Ellusa Bipolar Wands

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November 2, 2020 Ellusa, LLC Ms. Suzanne Lucas Sr. Regulatory Affairs Specialist 2473 Grand Avenue Baldwin, New York 11510 Re: K202558 Trade/Device Name: Ellusa Bipolar Wands Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 31, 2020 Received: September 4, 2020 Dear Ms. Lucas: 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). 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Sincerely, Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) #### K202558 Device Name Ellusa Bipolar Wands Indications for Use (Describe) The Ellusa Bipolar Wands are intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed. 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. 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A swooping black design element is on the left side of the word, adding a dynamic and modern touch to the overall logo. # 510(k) Summary (As required by 21 CFR 807.92(a)) (K202558) Date Prepared October 29, 2020 ### Submitter's Information (807.92(a)(1)) Company Name and Address: Ellusa, LLC 2473 Grand Avenue Baldwin, NY 11510 Phone: (516) 866-0001 www.ellusa.com Establishment Registration number: 3016087306 #### Contact Information: Ms. Suzanne Lucas Sr. Regulatory Affairs Specialist Phone: (516) 866-0001 Email: slucas@ellusa.com #### Device Information (807.92(a)(2)) Trade Name: Ellusa Bipolar Wands #### Common/Usual Name Electrosurgical, Cutting & Coagulation Device & Accessories #### Classification Name and Regulation Electrosurgical Cutting and Coagulation Device and Accessories; 21 CFR 878.4400 #### Classification Panel Division of General, Restorative, and Neurological Devices #### Device Class/Product Code FDA Classification: Class 2 FDA Product Code: GEI {4}------------------------------------------------ # Predicate Devices (807.92(a)(3)) Soniquence Bipolar Electrodes (K190336) ### Use of Guidance Documents The content provided within this 510k follows the FDA guidance document "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" issued on March 9, 2020. ### Device Description (807.92(a)(4)) The Ellusa Bipolar Wand family is a line of disposable bipolar electrosurgical devices which is intended for use by a physician familiar with electrosurgery in bipolar coagulation for general surgery where coagulation of soft tissue is needed. The basic design of the Ellusa Bipolar Wands is a plastic handle, an elongated, insulated electrode shaft, a bipolar electrode tip, and an integrated cable and plug which is designed to connect exclusively to the Ellusa line of highfrequency RF energy sources. The operational principle of the device is common to all active bipolar electrosurgical devices; the active tip of the Ellusa Bipolar Wand emits RF energy generated according to settings established on the Ellusa Generator which emits high frequency, low temperature radiowaves directed to the electrode tip. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. This energy is capable of cutting or coagulating target tissue depending on the waveform associated with the mode and power setting of the generator. The devices are disposable and intended for single use only. The devices are intended for transient contact with the patient and are provided sterilized by ethylene oxide and has a shelf life of three years from the date of sterilization. #### Intended Use: The Ellusa Bipolar Wands are intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed. # Comparison of Technological Characteristics (807.92(a)(6)) The Ellusa Bipolar Wands are identical in technological characteristics to the Soniquence Bipolar Electrodes (K190336) based on a comparison of physical and performance characteristics. There are no technological differences between the subject device as compared to the predicate devices, and the indications for use are identical. {5}------------------------------------------------ | Technological Characteristic | Soniquence Bipolar Electrodes | Ellusa Bipolar Wand | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | PREDICATE DEVICE (K190336) | SUBJECT DEVICE | | Intended Use | The Soniquence Bipolar Electrode is intended<br>for use by a physician familiar with bipolar<br>coagulation with electrosurgery where<br>coagulation/contraction of soft tissue is<br>needed. | The Ellusa Bipolar Wands are intended for<br>use by a physician familiar with bipolar<br>coagulation with electrosurgery where<br>coagulation/contraction of soft tissue is<br>needed. | | Product Code | GEI | Identical to predicate | | Device Classification | Class II | Identical to predicate | | Functions | Cutting/coagulation | Identical to predicate | | Operating principle | Bipolar | Identical to predicate | | Energy Source | RF Energy | Identical to predicate | | Electrode Materials | Stainless steel | Identical to predicate | | Tip Configurations | Ball Tip, Standard, Hex blade | Identical to predicate | | Tip dimensions | 0.5 - 8mm | Identical to