X-SURGE

{0}------------------------------------------------ October 17, 2017 GENICON, Inc. Ms. Katlyn Kachman Director of Quality 6869 Stapoint Court Suite 114 Winter Park, Florida 32792 Re: K171752 Trade/Device Name: X-Surge Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 2, 2017 Received: October 3, 2017 Dear Ms. Kachman: 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, 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 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. {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 (DICE) 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 (DICE) 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, Jennifer R. Stevenson -S3 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) K171752 Device Name X-Surge Indications for Use (Describe) Indeathis surgical procedures. It is a family of instruments which includes graspers, dissectors, which are intended to be used to grasp, manipulate, cut, and cauterized soft tissue. Type of Use (Select one or both, as applicable) > 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." EF PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for GENICON. The logo is in blue and features the company name in a bold, sans-serif font. A curved line in shades of blue and green runs beneath the name, adding a dynamic element to the design. K171752 Page 1 of 3 # K171752 510(k) Summary 1. Contact Information GENICON 6869 Stapoint Court, Suite 114, Winter Park, FL 32792 Phone (407) 657-4851 Fax (407) 677-9773 Katlyn Kachman, Director of Quality July 7, 2017 - 2. Device Name - Trade Name X-Surge ● - Common Name Laparoscopic Instruments . - Classification Name Electrosurgical, Cutting & Coagulation & Accessories (21 CFR 878.4400, ● Product Code GEI) - 3. Substantially Equivalent Device Legally Marketed (unmodified device) GENICON Electrosurgical Instrumentation, K061417 | Device | GENICON Electrosurgical Instrumentation 510(k)<br>K061417 | GENICON X-Surge 510(k): K171752 | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | General & Plastic Surgery (GEI) | General & Plastic Surgery (GEI) | | Component<br>Design | Current Electrosurgical Instrument<br>Assembly<br>Image: Current Electrosurgical Instrument Assembly<br>A. Insulated Shaft<br>B. Rotation Knob<br>C. Monopolar Post<br>D. Handle<br>E. Jaw assembly | Shaft and Handle assembly<br>Image: Shaft and Handle assembly<br>A. Insulated Shaft<br>B. Shaft Locking Knob<br>C. Rotation Knob<br>D. Monopolar Post<br>E. Handle<br>F. Jaw Assembly<br><br>Tip and Handle assembly<br>Image: Tip and Handle assembly<br>A. Insulated Tip<br>B. Insulated Shaft<br>C. Rotation Knob<br>D. Monopolar Post<br>E. Handle<br>F. Jaw Assembly | | Design | The GENICON disposable electrosurgical<br>instruments are single use sterile instruments made<br>from biocompatible plastic and stainless steel with<br>a working length of 33cm. Current may be supplied<br>by an approved electrosurgical generator which<br>provides the ability for the coagulation of tissue<br>when used with an appropriate ground electrode. | GENICON X-Surge instrumentation line is composed of<br>single use sterile instruments (Reposable handle option<br>available), made from biocompatible plastic, aluminum<br>and stainless steel. When combined the working length is<br>20cm to 45cm. Current may be supplied by an approved<br>electrosurgical generator which provides the ability for the<br>coagulation of tissue when used with an appropriate<br>ground electrode. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Genicon. The word "GENICON" is written in large, bold, blue letters. Underneath the word is a curved line that is blue on top and fades into green on the bottom. The logo is simple and professional. K171752 Page 2 of 3 | Diameter | 3mm to 5mm | SAME | |-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Materials | Patient Contact - AISI Stainless Steel, Radel<br>Non-Patient Contact - Polycarbonate, Nylon, ABS,<br>HDPE/LDPE | Patient Contact - AISI Stainless Steel, FEP<br>Non-Patient Contact - Aluminum, Polycarbonate, Nylon,<br>ABS, HDPE/LDPE, TPE | | Testing | Fully assembled device was tested for cut and<br>coagulation performance on three tissue samples<br>of different origin. The test was performed at the<br>lowest, default, and highest settings of a typical<br>surgery center, and results were recorded. | Performance of the X-Surge product showed that the<br>device performed equivalent or better and is therefore<br>substantially equivalent in performance to the predicate<br>device. | | Performance | GENICON Disposable Electrosurgical<br>Instrumentation is indicated for use in endoscopic<br>surgical procedures. It is a family of instruments<br>which includes graspers, dissectors, and scissors,<br>which are intended to be used to grasp,<br>manipulate, cut, and cauterize soft tissue. | SAME | | Sterilization | Irradiation or Ethylene Oxide | SAME | | Prescription Only | YES | SAME | | Biocompatibility | Conforms to ISO10993 | SAME | #### 4. Device Description The GENICON X-Surge monopolar laparoscopic instruments are sterile packaged Single Use Mono-Polar