Aquas Probes

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 14, 2019 GENICON, Inc. Ms. Katlyn Kachman Director of Quality and Regulatory Compliance 6869 Stapoint Court Suite 114 Winter Park, Florida 32792 Re: K190168 Trade/Device Name: GENICON Aquas Probes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 23, 2019 Received: January 31, 2019 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. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 medical devices and radiation-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. Image /page/1/Picture/5 description: The image shows a digital signature for Long H. Chen -S, dated 2019.03.14 at 10:49:57 -04'00'. The signature is for Binita S. Ashar, M.D., M.B.A., F.A.C.S. The name Long H. Chen -S is also present on the left side of the image. 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) K190168 Device Name GENICON Aquas Probes Indications for Use (Describe) Indications for Use (Describe) The GENICON Aquas Probes are instruments insulated for optional monopolar consembly as annonio I the GENCON Aquas I 100-3 are martine internal tissue or organs while performing laparoscopic procedures. 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 I he burden time ior this collection of information to commaint the data needed and complete tirre to review instruction. Send comments regarding this burden estimate or any other aspect and review the 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 Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "GENICON" in a bold, sans-serif font. The word is slightly curved, and there is a curved line underneath it. The font is a dark color, and the background is white. There is a registered trademark symbol to the right of the word. K190168 ب .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . # K190168 510(k) Summary Contact Information 1. GENICON 6869 Stapoint Court, Suite 114, Winter Park, FL 32792 Phone (407) 657-4851 Fax (407) 677-9773 Katlyn Kachman, Director of Quality January 23, 2019 - 2. Device Name - Trade Name GENICON Aquas Probes 0 - Trade Name OLNOON Aquao Probe, Electrocautery Probe, Electrosurgical Probe e - Common Name Monopolar Electrourgical, Cutting & Coagulation & Accessories (21 CFR e - 878.4400, Product Code GEI) - Substantially Equivalent Device 3. Substantially Equivalent Devices: Stryker Stiletto Electrosurgical Probe, K052141 Legally Marketed (unmodified) Devices: Stryker Stilettos (1800017 Paiunks HF Electrodes, K062047 | | | Pajunks HF Electrodes, K062047 | | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | Stryker Stiletto Electrosurgical<br>Probe (K052141) | Pajunks HF Electrodes (K062047) | GENICON Aquas Probes | | Component<br>Design | A. Electrosurgical Tip<br>B. Insulation<br>C. Insulation Control Knob<br>D. HF Post<br>E. Handle | A. Electrosurgical Tip<br>B. Insulation<br>C. Insulation Control Knob<br>D. HF Post<br>E. Handle | A. Electrosurgical Tip<br>B. Insulation<br>C. Insulation Control Knob<br>D. HF Post<br>E. Handle | | Design | The Stryker Stiletto Electrosurgical Probe is a<br>suction/irrigation probe with electrosurgical<br>capability indicated for use in laparoscopic<br>surgical procedures.<br><br>The device allows for suction and irrigation of<br>sterile irrigant solution. In addition, the device<br>is intended to be used for electrosurgical<br>cutting/coagulation during laparoscopic<br>procedures.<br><br>Products include optional retractable insulation<br>and are also provided without the<br>suction/irrigation functions. | The Pajunk adaptable and retractable HF<br>Electrodes are multiple use, non-sterile<br>delivered and latex free medical devices. The<br>instruments are insulated for optional<br>monopolar coagulation which enables a<br>surgeon to manipulate, dissect, retrieve,<br>biopsy, cut, or coagulate internal tissue or<br>organs while performing laparoscopic<br>procedures.<br><br>Pajunk provides electrodes with and without<br>suction and irrigation element and electrodes<br>with suction and irrigation capacity with<br>retractable/extendable tips. | The GENICON Reusable Electrosurgical Probe<br>are multiple use, non-sterile delivered medical<br>devices. The instruments are insulated for<br>optional monopolar coagulation which enables a<br>surgeon to manipulate, cut, or coagulate soft<br>tissue or organs while performing laparoscopic<br>procedures.<br><br>GENICON provides electrodes with and without<br>suction and irrigation element and electrodes<br>with suction and irrigation capacity with<br>retractable/extendable tips. | | Diameter | 5 mm | 5 mm | 5 mm | | Working<br>Length | 33 to 45 cm | 34 to 44 cm | 20 to 45 cm | | Electrosurgical<br>Tips | Spatula, L-Hook, J-Hook, Ball,<br>Needle, Spoon | Spatula, L-Hook, J-Hook, Knife,<br>Needle, 45 Deg | Spatula, L-Hook, J-Hook, Knife,<br>Needle, 45 Deg | TEL 407.657.4851 --- WWW.GENICONENDO.COM -- FAX 407.677.9773 US OFFICE • 6869 Stapoint Court #114, Winter Park, Florida USA 32792 —— EU OFFICE • 44 Airedale Avenue, Chiswick, London U.K W4 2NW {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "GENICON" in a bold, sans-serif font. The word is slightly curved, with the left side of the word being higher