predicate | | Shaft lengths | 11 - 40cm | Identical to predicate | | Shaft diameter | 1.2 - 6mm | Identical to predicate | | Stability and Shelf Life | 3 years | Identical to predicate | | Coating | None | Identical to predicate | | Cable Length (m) | 3m | Identical to predicate | | Activation Method | Footswitch | Identical to predicate | | Testing standards used | IEC 60601-1 and IEC 60601-2-2 | Identical to predicate | | Biocompatibility | ISO 10993 | Identical to predicate | | Sterilization Methods | Ethylene Oxide | Identical to predicate | | Packaging | Sterile, Blister Tray | Identical to predicate | | Min., Max., Default output<br>Values (Wattage) | 0-170 | Identical to predicate | {6}------------------------------------------------ # Non-Clinical Testing (807.92(b)(1)) The Ellusa Bipolar Wands will be manufactured in accordance with the design control requirements of 21 CFR 820.30. Appropriate non-clinical verification and validation activities were planned and conducted to address identified risks and ensure the safety and effectiveness of the device. The following standards have been applied to the devices and passed all applicable tests requirements. - . IEC 60601-1:2005/(R)2012 and A1:2012 - Medical Electrical Equipment, Part I: General requirements for basic safety and essential performance - IEC 60601-1-6:2010 (Third Edition) + A1 2013: General requirements for basic safety and . essential performance - Collateral standard: Usability - . IEC 62366:2007 (First Edition) + A1:2014: Medical devices – Application of usability engineering to medical devices - . IEC 60601-1-2:2014 - Medical Electrical Equipment, Part l-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic Compatibility - . IEC 60601-2-2: 2017 6th edition- Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories # Sterilization: - . ISO 11135:2014 - Sterilization of health-care products — Ethylene oxide —Requirements for the development, validation and routine control of a sterilization process for medical devices - . ISO 11737-1: 2018 Sterilization of medical products--Microbiological methods--Part 1: Determination of population of microorganisms on product - . ISO 11737-2: 2019 Sterilization of medical devices--Microbiological methods--Part 2: Tests of sterility performed in the validation of a sterilization process - . ISO 11138-1:2017 Sterilization of health care products--Biological indicators--Part1: General Requirements - . ISO 11138-2:2017 Sterilization of health care products--Biological indicators--Part2: Biological indicators for ethylene oxide sterilization processes # Biocompatibility Testing: - . ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process {7}------------------------------------------------ - . ISO 10993-4:2017: 2017 Biological Evaluation of Medical Devices, Part 4: Selection of test for interactions with blood. - . ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - . ISO 10993-7:2008 Biological evaluation of medical device--Part: 7: Ethylene Oxide sterilization residual. - . ISO 10993-10:2010 - Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization - . ISO 10993-11:2017 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity # Shelf Life Testing: - . ASTM F1886/F1886M -Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection - . ASTM F1929 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration - . ASTM F1980 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices ### Performance Testing The subject device is composed of biocompatible materials, has passed dielectric testing, and performs identical to the predicate devices. Bench tests used ex vivo tissue that included liver, kidney, and muscle tissue. The subject devices were tested to demonstrate the thermal effect on tissue by measuring the width and depth of the thermally damaged zones in relation to tissue type, intensity setting, and duration of activation. The temperature profile of the subject device applicator and cable was recorded during simulation use for the maximum energy delivery duration at the maximum power to demonstrate the maximum applicator surface area and maximum cable surface temperature will be safe to the user and/or to the patient. The peak temperatures of the electrode tips and target tissue/vessels when the device is used for the maximum recommended duration and generator output settings was compared. Based on the results of the various bench tests, it was determined that the subject device is safe and effective. #### Clinical Testing (807.92(b)(2)) This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence. {8}------------------------------------------------ # Conclusion (807.92(b)(3)) In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate devices in terms of technology, performance, and indications for use, Ellusa, LLC concludes that the subject device, Ellusa Bipolar Wands do not raise any issues of safety or effectiveness and are substantially equivalent to the predicate devices as described above.