Resection Electrodes with HF cable

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August 3, 2021 Olympus Winter & Ibe GmbH % Christina Flores Manager, Regulatory Affairs Olympus Surgical Technologies America 118 Turnpike Road Southborough, Massachusetts 01772 Re: K210651 Trade/Device Name: Resection Electrodes with HF cable Regulation Number: 21 CFR 884.1690 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FAS, HIH, FJL Dated: July 16, 2021 Received: July 20, 2021 Dear Christina Flores: 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210651 #### Device Name Resection Electrodes with HF cable (WA22702S, WA22705S, WA22706S, WA22707S, WA22721S, WA22723S, WA227328, WA22737S, WA22739S, WA22751S, WA22755S, WA22760S, WA22766S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S) #### Indications for Use (Describe) Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> 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}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K210651 #### Device Name Resection Electrodes with HF cable (WA47705S, WA47707S, WA47721S, WA47723S, WA47732S, WA47737S, WA47738S, WA47739S, WA47751S, WA47755S, WA47760S, WA47740S, WA47741S, WA47741S, WA47742S, WA47743S, WA47744S) #### Indications for Use (Describe) Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system. Specific indications: - transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis) - lysis of intrauterine septa - endometrial ablation | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X 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." {4}------------------------------------------------ # 510(k) Summary ## 1. Submitter Information | Submitter Address: | Olympus Winter & Ibe GmbH | |--------------------|---------------------------| | | Kuehnstr. 61 | | | 22045 Hamburg | | | Germany | | Contact person: | Christina Flores, RAC | |-----------------|---------------------------------------| | | Regulatory Affairs Manager | | | Olympus Surgical Technologies America | | | 800 West Park Drive | | | Westborough, MA 01581 | | | Phone: (508) 808-3341 | | | Email: christina.flores@olympus.com | | | | August 3, 2021 Date prepared: ### 2. Device Information | Trade Name: | Resection Electrodes with HF cable | |--------------------|------------------------------------------------------| | Common Name: | Electrode, Electrosurgical, active, urological | | Regulation Number: | 876.4300 | | Classification | Endoscopic electrosurgical unit and accessories | | Device Class: | II | | Product Code: | FAS / HIH / FJL | | Review Panel: | Gastroenterology / Urology / Obstetrics / Gynecology | Model numbers: WA22702S, WA22703S, WA22705S, WA22706S, WA22707S, WA22721S, WA22723S, WA22732S, WA22737S, WA22738S, WA22739S, WA22751S, WA22755S, WA22760S, WA22766S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S WA47705S, WA47706S, WA47707S, WA47721S, WA47723S, WA47732S, WA47737S, WA47738S, WA47739S, WA47751S, WA47755S, WA47760S, WA47766S, WA47740S, WA47741S, WA47742S, WA47743S, WA47744S {5}------------------------------------------------ # 3. Predicate Devices The predicate device was chosen from the following predicate 510(k): | 510(k)<br>No. | Name | Predicate Model No. | Product code /<br>Reg No. | |---------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------| | K171965 | Resection Electrodes with<br>HF cable | WA22702S, WA22703S,<br>WA22705S, WA22706S,<br>WA22707S, WA22721S,<br>WA22723S, WA22732S,<br>WA22737S, WA22738S,<br>WA22739S, WA22751S,<br>WA22755S, WA22760S,<br>WA22766S, WA22740S,<br>WA22741S, WA22742S,<br>WA22743S, WA22744S,<br>WA47705S, WA47706S,<br>WA47707S, WA47721S,<br>WA47723S, WA47732S,<br>WA47737S, WA47738S,<br>WA47739S, WA47751S,<br>WA47755S, WA47760S,<br>WA47766S, WA47740S,<br>WA47741S, WA47742S,<br>WA47743S, WA47744S | FAS / 876.4300<br>FJL / 876.1500<br>HIH / 884.1690 | These predicates have not been subject to a design-related recall. {6}------------------------------------------------ ## 4. Product Description The Olympus Resection Electrodes with HF cable that are subject to this submission are for application in saline. Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporization and cutting. The subject HF-Resection Electrodes consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft). The accompanying HF cables consist of two lantern plugs on the instrument side and one generator plug on the generator side. The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons. The electrodes have a shaft diameter of 24 Fr, range in length from 261.8-336.7mm, and range in tip angle from 12° - 30° tips. The design of the HF cable plugs fits Olympus electrosurgical generators with Universal Socket. All subject Resection Electrodes are single-use electrodes and are delivered sterile. All subject Resection Electrodes are provided with a single-use, sterile cable to connect the electrode to the generator. ## 5. Indications for Use ## Resection Electrodes with HF cable for use in Urology Article no .: WA22702S, WA22703S, WA22706S, WA22706S, WA22707S, WA22721S, WA22723S, WA22732S, WA22737S, WA22738S, WA22739S, WA22751S, WA22755S, WA22760S, WA22766S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current. ## Resection Electrodes with HF cable for use in Gynecology Article no .: WA47705S, WA47706S, WA47707S, WA47721S, WA47723S, WA47732S, WA47737S, WA47738S, WA47739S, WA47751S, WA47755S, WA47760S, WA47766S, WA47740S, WA47741S, WA47742S, WA47743S, WA47744S Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system. {7}------------------------------------------------ ## Specific indications: - transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis) - lysis of intrauterine septa - - endometrial ablation - The subject and predicate devices have the same indications for use statements. # 6. Comparison of Technological characteristics The following