The Ellusa Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.

The Ellusa Monopolar Tips are intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures.

Device Description

The Ellusa Generators are radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device is designed to enable the performance of monopolar and bipolar functions for cutting, coagulation, and hemostasis in conjunction with separately-marketed electrosurgical accessories and ancillary equipment which have been developed for mutually- exclusive use with the Ellusa line of generators.

All selections are effected through push buttons and lamps, which give the operator feedback of status. The power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and /or hand switches.

Ellusa Electrodes are used with the Ellusa Generator. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation. The Ellusa family of electrodes is available in various shapes and sizes depending on the need of the surgeon. The devices are available in classic alloys (Tungsten, brass, stainless steel).

These devices are designed to comply with international safety standards including applicable IEC series electrical safety standards.

AI/ML Overview

The provided text is an FDA 510(k) summary for a medical device (Ellusa Generator and Monopolar Tips). It demonstrates substantial equivalence to a predicate device rather than presenting a study of its own for novel acceptance criteria.

Therefore, the information required to directly answer the request (acceptance criteria and a study proving the device meets them, especially in the context of AI/human reader performance) is not present in the provided document.

The document states that:

The device is "substantially equivalent" to a predicate device (Soniquence RF Generator & Monopolar Electrodes, K183611).
"There are no technological differences between the subject device as compared to the predicate devices, and the indications for use are identical to the predicate devices."
"The only difference between the subject devices of this 510k and the predicate devices is a rebranding with the Ellusa name. The technology remains the same."

This type of submission focuses on demonstrating that the new device operates fundamentally the same as a device already on the market, by comparing technological characteristics and showing compliance with relevant safety and performance standards. It does not involve AI or human reader studies.

However, I can extract information regarding the non-clinical testing performed to demonstrate safety and performance equivalence, which acts as the "proof" for this type of submission.

Here's an interpretation of the "acceptance criteria" and "study" based on the provided document, framed within the context of a 510(k) submission for substantial equivalence:

Acceptance Criteria and Demonstrating Equivalence (as per a 510(k) submission):

The acceptance criteria for a 510(k) are not typically expressed as specific performance metrics of a novel AI algorithm or human reader improvement. Instead, they revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. For this device (an electrosurgical generator and tips), the "acceptance criteria" are implicitly met by:

Identical Intended Use: The device performs the same functions for the same purposes as the predicate.
Substantially Equivalent Technological Characteristics: No new questions of safety or effectiveness are raised compared to the predicate. Minor differences are shown not to affect safety or performance.
Compliance with Recognized Standards: The device meets relevant international safety, performance, biocompatibility, and sterilization standards.
Successful Non-Clinical Testing: Specific tests confirm the device's electrical output, thermal effects, and general functionality are comparable and within acceptable limits.

The "Study" Proving the Device Meets Acceptance Criteria (Non-Clinical Testing):

The "study" in this context is the Non-Clinical Testing section, which provides the technical evidence for substantial equivalence.

