(103 days)
The NuFACE FIX™ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
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.
The NuFACE FIX Skin Toning Device is intended for facial stimulation for over-the-counter cosmetic use. The 510(k) summary provided indicates substantial equivalence to the predicate device, NuFACE Trinity ELE (K131251), rather than presenting specific performance criteria and a study demonstrating the device meets those criteria.
However, since a direct study proving the device meets individual acceptance criteria is not provided, the following outlines the acceptance criteria established by the manufacturer and the reported performance as demonstrated through a substantial equivalence comparison to a predicate device, rather than a standalone performance study with specific device performance metrics against predefined acceptance thresholds.
1. Table of Acceptance Criteria and Reported Device Performance
As this submission establishes substantial equivalence, the "acceptance criteria" for the new device are implicitly that its technological characteristics, intended use, indications for use, and performance data are either the same as or demonstrate equivalence to the predicate device.
| Category | Acceptance Criteria (Based on Predicate Device K131251) | Reported Device Performance (NuFACE FIX) | Justification / (Same/Different) |
|---|---|---|---|
| Intended Use | Intended for facial stimulation and indicated for over-the-counter cosmetic use. | Intended for facial stimulation and indicated for over-the-counter cosmetic use. | Same |
| Indications for Use | Over-the-Counter Cosmetic Use | Over-the-Counter Cosmetic Use | Same |
| Regulation Number | 21 C.F.R. § 882.5890 (Transcutaneous electrical nerve stimulator for pain relief) | 21 C.F.R. § 882.5890 (Transcutaneous electrical nerve stimulator for pain relief) | Same |
| Regulatory Class | Class II | Class II | Same |
| Product Code | NFO | NFO | Same |
| Waveform | Pulsed Biphasic | Pulsed Biphasic | Same |
| Shape | Modulated Square | Modulated Square | Same |
| Maximum Output Voltage | 28 VDC | 28 VDC | Same |
| Maximum Output Current | 208 μΑ @ 500Ω | 200 μΑ @ 500Ω | Same (within acceptable limits) |
| Maximum Output Current Density | 0.800 μΑ/cm² | 0.418 μΑ/cm² | Same (though value is lower, it's considered within safe/effective range for equivalence) |
| Output Tolerance | +/- 10% | +/- 10% | Same |
| Pulse Width | 60 ms | 60 ms | Same |
| Frequency (Hz) | Approximately 8.3 Hz | Approximately 8.3 Hz | Same |
| Power Source | Internal rechargeable Lithium Ion battery | Internal rechargeable Lithium Ion battery | Same |
| External Power Adapter | NuFACE 7-volt power adapter | User supplied standard 5-volt USB port | Different (but considered equivalent in functionality) |
| Automatic Shut-Off | 20 minutes | 3 minutes | Different (justified as not impacting safety/effectiveness) |
| Weight | 9 oz. without charging base | Approximately 2 oz. | Different (justified as not impacting safety/effectiveness) |
| Dimensions | 2.8" x 5.1" x 1.3" | Approximately 5.7" x 0.82" | Different (justified as not impacting safety/effectiveness) |
| Housing Materials | Thermoplastic | Thermoplastic | Same |
| Safety Standards | Compliance with various IEC/ANSI/CAN/CSA standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 62366, IEC 60601-1-11, IEC 62133, ANSI/AMI ES60601-1, CAN/CSA-C22.2 No. 60601-1, IEC 60529 (Ingress Protection), IEC 62304 (Software)) | Compliance with identical set of IEC/ANSI/CAN/CSA standards. (Specific testing performed and passed for electrical safety, EMC, usability engineering, battery testing, software V&V, ingress protection). | Same conformance |
2. Sample size used for the test set and the data provenance
The primary evidence presented is a comparison against a predicate device's specifications and compliance with recognized standards. There isn't a "test set" in the traditional sense of a clinical trial or performance study with a specific sample size of patients or images for which direct performance metrics against acceptance criteria are measured.
Instead, the "test set" for this substantial equivalence submission comprises:
- Engineering and Bench Testing Data: This includes measurements of electrical output specifications (voltage, current, pulse width, frequency), mechanical integrity, and software functionality.
- Safety Standard Compliance Reports: Documentation demonstrating that the device meets the requirements of various international and national safety and performance standards (e.g., IEC 60601 series, ISO 14971, IEC 62366).
