NuFACE FIX Skin Toning Device

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 17, 2018 Carol Cole Company dba NuFACE Donald Ellis Head - R&D Projects, Ouality & Regulatory Affairs 1325 Sycamore Ave. Suite A Vista, California 92081 Re: K182424 Trade/Device Name: NuFACE FIX Skin Toning Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: September 5, 2018 Received: September 6, 2018 Dear Donald Ellis: 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Vivek J. Pinto -S for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182424 Device Name NuFACE FIX Device Indications for Use (Describe) The NuFACE FIX™ Device is intended for facial 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. 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." {3}------------------------------------------------ ## NuFACE FIX Device 510(k) Summary ### DATE PREPARED: OCTOBER 2, 2018 ### 510(K) SUBMITTER/OWNER Carol Cole Company 1325 Sycamore Ave, Suite A Vista, CA 92081, USA ## CONTACT INFORMATION: Donald Ellis, Regulatory Affairs/Quality Assurance Phone: (760) 509-1264 Facsimile: (760) 650-3667 Email: DELLIS@mynuface.com #### DEVICE NAMES Device Trade/ Proprietary Name: Device Common or Usual Name: Classification Name: NuFACE FIX Skin Toning Device NuFACE FIX Transcutaneous electrical nerve stimulator for pain relief 21 CFR 882.5890 NFO Requlation Number: Product Code: #### PREDICATE DEVICES The legally marketed predicate device to which the Carol Cole Company is claiming equivalence for over-the-counter use: K131251 510(k) Number: Manufacturer: Carol Cole Company dba NuFACE Trade Name: Trinity ELE Product Code: NFO #### DEVICE DESCRIPTION NuFACE FIX Skin Toning Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use. Two (2) spherical electrodes, fixed on the NuFACE FIX device main face, deliver low level electrical impulses (aka. microcurrent) to targeted locations on the face. #### INTENDED USE NuFACE FIX Device is intended for facial stimulation and is indicated for over-thecounter cosmetic use. {4}------------------------------------------------ # TECHNOLOGICAL CHARACTERISTICS The proposed NuFACE FIX device has the same, or similar, technological characteristics as the NuFACE Trinity ELE predicate device. The differences do not alter the clinical utility of our proposed NuFACE FIX device relative to the cleared NuFACE Trinity ELE predicate device listed below. - NuFACE FIX device is powered by a rechargeable, nonreplaceable, battery i) which uses a lithium ion chemistry. - Microcurrent is discharged through two (2) smooth, chrome-plated, spherical ii) electrodes. - NuFACE FIX device generates continuous alternating microcurrent comparable iii) to that of the NuFACE Trinity ELE predicate device. # PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. # ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY (EMC) The following electrical safety and EMC tests have been performed: - IEC 60601-1-2: 2014-02 -Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility. - . IEC 60601-1-6: 2010 + AMD1:2013 TRF (Third Edition) - Medical electrical equipment -Part 1-6 General requirements for safety - Collateral Standard: Usability - . IEC 60601-2-10: 2012 (Second Edition), medical electrical equipment -- part 2-10: particular requirements for the basic safety and essential performance of nerve and muscle stimulators. (Neurology) - IEC 60601-1-11 2015/01/20 Ed. 2 Medical Elec. Equip.- Part 1-11 : Gen. Reg. for . Basic Safety & Essential Perf.