical's Percuvance™ Percutaneous Surgical System is substantially equivalent in to the predicate device cleared to market via 510(k) K153063. The modifications to the proposed Percuvance™ Percutaneous Surgical System do not introduce any new issues of safety and effectiveness.