- Usability Study: A prospective usability study was conducted. Details on sample size or provenance are not provided in this summary.
Data Provenance: The data originates from the manufacturer's internal testing and evaluations, conducted according to recognized industry standards. No external clinical data or specific geographic provenance (e.g., country of origin) for a clinical "test set" is explicitly mentioned for the substantial equivalence claim. The usability study is described as "prospective" but no further detail on its sample size or provenance is provided within this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Given that this is a 510(k) submission based on substantial equivalence to a predicate device and compliance with engineering and safety standards, the concept of "ground truth" derived from expert consensus on a clinical test set is not directly applicable in the same way as it would be for a diagnostic AI device.
- Engineering/Safety Standards: The "ground truth" here is established by the specifications and performance requirements outlined in the international and national standards themselves (e.g., IEC 60601 series). Compliance is typically assessed by engineers and technicians who are qualified in the relevant testing methodologies and regulatory requirements.
- Usability Study: If the usability study involved expert feedback, the qualifications of those experts (e.g., human factors engineers, ergonomists, clinicians who would use such a device) would be relevant. However, this detail is not provided in the summary.
4. Adjudication method for the test set
Not applicable in the context of this 510(k) submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or reader studies where multiple experts independently review cases and then resolve disagreements to establish a consensus ground truth. This type of clinical adjudication is not described or implied for the non-clinical and technical testing presented for substantial equivalence.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The NuFACE FIX Device is a direct-to-consumer cosmetic device, not an AI-assisted diagnostic or therapeutic tool that would involve "human readers" or "AI assistance" in the clinical decision-making process. Therefore, an MRMC comparative effectiveness study involving AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an "algorithm-only" performance, which is not applicable here as the device is a physical, microcurrent stimulation device for cosmetic use, not a software algorithm. The device does have software (as confirmed by IEC 62304 compliance), but it's embedded control software, not a standalone AI algorithm with a distinct performance metric for a specific clinical task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for demonstrating substantial equivalence and safety/performance in this context is predominantly:
- Engineering Specifications and Measurements: The measured electrical output values (voltage, current, pulse width, frequency) are compared directly against the specified values and the predicate device's values.
- Compliance with Recognized Standards: The successful completion of tests required by established international and national safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60529). These standards themselves define what constitutes acceptable performance and safety.
- Predicate Device Comparison: The "ground truth" for the equivalence claim is the established safety and effectiveness profile of the legally marketed predicate device (NuFACE Trinity ELE, K131251). The new device is deemed safe and effective if its differences from the predicate device do not raise new questions of safety or effectiveness.
8. The sample size for the training set
Not applicable. As this device is not an AI/ML algorithm requiring a training set, this concept does not apply.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML algorithm was used.
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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
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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
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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)
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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.
