The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, incision, and hemostasis in soft tissue surgical procedures.

Device Description

The subject device Soniquence Reusable 3 Button Fingerswitch Wand is an accessory to the Soniquence SmoothWave RF Generator. It is connected to a High Frequency Generator via the male end, and the female end termination connects to the Monopolar Electrode. This device will be provided non-sterile and is intended to be used with Soniquence Monopolar Electrodes. The 3-Button Fingerswitch Wand includes access to all three monopolar waveforms without unit manipulation. This patented, unique handpiece is utilized to activate CUT, BLEND, and HEMO modes via finqerswitch for general surqical procedures. The depressed button function will be the actual output function and disregards the front display settings. The fingerswitch operational features are as follows: a) The CUT button will activate CUT mode. When depressed, the vellow indicator (CUT) illuminates. b) The BLEND button will activate BLEND mode. When depressed, the yellow indicator (BLEND) illuminates. c) The HEMO button will activate the HEMO mode. When depressed, the blue indicator (HEMO) illuminates.

AI/ML Overview

The provided document is a 510(k) summary for the Soniquence Reusable 3 Button Fingerswitch Wand. It does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML product.

Instead, this document describes a traditional medical device (an electrosurgical accessory) and its substantial equivalence to a predicate device. The "acceptance criteria" discussed are related to electrical safety, biocompatibility, and sterilization validation for this hardware device, not performance metrics for an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, study details (test/training set size, data provenance, expert consensus, adjudication, MRMC studies, standalone performance, ground truth establishment) as this document does not pertain to an AI/ML device.

The document indicates "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence," further confirming that it's not a performance study for an AI/ML algorithm.

However, I can extract the specific non-clinical testing performed for the Soniquence Reusable 3 Button Fingerswitch Wand, which serve as its "acceptance criteria" and the "study" proving it meets them:

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

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Electrical Safety	IEC 60601-1: 3rd edition, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance	Successfully performed
	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	Successfully performed
Biocompatibility	Intracutaneous Reactivity Test, ISO 10993-10:2010, Biological evaluation of medical devices. Part 10: Tests for irritation and skin sensitization	Passed all tests
	Skin Sensitization Test, ISO 10993-10:2010, Biological evaluation of medical devices. Part 10: Tests for irritation and skin sensitization	Passed all tests
	In Vitro Cytotoxicity, ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity	Passed all tests
Sterilization Validation	ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices	Passing results
	AAMI TIR12:2020 Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers	Passing results
	ASTM E1766-15 - Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices	Passing results

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 as these are non-clinical hardware tests, not data-driven performance studies.

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 provided as the tests are based on established engineering and biological standards, not expert medical opinion for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as this is not an expert-driven ground truth assessment for an AI/ML product.

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 device is a hardware accessory, not an AI/ML product designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable; this is a hardware device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for these tests are the pass/fail criteria defined by the listed international and industry standards (e.g., ISO, IEC, ASTM, AAMI).

8. The sample size for the training set:
Not applicable; this is not an AI/ML product that utilizes a training set.

9. How the ground truth for the training set was established:
Not applicable.

Summary

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September 2, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo, featuring an abstract eagle emblem encircled by the department's name. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" in bold blue letters, and "ADMINISTRATION" in smaller blue letters below.

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

Re: K212222

Trade/Device Name: Soniquence Reusable 3 Button Fingerswitch Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 3, 2022 Received: August 8, 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 medical devices and radiation-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

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

510(k) Number (if known) K212222

Device Name

Soniquence Reusable 3 Button Fingerswitch Wand

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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K212222

Image /page/3/Picture/1 description: The image is a logo featuring a stylized letter 'S' in white, set against a square background with rounded corners. The background is a shade of purple. The 'S' appears to be formed from a ribbon or piece of paper that is folded or curved to create the shape, with subtle shading to give it a three-dimensional appearance.

Image /page/3/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, with a registered trademark symbol to the right of the word.

Exhibit 2. 510(k) SUMMARY

(As required by 21 CFR 807.92(a))

Date Prepared

August 30, 2022

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

Company Name and Address:

Soniquence, LLC 2477 Grand Avenue Baldwin, NY 11510 Phone: (516) 634-1370 www.soniquence.com

Establishment Registration #: 3014982808

Contact Information:

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

Device Information (807.92(a)(2))

Trade Name: Soniquence Reusable 3 Button Fingerswitch Wand

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

Soniquence, LLC. 2477 Grand Avenue, Baldwin, NY 11510-3531 U.S.A. (516) 654-4000 • Fax: (516) 654-8000 www.soniquence.com

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Image /page/4/Picture/0 description: The image shows the text 'K212222' in a simple, sans-serif font. The text is horizontally oriented and appears to be a code or identifier. The characters are uniformly sized and spaced, with the 'K' standing out as the only letter among a series of numbers.

Image /page/4/Picture/1 description: The image is a logo with a purple square background and rounded corners. Inside the square is a white, stylized letter 'S' that appears to be made of a ribbon or paper strip. The 'S' shape has a flowing, curved design, giving it a dynamic and elegant appearance against the solid purple backdrop.

Image /page/4/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.