than the right side. There is a curved line underneath the word, which is thicker on the left side and thinner on the right side. The registered trademark symbol is located to the right of the word. | | | | K190168 | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Materials | Stainless Steel, Polyimide, PTFE,<br>Silicone, Rubber | Stainless Steel, Polyamide or<br>Ceramic | Stainless Steel, PEEK, POM, PPSU,<br>PTFE/FEP, Silicone | | Testing | Electrical and mechanical<br>performance of the predicate<br>devices were evaluated and<br>benchmarks established. | Electrical and mechanical<br>performance of the predicate<br>devices were evaluated and<br>benchmarks established. | Performance of the GENICON<br>Reusable Electrosurgical Probe<br>product showed that the device<br>performed equivalent or better and is<br>therefore substantially equivalent in<br>performance to the predicate devices. | | Performance | The Stryker Stiletto Electrosurgical<br>Probe allows for suction and<br>irrigation of sterile irrigant solution<br>and is intended to be used for<br>electrosurgical cutting/coagulation<br>during laparoscopic procedures.<br>Electrical safety complies with IEC<br>60601. | SAME | SAME | | Sterilization | Sterile/Single-Use and Non-<br>Sterile/Reusable | Non-Sterile/Reusable | Non-Sterile/Reusable | | Prescription<br>Only | Yes | Yes | SAME | | Biocompatibility | Unknown | Unknown | Conforms to ISO 10993 | #### Device Description 4. Device Description The GENICON Aquas Probes product line are multiple-use provided nor-sterile. The The GENICON Aquas Prodes product line are multiple aco modious a surgeon to manipulate, cut, or probes are insulated for optionwhile performing laparoscopic procedures. The GENICON Aquas Probes have an outside diameter of 5 mm and are provided in varying lengths and The GENCON Aquas Probes nave an outside on up to 45 cm. Common the configurations include La the connigurations. Volking lengths fange from 20 to the other on the more of the more of the many of Hook (Right Angle), 3-100K, Spatula, 40 , Kinic, Bar, Nostal, and on channel for suction and irigation of sterile irrigant solution when attached to a compatible lavage device. Devices may also include sterlie inrigant solution when attached to a compansion and insulation at the digression of the user. Device are intended to be reused up to 50 times, and may be sterilized by high-pressure steam autoclave. #### Intended Use 5. Interiod Use The GENICON Aquas Probes are instruments insulated for optional monopolar coagulation which enable The GENCON Aquas Probes are instrancents modiated for optional more of the mail the or organs while performing laparoscopic procedures. - 6. Technological Characteristics of the Subject Device Compared to the Predicate Device l echnological Characteristics of the Subject Device to the predicate in terms of finished device. There are no new technologies being added to the predicate in terms of fini There are no new teennologics bother and application as the predicate device. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "GENICON" in a bold, sans-serif font. The word is slightly curved, and there is a curved line underneath it. The registered trademark symbol is located to the right of the word. - Non-Clinical Tests 7. K190168 Non-clinical tests were conducted to verify that the GENICON Reusable Electrosurgical Probe product Non cimical tosts were contactions as the substantially equivalent predicate device and any additional test ime met an acongin opomodiations as i recluded in this submission include the following: - · Medical Electrical Equipment Testing - - Autoclave Sterilization Validation IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC 60601-2-2:2009 IEC 60601-2-18:2009 ISO 17655-1:2006 Cycle Count Testing In addition the GENICON Aquas Probes product line has been compared to the predicate device through m adultion the OENTOON Aqadoral use/performance and electrical safety and effectiveness. Electrical performance of the device was completed following FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" issued August 15, 2016. This (210(K)) Submissions for Licclosurgiour Donost for General Cally and maximum generator power in requires testing on three unferent tissue types. The spread is then measured under order to simular themal opread with the predicate product. Results showed an equivalent maginlication, and TCOrdou to be occipared the different tissue types and power settings. The GENICON Aquas Probes product line was also compared to the predicate device through bench THE SENION Aqual & operational use, ergonomic forces, and electrical safety. Testing on testing which included visual a operations that the devices met the same requirements as the predicate product. - 8. Clinical Tests Ollinian Fests There were no clinical trials performed on the GENICON Reusable Electrosurgical Probe product line. - 9. Conclusions Conclusions The Subject device has herformance and bench testing of the GENICON Aquas Probes Characteristics, non-cinical testing and portomiane and meets the same performance standard. product life show that the device to as enostantially equivalent to the predicate.