Soniquence Reusable Neutral Plate

K220071 · Soniquence, LLC · GEI · Feb 3, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220071
• Device Name: Soniquence Reusable Neutral Plate
• Applicant: Soniquence, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 3, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Indications for Use

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

Device Story

Device is a flexible silicone rubber plate with a 10-foot cable; functions as a return electrode for monopolar electrosurgical current. Used in nonsterile environments during minor surgical applications. Operates by connecting to a Soniquence electrosurgical generator to complete the RF energy circuit, ensuring safe current return to the generator. Used by clinicians to prevent thermal injury at the return site. Benefits patient by enabling safe delivery of electrosurgical energy for cutting and coagulation.

Clinical Evidence

No clinical data provided. Substantial equivalence demonstrated via bench testing, including electrical safety per IEC 60601-2-2 (thermal effects, dielectric strength, contact impedance) and biocompatibility per ISO 10993 (cytotoxicity, sensitization, irritation).

Technological Characteristics

Flexible silicone rubber plate; 10-foot cable; monopolar RF energy return; non-sterile. Tested to IEC 60601-2-2 for high-frequency surgical accessories. Biocompatibility per ISO 10993-5 and ISO 10993-10.

Indications for Use

Indicated for patients undergoing minor surgical procedures requiring electrosurgical current, providing a safe return path for the current when used with Soniquence Generators.

Regulatory Classification

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.

Predicate Devices

• Soniquence Disposable Neutral Plate (K183611)

Submission Summary (Full Text)

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February 3, 2022

Soniquence, LLC Ms. Suzanne Lucas Sr. Regulatory Affairs Specialist 2477 Grand Avenue Baldwin, New York 11510

Re: K220071

Trade/Device Name: Soniquence Reusable Neutral Plate Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 6, 2022 Received: January 10, 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/cfpm/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 (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 [phone] 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) K220071

Device Name Soniquence Reusable Neutral Plate

#### Indications for Use (Describe)

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

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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K220071

Image /page/3/Picture/1 description: The image is a logo with a purple square background and a white border. Inside the square is a stylized white "S" shape. The "S" appears to be made of a ribbon or folded paper, giving it a three-dimensional look. The logo is simple and modern, with a clean design.

Image /page/3/Picture/2 description: The image shows the logo for Soniquence. The logo is purple and features a stylized "S" that looks like a ribbon. The rest of the word "oniquence" is written in a simple, sans-serif font. There is a registered trademark symbol to the right of the word.

# Exhibit 6. 510(k) SUMMARY

(As required by 21 CFR 807.92(a))

## Date Prepared

January 31, 2022

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

Company Name and Address:

Soniquence, LLC 2477 Grand Avenue Baldwin, NY 11510 Phone: [phone] www.soniquence.com

Establishment Registration #: 3014982808

### Contact Information:

Ms. Suzanne Lucas Sr. Regulatory Affairs Specialist Phone: [phone] Email: [e-mail]

Device Information (807.92(a)(2))

Trade Name: Soniquence 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))

- Soniquence Disposable Neutral Plate (K183611) .

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Image /page/4/Picture/0 description: The image shows the text 'K220071' in a bold, sans-serif font. The text is black and stands out against a white background. The characters are evenly spaced and easily readable. The image appears to be a close-up of the text.

Image /page/4/Picture/1 description: The image is a logo with a purple square background and a white border. Inside the square is a stylized white "S" shape that appears to be made of ribbon or fabric. The "S" is three-dimensional, with shading that gives it depth and a sense of movement.

Image /page/4/Picture/2 description: The image shows the word "Soniquence" in a stylized purple font. The "S" is designed as a flowing ribbon shape, adding a unique visual element to the logo. To the right of the word is the registered trademark symbol. The overall design is clean and modern.

## Device Description (807.92(a)(4))

The Soniquence 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 the reusable neutral plate as compared to the disposable neutral plate. They are both used to provide a safe return path for electrosurgical current.

### Intended Use:

The Soniquence Reusable Neutral Plate provides a safe return path for electrosurgical current and is designed for use with Soniquence 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 Soniquence Reusable Neutral Plate is substantially equivalent in intended use, technological characteristics, operating principle, and performance characteristics to the predicate device by Soniquence (K183611).

| Predicate<br>Information | Soniquence Reusable Neutral Plate<br>(SUBJECT DEVICE) | Soniquence Disposable Neutral Plate<br>(K183611)<br>(PREDICATE DEVICE) |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Reusable Neutral Plate provides a<br>safe return path for electrosurgical<br>current and is designed for use with<br>Soniquence Generators for minor<br>surgical applications. The Reusable<br>Neutral Plate is provided nonsterile and<br>intended for use only in nonsterile<br>environments. | The Neutral Plate/ Grounding Pad is<br>designed for use with Soniquence RF<br>Generators and provides a safe return<br>path for electrosurgical current. |
| Product Code | GEI | GEI |
| Device Classification | Class II | Class II |
| Functions | Connect to Electrosurgical Generator to<br>provide safe return path. | Connect to Electrosurgical Generator to<br>provide safe return path. |
| Operating mode | Monopolar | Monopolar |
| Energy Source | RF Energy | RF Energy |
| Cable Length (ft) | 10 feet | 9 feet |
| Patient Contacting<br>Materials | Silicone | Aluminum |
| Testing standards<br>used | IEC 60601-2-2 | IEC 60601-2-2 |

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Image /page/5/Picture/0 description: The image is a logo with a purple square background and a white border. Inside the square is a stylized white ribbon or paper that forms an 'S' shape. The ribbon appears to be folded or curved, giving it a three-dimensional look against the flat purple background.

Image /page/5/Picture/2 description: The image shows the logo for Soniquence. The logo is purple and features a stylized "S" that resembles a ribbon or wave. The rest of the word "oniquence" is written in a simple, sans-serif font to the right of the "S". There is a registered trademark symbol to the upper right of the word.

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

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