ZIIP Device

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a design that resembles an abstract caduceus or flowing fabric beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 24, 2017 ZIIP, LLC David Mason Co-Founder 1871 Trestle Glen Rd Piedmont, California 94610 Re: K161484 Trade/Device Name: ZIIP Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NFO Dated: January 16, 2017 Received: January 24, 2017 Dear Mr. Mason: 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 (reporting of medical device {1}------------------------------------------------ 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. Sincerely yours, # Michael J. Hoffmann -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) K161484 Device Name ZIIP Device Indications for Use (Describe) The ZIIP 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}------------------------------------------------ #### 510(k) SUMMARY #### 510(k) Notification K161484 #### GENERAL INFORMATION Applicant (§807.92(a)(1)) : ZIIP LLC 182 Howard St. #151 San Francisco, CA 94105 Telephone: 1-800-944-7031 Contact Person (§807.92(a)(1)): David Mason Co-Founder ZIIP, LLC david@ziipbeauty.com Date Prepared (§807.92(a)(1)): May 17, 2016 #### Device Information Trade Name (§807.92(a)(2)): ZIIP Device Generic/Common Name (§807.92(a)(2)): Facial Toning Device Classification (§807.92(a)(2)): Transcutaneous Electrical Nerve Stimulator – CFR 882.5890 Product Code: NFO #### PREDICATE DEVICE(s) (§807.92(a)(3)) - . K103472 - NuFace Plus Facial Toning Device {4}------------------------------------------------ ### DEVICE DESCRIPTION (§807.92(a)(4)) The ZIIP Device is a hand-held, battery-powered device used with conductive gel to stimulate the face superficially through application of transcutaneous electrical currents. It is intended to be used by a single user (multiple applications). ### INDICATIONS FOR USE/INTENDED USE (§807.92(a)(5)) The ZIIP Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use. #### TECHNOLOGICAL CHARACTERISTICS/PRINCIPLES OF OPERATION (§807.92(a)(6)) The ZIIP Device is a Facial Toning Device intended for facial stimulation. It produces a small electrical current discharged through the two electrodes. The current delivered is an aesthetic modality providing a small electric current in millionths of an ampere and has the ability to increase facial contour and firm the skin and muscles by supplying a maximum of +/- 200 micro amperes of current. The device measures 2.00" W x 3.9" L x 1.40" D (fits in the palm of a hand) and weighs 3.2 ounces. The outer case of the ZIP Device is manufactured using injectionmolded of thermoplastic resin and the output contacts (probes) consist of chrome-plated spheres. The device is powered by Lithium-lon rechargeable batteries (3.7V, 700mAh (503048-2C) / 2.59Wh, 1.4A rate). The ZIIP Device is shipped with a portable batter-charger (Charging Rate: 0.7A Max. 1.0C rate). The ZIIP Device was designed with an easy-to-use, ergonomic user interface that has one button to power the device on and off, curved design, and protruding chrome-plated electrodes for ease of facial application. The device is turned on by momentarily pressing the ON/OFF button once. The device annunciates its being turned on by beeping once, flashing a light indicator, and by a single haptic vibration. The device may be turned off at any time by pressing the ON/OFF button once. The device annunciates its being turned off by beeping twice. The unit turns-off if the battery voltage drops below 3.4 Volts. The ZIIP Device spherical probes are designed for optimal contact with the face. The white LEDs turn-on if the unit can sense 100 nA or greater of electrode current. There is no specific skin impedance at which this happens. The device requires the use of a conductive gel. The conductive gel is used to reduce the impedance between the electrodes and the skin of the user. #### Waveform Description The ZIIP Device provides one continuous waveform output type, a square wave. For duty cycle, the ZIP device has a 100% duty cycle because the user is receiving energy on both the positive and negative portions of the square waves at the electrodes. This then translates to the values for "maximum current density" and "maximum power density" which are premised on the calculated value of the peak current in use. {5}------------------------------------------------ ### Substantial Equivalence Discussion & Summary of Comparison Data (§807.92(a)(6)((a)(b)) The ZIIP device has the same intended use and indications for use as the claimed predicate device. The device also has similar technological characteristics. During the design and development, risk management tools were employed in accordance with ISO 14971 (Medical devices — Application of risk management to medical devices) requirements. The risk assessment for the ZIIP Device was used to identify potential hazards that could occur during the use of the device, or in the event of failure modes associated with device components. Risk analysis was used to identify risk reduction measures which have been incorporated in the device design and labeling. | Basic Unit<br>Characteristics | ZIIP Device | NuFace® Plus | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K161484 | K103472 | | Regulation Number | 21 CFR, Part 882.5890 | 21 CFR, Part 882.5890 | | Regulation Name | Transcutaneous Electrical Nerve<br>Stimulator | Transcutaneous Electrical<br>Nerve Stimulator | | Regulation Class | Class II | Class II | | Product Code | NFO | NFO | | Intended Use | Stimulate the Face - Skin Toning | Stimulate the Face - Skin<br>Toning | | Indications for Use | Over-the-counter cosmetic use | Over-the-counter cosmetic use | | Technological<br>Characteristics | The ZIIP Device is a Facial Toning<br>Device intended for facial<br>stimulation. It produces a small<br>electrical current discharged<br>through the two electrodes. The<br>current delivered is an aesthetic<br>modality providing a small<br>electric current in millionths of<br>an ampere and has the ability to<br>increase facial contour and firm<br>the skin and muscles by<br>supplying a maximum of +/- 200<br>micro amperes of current. The<br>device measures 2.00" W x 3.9"<br>L x 1.40" D (fits in the palm of a<br>hand) and weighs 3.2 ounces.<br>The outer case of the ZIIP Device<br>is manufactured using injection-<br>molded of thermoplastic resin<br>and the output contacts<br>(probes) consist of chrome-<br>plated spheres. The device is<br>powered by Lithium-Ion<br>rechargeable batteries (3.7V,<br>700mAh (503048-2C) / 2.59Wh,<br>1.4A rate), The ZIIP Device is | The Nu-Face Plus is a Facial<br>Toning Device intended for<br>facial stimulation. It produces a<br>micro-current discharged<br>through the two spherical<br>probes. Micro-current is an<br>aesthetic modality providing<br>electric current in millionths of<br>an ampere and has the ability<br>to increase facial contour and<br>firm the skin and muscles by<br>supplying 80 - 400 pA.<br>The device measures 3" W x<br>5.25' L x 1.25' D. Its outer case<br>is injection molded of<br>thermoplastic resin and the<br>output contacts (probes)<br>consist of chrome-plated<br>spheres. The device is powered<br>by 4 rechargeable batteries.<br>The NuFACE® Plus comes with<br>a rechargeable base, which<br>measures 3.25" W x 4" L x<br>3.25" D. | #### Device Descriptions - Comparison ZIIP Device with Predicate (§807.92(a)(6)(a)(b)) {6}------------------------------------------------ | ' shipped with a portable batter- | | |-----------------------------------|--| | ' charger (Charging Rate: 0.7A | | | Max. 1.0C rate). | | # Basic Unit & Output Characteristics (§807.92(a)(6)(a)(b)) | Basic Unit Characteristics | ZIIP Device | NuFace® Plus | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------| | 510(k) Number | K161484 | K103472 | | Device Name & Model | ZIIP Device | NuFace® Plus | | Manufacturer | ZIIP, LLC | Carol Cole Company | | Regulation Name | Transcutaneous<br>Electrical Nerve<br>Stimulator | Transcutaneous<br>Electrical Nerve<br>Stimulator | | Power Source(s) | | | | a. Method of Line Current Isolation | One Rechargeable<br>Lithium-Ion Battery,<br>and External Charger<br>Isolation<br>(External Charger<br>Included) | 4 rechargeable AA<br>NiMH batteries | | b. Patient Leakage Current | | | | 1. Normal Condition | 46uA | N/A - Battery<br>Operated | | 2. Single Fault Condition | 46uA | N/A - Battery<br>Operated | | Number of Output Modules | N/A | 1 | | Number of Output Channels | 1 | 1 | | a. Synchronous or Alternating | N/A - 1 Output<br>Channel | N/A - 1 Output<br>Channel | | b. Method of Channel Isolation | N/A - 1 Output<br>Channel | N/A - 1 Output<br>Channel | | Regulated Current or Regulated Voltage | Both | Both | | Software/Firmware/Microprocessor<br>Controlled | Yes | Yes | | Automatic Overload Trip | Not required because<br>of circuit design<br>(Current and Voltage<br>Limited by Circuit<br>Design and Firmware) | Not required because<br>of circuit design | | Automatic No-Load Trip | Yes (Reversion to<br>Fixed Voltage Output) | Yes | | Automatic Shut Off | Yes | Yes | | Patient Override Control | Yes | Yes | | Indicator Display | | | | a. On/Off Status | Yes (LED Illumination<br>on Conduction) | Yes | | b. Low Battery | Yes | Yes | | c. Voltage/Current Level | Yes (LED Illumination<br>on Target Current<br>Levels) | Yes | | Timer Range | Yes | Yes (21-Minutes) | {7}------------------------------------------------ | Basic Unit