Predicate Devices (807.92(a)(3))

Soniquence Disposable 3 Button Fingerswitch Handpiece (K183611) .

Device Description (807.92(a)(4))

The 3-Button Fingerswitch Wand includes access to all three monopolar waveforms without unit manipulation. This patented, unique handpiece is utilized to activate CUT, BLEND, and HEMO modes via finqerswitch for general surqical procedures. The depressed button function will be the actual output function and disregards the front display settings. The fingerswitch operational features are as follows:

a) The CUT button will activate CUT mode. When depressed, the vellow indicator (CUT) illuminates.
b) The BLEND button will activate BLEND mode. When depressed, the yellow indicator (BLEND) illuminates.
c) The HEMO button will activate the HEMO mode. When depressed, the blue indicator (HEMO) illuminates.

Intended Use:

The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, dissection, incision, and hemostasis in soft tissue surgical procedures.

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Image /page/5/Picture/1 description: The image is a logo featuring a stylized white "S" shape against a purple square background with rounded corners. The "S" appears to be made of a ribbon or folded paper, giving it a three-dimensional effect. The overall design is simple and modern, with a focus on the letter "S" as the central element.

Image /page/5/Picture/2 description: The image shows the logo for Soniquence. The logo is purple and features a stylized ribbon-like shape on the left side, followed by the word "oniquence" in a sans-serif font. A registered trademark symbol is present to the right of the word.

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

The Soniquence Reusable 3 Button Fingerswitch Wand is substantially equivalent in intended use, technological characteristics, operating principle, and performance characteristics to the predicate device.

Characteristic	Soniquence Reusable 3 ButtonFingerswitch Wand(SUBJECT DEVICE)	Soniquence 3 Button Fingerswitch Wand(K183611)PREDICATE
Intended Use	The Soniquence Reusable 3 ButtonFingerswitch Wand is designed to beused with a Soniquence RF Generatorand Soniquence monopolar electrodes forresection, dissection, incision, andhemostasis in soft tissue surqicalprocedures.	The Soniquence 3 Button Fingerswitch Wand isdesigned to be used with a Soniquence RFGenerator and Soniquence monopolar electrodesfor resection, dissection, incision, and hemostasisin soft tissue surgical procedures.
Regulation number	21 CFR 878.440	21 CFR 878.440
Product Code	GEI	GEI
OTC orPrescription	RX Only	RX Only
DeviceClassification	Class II	Class II
General descriptionof procedures	Soft tissue surgical procedures	Soft tissue surgical procedures
Modes of operation	Monopolar Cut, Blend, and Hemo	Monopolar Cut, Blend, and Hemo
Operatingmechanism	Button Switch	Button Switch
Energy Type	Radio Frequency	Radio Frequency
Electrode Tipconfigurations	Ball, Loop, Wire, Needle, Spatula, Diamond	Ball, Loop, Wire, Needle, Spatula, Diamond
Shaft workinglength	20mm - 180mm	20mm - 180mm
Activation Method	Hand control	Hand control
Materials	ABS, TPE	ABS, TPE

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Image /page/6/Picture/0 description: The image is a logo with a purple square background and rounded corners. Inside the square is a white, stylized letter "S" that appears to be made of a ribbon or folded paper. The "S" shape is flowing and elegant, with a gradient effect that gives it a three-dimensional appearance.

K212222

Image /page/6/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 in a sans-serif font. There is a registered trademark symbol to the right of the word.

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

The Soniquence Reusable 3 Button Fingerswitch Wand 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.

Electrical Safety -The following tests were successfully performed:

IEC 60601-1: 3ª edition, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-2-2: 2017 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surqical equipment and high frequency surgical accessories

Biocompatibility:

The device was subjected to the following biocompatibility tests which passed all tests.

Intracutaneous Reactivity Test, ISO 10993-10:2010, Biological evaluation of medical devices. Part 10: Tests for irritation and skin sensitization
Skin Sensitization Test, ISO 10993-10:2010, Biological evaluation of medical devices. Part A 10: Tests for irritation and skin sensitization
In Vitro Cytotoxicity, ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

Sterilization Validation: The device has undergone sterilization reprocessing with passing results according to the requirements of:

ISO 14937:2009 Sterilization of health care products General requirements for A characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
AAMI TIR12:2020 Designing, testing, and labeling medical devices intended for processing by A health care facilities: A quide for device manufacturers
A ASTM E1766-15 - Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices

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Image /page/7/Picture/0 description: The image is a logo with a purple square background and rounded corners. Inside the square is a white, stylized letter "S" that appears to be made of a ribbon or folded paper. The "S" shape has a gradient effect, giving it a three-dimensional appearance. The overall design is simple and modern.

K212222

Image /page/7/Picture/2 description: The image shows the word "Soniquence" in a stylized purple font. The "S" in "Soniquence" is designed to look like a ribbon or wave, adding a dynamic and fluid element to the logo. The rest of the letters are in a clean, sans-serif font, providing a modern and professional look. There is a registered trademark symbol to the right of the word.

Technological Characteristics

The devices are substantially equivalent to the predicate devices based on a comparison of physical and performance characteristics.

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 3 Button Fingerswitch Wands does not raise any issues of safety or effectiveness and are substantially equivalent to the predicate device as described above.

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.