table compares the technological characteristics of the subject and predicate devices: | Device & Predicate<br>Device(s): | K210651 | K171965 | |-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------| | Indication (anatomical<br>site) | Gynecological and Urological | Gynecological and Urological | | Mode of ablation | Bipolar (resection in saline) | Bipolar (resection in saline) | | Irrigation solution | Saline | Saline | | Length | 261.8 - 336.7 mm | 261.8 – 336.7 mm | | Compatible scope shaft<br>diameter | 24 Fr | 24 Fr | | Electrode Active tip<br>shapes | Loop, band, needle, roller, button | Loop, band, needle, roller, button | | Electrode Active tip<br>designs | 12° - 30° angles | 12° - 30° angles | | Patient Contact<br>Materials | stainless steel, elastosil (glue),<br>ceramic, loctite 4303 (glue), PTFE,<br>PtIr, tungsten | Stainless steel, Al2O3, PTFE (colors),<br>PtIr | | Stabilizing tube<br>diameter | 4.1 mm | 4.1 mm | | Sterilization and<br>Packaging Materials | Provided sterile (EtO), Tyvek/Blister<br>PET | Provided sterile (EtO), Tyvek/Blister<br>PET | | HF Cables packaged<br>with the subject device | Yes | Yes | | Shelf life | 3 years | 3 years | | Compatible generator(s) | Current Olympus electrosurgical<br>generators with UNIVERSAL<br>socket [ESG-400 (K141225 and<br>K203682), ESG-410 (K203277)]<br>as well as future ESG-generations<br>with UNIVERSAL socket | ESG-400 (K141225 and pending<br>K203682) | At a high level, the subject and predicate devices are based on the same technological principle with the same elements: {8}------------------------------------------------ - . Resection electrodes consisting of an active (distal) tip, PTFE color code identification at the distal and proximal ends, an insulator between the electrode and electrode tube, a stabilizing (guiding) tube, and arm (shaft) - . HF cables consisting of two lantern plugs on the instrument side and one generator plug on the generator side - 트 Used in combination with a resectoscope system - . Like the predicate electrodes, the subject device resection electrode series features loops, bands, needles, rollers, and a button as active tip shapes - Resection electrodes utilizing ablation or for resection in saline (dependent on model) - I Respectively identical outer dimensions - I Design changes of the electrodes and cables are minor and do not negatively impact safety or effectiveness of the subject devices - . The same or similar materials in patient contact are used in predicate and subject device and have all been successfully tested for biocompatibility. As stated above, the subject and predicate devices have similar design characteristics and performance specifications, with the exception of the compatibility to the Olympus electrosurgical generators with UNIVERSAL socket. These minor differences, however, do not raise different questions of safety or effectiveness. As demonstrated in the non-clinical testing (e.g., electrical safety, sterilization validation, and package integrity), the different technological characteristics do not affect the safety and effectiveness of the subject devices. ## 7. Summary of Non-Clinical Performance Testing The following tests were conducted to demonstrate the compatibility to Olympus HF generators that have UNIVERSAL socket to the instructions for use of the resection electrodes: Mechanical performance: - Mechanical compatibility ● - Detaching force of electrode ● - Lifetime connection/disconnection of the electrodes - Compression and tension between guiding sheets and contact part - . Detaching force of the cable from ESG410 Resection/Coagulation performance: - Duration of single activation in combination with a HF generator Transport tests: - Communication with a HF generator ● - Electrode pull back to proximal stop . {9}------------------------------------------------ In addition, tests to evaluate manual assembly of the system and visual inspection of the generator display were conducted. Electrical Safety was tested according to the following standards: | AAMI/ANSI ES 60601-<br>1:2005 + A1:2012, C1:2009<br>and A2:2010 | Medical Electrical Equipment - Part 1.1 General<br>requirements for safety and essential performance. | |-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | AAMI/ANSI/IEC 60601-2-2<br>2017 | Medical Electrical Equipment - Part 2-2: Particular<br>Requirements for the Basic Safety And Essential<br>Performance of High Frequency Surgical Equipment<br>and High Frequency Surgical Accessories | | IEC 60601-2-18:2009 | Medical electrical equipment - Part 2-18: Medical<br>Electrical Equipment - Part 2-18: Particular<br>requirements for the basic safety and essential<br>performance of endoscopic equipment. | Sterilization is performed according to ISO 11135:2014 and packaging conforms with ISO 11607-1: 2019. The EtO sterilization cycle has been validated. A sterility assurance level (SAL) of 106 was reached during validation and will be used for routine sterilization in compliance with regulations in force for sterile medical devices. The EtO residuals are within the limits after tunnel degassing time. The subject device passed the simulated shipping distribution and associated packaging integrity testing conducted per ASTM D4169:2016, ASTM F88, ASTM F1929, and ASTM F2096. The biocompatibility was evaluated in accordance with ISO-10993, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010), irritation (ISO 10993-10:2010), acute systemic toxicity (ISO10993-11:2017), and material-mediated pyrogenicity (ISO10993-11:2017). ## 8. Conclusion The performance data support the safety and effectiveness of the subject device and demonstrate that the subject device is substantially equivalent to the predicate device. In conclusion, the Resection Electrodes with HF cable are substantially equivalent to the predicate devices.