The Ellusa Reusable Neutral Plate provides a safe return path for electrosurgical current and is designed for use with Ellusa Generators for minor surgical applications. The Reusable Neutral Plate is provided nonsterile and intended for use only in nonsterile environments.

Device Description

The Ellusa Reusable Neutral Plates will be provided as a flexible plate made of silicone rubber and will be supplied with a 10-foot cable and is non-sterile. There are no differences in the functionality of a reusable neutral plate as compared to the disposable neutral plate. They are both used to provide a safe return path for electrosurgical current.

AI/ML Overview

This submission is for an Ellusa Reusable Neutral Plate, which is an electrosurgical accessory. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific clinical performance acceptance criteria. Therefore, most of the requested information regarding clinical studies, ground truth, expert consensus, and multi-reader multi-case studies is not applicable to this document.

The acceptance criteria provided here are related to non-clinical testing and engineering standards for the device's safety and performance with respect to its function as an electrosurgical accessory.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard / Test)	Reported Device Performance	Comments
IEC 60601-2-2: 2017 - 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	"Testing was conducted for the following standard and resulted in passing results."	This blanket statement indicates all sub-elements of this standard were met. Specific sub-elements tested include:
- Cl. 201.8.7.3.101: Thermal effects of HF Leakage Currents	Passing results	Ensures the plate does not cause excessive heating due to leakage currents.
- Cl. 201.8.8.3.103: ACTIVE ACCESSORY HF dielectric strength	Passing results	Tests the insulation integrity under high-frequency voltage.
- Cl. 201.8.8.3.104: ACTIVE ACCESSORY mains frequency dielectric strength	Passing results	Tests the insulation integrity under mains frequency voltage.
- Cl. 201.15.101.2: NE cord attachment	Passing results	Ensures the cord is securely attached.
- Cl. 201.15.101.4: NE cord insulation	Passing results	Tests the insulation of the neutral electrode cord.
- Cl. 201.15.101.6: NE contact impedance	Passing results	Measures the resistance of the contact between the plate and the patient/generator to ensure efficient current return.
Biocompatibility Requirements	"All tests resulted in passing results."	This blanket statement indicates all biocompatibility tests were met. Specific tests include:
- In-Vitro Cytotoxicity ISO 10993-5:2010	Passing results	Assesses potential for the device materials to be toxic to cells.
- Sensitization ISO 10993-10:2010	Passing results	Assesses potential for the device materials to cause allergic reactions.
- Irritation ISO 10993-10:2010	Passing results	Assesses potential for the device materials to cause skin irritation.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided in the document. The document describes non-clinical engineering and biocompatibility testing, which typically uses a specified number of device units or material samples for testing rather than a "test set" in the context of clinical data. The provenance of such testing data is usually from accredited testing laboratories, but specific details are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable as there was no clinical test set requiring expert ground truth establishment for this type of device (electrosurgical neutral plate). The "ground truth" for non-clinical testing is adherence to established engineering and biocompatibility standards.

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

This information is not applicable as there was no clinical test set requiring adjudication in this context. The "adjudication" for non-clinical testing involves the interpretation of test results against predefined pass/fail criteria of the 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:

This information is not applicable. This document is for an electrosurgical neutral plate, which is a hardware accessory, not an AI-enabled diagnostic tool. Therefore, an MRMC study or AI assistance is irrelevant.

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

This information is not applicable. The device is an electrosurgical neutral plate, not an algorithm.

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

The "ground truth" for the non-clinical testing described is based on the pass/fail criteria defined within the referenced international standards (IEC 60601-2-2 and ISO 10993 series). These standards themselves are developed through expert consensus within their respective fields to ensure safety and performance.

8. The sample size for the training set:

This information is not applicable. As a hardware device, there is no "training set" in the context of machine learning. The device design and manufacturing processes are likely informed by engineering principles and previous device experience, but not a dataset used for training an algorithm.

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

This information is not applicable for the reasons stated above.