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implicit for 510(k) Equivalence)	Reported Device Performance (Summary from Non-Clinical Testing Section)
Identical Intended Use	The Ellusa Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures... The Ellusa Monopolar Tips are intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures. (Identical to Predicate).
Technological Equivalence (Generators)	Principle of Operation: Identical to predicate (Conversion of electrical energy to high-frequency RF energy). Modes of Operation/Mechanism of Action: Predominantly identical; minor nomenclature changes (e.g., "Cut/Coag" vs. "Blend") and some models with reduced max output (e.g., 120W vs. 170W) which are stated not to introduce new risks or affect safety/effectiveness. Output Frequency: Identical (4 MHz monopolar, 1.7 MHz bipolar). Maximum Power Output: Predominantly identical; some models 120W (vs. 170W for predicate). Peak-to-Peak Voltage: Identical (1,200V). Power Activation Control: Identical (Footswitch and/or fingerswitch). Applied Part Type: Predominantly identical CF; some models BF (stated not to affect equivalence).
Technological Equivalence (Monopolar Tips)	Intended Use: Identical to predicate. Product Code/Classification: Identical.Functions/Energy Type: Identical (Cutting/coagulation, Monopolar). Design Specifications/Shaft Forms/Malleability/Lengths/Diameter/Tip Configurations/Material Composition/Biocompatibility/Sterilization/Packaging/Activation Method/Cable Length/Temperature Probe/Cooling Function: All identical to predicate.
Electrical Safety & EMC Testing	Successfully performed: AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2.
Usability Engineering	Successfully performed: IEC 62366.
Sterilization Validation	Successfully performed: ISO 11135, ISO 11737-1, ISO 11737-2, ISO 11138-1.
Biocompatibility	Successfully performed: ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11.
Shelf Life Testing	Successfully performed: ASTM F1980-07.
Performance Testing (Generator & Tips)	Successfully performed: Software V&V (IEC 62304, FDA Guidance), Energy Output Verification (all five modes, compared to predicate), Thermal Effect Comparison (representative modes on ex-vivo bovine tissue), Design Verification/Validation (output power, Hipot test, pull test, lateral heat spread in tissue, temperature profile, final test). All passed applicable acceptance criteria.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: The document mentions "ex-vivo bovine tissue" for thermal effect comparison, but does not specify a quantitative sample size (e.g., number of tissue samples or test runs). For electrical safety and other standard compliance tests, the "sample" would be the device units tested, but a specific number is not provided, though it would be standard practice to test a representative number of units.
Data Provenance: The tests are "non-clinical verification and validation activities" conducted by the submitter (Ellusa, LLC). The data provenance would be internal laboratory testing.
Retrospective or Prospective: These tests are prospective, conducted specifically to support the 510(k) submission.
Country of Origin of Data: Not explicitly stated, but assumed to be the testing facilities used by Ellusa, LLC (US-based).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable to this type of device and submission. "Ground truth" in the context of AI or diagnostic imaging usually refers to clinical diagnoses or pathology results established by medical experts used to train and validate algorithms. For an electrosurgical device, performance is evaluated against engineering specifications and physical measurements, not expert clinical interpretations of images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are used in studies involving human readers or AI output where there might be disagreements in interpretation (e.g., diagnosis from medical images). This document describes engineering validation and verification tests.

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:

No. This is an electrosurgical device, not an AI or diagnostic imaging product designed to assist human readers. Therefore, an MRMC study was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This device is hardware (generator and tips) for surgical procedures. It does not have an AI algorithm for standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the performance tests (e.g., energy output, thermal effect), the "ground truth" is established by physical measurements and engineering specifications, often compared against the predicate device's known performance or against established scientific principles of energy delivery and tissue interaction. For example, for "Energy output verification," the ground truth is the expected power output for a given setting, measured by calibrated equipment. For "Thermal effect comparison," the ground truth involves measuring the actual thermal spread in tissue and comparing it to expected or predicate device behavior.

8. The sample size for the training set:

Not applicable. This device is not an AI system that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable. As above, no AI training set is involved.

In summary, the provided document details a 510(k) submission for substantial equivalence of an electrosurgical device based on engineering and safety testing, not on AI or human-in-the-loop performance studies.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

November 2, 2020

Ellusa, LLC Ms. Suzanne Lucas Sr. Regulatory Affairs Specialist 2473 Grand Avenue Baldwin, New York 11510

Re: K202562

Trade/Device Name: Ellusa Generator and Monopolar Tips

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.

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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) 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.

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) K202562

Device Name Ellusa Generator and Monopolar Tips

Indications for Use (Describe)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

The Ellusa Monopolar Tips are intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical 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)

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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. There are three curved lines to the left of the word, which appear to be a design element. The font is sans-serif and has rounded edges.

510(k)SUMMARY (As required by 21 CFR 807.92(a)) (K202562)

October 28, 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 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 Generator and Monopolar Tips

Common/Usual Name

Electrosurgical unit and accessories, electrosurgical cutting and coagulation device and accessories

Classification Name and Regulation

Electrosurgical Cutting and Coagulation Device and Accessories; 21 CFR 878.4400

Classification Panel

General and Plastic Surgery Device

Device Class/Product Code

FDA Classification: Class II FDA Product Code: GEI

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Predicate Device (807.92(a)(3))

Soniquence RF Generator & Monopolar Electrodes (K183611)

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))

These devices are designed to comply with international safety standards including applicable IEC series electrical safety standards.

Intended Use:

The Ellusa Monopolar Tips are intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures.

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Comparison of Technological Characteristics

The subject devices are substantially equivalent to the predicate devices 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 to the predicate devices.

