Back 3 COLOR

K214090 · Swims America Corp · PBX · Nov 1, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K214090
• Device Name: Back 3 COLOR
• Applicant: Swims America Corp
• Product Code: PBX · General, Plastic Surgery
• Decision Date: Nov 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BACK3 COLOR 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 BACK3 COLOR massage device is intended to provide a temporary reduction in the appearance of cellulite.

Device Story

BACK3 COLOR is a cart-mounted electrosurgical console providing radiofrequency (RF) therapy; generates high-frequency sinusoidal current (300kHz–1MHz) in monopolar (capacitive/resistive) and multipolar modes. System includes power console, LCD monitor, and various electrode accessories. Operated by a therapist in a clinical setting; fixed electrode placed on patient, handheld electrode manipulated by therapist to close electrical circuit. Device provides topical heating to elevate tissue temperature. Output intensity adjustable 0-100%. Includes safety features like patient safety switch. Benefits include pain relief, muscle spasm reduction, improved local circulation, and temporary cellulite reduction.

Clinical Evidence

Bench testing only. Included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity), and software validation. Human tissue temperature elevation study conducted on three subjects across three body parts using all modes and power settings confirmed the device's ability to maintain therapeutic skin surface temperatures.

Technological Characteristics

Cart-mounted console; RF frequency 300kHz–1MHz; max power 300W. Monopolar (capacitive/resistive) and multipolar modes. Accessories include various electrodes (CET, RET, 3-polar, 6-polar). Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Biocompatible tissue-contacting probes. User interface with LCD monitor.

Indications for Use

Indicated for patients requiring topical heating for pain relief, muscle spasm reduction, increased local circulation, and temporary reduction in cellulite appearance.

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

• Winback Back 3SE (K162828)

Submission Summary (Full Text)

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11/1/2022

SWIMS America Corp % Mr. Matthieu COMMEAU Managing Director SWIMS America Corp, 1133 Westchester Avenue Suite N 220 White Plains, New York 10604

## Re: K214090

Trade/Device Name: BACK3 COLOR Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX Dated: September 30, 2022 Received: October 3, 2022

Dear Mr. 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 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 ([e-mail]) or phone [phone] 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) K214090

Device Name BACK3 COLOR

## Indications for Use (Describe)

The BACK3 COLOR 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 BACK3 COLOR massage device is intended to provide a temporary reduction in the appearance of cellulite.

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

| <span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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#### 510(k) Premarket Notification SWIMS America Corp K214090

## 510(k) Summary Pursuant to 21 CFR 807.92

## Date: 10/31/2022

| 1. | Submitted By: | SWIMS America Corp<br>1133 Westchester Avenue Suite N 220<br>White Plains, NY 10604 |
|----|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact Person: | Mr. Matthieu COMMEAU,<br>Managing Director of SWIMS America Corp,<br>1133 Westchester Avenue Suite N 220<br>White Plains, NY 10604<br>Phone: [phone]<br>Email: [e-mail] |
| 3. | Common Name: | Winback Back 3SE Massager, Radiofrequency Induced Heat |
| 4. | Trade Name: | BACK3 COLOR |
| 5. | Classification: | Class II |
| 6. | Device Product Code: | PBX |

## Description:

The BACK3 COLOR 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 capacitor resistive monopolar mode and a multipolar mode.

The product consists of a power console on a moveable trolley, LCD monitor, and accessories including capacitive resistive electrodes and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 300kHz to 1MHz.

## Intended Use:

The BACK3 COLOR 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 BACK3 COLOR massage device is intended to provide a temporary reduction in the appearance of cellulite.

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#### 510(k) Premarket Notification SWIMS America Corp K214090

## Substantial Equivalence/Technological Characteristics:

The BACK3 COLOR device is substantially equivalent to the Back 3SE device from Winback USA Corp which was cleared under premarket notification K162828. Both devices are cart mounted consoles with electrode accessories capable of operation in monopolar and multipolar modes in the range of 300kHz to 1MHz radiofrequency.

Both devices operate in the same treatment range and feature intensity adjustments from 0 to 100%. 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:<br>BACK3 COLOR<br>K214090 | Predicate Device:<br>Winback Back 3SE<br>K162828 | Explanation of<br>Differences |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Regulation and Product<br>Classification Code | 21 CFR 878.4400<br>PBX | 21 CFR 878.4400<br>PBX | None |
| Indications for Use | The BACK3 COLOR device is<br>intended to provide topical heating<br>for the purpose of elevating tissue<br>temperature for the treatment of<br>selected medical conditions such as<br>relief of pain, muscle<br>spasms, and increase in local<br>circulation.<br><br>The BACK3 COLOR massage<br>device is intended to provide a<br>temporary reduction in the<br>appearance of cellulite. | The Winback Back 3SE device<br>is intended to provide topical<br>heating for the purpose of<br>elevating tissue temperature for<br>the treatment of selected<br>medical conditions such as<br>relief of pain, muscle<br>spasms, and increase in local<br>circulation.<br><br>The Winback Back 3SE<br>massage device is intended to<br>provide a temporary reduction<br>in the appearance of cellulite. | Identical |
| Massaging Hand piece | Yes | Yes | Identical |
| 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 | Multipolar/Unipolar | Multipolar/Unipolar | Identical |
| RF Frequency | 300kHz – 1MHz | 300kHz – 1MHz | Identical |
| Max RF Power | 300W | 300W | Identical |
| Intensity Adjustment | 0-100% | 0-100% | Identical |
| Configuration | Cart mounted console with<br>accessories | Cart mounted console with<br>accessories | Identical |
| Patient Safety Switch | Yes | Yes | Identical |

