K Number

Device Name

Winback Back 3SE

Manufacturer

WINBACK USA CORP

Date Cleared

2017-09-18

(346 days)

Product Code

PBX

Regulation Number

878.4400

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.

Device 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K133739

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on radiofrequency (RF) technology and its application through electrodes, with no mention of AI or ML capabilities. The performance studies assess tissue temperature elevation, which is a direct physiological effect of RF, not an AI/ML output.

Therapeutic

Yes
The device is intended to provide topical heating for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation, which are therapeutic purposes.

Diagnostic

The device description and intended use indicate it provides therapeutic treatment (topical heating, pain relief, muscle spasm reduction, circulation increase, cellulite reduction) rather than diagnosing conditions.

SaMD (Software as a Medical Device)

The device description explicitly details hardware components such as a power console, electrodes, and a moveable trolley, indicating it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Winback Back 3SE device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for "topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions" and "temporary reduction in the appearance of cellulite." These are therapeutic applications performed on the patient's body.
Device Description: The description details a device that generates electrical current and uses electrodes applied to the patient. This is consistent with a physical therapy or aesthetic device, not a device that analyzes biological samples outside the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Winback Back 3SE does not fit this definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

PBX

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K133739

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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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

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

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)

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

510(k) Summary Pursuant to 21 CFR 807.92

Date: August 13, 2017 K162828

| 1. | Submitted By: | WINBACK USA Corp
302 High Plains Drive
Dripping Springs, TX 78620
323-898-2469 |
|----|--------------------|-------------------------------------------------------------------------------------------------|
| 2. | Contact: | David C. Furr
FDC Services, LLC
8708 Capehart Cove
Austin, Texas 78733
512-906-9654 |
| 3. | Product: | Winback Back 3SE
(21CFR§878.4400) Class II
Winback Back 3SE
Product code PBX |
| 4. | Common/Trade Name: | Massager, Radiofrequency Induced Heat
Winback Back 3SE |

Description:

Intended Use:

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.

Element of Comparison	510(k) Device:	Predicate Device:	Explanation of Differences
	Winback 3SE	truSculpt, Cutera Incorporated
K133739
Regulation and Product
Classification Code	21 CFR 878.4400
PBX	21 CFR 878.4400
PBX	None
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.	The truSculpt RF energy 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 truSculpt massage device is
intended to provide a temporary
reduction in the appearance of
cellulite.	No significant
difference for
radiofrequency
device.
Massaging Hand piece	Yes	Yes	Identical
Electrode Shapes	Square and circular	Square and rectangle	Electrode shape is
not a significant
difference
Infrared Light	No	No	Identical
Vacuum (suction)	No	No	Identical
Treatment Activation	Finger selection on console	Finger switch	No significant
difference
RF Type	Multipolar/Unipolar	Bipolar/Monopolar	No significant
difference
RF Frequency	300kHz – 1 MHz	300kHz - 50 MHz	truSculpt clearance
is for up to 50 MHz
however actual
truSculpt product
specifications are
identical (300kHz-1
MHz)
Max RF Power	300 W	300 W	Identical
Intensity Adjustment	0-100%	0-100%	Identical
Configuration	Cart mounted console with
accessories	Cart mounted console with
accessories	Identical
Patient Safety Switch	Yes	Unknown	Subject device has a
patient circuit
breaker safety switch
Standards Compliance	ISO10993, IEC60601-1 &
IEC60601-1-2 Compliant	ISO10993, IEC60601-1 &
IEC60601-1-2 Compliant	Identical

Predicate Device Comparison Table

Summary of Testing:

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.