Comparison of Generator models

Characteristic	Soniquence GeneratorK183611PREDICATE	Ellusa GeneratorType 1Proposed Device	Ellusa GeneratorType 2Proposed Device	Ellusa GeneratorType 3Proposed Device
Photo	Image: Soniquence Generator K183611 PREDICATE	Image: Ellusa Generator Type 1 Proposed Device	Image: Ellusa Generator Type 2 Proposed Device	Image: Ellusa Generator Type 3 Proposed Device
Modelnumbersavailable	(Type 1 models)IEC6-SESP120, IEC6-IESP170,IEC6-IENSP170, IEC6-SESP170,IEC6-SENSP170(Type 2 models)IEC6-IESU120, IEC6-IENSU120,IEC6-SENSU120, IEC6-SESU120, IEC6-IESU170, IEC6-IENSU170, IEC6-SESU170,IEC6-SENSU170(Type 3 models)IEC6-IESV120, IEC4-SEN120,IEC6-SENSV120, IEC6-SESV120, IEC6-IESV170, IEC6-IENSV170, IEC6-SESV170,IEC6-SENSV170	IEC6-SEEP120IEC6-IEEP170IEC6-IENEP170IEC6-SEEP170IEC6-SENEP170IEC4-ESM120IEC4-ESPIEC3A-ES30W	IEC6-IEEU120IEC6-IENEU120IEC6-SENEU120IEC6-SEEU120IEC6-IEEU170IEC6-IENEU170IEC6-SEEU170IEC6-SENEU170	IEC6-IEEV120IEC4-SEN120IEC6-SENEV120IEC6-SEEV120IEC6-IEEV170IEC6-IENEV170IEC6-SEEV170IEC6-SENEV170IEC4-EJSM120
Principle ofOperation	Conversion of electricalenergy to high-frequencyRF energy (monopolar andbipolar)	Identical to predicate	Identical to predicate	Identical to predicate
Characteristic		Soniquence GeneratorK183611PREDICATE	Ellusa GeneratorType 1Proposed Device	Ellusa GeneratorType 2Proposed Device	Ellusa GeneratorType 3Proposed Device
Modes ofoperation /mechanism ofaction	Cut	4.0 MHzsquare waveenvelope150W max.output	All Identical topredicate exceptmodelsIEC4-ESM120, IEC4-ESP, &IEC3A-ES30W are max120W output	Identical to predicate	All Identical topredicate exceptmodel IEC4-EJSM120is max 120W output
	Blend	4.0 MHzsquare waveenvelope110W max.output	All Identical topredicate exceptmodelsIEC4-ESM120, IEC4-ESP, &IEC3A-ES30W are max90W output and themode is calledCut/Coag	Identical to predicate	All Identical topredicate exceptmodel IEC4-EJSM120is 90W output andthe mode is calledCut/Coag.
	Hemo	4.0 MHzsquare waveenvelope60W max.output	Identical to predicate	Identical to predicate	Identical to predicate
	Bipolar	1.7 MHz CWsinusoidalwave40W maxoutput	Identical to predicateexcept modelsIEC4-ESM120, IEC4-ESP, &IEC3A-ES30W mode iscalled Bipolar Hemo(minor change innomenclature only,function andperformance stay thesame)	Identical to predicate	All Identical topredicate exceptmodel IEC4-EJSM120is Fulgurate(Monopolar) and 4.0MHzSinusoidal wave40W max. output
	BipolarTurbo	1.7 MHzsquare waveenvelope170W max.output	All Identical topredicate exceptmodelsIEC4-ESM120, IEC4-ESP, &IEC3A-ES30W are max120W output	Identical to predicate	All Identical topredicate exceptmodel IEC4-EJSM120is max120W outputand mode is Bipolar
Outputfrequency		4 MHz (monopolar)1.7 MHz (bipolar)	Identical to predicate	Identical to predicate	Identical to predicate
Maximumpower output		170W	All Identical topredicate exceptmodelsIEC4-ESM120, IEC4-ESP, &IEC3A-ES30W	Identical to predicate	All Identical topredicate exceptmodel IEC4-EJSM120is 120W
	Soniquence GeneratorK183611PREDICATE	Ellusa GeneratorType 1Proposed Device	Ellusa GeneratorType 2Proposed Device	Ellusa GeneratorType 3Proposed Device
Characteristic
		IEC3A-ES30W are120W
Voltage(peak-to-peak)	1,200V	Identical to predicate	Identical to predicate	Identical to predicate
Poweractivationcontrol	Footswitch and/orfingerswitch	Identical to predicate	Identical to predicate	Identical to predicate
Electricalsafety andEMC testingstandards	AAMI ANSI ES60601-1IEC 60601-1-2IEC 60601-2-2	Identical to predicate	Identical to predicate	Identical to predicate
Applied parttype	CF	All Identical topredicate exceptmodelsIEC4-ESM120,IEC4-ESP, &IEC3A-ES30W aretype BF	Identical to predicate	All Identical topredicate exceptmodel IEC4-EJSM120is type BF

