(269 days)
The ZIIP Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
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).
The provided document is a 510(k) premarket notification for the ZIIP Device, a transcutaneous electrical nerve stimulator for pain relief, specifically indicated for facial stimulation and over-the-counter cosmetic use.
Here's an analysis of the acceptance criteria and study information contained within the document:
1. Table of Acceptance Criteria & Reported Device Performance
The acceptance criteria are not explicitly stated as distinct performance targets with pass/fail thresholds. Instead, the document demonstrates substantial equivalence to a predicate device (NuFace Plus Facial Toning Device) by comparing technological characteristics and compliance with recognized standards. The "performance" is implicitly meeting these standards and having comparable specifications to the predicate.
| Acceptance Criteria (Implied) | ZIIP Device Performance (Reported) |
|---|---|
| Safety and Essential Performance | |
| Compliance with IEC 60601-1 (Electrical Safety) | Pass |
| Compliance with IEC 60601-1-2 (Electromagnetic Disturbances) | Pass |
| Compliance with 21 CFR Part 898 (Electrode Lead Wires and Patient Cables) | In compliance |
| Biocompatibility (materials in contact with skin) | Assessed in accordance with ISO 10993 |
| Functional Equivalence to Predicate Device | (Note: Performance here is a comparison to the predicate, not an absolute threshold) |
| Intended Use | Stimulate the Face - Skin Toning (Same as predicate) |
| Indications for Use | Over-the-counter cosmetic use (Same as predicate) |
| Maximum Output Current | 308µA @ 500Ω, 232µA @ 2KΩ, 202µA @ 10KΩ (Comparable to predicate: 274µA @ 500Ω, 387µΑ @ 2ΚΩ, 383μΑ @ 10ΚΩ; ZIIP is within range for safety and efficacy as a microcurrent device) |
| Maximum Output Voltage | 154mV @ 500Ω, 465mV @ 2KΩ, 2.2V @ 10KΩ (Comparable to predicate: 137mV @ 500Ω, 769mV @ 2KΩ, 3.82V @ 10KΩ; ZIIP is within range for safety and efficacy as a microcurrent device) |
| Waveform Shape | Modulated Square Wave (Same as predicate) |
| Other electrical and physical characteristics | Comparable specifications for power source, patient leakage current, number of output channels, automatic overload/no-load trip, automatic shut-off, patient override control, indicator displays, timer range, weight, dimensions, housing material, and requirement for electro-conductive material (all deemed substantially equivalent). |
2. Sample size used for the test set and data provenance
The document does not describe a test set in the context of human subjects or clinical data for performance evaluation. The "testing" refers to bench testing and compliance with electrical safety and EMC standards.
- Test Set Sample Size: Not applicable for clinical performance assessment. The "samples" would be the device units used for engineering tests.
- Data Provenance: Not applicable for clinical performance assessment. The testing was non-clinical (bench testing for electrical safety, EMC, and performance specifications).
3. Number of experts used to establish the ground truth for the test set and their qualifications
This information is not applicable as there was no study involving expert interpretation of data or images to establish a ground truth. The acceptance was based on non-clinical engineering and safety compliance.
4. Adjudication method for the test set
This information is not applicable as there was no test set requiring adjudication in the context of clinical performance or interpretation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, information about effect size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "There was no clinical testing performed in support of this 510(k) submission." Therefore, there is no effect size related to human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm-only performance study was not done. The device is a physical electro-stimulation device, not an AI or software algorithm that provides diagnostic or assistive output.
7. The type of ground truth used
The "ground truth" for the non-clinical testing was established by the specified international and FDA standards (IEC 60601-1, IEC 60601-1-2, 21 CFR Part 898, ISO 10993). Compliance with these standards served as the "ground truth" for safety and electrical performance. For equivalence, the ground truth was the technical specifications of the predicate device (NuFace Plus).
8. The sample size for the training set
This information is not applicable as there was no AI/machine learning component involved in this device submission, and therefore no "training set."
9. How the ground truth for the training set was established
This information is not applicable as there was no AI/machine learning component involved in this device submission, and therefore no "training set" or ground truth for it.
