The RSHOCK device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The RSHOCK massage device is intended to provide a temporary reduction in the appearance of cellulite.

Device Description

The RSHOCK device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a handheld electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in a resistive monopolar mode. The product consists of a power console, LCD monitor, and accessories including resistive electrodes. The unit can provide one level of treatment frequency at 300kHz.

AI/ML Overview

The provided text is a 510(k) summary for the RSHOCK device, a radiofrequency cutting and coagulation device. It primarily focuses on demonstrating substantial equivalence to a predicate device (Winback Back 3SE) rather than detailing a study that proves the device meets specific acceptance criteria based on clinical performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this document because this is a 510(k) submission, not a clinical trial report. 510(k) clearances typically rely on demonstrating equivalence to a legally marketed predicate device through technical and performance comparisons, rather than extensive new clinical studies proving efficacy or specific performance metrics that would require the detailed information you've requested.

However, I can extract the information that is present and explain why other information is not available in this type of document.

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

The document does not present a table of acceptance criteria for clinical performance and reported device performance in the way a clinical study report would. Instead, it demonstrates substantial equivalence to a predicate device (Winback Back 3SE) by comparing their characteristics. The "acceptance criteria" here are implicitly that the RSHOCK device's characteristics are similar enough to the predicate device to be considered substantially equivalent, particularly regarding safety and intended use.

Here's a table based on the "Predicate Device Comparison Table" provided, highlighting key comparisons:

Element of Comparison	510(k) Device: RSHOCK	Predicate Device: Winback Back 3SE (K162828)	Explanation of Differences
Regulation and Product Classification Code	21 CFR 878.4400 (PBX)	21 CFR 878.4400 (PBX)	None
Indications for Use	Intended to provide topical heating for elevating tissue temperature to treat pain, muscle spasms, and increase local circulation. Also intended for temporary reduction in the appearance of cellulite.	Identical to RSHOCK.	Identical
RF Type	Unipolar	Multipolar/Unipolar	No significant difference
RF Frequency	300kHz	300kHz – 1MHz	No significant difference
Max RF Power	100W	300W	No significant difference (presumably because 100W is within acceptable range or sufficient for intended use, and lower power often implies equivalent or greater safety)
Intensity Adjustment	0-3 levels	0-100%	Not the same scale but the same values (implies comparable range of effect)
Electrical Safety & Biocompatibility	Established through testing (IEC 60601-1) & Biocompatibility testing	Established for predicate	Identical safety profile for equivalence

The "acceptance criteria" are implied by the "Explanation of Differences" column, which consistently states "None," "Identical," or "No significant difference." This indicates that the device's characteristics meet the implicit criterion of being sufficiently similar to the predicate to warrant substantial equivalence.

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

This document does not describe a clinical "test set" with a sample size for evaluating clinical performance. The testing mentioned (Electrical Safety, Biocompatibility, Software Assessment, EMC, Usability, Risk Management) is regulatory compliance testing, not a clinical trial. Therefore, information about data provenance (country, retrospective/prospective) for a clinical test set is not applicable here.

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

Not applicable. As no clinical "test set" for performance evaluation against a ground truth is described, there's no information about experts or their qualifications for establishing ground truth.

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

Not applicable. No clinical test set.

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 not an AI-assisted diagnostic tool; it's an electrosurgical device for therapeutic heating. Therefore, an MRMC study is not relevant to its clearance.

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

Not applicable. This is not an algorithm, but a physical device.

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

Not applicable. No clinical performance study against a ground truth is described. The "ground truth" for this 510(k) submission is the demonstrated safety and performance of the substantially equivalent predicate device, as well as the successful completion of various engineering and safety tests.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device undergoing model training.

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

Not applicable. This is not an AI/machine learning device undergoing model training.

Summary of the study/evidence presented in the 510(k) submission:

The "study" in this context refers to the due diligence and testing conducted to demonstrate Substantial Equivalence (SE) to a legally marketed predicate device (Winback Back 3SE, K162828). The core of the evidence is a comparison of technical characteristics and the completion of regulatory safety and performance testing.

Acceptance Criteria (Implicit): That the RSHOCK device's technical specifications, intended use, and safety profile are "substantially equivalent" to (i.e., do not raise different questions of safety and effectiveness from) the Winback Back 3SE predicate device. The detailed comparison table illustrates how these criteria were met by showing similarities or non-significant differences.
Performance/Testing:
- Electrical Safety: Complied with IEC 60601-1.
- Biocompatibility: Samples of tissue-contacting probes tested for cytotoxicity, sensitization, and intracutaneous reactivity.
- Software Assessment: Assessed in accordance with FDA software validation guidelines (Levels of Concern, User & System Requirements, Hazard Analysis, Software Requirements, Architectural Design, Software Validation & Testing).
- Electromagnetic Compatibility (EMC): Evaluated emissions and immunity to electromagnetic fields in accordance with IEC 60601-1-2.
- Usability and Risk Management: Assessments done using "worst-case assumptions" to verify user interface, safety features, and satisfactory performance.