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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) .
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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.
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PREDICATE COMPARISON
| Device Descriptions | NUFACE® FIX DEVICE(NEW DEVICE) | NUFACE® TRINITY ELEDEVICE (PREDICATE) | SAME OR DIFFERENTTECHNOLOGICALCHARACTERISTICS |
|---|---|---|---|
| 1. 510(k) Number | K182424 | K131251 | |
| 2. RegulationNumber | 21 C.F.R. §882.5890 | 21 C.F.R. § 882.5890 | Same |
| 3. RegulationName | Transcutaneouselectrical nervestimulator for painrelief | Transcutaneouselectrical nervestimulator for painrelief | Same |
| 4. Regulatory Class | Class II | Class II | Same |
| 5. DeviceClassificationName | Stimulator,TranscutaneousElectrical,Aesthetic Purposes | Stimulator,TranscutaneousElectrical, AestheticPurposes | Same |
| 6. Product Code | NFO | NFO | Same |
| 7. RegulationMedicalSpecialty | Neurology | Neurology | Same |
| 8. Intended Use | NuFACE FIX Deviceis intended forfacial stimulationand is indicatedfor over-the-counter cosmeticuse. | NuFACE Trinity ELE isintended for facialstimulation and isindicated for over-the-countercosmetic use | Same |
| 9. Indications forUse | Over-the-CounterCosmetic Use | Over-the-CounterCosmetic Use | Same |
| 10. Anatomic Sites | Face | Face | Same |
| 11. TechnologicalCharacteristics | The NuFACE FIX isan over-the-counter facialstimulation device.Its outer case isinjection moldedthermoplasticresin. The outputcontacts consist ofchrome-platedspherical | The NuFACE TrinityELE is an over-the-counter facialstimulation device.Its outer case isinjection moldedthermoplastic resin.The outputcontacts consist ofchrome-platedspheres. The | Same |
| Device Descriptions | NUFACE® FIX DEVICE(NEW DEVICE) | NUFACE® TRINITY ELEDEVICE (PREDICATE) | SAME OR DIFFERENTTECHNOLOGICALCHARACTERISTICS |
| electrodes. TheNUFACE FIX deviceis powered by arechargeablelithium ion battery.NUFACE FIX deviceproduces | device is poweredby a rechargeablelithium ion batteryand produces amicrocurrent that isdischarged throughtwo fixed, smooth | ||
| microcurrent thatis dischargedthrough two fixed,smooth sphericalelectrodes. To turnthe NUFACE FIX | electrode spheres.To turn the deviceon, the on/offbutton is pressed.Ascending tonalbeeps indicate the | ||
| device on, theon/off button ispressed. The twospheres gentlyglide over the skin | device is on. Oneto five red LED lightsilluminateindicating theoutput intensity | ||
| to deliver low-levelelectrical impulsesto targetedlocations on theface. The NuFACE | level and the unit isready for use. Usersthen follow theinstructions for use.The two spheres | ||
| FIX device spheresare designed foroptimal contactwith facial skin.The NuFACE FIXdevice delivers | gently glide overthe skin to deliverlow-level electricalimpulses totargeted locationson the face. | ||
| microcurrent as aconstant biphasicsquare wavecomprised of (10) | NUFACE Trinity ELEspheres aredesigned foroptimal contact | ||
| positive pulsesfollowed by (10)negative pulses.The microcurrentoutput | with the face. TheNUFACE Trinity ELEdeliversmicrocurrent as aconstant biphasic | ||
| continuouslyalternatesbetween the | square wavecomprising a (10)positive pulses | ||
| Device Descriptions | NuFACE® FIX DEVICE(NEW DEVICE) | NuFACE® TRINITY ELEDEVICE (PREDICATE) | SAME OR DIFFERENTTECHNOLOGICALCHARACTERISTICS |
| positive andnegative sphericalelectrodes.The NuFACE FIXdevice requiresthe use of aconductive gel.To promote properuse and providefeedback to theuser, the NuFACEFIX Deviceincreases tactilefeedback to cuethe user torelocate theNuFACE FIX deviceapproximatelyevery 5 seconds. | followed by (10)negative pulses.The microcurrentoutput continuouslyalternates betweenthe positive andnegative electrodespheres and allowsthe user to adjustthe output for apersonalizedcomfort level. TheNuFACE Trinity ELErequires the use ofa conductive gel.To promote properuse and providefeedback to theuser, the NuFACETrinity ELE beeps tocue the user torelocate thedeviceapproximatelyevery 5 seconds. | ||
| Basic UnitCharacteristics | NUFACE® FIX DEVICE(NEW DEVICE) | NUFACE® TRINITYELE DEVICE(PREDICATE) | SAME OR DIFFERENTTECHNOLOGICALCHARACTERISTIC |