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Comparison of Monopolar Tips

Predicate Information	Soniquence Monopolar Electrodes(K183611)	Ellusa Monopolar Tips
	PREDICATE	PROPOSED DEVICE
Intended Use	The Soniquence Monopolar Electrodes areintended for use by a physician familiar withresection, dissection, incision, and hemostasisin soft tissue surgical procedures.	The Ellusa Monopolar Tips are intended foruse by a physician familiar with resection,dissection, incision, and hemostasis in softtissue surgical procedures.
Product Code	GEI	Identical to predicate
Device Classification	Class II	Identical to predicate
Functions	Cutting/coagulation	Identical to predicate
Energy type/ operatingprinciple	Monopolar	Identical to predicate
Design Specifications	Integrated sterile components; handle, cable,connector, shaft, monopolar electrode	Identical to predicate
Shaft forms	Straight, Bayonet, angled, and curved	Identical to predicate
Shaft malleability	Fixed and malleable models	Identical to predicate
Shaft lengths	1.9 – 60 cm	Identical to predicate
Shaft diameter	1/16"	Identical to predicate
Tip Configurations	Loop (round, diamond), ball, and blade (needle,fine wired, spatula)	Identical to predicate

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Material Composition		Identical to predicate
Handle	Molded Plastic
	Surgical Stainless Steel/Brass
Shaft	Surgical Stainless Steel/ Tungsten/Brass
Electrode	Surgical stainless steel / PFA insulation
Patient contactingmaterials	Medical grade stainless steel, brass, tungsten,Loctite, PFA, and PTFE	Identical to predicate
Coating	None	Identical to predicate
Biocompatibility	ISO 10993	Identical to predicate
Sterilization Methods	Gamma or Ethylene Oxide	Identical to predicate
Expiration Dating	Yes	Identical to predicate
Packaging	Sterile, Blister TraySterile, Peel Pouch	Identical to predicate
Activation Method	Fingerswitch/Footswitch	Identical to predicate
Manual Controls	No, all power settings established on generator	Identical to predicate
Min., Max., Defaultoutput Values (Wattage)	0-170	Identical to predicate
Cable Length (m)	3	Identical to predicate
Temperature Probe	No	Identical to predicate
Cooling Function	None	Identical to predicate

Summary of Technological Characteristics

The Ellusa Generator and Monopolar Tips are equivalent in intended use, technological characteristics, operating principle, and technical specifications to the predicate device Soniquence Generator and Monopolar Electrodes (K183611).

The differences of minor changes in nomenclature of operating modes does not affect the function or performance of the devices. In addition, the reduced output power on some models does not introduce new risks or affect the safety and effectiveness of the devices.

Non-Clinical Testing (807.92(b)(1))

The Ellusa Generator and Monopolar Tips 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 in order to address identified risks and ensure the safety and effectiveness of the device. The following tests were successfully performed:

. AAMI ANSI ES60601-1 - Medical Electrical Equipment, Part I: General requirements for basic safety and essential performance

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. IEC 60601-1-2 - Medical Electrical Equipment, Part I-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic Compatibility
IEC 60601-2-2 - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 62366 Medical devices Application of usability engineering to medical devices. .

Sterilization of Monopolar Tips:

. ISO 11135 - 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 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
. ISO 11737-2 - Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process /
. ISO 11138-1 - Sterilization of health care products - Biological indicators - Part 1: General requirements

Biocompatibility Testing:

. ISO 10993-1 - Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
. ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-7 - Biological evaluation of medical devices - part 7: ethylene oxide sterilization residuals
. ISO 10993-10 - Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

Shelf Life Testing:

. ASTM F1980-07 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Performance Testing:

. Software verification and validation in accordance with IEC 62304 and the FDA Final Guidance document titled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
. Energy output verification of each of the five modes and comparison to predicate.

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. Thermal effect comparison for representative modes of the subject device and predicate on ex-vivo bovine tissue.
. A design verification /validation was conducted to validate the design and functionality of the generator and Monopolar Tip accessories. Tests included output power test, Hipot test, pull test, lateral heat spread in tissue test, evaluation of temperature profile, and final test. All tests passed their applicable acceptance criteria.

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 Ellusa Generator and Monopolar Tips are substantially equivalent to and as safe and effective as the predicate devices described above. The only difference between the subject devices of this 510k and the predicate devices is a rebranding with the Ellusa name. The technology remains the same.

Regulation Number and Section

§ 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.