The Soliton Resonic™ Rapid Acoustic Pulse device is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The Resonic device is also indicated for short-term improvement in the appearance of cellulite.

Device Description

The Soliton Resonic™ Rapid Acoustic Pulse device is composed of three parts: the Console, the Hand Piece and the Cable connecting the Hand Piece to the Console. The Console supplies saline to the Hand Piece to enable formation of the shock wave within the acoustic pulse chamber. The Hand Piece generates acoustic waves in the saline. The acoustic waves pass through the acoustically transparent Window and acoustic ultrasound gel or similar hydrogel pad, which when placed against the surface of the skin to be treated.

AI/ML Overview

This document describes the Soliton Resonic™ Rapid Acoustic Pulse device, concentrating on its substantial equivalence to a previously cleared device (K201801). The information provided focuses on the modifications made and the types of testing performed to demonstrate that these changes do not alter the fundamental technology or safety/effectiveness.

Here's an analysis of the provided text in relation to your request:

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

The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating that the modified device functions "as specified" and is "as safe and effective as its predicate device." The performance data section focuses on ensuring the modifications did not negatively impact safety or fundamental operation.

Acceptance Criteria (Implied)	Reported Device Performance
Device functions as specified	Verification testing confirmed the Resonic RAP device functions as specified.
As safe as predicate device	Electrical safety and EMC testing repeated an independent lab (IEC 60601-1, IEC 60601-1-2). Biocompatibility established based on predicate (no new patient-contacting materials).
As effective as predicate device	Verification testing demonstrated the Resonic RAP device is as effective as its predicate.
Software changes are acceptable	Software verification testing conducted and results found acceptable.
No alteration to fundamental scientific technology	Modifications did not alter the fundamental scientific technology (shape, frequency, repetition rate of acoustic waves unchanged).
No new questions of safety or effectiveness	Minor differences do not alter fundamental technological characteristics or present new safety/effectiveness questions.

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

Sample Size: The document does not specify a separate sample size for a "test set" in the context of clinical performance. The "verification testing" mentioned would typically refer to engineering and functional tests.
Data Provenance: The document does not provide information about the country of origin or whether data是在retrospective or prospective.

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

This information is not provided. The document focuses on engineering verification and equivalence to a predicate, not a clinical study involving expert assessment of ground truth.

4. Adjudication method for the test set:

This information is not provided as there is no specific mention of a clinical test set requiring adjudication in this document.

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 is not applicable. The device described, the Soliton Resonic™ Rapid Acoustic Pulse device, is a physical medical device (an accessory to a laser for tattoo removal and for cellulite improvement), not an AI/software device that would involve human readers or AI assistance in image interpretation.

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

This is not applicable for the same reason as point 5.

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

Given the context of demonstrating substantial equivalence for hardware modifications, "ground truth" as typically understood in clinical or AI studies (e.g., pathology for disease diagnosis) is not relevant here. The "truth" used for verification is that the device functions according to its engineering specifications and meets safety standards, and that its output (acoustic waves) remains fundamentally unchanged from the predicate device.

8. The sample size for the training set:

This is not applicable. This is not an AI/machine learning device that requires a training set.

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

This is not applicable as there is no training set mentioned.

Summary of what the document does provide regarding the study:

The document focuses on a design control and risk analysis approach to demonstrate substantial equivalence for minor hardware and software modifications to an already cleared device (K201801). The "study" isn't a traditional clinical efficacy study but rather a series of engineering and functional verification tests.

Verification testing: Conducted using the "same methods as used for the predicate device" to show the Resonic RAP functions as specified and is as safe and effective.
Electrical safety and EMC testing: Repeated by an independent lab in accordance with IEC 60601-1 and IEC 60601-1-2.
Biocompatibility: Established based on the predicate device, as "no new materials are used on the surface of the device that contacts the patient skin."
Software verification testing: Conducted, and results were found acceptable for the software changes.

The core argument is that the "minor differences in the newer device version (the subject device) do not alter the fundamental technological characteristics or present different questions of safety or effectiveness as compared to the predicate device." Therefore, extensive new clinical studies to establish efficacy or clinical ground truth were not deemed necessary for this 510(k) submission.

Summary

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April 27, 2021

Soliton Inc. % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103

Re: K210964

Trade/Device Name: Resonic Rapid Acoustic Pulse Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: March 31, 2021 Received: March 31, 2021

Dear Janice Hogan:

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.

Purva Pandya 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known)

K210964

Device Name

Resonic™ Rapid Acoustic Pulse device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

O Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

Soliton Resonic™ Rapid Acoustic Pulse Device

Submitted by:	Soliton, Inc.5304 Ashbrook DriveHouston, TX 77081
Contact Person:	Leslie HondaVP, Regulatory Affairs and Quality SystemsTel: 206.375.8586
Date Prepared:	March 31, 2021
Trade Name:	Soliton Resonic™ Rapid Acoustic Pulse Device
Common Name:	Dermatology Laser System
Classification:	Class IILaser surgical instrument for use in general and plastic surgery and indermatology (21 CFR 878.4810)Product Code GEX
Predicate Devices:	Soliton Rapid Acoustic Pulse Device (K201801)

Intended Use:

Summary of Technological Characteristics:

The Resonic RAP is a modification to the company's Rapid Acoustic Pulse (RAP) device that has already been cleared for the same indications for use (K201801). Only minor hardware and software changes have been made. These changes do not alter the fundamental scientific technology of the modified device. Specifically, the shape, frequency and repeition rate of the acoustic waves are not changed.

Performance Data:

In accordance with Soliton's design control procedures, risk analysis was conducted to assess the impact of the modifications on the device. Verification testing using the same methods as

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used for the predicate device demonstrates that the Resonic RAP device functions as specified and is as safe and effective as its predicate device.

Electrical safety and electromagnetic compatibility (EMC) testing was repeated for the Resonic RAP device by an independent test laboratory in accordance with IEC 60601-1, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.

The biocompatibility of Resonic RAP device is established based on the evaluation of the RAP. No new materials are used on the surface of the device that contacts the patient skin.

Software verification testing was conducted and the testing results were found acceptable for the software changes.

Conclusions:

The Resonic RAP device is as safe and effective as the predicate RAP device previously cleared in K201801. The Resonic RAP device and its predicate device have the same intended use and indications for use, and similar technological characteristics and principles of operation. The minor differences in the newer device version (the subject device) do not alter the fundamental technological characteristics or present different questions of safety or effectiveness as compared to the predicate device. Thus, The Resonic RAP device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.