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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
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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.
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
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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)
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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
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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.
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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 UnitCharacteristics | 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 NerveStimulator | Transcutaneous ElectricalNerve Stimulator |
| Regulation Class | Class II | Class II |
| Product Code | NFO | NFO |
| Intended Use | Stimulate the Face - Skin Toning | Stimulate the Face - SkinToning |
| Indications for Use | Over-the-counter cosmetic use | Over-the-counter cosmetic use |
| TechnologicalCharacteristics | The ZIIP Device is a Facial ToningDevice intended for facialstimulation. It produces a smallelectrical current dischargedthrough the two electrodes. Thecurrent delivered is an aestheticmodality providing a smallelectric current in millionths ofan ampere and has the ability toincrease facial contour and firmthe skin and muscles bysupplying a maximum of +/- 200micro amperes of current. Thedevice measures 2.00" W x 3.9"L x 1.40" D (fits in the palm of ahand) and weighs 3.2 ounces.The outer case of the ZIIP Deviceis manufactured using injection-molded of thermoplastic resinand the output contacts(probes) consist of chrome-plated spheres. The device ispowered by Lithium-Ionrechargeable batteries (3.7V,700mAh (503048-2C) / 2.59Wh,1.4A rate), The ZIIP Device is | The Nu-Face Plus is a FacialToning Device intended forfacial stimulation. It produces amicro-current dischargedthrough the two sphericalprobes. Micro-current is anaesthetic modality providingelectric current in millionths ofan ampere and has the abilityto increase facial contour andfirm the skin and muscles bysupplying 80 - 400 pA.The device measures 3" W x5.25' L x 1.25' D. Its outer caseis injection molded ofthermoplastic resin and theoutput contacts (probes)consist of chrome-platedspheres. The device is poweredby 4 rechargeable batteries.The NuFACE® Plus comes witha rechargeable base, whichmeasures 3.25" W x 4" L x3.25" D. |
Device Descriptions - Comparison ZIIP Device with Predicate (§807.92(a)(6)(a)(b))
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| ' 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 | TranscutaneousElectrical NerveStimulator | TranscutaneousElectrical NerveStimulator |
| Power Source(s) | ||
| a. Method of Line Current Isolation | One RechargeableLithium-Ion Battery,and External ChargerIsolation(External ChargerIncluded) | 4 rechargeable AANiMH batteries |
| b. Patient Leakage Current | ||
| 1. Normal Condition | 46uA | N/A - BatteryOperated |
| 2. Single Fault Condition | 46uA | N/A - BatteryOperated |
| Number of Output Modules | N/A | 1 |
| Number of Output Channels | 1 | 1 |
| a. Synchronous or Alternating | N/A - 1 OutputChannel | N/A - 1 OutputChannel |
| b. Method of Channel Isolation | N/A - 1 OutputChannel | N/A - 1 OutputChannel |
| Regulated Current or Regulated Voltage | Both | Both |
| Software/Firmware/MicroprocessorControlled | Yes | Yes |
| Automatic Overload Trip | Not required becauseof circuit design(Current and VoltageLimited by CircuitDesign and Firmware) | Not required becauseof circuit design |
| Automatic No-Load Trip | Yes (Reversion toFixed Voltage Output) | Yes |
| Automatic Shut Off | Yes | Yes |
| Patient Override Control | Yes | Yes |
| Indicator Display | ||
| a. On/Off Status | Yes (LED Illuminationon Conduction) | Yes |
| b. Low Battery | Yes | Yes |
| c. Voltage/Current Level | Yes (LED Illuminationon Target CurrentLevels) | Yes |
| Timer Range | Yes | Yes (21-Minutes) |
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| Basic Unit Characteristics | ZIIP Device | NuFace® Plus |
|---|---|---|
| Compliance with Voluntary Standards | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 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(§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/10.0msNegative | 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
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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:General requirements for basic safetyand essential performance | ITC Engineering services | Pass |
| IEC 60601-1-2 | Medical electrical equipment — Part 1-2:General requirements for basic safetyand essential performance – CollateralStandard: Electromagnetic disturbances– 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.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).