(59 days)
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.
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.
This document describes the Ellusa Bipolar Wands, an electrosurgical device, and its acceptance criteria as part of its 510(k) submission (K202558) to the FDA. The submission aims to demonstrate substantial equivalence to a predicate device, the Soniquence Bipolar Electrodes (K190336).
1. Table of Acceptance Criteria and Reported Device Performance
The device is assessed against a predicate device, the Soniquence Bipolar Electrodes (K190336). The acceptance criterion is that the Ellusa Bipolar Wands are "Identical to predicate" across a range of technological characteristics.
| Technological Characteristic | Acceptance Criteria (Predicate: Soniquence Bipolar Electrodes, K190336) | Reported Device Performance (Ellusa Bipolar Wand) |
|---|---|---|
| Intended Use | The Soniquence Bipolar Electrode is intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed. | Identical to predicate |
| 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 Values (Wattage) | 0-170 | Identical to predicate |
The study demonstrates that the Ellusa Bipolar Wands meet these acceptance criteria by asserting that they are "identical in technological characteristics to the Soniquence Bipolar Electrodes (K190336) based on a comparison of physical and performance characteristics."
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly specify a sample size for a "test set" in the context of an AI/algorithm-based device as this is a medical device (electrosurgical wands) that relies on physical and performance testing for substantial equivalence, not algorithmic performance. The testing involved ex vivo tissue (liver, kidney, and muscle tissue) for performance bench tests. The quantity of tissue samples used is not provided. The data provenance is derived from these bench tests and adherence to various ISO and IEC standards. The data would be prospective, generated during the verification and validation activities for the Ellusa Bipolar Wands.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an AI/algorithm-based device requiring expert ground truth establishment for a test set. The substantial equivalence is determined by comparing physical and performance characteristics against a predicate device and adherence to recognized standards.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI/algorithm-based device requiring an adjudication method. The assessment is based on objective measurements and compliance with standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-only device. It is a physical electrosurgical instrument.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Predicate Device Characteristics: The known, legally marketed predicate device (Soniquence Bipolar Electrodes, K190336) serves as the benchmark for technological characteristics and intended use.
- Industry Standards: Adherence to recognized national and international standards (IEC 60601-1, IEC 60601-1-6, IEC 62366, IEC 60601-1-2, IEC 60601-2-2 for electrical safety and performance; ISO 11135, ISO 11737-1, ISO 11737-2, ISO 11138-1, ISO 11138-2 for sterilization; ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11 for biocompatibility; ASTM F1886/F1886M, ASTM F1929, ASTM F1980 for shelf life). This implies that meeting these standards constitutes acceptable performance and safety.
- Bench Test Results: Direct measurements of thermal effects on ex vivo tissue and temperature profiles during simulated use to demonstrate safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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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). 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
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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 (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 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,
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
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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)
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Image /page/3/Picture/1 description: The image shows the word "ellusa" in a stylized font. The word is in black and is set against a white background. 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
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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.
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| Technological Characteristic | Soniquence Bipolar Electrodes | Ellusa Bipolar Wand |
|---|---|---|
| PREDICATE DEVICE (K190336) | SUBJECT DEVICE | |
| Intended Use | The Soniquence Bipolar Electrode is intendedfor use by a physician familiar with bipolarcoagulation with electrosurgery wherecoagulation/contraction of soft tissue isneeded. | The Ellusa Bipolar Wands are intended foruse by a physician familiar with bipolarcoagulation with electrosurgery wherecoagulation/contraction of soft tissue isneeded. |
| 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 outputValues (Wattage) | 0-170 | Identical to predicate |
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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
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- . 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.
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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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.