## Predicate Device Comparison Table

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# 510(k) Premarket Notification

| | K214090 | | | | | |
|----------------------------------------------------------------------------|---------------------------------|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------------|--|
| Accessories provided<br>with the device (diameter<br>of the electrodes-mm) | CET handpiece | CET Handpiece | Addition of some new<br>accessories which does<br>not impact the security<br>and the performance of<br>the subject device.<br>These accessories have<br>been added to facilitate<br>the treatment of the<br>therapist depending on<br>the area to be treated.<br>These accessories have<br>however the same<br>utility, the same<br>intended uses and the<br>associated modes are<br>identical to those of the<br>predicate (CET, RET...<br>etc). | | | |
| | RET handpiece | RET Handpiece | | | | |
| | CET straight | CET electrodes (40, 60, 70mm) | | | | |
| | CET electrodes (40, 60, 70mm) | RET electrodes (40, 60,70mm) | | | | |
| | RET electrodes (40, 60, 70mm) | Active cable for CET electrodes | | | | |
| | Convex CET electrodes | Active cable for RET electrodes | | | | |
| | Thai CET Electrode | Neutral plate | | | | |
| | Convex RET Electrode | Safety switch | | | | |
| | Protect Ring | 3-Polar applicator for Body | | | | |
| | Neutral plate | 6- Polar applicator for Body | | | | |
| | Physio Blade and Connector | 3- Polar applicator for Face | | | | |
| | RET Bracelet | | | | | |
| | Capacitive Fix Pad | | | | | |
| | Resistive Fix Pad | | | | | |
| | Neutral Fix Pad | | | | | |
| | Finger handpiece | | | | | |
| | Flex Pack | | | | | |
| | TECAR 6.0 Handpiece | | | | | |
| | TECAR 6.0 Tip (M) | | | | | |
| | 3-Polar applicator for Body | | | | | |
| | 3-Polar applicator for Face | | | | | |
| | Safety Switch | | | | | |
| | Double Cable | | | | | |
| | Active cable for CET electrodes | | | | | |
| | Active cable for RET electrodes | | | | | |
| Modes | CET | CET | Addition of some new<br>modes which does not<br>impact the security and<br>the performance of the<br>device. These modes<br>have been added to<br>facilitate the treatment<br>of the therapist<br>depending on the area<br>to be treated. These<br>modes have however<br>the same utility and the<br>same intended uses as<br>those of the predicate<br>(CET, RET, etc). | | | |
| | RET | RET | | | | |
| | DEEP RET | DEEP CET | | | | |
| | DEEP CET | FACE 3-POLAR | | | | |
| | PULSE | BODY 3-POLAR | | | | |
| | FRACTAL | BODY 6-POLAR | | | | |
| | FACE 3-POLAR | | | | | |
| | BODY 3-POLAR | | | | | |
| | | | The FRACTAL mode is<br>only compatible with<br>the use of the accessory<br>TECAR 6.0.<br>Its frequency is the<br>same as the RET. This<br>mode has for aim to<br>deliver TECAR energy | | | |
| | | | in fractional form which<br>is divided into several<br>heating points for a<br>focused and targeted<br>deep action. | | | |
| Functions | MINI | LOWPULSE | Addition of some new<br>functions which does | | | |
| | MEDIUM | CONTINUOUS | not impact the security | | | |
| | BOOST | BOOST | SUPERPULSE | SUPERPULSE | not impact the security | |
| SWAP | NORMAL | and the performance of | | | | |
| DYNAMIC | DYNAMIC | the device. These | | | | |
| | BOOST | modes have been added | | | | |
| | | to facilitate the | | | | |
| | | treatment of the | | | | |
| | | therapist depending on | | | | |
| | | the area to be treated. | | | | |
| | | These modes have | | | | |

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# 510(k) Premarket Notification
SWIMS America Corp

| K214090 | | | |
|--------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | however the same<br>utility and the same<br>intended uses as those<br>of the predicate (CET,<br>RET, etc).<br><br>Change of name of<br>functions:<br>The name of the<br>functions has been<br>modified. However, the<br>functions are the same<br>as those of the<br>predicate.<br><br>LOWPULSE function<br>was renamed by MINI.<br>CONTINUOUS was<br>renamed by MEDIUM<br>and<br>SUPERPULSE by<br>BOOST. |
| Design | Front view:<br>Image: Front view of device with annotations | Front view:<br>Image: Front view of device | Aesthetic difference:<br>The user interface<br>design evolved: graphic<br>and color changes. |
| | User Interface:<br>Image: User interface of device | User Interface:<br>Image: User interface of device | |
| Size (height x width x<br>depth)- in millimeters | 148x306x358 | 148x306x358 | Identical |
| Weight | 5 kg | 5 kg | Identical |

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#### 510(k) Premarket Notification SWIMS America Corp K214090

## Summary of Testing:

The technological characteristics of the BACK3 COLOR System has been verified based on assessments of electrical safety, performance, biocompatibility, software and usability.

The following testing has been conducted with satisfactory results:

- BACK3 COLOR 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.
- Human being testing : a tissue temperature elevation study was conduct to demonstrate ability of all applicators of subject device to maintain therapeutic temperature on the surface of the human skin. The study was conduct on three different people on three body parts with all device operation modes and at the lowest and highest power settings. The skin and room temperatures were measured.

## Conclusion:

The BACK3 COLOR is substantially equivalent to the predicate device (K162828). Both devices operate in the same treatment range and feature intensity adjustments from 0 to 100%. Electrical safety and biocompatibility have been established for both devices.