NuFACE Mini Plus

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February 19, 2021 Carole Cole Company Bob Duffy Regulatory Affairs Senior Manager 1325 Sycamore Ave. Suite A Vista, California 92081 Re: K201680 Trade/Device Name: NuFACE Mini Plus Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NFO Dated: December 9, 2020 Received: December 10, 2020 Dear Bob Duffy: We have reviewed vour 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, 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 {1}------------------------------------------------ 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) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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, Heather Dean, PhD Assistant Director. Acute Iniury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201680 Device Name NuFACE Mini Plus Indications for Use (Describe) The NuFACE® Mini Plus device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {3}------------------------------------------------ #### 510(k) Summary This 510(k) summary is being submitted in accordance with the requirements established by 21 CFR 807.92. ### 1. Submitter Information | Submitter: | Carol Cole Company dba NūFACE | |------------|-----------------------------------------------------| | Address: | 1325 Sycamore Ave, Suite A<br>Vista, CA 92081 (USA) | | Contact Person: | Tera Peterson | |-----------------|-------------------------------| | | Chief Executive Officer | | | Phone: (760) 509-1187 | | | Email: tpeterson@myNuFACE.com | Date Prepared: February 17, 2021 ## 2. Subject Device | 510(k) Premarket Notification: | K201680 | |----------------------------------|------------------------------------------------------------| | Device Trade / Proprietary Name: | NūFACE® Mini Plus | | Device Common or Usual Name: | NūFACE® Mini Plus Facial and Neck Toning Device | | Regulation Number: | 21 CFR 882.5890 | | Classification Name: | Transcutaneous electrical nerve stimulator for pain relief | | Product Code: | NFO | | FDA Panel: | 84 - Neurology | | Class: | II | ## 3. Predicate Device Legally marketed predicate device to which the Carol Cole Company dba NūFACE is claiming substantial equivalence to: | 510(k) Number: | K191672 | |----------------------|------------------------------------------------------------| | Manufacturer: | Carol Cole Company dba NūFACE | | Trade Name: | NūFACE® Mini | | Regulation Number: | 21 CFR 882.5890 | | Classification Name: | Transcutaneous electrical nerve stimulator for pain relief | | Product Code: | NFO | | FDA Panel: | 84 - Neurology | | Class: | II | {4}------------------------------------------------ ### 4. Device Description The NuFACE® Mini Plus (subject device) comprises the Mini Plus device itself and a wall-mount power adaptor. A tube of NuFACE® Gel Primer is provided with the device as an accessory. The Instructions for Use (IFU) are also included with the device and all its associated components are reusable and provided non-sterile. The subject device produces low levels of microcurrent that is discharged through two chrome-plated spheres when they come in contact with and are glided over the skin being treated. The subject device allows the user to turn on and turn off the device at any time during the treatment. Once the device is on, the user can select different microcurrent intensity levels. The device provides visual (lights), audible (beeps) and haptic (hum) feedback to guide the user during treatment. The device will shut off automatically after 20 minutes of use. The subject device is powered by one internal rechargeable, non-removable battery which is charged via the provided wall-mount power adaptor. During battery charging the device microcurrent output is disabled to prevent accidental and/or intentional use. The subject device is capable of pairing and connecting to compatible smart devices using Bluetooth Low Energy (BLE) technology. BLE allows the subject device to wirelessly communicate with other devices such a smart phone running the NuFACE® App. The NuFACE® App allows the user to customize treatment options. The subject device is made from thermoplastic and metal materials already used in other FDA-cleared medical devices. The device measures 2.7" W x 3.6" L x 2.6" D. #### 4.1. Intended Use The Indications for Use statement for the subject device is identical to the predicate device. | Subject Device | Predicate device | |------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | The NūFACE® Mini Plus device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use. | The NūFACE® Mini Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use. | #### 5. Technological Characteristics Table 1provides a comparison between the technological characteristics of the NuFACE® Mini Plus and the predicate device. | | | Table 1: Technological Characteristics | |--|--|----------------------------------------| |--|--|----------------------------------------| | Item | Subject Device | Predicate Device | Same /<br>Different | |--------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------| | Type of Energy<br>Output | Microcurrent | Microcurrent | Same | | Energy Delivery | Microcurrent is delivered via<br>plated dual sphere electrodes<br>(optimized for contact with the<br>skin) | Microcurrent is delivered via<br>plated dual sphere electrodes<br>(optimized for contact with the<br>skin) | Same | {5}------------------------------------------------ | Item | Subject Device | Predicate Device | Same /<br>Different | |--------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------| | Energy Flow | Microcurrent continuously alternates between the positive and negative electrode spheres | Microcurrent continuously<br>alternates between the positive<br>and negative electrode spheres | Same | | Energy Output | User adjustable | User adjustable | Same | | Energy Power<br>Source | Internal rechargeable battery | Internal rechargeable battery | Same | | Battery Type | Lithium Ion | Lithium Ion | Same | | Charging<br>Circuitry | Internal to Device | Internal to Device | Same | | Power Supply<br>Type | Pre-approved wall-mount Power Adaptor | Pre-approved wall-mount Power<br>Adaptor | Same | | Special<br>Requirements | Conductive Gel Primer | Conductive Gel Primer | Same | | Output<br>Frequency (Hz) | Variable | Fixed | Different | | Wireless<br>Technologies | Bluetooth Low Energy (BLE) | None | Different | ### 6. Performance Specifications Comparison Table 2 provides a comparison between the performance specifications of the NuFACE® Mini Plus and the predicate device. | Item | Subject Device<br>Specification | Predicate Device<br>Specification | Same /<br>Different | |------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------|---------------------| | Waveform Type | Pulsed Biphasic | Pulsed Biphasic | Same | | Shape (e.g., rectangular, spike) | Modulated Square | Modulated Square | Same | | Maximum Output<br>Voltage | 28 VDC | 28 VDC | Same | | Maximum Output<br>Current | 335 μA | 348 μA | Same | | Maximum Output<br>Current Density | 0.435 mA/cm² | 0.452 mA/cm² | Same | | Item | Subject Device<br>Specification | Predicate Device<br>Specification | Same /<br>Different | | Microcurrent<br>Output (Device<br>OFF / Not<br>Stimulating | < 10 μ Α<br>(device is OFF or Charging<br>the battery) | < 1 µA<br>(device is OFF or Charging<br>the battery) | Different | | Output Tolerance | +/- 5% (RMS) | +/- 5% (RMS) | Same | | Pulse Period<br>(Pulse Width) | Varies with Output<br>Frequency | 60 msec | Different | | Output Frequency<br>(Hz) | 0.3 - 50 Hz (Variable) | Approximately 8.3 Hz | Different | | Beat Frequency<br>(Hz) | No Beat Frequency | No Beat Frequency | Same | | Symmetrical<br>Phases | Not Multiphasic | Not Multiphasic | Same | | Phase Duration | Not Multiphasic | Not Multiphasic | Same | | Net Charge (μC<br>per pulse) | N/A - Battery operated | N/A - Battery operated | Same | | Pulses Per Burst | 20 (10 positive and 10<br>negative) | 20 (10 positive and 10<br>negative) | Same | | Pulses Per Second | Variable | 8.3 | Different | | Burst Duration<br>(sec) | Variable | 2.4 sec | Different | | Duty Cycle (DC) | 50% | 50% | Same | | ON Time (msec) | Variable | 60 | Different | | OFF Time (msec) | Variable | 60 | Different | | Output Current<br>Range | 70 to 335 µA | 35 to 348 μ A | Same | | Default Treatment<br>Frequency (Hz) | Approximately 8.3 Hz | Approximately 8.3 Hz | Same | Table 2: Performance Specifications Comparison {6}------------------------------------------------ # 7. Non-Clinical Performance Data A program of non-clinical verification and validation testing was conducted that includes: - . Biocompatibility - Electrical Safety, EMC, and Performance Testing . - Software Verification and Validation Testing CONFIDENTIAL NūFACE® {7}------------------------------------------------ ### 7.1. Biocompatibility Table 3 the conclusions drawn for each type of material used in the construction of the subject device and the accessories included with it. The metal and thermoplastic materials used in the NuFACE® Mini Plus are identical to materials already used in FDA-cleared devices in formulation, processing, sterilization, and geometry, and no other chemicals have been added. Biocompatibility is addressed in detail in a separate document in this premarket submission. | Material | Where Used<br>(Subject Device) | Categorization<br>(ISO 10993-1) | Conclusion | |---------------------|------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------| | Metal | · Spheres. | Surface device, intact<br>skin, limited contact<br>duration (<24h). | Biocompatible.<br>These materials are used<br>in other FDA-cleared<br>devices. | | Thermoplastic | · Device Enclosure.<br>· Grip Over-Mold.<br>· Wall-Mount Power supply. | Surface device, intact<br>skin, limited contact<br>duration (<24h). | Biocompatible.<br>These materials are used<br>in other FDA-cleared<br>devices. | | Moisturizing<br>Gel | • Conductivity Gel Primer. | Surface device, intact<br>skin, limited contact<br>duration (<24h). | Biocompatible.<br>These materials are used<br>in other FDA-cleared<br>devices. | #### Table 3: NuFACE® Mini Plus Materials Biocompatibility ### 7.2. Electrical Safety, EMC, and Performance Testing The following conclusions were drawn from the conducted Safety, Performance and Bench Testing: - 1) Electrical Safety testing results demonstrated that the NuFACE® Mini Plus is compliant with applicable Standards for Electrical Safety. - 2) Electromagnetic Compatibility (EMC) testing results demonstrated that the NuFACE® Mini Plus is compliant with applicable Standards for Electromagnetic Compatibility and Wireless Coexistence. - 3) Performance Bench testing results demonstrated that the NūFACE® Mini Plus meets its performance specifications and is substantially equivalent to the predicate device performance. #### 7.3. Software Verification and Validation Testing Software Verification and Validation Testing results demonstrated that: 1) All requirements and specifications in the NuFACE® Mini Plus Software Requirements Specification were implemented and operate correctly. 2) All Risk Mitigations to be implemented in software were implemented and operate correctly, and 3) the software conforms with the user needs and intended uses of the NuFACE® Mini Plus device. #### CONFIDENTIAL NūFACE® {8}------------------------------------------------ ### 7.4. Animal Testing The substantial equivalence for the subject device is not supported by animal testing. Therefore, no animal testing was conducted. ### 7.5. Clinical Testing The substantial equivalence for the subject device is not demonstrated by results of clinical testing. Therefore, no clinical testing were performed. ### 8. Overall Conclusion The documentation and test results provided in this submission and comparison of intended use, principle of operation, performance data, design and the overall technological characteristics, demonstrate that the NuFACE® Mini Plus is as safe, as effective, and performs as well as the predicate device.