attachments intended for use in combination with a compatible reposable handle. It is designed to include graspers, dissectors, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue. The device diameter has a range of 3 - 5mm, and connects to a handle with the appropriate configuration. The handle has a male cautery connector that will be utilized for cauterizing soft tissue when attached to standard monopolar cautery cables and their generators. The disposable shaft and tips are composed of an aluminum outer shaft, and a stainless steel drive rod which connects to the scissor blades and interacts with the handle activation rod. The outer insulation consists of fluorinated ethylene which is an insulation with functional material properties that are improved over Polytetrafluoroethylene PTFE, and is less rigid than Radel insulation. The disposable shafts and tips are to be supplied sterile in single unit trays with Tyvek lid, similar to the current GENICON electrosurgical instrumentation line. The Reposable handle is sterilized by the user using an autoclave process and is then connected to the sterile disposable shaft or tip. Once the procedure is completed, the instrument ends are disassembled from the handle, and are disposed of appropriately, and the handle is cleaned and sterilized for the next procedure. - 5. Intended Use The GENICON X-Surge instrumentation line is intended for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue. - 6. Technological Characteristics of the Subject Device Compared to the Predicate Device There are no new technologies being added to the device from the predicate in terms of finished device. The device has the same intended use and application as the predicate device. The X-Surge device will have an additional connection point. The X-Surge device will also have a detachable shaft/tip from the handle, but the same technology is used when discussing function of the device. In both instances electrical current will be passed through an insulated shaft and applied to the appropriate tip assembly to grasp, manipulate, cut, and cauterize soft tissues. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Genicon. The word "GENICON" is written in large, bold, blue letters. Underneath the word is a curved line that is blue on top and fades into green on the bottom. The logo is simple and modern. K171752 Page 3 of 3 ### 7. Non-Clinical Tests Non clinical tests were conducted to verify that the X-Surge met all design specifications as the substantially equivalent predicate device and any additional test needed to show equivalence. Testing included in this submission include the following: - · Biocompatibility Testing - o Cytotoxicity Test - - Skin Sensitization/Irritation Test o - Acute System Toxicity Test o - · Medical Electrical Equipment testing - For both single use and reusable o - Aging Study under ETO - Aging Study under Gamma - Autoclave testing verification ISO 10993-11:2010 IEC 60601-1, IEC 60601-2 ISO 10993-5:2009 ISO 10993-10:2010 In addition the GENICON X-Surge instrumentation line has been compared to the predicate device through performance studies to test cutting performance and electrical safety and effectiveness. Cut performance across different mediums using the predicate as a baseline was completed in order to compare any instances of slipping, overall cut length across testing mediums, and scissor geometry including: scissor length, scissor width, and opening and closing dimensions. Testing showed the X-Surge device performed equivalent or better than the predicate Genicon product. Electrical performance of the device was completed following FDA guidance "Premarket Notification (510(k)) Submissions for Electrosural Devices for General Surgery" issued August 15, 2016. This requires testing on three different tissue types at minimum, default, and maximum generator power in order to simulate thermal spread across different tissue types. The spread is then measured under magnification, and recorded to be compared with the predicate product. Results showed an equivalent or less area of thermal spread under the same conditions across the different tissue types and power settings. The GENICON X-Surge instrumentation line was also compared to the predicate device through bench testing which included visual & operational use, ergonomic forces (i.e. attachment, activation, etc.). Testing on performance and general ergonomic use showed that the X-Surge device met the same requirements as the predicate product in terms of closure force, opening angle, finger spacing, and rotation knob interaction. ### 8. Clinical Tests There were no clinical trials performed on the GENICON X-Surge instrumentation line. - 9. Conclusions The subject device has identical indications for use as the predicate device. The technological characteristics, non-clinical testing and performance and bench testing of the GENICON X-Surge instrumentation line show that the device is as safe, as effective, and meets the same performance standard. Therefore, the proposed GENICON X-Surge instrumentation is substantially equivalent to the predicate.