Summary

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September 8, 2022

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

Re: K222425

Trade/Device Name: Ellusa Reusable Neutral Plates Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 24, 2022 Received: August 11, 2022

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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,

for

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) K222425

Device Name Ellusa Reusable Neutral Plate

Indications for Use (Describe)

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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K222425

Exhibit 6. 510(k) SUMMARY

(As required by 21 CFR 807.92(a))

Date Prepared

September 7, 2022

Submitter's Information (807.92(a)(1))

Company Name and Address: Ellusa, LLC 2473 Grand Avenue Baldwin, NY 11510 Phone: (516) 634-1370 Establishment Registration #: 3016087306

Contact Information:

Ms. Suzanne Lucas Sr. Requlatory Affairs Specialist Phone: (516) 634-1370 Email: slucas@ellusa.com

Device Information (807.92(a)(2))

Trade Name: Ellusa Reusable Neutral Plate

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: General and Plastic Surgery

Device Class/Product Code

FDA Classification: Class 2 FDA Product Code: GEI

Predicate Devices (807.92(a)(3))

Ellusa Disposable Neutral Plate (K202562) ●
ellusa LLC. 2473 Grand Avenue, Baldwin, NY 11510 Main: (516) 654-4000 • Fax: (516) 654-8000 www.ellusa.com

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K222425

Image /page/4/Picture/2 description: The image shows the word "ellusa" in a stylized, sans-serif font. To the left of the word is a curved, swooping design element that adds a dynamic touch to the logo. The font is modern and clean, with rounded edges that give it a friendly and approachable feel. The overall design is simple yet effective, creating a memorable and recognizable brand image.

Device Description (807.92(a)(4))

Intended Use:

The Reusable Neutral Plate provides a safe return path for electrosurgical current and is designed for use with Ellusa RF Generators for minor surgical applications. The Reusable Neutral Plate is provided nonsterile and intended for use only in nonsterile environments.

Substantial Equivalence Comparison (807.92(a)(6))

The Ellusa Reusable Neutral Plate is substantially equivalent in intended use, technological characteristics, operating principle, and performance characteristics to the predicate device by Ellusa (K202562).

PredicateInformation	Ellusa Reusable Neutral Plate(SUBJECT DEVICE)	Ellusa Disposable Neutral Plate(K202562(PREDICATE DEVICE)
Intended Use	The Reusable Neutral Plate provides a safereturn path for electrosurgical current and isdesigned for use with Ellusa Generators forminor surgical applications. The ReusableNeutral Plate is provided nonsterile andintended for use only in nonsterileenvironments.	The Neutral Plate/Grounding Pad isdesigned for use with Ellusa Generatorsand provides a safe return path forelectrosurgical current.
Product Code	GEI	GEI
Device Classification	Class II	Class II
Functions	Connect to Electrosurgical Generator toprovide safe return path.	Connect to Electrosurgical Generator toprovide safe return path.
Operating mode	Monopolar	Monopolar
Energy Source	RF Energy	RF Energy
Cable Length (ft)	10 feet	9 feet
Patient ContactingMaterials	Silicone	Silicone
Testing standardsused	IEC 60601-2-2 (6th edition)	IEC 60601-2-2 (6th edition)

ellusa LLC. 2473 Grand Avenue, Baldwin, NY 11510 Main: (516) 654-4000 • Fax: (516) 654-8000 www.ellusa.com

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

The Reusable Neutral Plates 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. Testing was conducted for the following standard and resulted in passing results.

-IEC 60601-2-2: 2017 - 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
- o IEC 60601-2-2: Cl. 201.8.7.3.101: Thermal effects of HF Leakage Currents
- IEC 60601-2-2: Cl. 201.8.8.3.103: ACTIVE ACCESSORY HF dielectric strength O
- IEC 60601-2-2: Cl. 201.8.8.3.104: ACTIVE ACCESSORY mains frequency dielectric strength O
- IEC 60601-2-2: Cl. 201.15.101.2: NE cord attachment O
- IEC 60601-2-2: Cl. 201.15.101.4: NE cord insulation o
- IEC 60601-2-2: Cl. 201.15.101.6: NE contact impedance O

The reusable neutral plate has been tested and evaluated against the following biocompatibility requirements. All tests resulted in passing results.

In-Vitro Cytotoxicity ISO 10993-5:2010 o
Sensitization ISO 10993-10:2010 O
Irritation ISO 10993-10:2010 o

Technological Characteristics

The devices are substantially equivalent to the predicate device based on a comparison of physical and performance characteristics. They are all intended to be used with electrosurgical generators to provide a safe return path for the electrosurgical current.

Clinical Testing (807.92(b)(2))

This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

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 Reusable Neutral Plates do not raise any issues of safety or effectiveness and are substantially equivalent to the predicate device as described above.

ellusa LLC. 2473 Grand Avenue, Baldwin, NY 11510 Main: (516) 654-4000 • Fax: (516) 654-8000 www.ellusa.com

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.