(308 days)
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.
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.
The provided text describes the BACK3 COLOR device, which is an electrosurgical cutting and coagulation device. The 510(k) summary focuses on establishing substantial equivalence to a predicate device (Winback Back 3SE, K162828) rather than presenting specific performance criteria and a study to prove meeting those criteria in the traditional sense of a clinical trial for diagnostic devices.
Instead, the acceptance criteria and study detailed here are focused on demonstrating that the new device (BACK3 COLOR) functions safely and effectively, and is technologically equivalent to the previously cleared predicate device, without introducing new questions of safety or effectiveness.
Here's a breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, the "acceptance criteria" are generally that the new device performs equivalently to the predicate device in terms of safety and technical specifications. The "reported device performance" is essentially the confirmation that these specifications are met for the new device.
| Acceptance Criteria (Equivalence to Predicate) | Reported Device Performance (BACK3 COLOR) |
|---|---|
| Regulation and Product Classification Code: 21 CFR 878.4400, PBX | Meets (Identical) |
| Indications for Use: Provides topical heating for pain relief, muscle spasms, increased local circulation, and temporary reduction in cellulite. | Meets (Identical) |
| Massaging Handpiece: Yes | Meets (Identical) |
| Electrode Shapes: Square and circular | Meets (Identical) |
| Infrared Light: No | Meets (Identical) |
| Vacuum (suction): No | Meets (Identical) |
| Treatment Activation: Finger selection on console | Meets (Identical) |
| RF Type: Multipolar/Unipolar | Meets (Identical) |
| RF Frequency: 300kHz – 1MHz | Meets (Identical) |
| Max RF Power: 300W | Meets (Identical) |
| Intensity Adjustment: 0-100% | Meets (Identical) |
| Configuration: Cart mounted console with accessories | Meets (Identical) |
| Patient Safety Switch: Yes | Meets (Identical) |
| Electrical Safety: Compliance with IEC 60601-1 | Satisfactory results reported |
| Electromagnetic Compatibility: Compliance with IEC 60601-1-2 | Satisfactory results reported |
| Biocompatibility: Tissue contacting probes tested for cytotoxicity, sensitization, intracutaneous reactivity | Satisfactory results reported |
| Software Assessment: Compliance with FDA software validation guidelines (Levels of Concern, User & System Requirements, Hazard Analysis, Software Requirements, Architectural Design, Software Validation & Testing) | Satisfactory results reported |
| Usability and Risk Management: Verification of user interface, safety features, and satisfactory performance using worse-case assumptions | Satisfactory results reported |
| Ability to maintain therapeutic temperature on human skin surface: Demonstrated for all applicators, operation modes, and power settings | Study conducted with satisfactory results |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The "Human being testing" for tissue temperature elevation involved three different people.
- Data Provenance: The document does not specify the country of origin or whether the study was retrospective or prospective. Given it's a testing requirement for the device's performance, it is highly likely to be a prospective study.
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 type of information is not typically applicable or detailed in a substantial equivalence filing for an electrosurgical device like this. The specific "Human being testing" described focused on physical measurements (temperature) directly from the device's application, rather than subjective interpretation by experts to establish a "ground truth" for a diagnostic outcome. Therefore, no experts for "ground truth" establishment in this sense are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The human being testing involved direct measurement of physical parameters (skin and room temperature) rather than subjective assessments that would require adjudication.
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 an electrosurgical and radiofrequency therapy device, not a diagnostic imaging device with AI assistance for human readers. No MRMC study was mentioned or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device delivers energy therapy; it is not an algorithm-based diagnostic tool. The "Software Assessment" done was for the device's operational software, not for a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Human being testing," the "ground truth" was the direct measurement of skin and room temperatures to demonstrate the device's ability to maintain a therapeutic temperature. This is a direct physical measurement, not a clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
Not applicable. This document describes a medical device for physical therapy, not a machine learning model that requires a training set in that context. The "Software Assessment" refers to validation testing of the device's operational software.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for a machine learning model.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
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 (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
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------- | ---------------------------------------------------------------------------- |
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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 Corp1133 Westchester Avenue Suite N 220White Plains, NY 10604 |
|---|---|---|
| 2. | Contact Person: | Mr. Matthieu COMMEAU,Managing Director of SWIMS America Corp,1133 Westchester Avenue Suite N 220White Plains, NY 10604Phone: 917-371-7388Email: mat@winback.com |
| 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:BACK3 COLORK214090 | Predicate Device:Winback Back 3SEK162828 | Explanation ofDifferences |
|---|---|---|---|
| Regulation and ProductClassification Code | 21 CFR 878.4400PBX | 21 CFR 878.4400PBX | None |
| Indications for Use | The BACK3 COLOR 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 BACK3 COLOR massagedevice is intended to provide atemporary reduction in theappearance of cellulite. | The Winback Back 3SE deviceis intended to provide topicalheating for the purpose ofelevating tissue temperature forthe treatment of selectedmedical conditions such asrelief of pain, musclespasms, and increase in localcirculation.The Winback Back 3SEmassage device is intended toprovide a temporary reductionin 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 withaccessories | Cart mounted console withaccessories | Identical |
| Patient Safety Switch | Yes | Yes | Identical |
Predicate Device Comparison Table
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510(k) Premarket Notification
| K214090 | ||||||
|---|---|---|---|---|---|---|
| Accessories providedwith the device (diameterof the electrodes-mm) | CET handpiece | CET Handpiece | Addition of some newaccessories which doesnot impact the securityand the performance ofthe subject device.These accessories havebeen added to facilitatethe treatment of thetherapist depending onthe area to be treated.These accessories havehowever the sameutility, the sameintended uses and theassociated modes areidentical to those of thepredicate (CET, RET...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 newmodes which does notimpact the security andthe performance of thedevice. These modeshave been added tofacilitate the treatmentof the therapistdepending on the areato be treated. Thesemodes have howeverthe same utility and thesame intended uses asthose of the predicate(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 isonly compatible withthe use of the accessoryTECAR 6.0.Its frequency is thesame as the RET. Thismode has for aim todeliver TECAR energy | ||||||
| in fractional form whichis divided into severalheating points for afocused and targeteddeep action. | ||||||
| Functions | MINI | LOWPULSE | Addition of some newfunctions 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 sameutility and the sameintended uses as thoseof the predicate (CET,RET, etc).Change of name offunctions:The name of thefunctions has beenmodified. However, thefunctions are the sameas those of thepredicate.LOWPULSE functionwas renamed by MINI.CONTINUOUS wasrenamed by MEDIUMandSUPERPULSE byBOOST. | |||
| Design | Front view:Image: Front view of device with annotations | Front view:Image: Front view of device | Aesthetic difference:The user interfacedesign evolved: graphicand color changes. |
| User Interface:Image: User interface of device | User Interface:Image: User interface of device | ||
| Size (height x width xdepth)- 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.
§ 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.