Characteristics | ZIIP Device | NuFace® Plus | |---------------------------------------|-------------------------------|------------------------------| | Compliance with Voluntary Standards | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 | | Weight | 3.2 oz | 9 oz | | Dimensions | 2" X 3.9" X 1.4" | 3" x 5.2" x 1.25" | | Housing Material Construction | Thermo Plastic | Thermo Plastic | | Electro-conductive Material required? | Conductive Gel<br>(§882.1275) | NuFACE Primer | # Waveform/Output Comparison (§807.92(a)(6)(a)(b)) | Basic Unit Characteristics | ZIIP Device | NuFace® Plus | |----------------------------------|------------------------------------|------------------------| | Waveform | Pulsed Biphasic | Pulsed Monophasic | | Shape | Modulated Square Wave | Modulated Square Wave | | Maximum Output Voltage | 154mV@ 500Ω | 137mV @ 500Ω | | | 465mV@ 2KΩ | 769mV @ 2KΩ | | | 2.2V @ 10ΚΩ | 3.82V @ 10KΩ | | Maximum Output Current | 308μA @ 500Ω | 274μA @ 500Ω | | | 232μA @ 2KΩ | 387μΑ @ 2ΚΩ | | | 202μΑ @ 10ΚΩ | 383μΑ @ 10ΚΩ | | Output Tolerance | +/- 10% | +/- 2% | | Pulse Width | 50µs | 119ms | | Frequency | 50.0Hz | 8.4Hz | | For Interferential Modes Only | | | | Beat Frequency | No Beat Frequency | No Beat Frequency | | For Multiphasic Waveforms | | | | Symmetric Phases? | Multiphasic | Not Multiphasic | | Phase Duration | 10.0ms Positive/10.0ms<br>Negative | Not Determined | | Net Charge(μC per pulse) | N/A - Battery Operated | N/A - Battery Operated | | On Time (Seconds) | Constant | Constant | | Off Time (Seconds) | None | None | | Maximum Phase Charge (μC) | 6.16μC @ 500Ω | 23.06μC @ 500Ω | | Maximum Current Density (mA/cm²) | 0.034mA/cm² @ 500Ω | 0.419mA/cm² @ 500Ω | | Maximum Power Density (μW/cm²) | 3.44μW/cm²@ 500Ω | 3.22μW/cm² @ 500Ω | #### Nonclinical Testing in Support of Substantial Equivalence Determination (§807.92(a)(6)(b)(1) The ZIIP Device was tested and found to be in compliance with FDA's performance standards in accordance with 21 CDR, Part 898 (Performance Standards for Electrode Lead Wires and Patient Cables). Additionally, the ZIP Device was tested and found to be in compliance with IEC 60601-1 -2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – requirements and tests) for radiated and power line conducted emissions. Furthermore, the ZIIP Device was evaluated and found to be in compliance with IEC 60601-1 (Medical electrical equipment: Part 1: General requirements for basic safety and essential performance) for Electrical Safety. Finally, the ZIIP Device has been tested to demonstrate its performance specifications are equivalent to {8}------------------------------------------------ the NuFace Plus, and has been validated in accordance with IEC 60601-1 and IEC 60601-1-2 requirements. Note: the materials that come in contact with the user skin have been assessed in accordance with ISO 10993 (Biological evaluation of medical devices package). #### LIST OF NONCLINICAL SAFETY TESTS PERFORMED Table below delineates the compilation of nonclinical testing employed for the testing of the ZIIP Device. ## Non-clinical Testing Employed | Test | Name | Testing Facility | Results | |---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|---------| | IEC 60601-1 | Medical electrical equipment: Part 1:<br>General requirements for basic safety<br>and essential performance | ITC Engineering services | Pass | | IEC 60601-1-2 | Medical electrical equipment — Part 1-2:<br>General requirements for basic safety<br>and essential performance – Collateral<br>Standard: Electromagnetic disturbances<br>– requirements and tests | ITC Engineering | Pass | #### Product Testing The ZIIP Device was thoroughly tested during design verification testing and design validation testing. A brief summary has been placed into the table above. Additionally, performance testing was performed in accordance with IEC 60601-1-2:2007, Medical Electrical Equipment. ## Compilation of Test Protocols & Reports | Protocol & Report Number | Title | Date | Results | |--------------------------|------------------------------------------|---------|---------| | 199001-005, Rev 0 | ZiiP 1.00 Validation Plan and Protocol | 2/28/16 | N/A | | 199001-006, Rev 0 | ZiiP 1.00 Validation Report | 2/28/16 | Pass | | 199001-007, Rev 0 | ZiiP 1.00 Verification Plan and Protocol | 2/28/16 | N/A | | 199001-008, Rev 0 | ZiiP 1.00 Verification Report | 2/28/16 | Pass | ## CLINICAL TESTING (§807.92(a)(6)(b)(2) There was no clinical testing performed in support of this 510(k) submission. ## Conclusion (§807.92(a)(6)(b)(3) The ZIIP Device is substantially equivalent to the predicate device identified in this summary and previously cleared by FDA in accordance with 21 CFR, Part 807 requirements.