- Collateral Standard - Req. for Medical Elec. Equip. & Medical Elec. Systems Used in the Home Healthcare Environment - . IEC 60601-1:2005Ed.3+A1 - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety & Essential Performance - o Excluding: Clause 11.7 (Biocompatibility) referencing ISO 10993 - . ANSI/AMI ES60601-1:2005/(R)2012, - o Excluding; Clause 11.7 (Biocompatibility) referencing ISO 10993 - . CAN/CSA-C22.2 No. 60601-1:2014-03 - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance - Excluding; Clause 11.7 (Biocompatibility) referencing ISO 10993 o # INGRESS PROTECTION - EC 60529 Degrees of protection provided by enclosures (IP Code) . {5}------------------------------------------------ ## USABILITY ENGINEERING - IEC 62366:2007Ed.1+A1 Medical Devices Application Of Usability Engineering To . Medical Devices ## BATTERY TESTING - · IEC 62133 Edition 2.0 2012-12 and EN 62133: 2013 ## SOFTWARE VERIFICATION AND VALIDATION TESTING Verification and validation testing of the device functionality including software was conducted in accordance with IEC 62304:2006 Ed. 1 +A1 - Medical Device Software -Software Life Cycle Processes. A risk analysis was completed and risk controls were implemented in accordance with ISO 14971. Human factors testing was conducted in accordance with IEC 60601-1-6, ISO 62366 and the FDA guidance on human factors engineering to demonstrate that the ergonomics of patient and user interfaces for the subject device are substantially equivalent to the predicate device. Usability of the device was assessed through a prospective Usability Study. ## BIOCOMPATIBILITY TESTING Biocompatibility testing is not needed for the NuFACE FIX device because the materials and manufacturing processes for the NuFACE FIX device are not significantly different to the NuFACE Trinity ELE predicate device and therefore did not raise questions of safety and effectiveness. ## ANIMAL STUDY Animal performance testing was not required to demonstrate safety and effectiveness of the device. ## CLINICAL STUDIES Clinical testing was not required to demonstrate the safety and effectiveness of the Device. {6}------------------------------------------------ # PREDICATE COMPARISON | Device Descriptions | NUFACE® FIX DEVICE<br>(NEW DEVICE) | NUFACE® TRINITY ELE<br>DEVICE (PREDICATE) | SAME OR DIFFERENT<br>TECHNOLOGICAL<br>CHARACTERISTICS | |----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------| | 1. 510(k) Number | K182424 | K131251 | | | 2. Regulation<br>Number | 21 C.F.R. §<br>882.5890 | 21 C.F.R. § 882.5890 | Same | | 3. Regulation<br>Name | Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief | Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief | Same | | 4. Regulatory Class | Class II | Class II | Same | | 5. Device<br>Classification<br>Name | Stimulator,<br>Transcutaneous<br>Electrical,<br>Aesthetic Purposes | Stimulator,<br>Transcutaneous<br>Electrical, Aesthetic<br>Purposes | Same | | 6. Product Code | NFO | NFO | Same | | 7. Regulation<br>Medical<br>Specialty | Neurology | Neurology | Same | | 8. Intended Use | NuFACE FIX Device<br>is intended for<br>facial stimulation<br>and is indicated<br>for over-the-<br>counter cosmetic<br>use. | NuFACE Trinity ELE is<br>intended for facial<br>stimulation and is<br>indicated for over-<br>the-counter<br>cosmetic use | Same | | 9. Indications for<br>Use | Over-the-Counter<br>Cosmetic Use | Over-the-Counter<br>Cosmetic Use | Same | | 10. Anatomic Sites | Face | Face | Same | | 11. Technological<br>Characteristics | The NuFACE FIX is<br>an over-the-<br>counter facial<br>stimulation device.<br>Its outer case is<br>injection molded<br>thermoplastic<br>resin. The output<br>contacts consist of<br>chrome-plated<br>spherical | The NuFACE Trinity<br>ELE is an over-the-<br>counter facial<br>stimulation device.<br>Its outer case is<br>injection molded<br>thermoplastic resin.<br>The output<br>contacts consist of<br>chrome-plated<br>spheres. The | Same | | Device Descriptions | NUFACE® FIX DEVICE<br>(NEW DEVICE) | NUFACE® TRINITY ELE<br>DEVICE (PREDICATE) | SAME OR DIFFERENT<br>TECHNOLOGICAL<br>CHARACTERISTICS | | | electrodes. The<br>NUFACE FIX device<br>is powered by a<br>rechargeable<br>lithium ion battery.<br>NUFACE FIX device<br>produces | device is powered<br>by a rechargeable<br>lithium ion battery<br>and produces a<br>microcurrent that is<br>discharged through<br>two fixed, smooth | | | | microcurrent that<br>is discharged<br>through two fixed,<br>smooth spherical<br>electrodes. To turn<br>the NUFACE FIX | electrode spheres.