Winback Back 3SE
Device Facts
| Record ID | K162828 |
|---|---|
| Device Name | Winback Back 3SE |
| Applicant | Winback USA Corp |
| Product Code | PBX · General, Plastic Surgery |
| Decision Date | Sep 18, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Winback Back 3SE 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 Winback Back 3SE massage device is intended to provide a temporary reduction in the appearance of cellulite.
Device Story
Winback Back 3SE is a cart-mounted radiofrequency (RF) device for topical tissue heating. Input: high-frequency sinusoidal current (300 KHz to 1 MHz). Operation: therapist manipulates handheld electrodes while a fixed electrode contacts the patient to close the electrical circuit; operates in capacitive resistive monopolar or multipolar modes. Output: controlled thermal energy to target tissue. Used in clinical settings by therapists. Output allows providers to deliver heat therapy for pain, muscle spasms, and circulation; also used for temporary cellulite reduction. Benefits include non-invasive therapeutic heating.
Clinical Evidence
Bench testing only. Performance verified via tissue temperature elevation studies on human volunteers of varying skin colors using different electrode sizes. Biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity) performed. Electrical safety (IEC 60601-1) and EMC (IEC 60601-1-2) testing completed. Usability and risk management assessments conducted.
Technological Characteristics
Cart-mounted console with LCD monitor and capacitive/resistive/multipolar electrodes. RF frequency: 300 KHz–1 MHz. Max power: 300 W. Intensity adjustment: 0-100%. Standards: ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC).
Indications for Use
Indicated for patients requiring topical heating for relief of pain, muscle spasms, and increased local circulation, or for temporary reduction in the appearance of cellulite.
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
- truSculpt (K133739)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2017
WINBACK USA Corp % David Furr Regulatory Correspondent FDC Services 8708 Capehart Cove Austin, Texas 78733
Re: K162828
Trade/Device Name: Winback Back 3SE Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: August 13, 2017 Received: August 16, 2017
Dear David Furr:
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. 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 801); medical device reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation 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: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K162828
Device Name Winback Back 3SE
Indications for Use (Describe)
The Winback Back 3SE 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 Winback Back 3SE 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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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# 510(k) Summary Pursuant to 21 CFR 807.92
#### Date: August 13, 2017 K162828
| 1. | Submitted By: | WINBACK USA Corp<br>302 High Plains Drive<br>Dripping Springs, TX 78620<br>323-898-2469 |
|----|--------------------|-------------------------------------------------------------------------------------------------|
| 2. | Contact: | David C. Furr<br>FDC Services, LLC<br>8708 Capehart Cove<br>Austin, Texas 78733<br>512-906-9654 |
| 3. | Product: | Winback Back 3SE<br>(21CFR§878.4400) Class II<br>Winback Back 3SE<br>Product code PBX |
| 4. | Common/Trade Name: | Massager, Radiofrequency Induced Heat<br>Winback Back 3SE |
## Description:
The Winback Back 3SE generates a 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 300 KHz to 1 MHz.
## Intended Use:
The Winback Back 3SE 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 Winback Back 3SE massage device is intended to provide a temporary reduction in the appearance of cellulite.
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Substantial Equivalence/Technological Characteristics:
The Winback 3SE device is substantially equivalent to the following device:
- . Predicate device clearance: K133739
- Trade Name: truSculpt .
- Company: Cutera Incorporated .
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 voltage 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.
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| Element of Comparison | 510(k) Device: | Predicate Device: | Explanation of Differences |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| | Winback 3SE | truSculpt, Cutera Incorporated<br>K133739 | |
| Regulation and Product<br>Classification Code | 21 CFR 878.4400<br>PBX | 21 CFR 878.4400<br>PBX | None |
| Indications for Use | 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 spasms,<br>and increase in local<br>circulation.<br>The Winback Back 3SE<br>massage device is intended to<br>provide a temporary reduction<br>in the appearance of cellulite. | The truSculpt RF energy is intended<br>to provide topical heating for the<br>purpose of elevating tissue<br>temperature for the treatment of<br>selected medical conditions such as<br>relief of pain, muscle spasms, and<br>increase in local circulation.<br>The truSculpt massage device is<br>intended to provide a temporary<br>reduction in the appearance of<br>cellulite. | No significant<br>difference for<br>radiofrequency<br>device. |
| Massaging Hand piece | Yes | Yes | Identical |
| Electrode Shapes | Square and circular | Square and rectangle | Electrode shape is<br>not a significant<br>difference |
| Infrared Light | No | No | Identical |
| Vacuum (suction) | No | No | Identical |
| Treatment Activation | Finger selection on console | Finger switch | No significant<br>difference |
| RF Type | Multipolar/Unipolar | Bipolar/Monopolar | No significant<br>difference |
| RF Frequency | 300kHz – 1 MHz | 300kHz - 50 MHz | truSculpt clearance<br>is for up to 50 MHz<br>however actual<br>truSculpt product<br>specifications are<br>identical (300kHz-1<br>MHz) |
| Max RF Power | 300 W | 300 W | 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 | Unknown | Subject device has a<br>patient circuit<br>breaker safety switch |
| Standards Compliance | ISO10993, IEC60601-1 &<br>IEC60601-1-2 Compliant | ISO10993, IEC60601-1 &<br>IEC60601-1-2 Compliant | Identical |
## Predicate Device Comparison Table
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#### Summary of Testing:
The technological characteristics of the Winback Back 3SE System has been verified based on assessments of electrical safety, performance, biocompatibility, software and usability. In addition, an assessment was done to demonstrate that the device effectively raises tissue temperature in a safe and efficient manner.
The following testing has been conducted with satisfactory results:
- Back 3SE Usability & Risk Management: Usability and Risk Management ● assessments were done using worse-case assumptions to verify user interface, safety features and satisfactory performance.
- Tissue Temperature Elevation Assessment: Studies were done in Korea & France . using volunteers of varying skin colors to assess the capacity of the device to elevate tissue temperature in the treatment areas. The smallest and the largest electrodes were tested as well as the facial applicator electrode. Results indicated satisfactory safe therapeutic increases in tissue temperature.
- . 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 Winback Back 3SE is substantially equivalent to the predicate device. Both devices operate in the same treatment range and voltage and feature intensity adjustments from 0 to 100%. Electrical safety and biocompatibility have been established for both devices.