| 1. 510(k) Number | K182424 | K131251 | |
| 2. Device Name,Model | NUFACE FIX Device | NUFACE Trinity ELEDevice | |
| 3. Manufacturer | Carol Cole Company(dba NuFACE) | Carol ColeCompany (dbaNUFACE) | Same |
| 4. Power Source(s) | Internalrechargeable LithiumIon battery | InternalrechargeableLithium Ion battery(updated inK181008) | Same |
| a. Method of LineCurrent Isolation | Type BF | Type BF | Same |
| b. Patient LeakageCurrent | |||
| 1). Normalcondition | N/A - Batteryoperated | N/A - Batteryoperated | Same |
| 2). Single faultcondition | N/A - Batteryoperated | N/A - Batteryoperated | Same |
| 5. External poweradapter | User suppliedstandard 5-volt USBport | NuFACE 7-voltpower adapter | Same |
| 6. Number of OutputChannels | 1 | 1 | Same |
| a. Synchronous orAlternating | N/A - 1 OutputChannel | N/A - 1 OutputChannel | Same |
| b. Method ofChannel Isolation | N/A - 1 Outputchannel | N/A - 1 Outputchannel | Same |
| 7. Regulated Currentor RegulatedVoltage | Both | Both | Same |
| 8. Software/Firmware/MicroprocessorControl | Yes | Yes | Same |
| 9. AutomaticOverload Trip | Not required due tocircuit design | Not required dueto circuit design | Same |
| 10. Automatic No-Load Trip | Yes | Yes | Same |
| 11. Automatic Shut Off | Yes | Yes | Same |
| Basic UnitCharacteristics | NUFACE® FIX DEVICE(NEW DEVICE) | NUFACE® TRINITYELE DEVICE(PREDICATE) | SAME OR DIFFERENTTECHNOLOGICALCHARACTERISTIC |
| 12. Patient OverrideControl | Yes | Yes | Same |
| 13. Indicator Display | |||
| a. On/Off Status | Yes | Yes | Same |
| b. Low Battery | Yes | Yes | Same |
| c. Voltage/CurrentLevel | Yes | Yes | Same |
| 14. Automatic Shut-Off(minutes) | Yes (3 minutes) | Yes (20 minutes) | Different |
| 15. Compliance withVoluntaryStandards | IEC 60601-1IEC 60601-1-2IEC 60529IEC 60601-2-10ISO 14971IEC 60601-1-6IEC 62366IEC 60601-1-11ANSI/AMI ES60601-1CAN/CSA-C22.2 No.60601-1IEC 62133 | IEC 60601-1IEC 60601-1-2 | Same |
| 16. Compliance with21 CFR 898 | Yes | Yes | Same |
| 17. Weight | Approximately 2 oz. | 9 oz. withoutcharging base | Different |
| 18. Dimensions ofdevice(inch)[WxLxD] | Approximately 5.7" x0.82" | 2.8" x 5.1" x 1.3" | Different |
| 19. Housing Materialsand Construction | Thermoplastic | Thermoplastic | Same |
Table 1: General Comparison Table
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Table 2: Basic Unit Characteristic Comparison
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Table 3: Output Specification Comparison Table
| OUTPUT SPECIFICATIONS | NuFACE FIXNew DEVICE | NuFACE TRINITY + ELEDEVICE(PREDICATE) | SAME ORDIFFERENTTECHNOLOGICALCHARACTERISTIC |
|---|---|---|---|
| 1. 510(k) Number | K182424 | K131251 | |
| 2. Waveform (e.g.,pulsedmonophasic, | Pulsed Biphasic | Pulsed Biphasic | Same |
| OUTPUT SPECIFICATIONS | NUFACE FIXNEW DEVICE | NUFACE TRINITY + ELEDEVICE(PREDICATE) | SAME ORDIFFERENTTECHNOLOGICALCHARACTERISTIC |
| biphasic) | |||
| 3. Shape (e.g.,rectangular, spike,rectifiedsinusoidal) | Modulated Square | Modulated Square | Same |
| 4. Maximum OutputVoltage | 28 VDC | 28 VDC | Same |
| 5. Maximum OutputCurrent | 200 μΑ @ 500Ω | 208 μΑ @ 500Ω | Same |
| 6. Maximum OutputCurrent Density | 0.418 μΑ/cm² | 0.800 μΑ/cm² | Same |
| 7. Output Currentwhen notstimulating | < 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 interferentialmodes, only | |||
| a. Beat Frequency(Hz) | No Beat Frequency | No Beat Frequency | Same |
| 12. For multiphasicwaveforms, only | |||
| a. Symmetricalphases | Not Multiphasic | Not Multiphasic | Same |
| b. Phase Duration(include units)c. (state range,if applicable)d. (bothphases, ifasymmetrical) | Not Multiphasic | Not Multiphasic | Same |
| 13. Net Charge (μCper pulse) | N/A - Battery operated | N/A - Battery operated | Same |
| 14. Burst Mode (i.e.,pulse trains) | |||
| a. Pulse ON time(msec) | 60 | 60 | Same |
| b. Pulse OFF time(msec) | 60 | 60 | Same |
| c. Pulses per burst | 20 | 20 | Same |
| OUTPUT SPECIFICATIONS | NuFACE FIXNEW DEVICE | NuFACE TRINITY + ELEDEVICE(PREDICATE) | SAME ORDIFFERENTTECHNOLOGICALCHARACTERISTIC |
| d. Pulses persecond | 8.3 | 8.3 | Same |
| e. Burst duration(sec) | 2.4 | 2.4 | Same |
| f. Duty Cycle | 50% | 50% | Same |
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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.
§ 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).