The document concludes that the RSHOCK device is substantially equivalent based on these assessments, indicating that it meets the regulatory requirements for clearance.

Summary

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March 1, 2023

SWIMS America Corp % Matthieu Commeau Managing Director EMERGO, by UL 1133 Westchester Avenue Suite N 220 White Plains, New York 10604

Re: K220014

Trade/Device Name: Rshock Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: January 30, 2023 Received: February 2, 2023

Dear Matthieu Commeau:

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

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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 (OS) 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,

Image /page/1/Picture/9 description: The image shows a digital signature. The signature is for Mark Trumbore and the date is 2023.03.01. The time of the signature is 08:24:30 -05'00'.

On behalf of 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) K220014

Device Name RSHOCK

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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Section 1.5

510(k) Summary

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510(k) Summary Pursuant to 21 CFR 807.92

Date: 09/02/2022

1.	Submitted By:	SWIMS America Corp1133 Westchester Avenue Suite N 220White Plains, NY 10604917-371-7388
2.	Contact:	Matthieu COMMEAUSWIMS America Corp, Managing Director1133 Westchester Avenue Suite N 220White Plains, NY 10604917-371-7388mat@winback.com
3.	Product:	RSHOCK(21CFR§878.4400) Class IIRSHOCKProduct code PBX
4.	Common/Trade Name:	Massager, Radiofrequency Induced HeatRSHOCK

Description:

The product consists of a power console, LCD monitor, and accessories including resistive electrodes. The unit can provide one level of treatment frequency at 300kHz.

Intended Use:

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510(k) Premarket Notification SWIMS America Corp K220014/S001

Substantial Equivalence/Technological Characteristics:

The RSHOCK device is substantially equivalent to the Back 3SE device from Winback USA Corp which was cleared under premarket notification K162828. Both devices are consoles with electrode accessories capable of operation in monopolar mode of 300kHz radiofrequency.

Both devices operate in the same treatment range and feature intensity adjustments. Electrical safety and biocompatibility have been established for both devices. No direct comparison was made since there are no significant differences in operation and test results indicate identical safety.

The table below summarizes the equivalence of the devices.

Element of Comparison	510(k) Device:RSHOCK	Predicate Device:Winback Back 3SEK162828	Explanation ofDifferences
Regulation and ProductClassification Code	21 CFR 878.4400PBX	21 CFR 878.4400PBX	None
Indications for Use	The RSHOCK device is intended toprovide topical heating for thepurpose of elevating tissuetemperature for the treatment ofselected medical conditions such asrelief of pain, musclespasms, and increase in localcirculation.The RSHOCK massage device isintended to provide a temporaryreduction in the appearance ofcellulite.	The Winback Back 3SE device isintended to provide topical heatingfor the purpose of elevating tissuetemperature for the treatment ofselected medical conditions such asrelief of pain, musclespasms, and increase in localcirculation.The Winback Back 3SE massagedevice is intended to provide atemporary reduction in theappearance of cellulite.	Identical
Massaging Hand piece	No	Yes	No significantdifference
Electrode Shapes	Square and circular	Square and circular	Identical
Infrared Light	No	No	Identical
Vacuum (suction)	No	No	Identical
Treatment Activation	Finger selection on console	Finger selection on console	Identical
RF Type	Unipolar	Multipolar/Unipolar	No significantdifference
RF Frequency	300kHz	300kHz – 1MHz	No significantdifference
Max RF Power	100W	300W	No significantdifference
Intensity Adjustment	0-3 levels	0-100%	Not the same scalebut the same values
Configuration	Console with accessories	Cart mounted console withaccessories	No significantdifference
Patient Safety Switch	Yes	Yes	Identical

Predicate Device Comparison Table

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510(k) Premarket Notification SWIMS America Corp K220014/S001

Summary of Testing:

The technological characteristics of the RSHOCK System has been verified based on assessments of electrical safety, performance, biocompatibility, software and usability.

The following testing has been conducted with satisfactory results:

RSHOCK Usability and Risk Management: Usability and Risk Management assessments were done using worse-case assumptions to verify user interface, safety features and satisfactory performance.
. Biocompatibility: Samples of the tissue contacting probes were tested for cytotoxicity, sensitization and intracutaneous reactivity.
. Software Assessment: Software features were assessed in accordance with FDA software validation guidelines. Levels of Concern, User & System Requirements, Hazard Analysis, Software Requirements, Architectural Design, Software Validation & Testing were all addressed.
. Electromagnetic Compatibility: EMC testing was done to evaluate emissions and immunity to electromagnetic fields in accordance with IEC 60601-1-2.
. Electrical Safety: Full electrical safety testing was done in compliance with IEC 60601-1.

Conclusion:

The RSHOCK is substantially equivalent to the predicate devices operate in the same treatment range and voltage and feature intensity adjustments. Electrical safety and biocompatibility have been established for both devices.

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.