<br>To turn the device<br>on, the on/off<br>button is pressed.<br>Ascending tonal<br>beeps indicate the | | | | device on, the<br>on/off button is<br>pressed. The two<br>spheres gently<br>glide over the skin | device is on. One<br>to five red LED lights<br>illuminate<br>indicating the<br>output intensity | | | | to deliver low-level<br>electrical impulses<br>to targeted<br>locations on the<br>face. The NuFACE | level and the unit is<br>ready for use. Users<br>then follow the<br>instructions for use.<br>The two spheres | | | | FIX device spheres<br>are designed for<br>optimal contact<br>with facial skin.<br>The NuFACE FIX<br>device delivers | gently glide over<br>the skin to deliver<br>low-level electrical<br>impulses to<br>targeted locations<br>on the face. | | | | microcurrent as a<br>constant biphasic<br>square wave<br>comprised of (10) | NUFACE Trinity ELE<br>spheres are<br>designed for<br>optimal contact | | | | positive pulses<br>followed by (10)<br>negative pulses.<br>The microcurrent<br>output | with the face. The<br>NUFACE Trinity ELE<br>delivers<br>microcurrent as a<br>constant biphasic | | | | continuously<br>alternates<br>between the | square wave<br>comprising a (10)<br>positive pulses | | | Device Descriptions | NuFACE® FIX DEVICE<br>(NEW DEVICE) | NuFACE® TRINITY ELE<br>DEVICE (PREDICATE) | SAME OR DIFFERENT<br>TECHNOLOGICAL<br>CHARACTERISTICS | | | positive and<br>negative spherical<br>electrodes.<br>The NuFACE FIX<br>device requires<br>the use of a<br>conductive gel.<br>To promote proper<br>use and provide<br>feedback to the<br>user, the NuFACE<br>FIX Device<br>increases tactile<br>feedback to cue<br>the user to<br>relocate the<br>NuFACE FIX device<br>approximately<br>every 5 seconds. | followed by (10)<br>negative pulses.<br>The microcurrent<br>output continuously<br>alternates between<br>the positive and<br>negative electrode<br>spheres and allows<br>the user to adjust<br>the output for a<br>personalized<br>comfort level. The<br>NuFACE Trinity ELE<br>requires the use of<br>a conductive gel.<br>To promote proper<br>use and provide<br>feedback to the<br>user, the NuFACE<br>Trinity ELE beeps to<br>cue the user to<br>relocate the<br>device<br>approximately<br>every 5 seconds. | | | Basic Unit<br>Characteristics | NUFACE® FIX DEVICE<br>(NEW DEVICE) | NUFACE® TRINITY<br>ELE DEVICE<br>(PREDICATE) | SAME OR DIFFERENT<br>TECHNOLOGICAL<br>CHARACTERISTIC | | 1. 510(k) Number | K182424 | K131251 | | | 2. Device Name,<br>Model | NUFACE FIX Device | NUFACE Trinity ELE<br>Device | | | 3. Manufacturer | Carol Cole Company<br>(dba NuFACE) | Carol Cole<br>Company (dba<br>NUFACE) | Same | | 4. Power Source(s) | Internal<br>rechargeable Lithium<br>Ion battery | Internal<br>rechargeable<br>Lithium Ion battery<br>(updated in<br>K181008) | Same | | a. Method of Line<br>Current Isolation | Type BF | Type BF | Same | | b. Patient Leakage<br>Current | | | | | 1). Normal<br>condition | N/A - Battery<br>operated | N/A - Battery<br>operated | Same | | 2). Single fault<br>condition | N/A - Battery<br>operated | N/A - Battery<br>operated | Same | | 5. External power<br>adapter | User supplied<br>standard 5-volt USB<br>port | NuFACE 7-volt<br>power adapter | Same | | 6. Number of Output<br>Channels | 1 | 1 | Same | | a. Synchronous or<br>Alternating | N/A - 1 Output<br>Channel | N/A - 1 Output<br>Channel | Same | | b. Method of<br>Channel Isolation | N/A - 1 Output<br>channel | N/A - 1 Output<br>channel | Same | | 7. Regulated Current<br>or Regulated<br>Voltage | Both | Both | Same | | 8. Software/Firmware/<br>Microprocessor<br>Control | Yes | Yes | Same | | 9. Automatic<br>Overload Trip | Not required due to<br>circuit design | Not required due<br>to circuit design | Same | | 10. Automatic No-<br>Load Trip | Yes | Yes | Same | | 11. Automatic Shut Off | Yes | Yes | Same | | Basic Unit<br>Characteristics | NUFACE® FIX DEVICE<br>(NEW DEVICE) | NUFACE® TRINITY<br>ELE DEVICE<br>(PREDICATE) | SAME OR DIFFERENT<br>TECHNOLOGICAL<br>CHARACTERISTIC | | 12. Patient Override<br>Control | Yes | Yes | Same | | 13. Indicator Display | | | | | a. On/Off Status | Yes | Yes | Same | | b. Low Battery | Yes | Yes | Same | | c. Voltage/Current<br>Level | Yes | Yes | Same | | 14. Automatic Shut-Off<br>(minutes) | Yes (3 minutes) | Yes (20 minutes) | Different | | 15. Compliance with<br>Voluntary<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60529<br>IEC 60601-2-10<br>ISO 14971<br>IEC 60601-1-6<br>IEC 62366<br>IEC 60601-1-11<br>ANSI/AMI ES60601-1<br>CAN/CSA-C22.2 No.<br>60601-1<br>IEC 62133 | IEC 60601-1<br>IEC 60601-1-2 | Same | | 16. Compliance with<br>21 CFR 898 | Yes | Yes | Same | | 17. Weight | Approximately 2 oz. | 9 oz. without<br>charging base | Different | | 18. Dimensions of<br>device(inch)<br>[WxLxD] | Approximately 5.7" x<br>0.82" | 2.8" x 5.1" x 1.3" | Different | | 19. Housing Materials<br>and Construction | Thermoplastic | Thermoplastic | Same | Table 1: General Comparison Table {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ Table 2: Basic Unit Characteristic Comparison {10}------------------------------------------------ Table 3: Output Specification Comparison Table | OUTPUT SPECIFICATIONS | NuFACE FIX<br>New DEVICE | NuFACE TRINITY + ELE<br>DEVICE<br>(PREDICATE) | SAME OR<br>DIFFERENT<br>TECHNOLOGICAL<br>CHARACTERISTIC | |-----------------------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------------------------|---------------------------------------------------------| | 1. 510(k) Number | K182424 | K131251 | | | 2. Waveform (e.g.,<br>pulsed<br>monophasic, | Pulsed Biphasic | Pulsed Biphasic | Same | | OUTPUT SPECIFICATIONS | NUFACE FIX<br>NEW DEVICE | NUFACE TRINITY + ELE<br>DEVICE<br>(PREDICATE) | SAME OR<br>DIFFERENT<br>TECHNOLOGICAL<br>CHARACTERISTIC | | biphasic) | | | | | 3. Shape (e.g.,<br>rectangular, spike,<br>rectified<br>sinusoidal) | Modulated Square | Modulated Square | Same | | 4. Maximum Output<br>Voltage | 28 VDC | 28 VDC | Same | | 5. Maximum Output<br>Current | 200 μΑ @ 500Ω | 208 μΑ @ 500Ω | Same | | 6. Maximum Output<br>Current Density | 0.418 μΑ/cm² | 0.800 μΑ/cm² | Same | | 7. Output Current<br>when not<br>stimulating | < 1 μΑ | < 1 μΑ | Same | | 8. Output Tolerance | +/- 10% | +/- 10% | Same | | 9. Pulse Width | 60 ms | 60 ms | Same | | 10. Frequency (Hz) | Approximately 8.3 Hz | Approximately 8.3 Hz | Same | | 11. For interferential<br>modes, only | | | | | a. Beat Frequency<br>(Hz) | No Beat Frequency | No Beat Frequency | Same | | 12. For multiphasic<br>waveforms, only | | | | | a. Symmetrical<br>phases | Not Multiphasic | Not Multiphasic | Same | | b. Phase Duration<br>(include units)<br>c. (state range,<br>if applicable)<br>d. (both<br>phases, if<br>asymmetrical) | Not Multiphasic | Not Multiphasic | Same | | 13. Net Charge (μC<br>per pulse) | N/A - Battery operated | N/A - Battery operated | Same | | 14. Burst Mode (i.e.,<br>pulse trains) | | | | | a. Pulse ON time<br>(msec) | 60 | 60 | Same | | b. Pulse OFF time<br>(msec) | 60 | 60 | Same | | c. Pulses per burst | 20 | 20 | Same | | OUTPUT SPECIFICATIONS | NuFACE FIX<br>NEW DEVICE | NuFACE TRINITY + ELE<br>DEVICE<br>(PREDICATE) | SAME OR<br>DIFFERENT<br>TECHNOLOGICAL<br>CHARACTERISTIC | | d. Pulses per<br>second | 8.3 | 8.3 | Same | | e. Burst duration<br>(sec) | 2.4 | 2.4 | Same | | f. Duty Cycle | 50% | 50% | Same | {11}------------------------------------------------ {12}------------------------------------------------ # CONCLUSION In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR part 807 and based on the non-clinical results and relative information provided in this premarket notification, we conclude the NuFACE FIX Device is substantially equivalent to the NuFACE Trinity ELE predicate device with regards to safety and effectiveness.