(177 days)
The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.
The NuFACE Trinity Device(proposed) is intended for facial and neck skin stimulation and is indicated for over-the-counter cosmetic use. It is identical to that of its NuFACE Plus (predicate) and its technological characteristics remain unchanged. It produces microcurrent discharged through the two spherical probes.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NuFACE Trinity Device:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the NuFACE Trinity Device does not present typical "acceptance criteria" in the sense of performance metrics with specific thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, it establishes substantial equivalence to a predicate device (NuFACE Plus). The primary "acceptance criteria" appear to be that the proposed device (NuFACE Trinity) is identical in technological characteristics and performance standards to the predicate device, with an expanded intended use to include the neck.
The table presented is a "Substantial Equivalence Comparison Table" which compares the proposed NuFACE Trinity Device to its predicate, the NuFACE Plus. The performance is "reported" by asserting that the devices are critically similar or identical in most technical specifications.
| Characteristic | Acceptance Criteria (based on Predicate) | Reported Device Performance (NuFACE Trinity) | Result/Comment |
|---|---|---|---|
| Intended Use | Facial stimulation for cosmetic use. | Facial and neck stimulation for cosmetic use. | Different (expanded to include neck), but deemed substantially equivalent. |
| Anatomic Sites | Face | Face and Neck | Different (expanded to include neck), but deemed substantially equivalent. |
| Technological Characteristics | Microcurrent, materials (injection molded thermoplastic resin, chrome-plated spheres), lithium-ion battery, biphasic square wave, 10 positive/10 negative pulses, alternating microcurrent, adjustable output, conductive gel requirement, 5-second usage cue. | Identical to predicate. | Same |
| Product Safety (IEC 60601-1) | Compliance with IEC 60601-1. | Compliance with IEC 60601-1. | Same (Based on non-clinical testing and assertion of identity to predicate). |
| EMC (IEC 60601-1-2) | Compliance with IEC 60601-1-2. | Compliance with IEC 60601-1-2. | Same (Based on non-clinical testing and assertion of identity to predicate). |
| FDA Performance Standards (21 CFR 898) | Compliance with 21 CFR 898. | Compliance with 21 CFR 898. | Same (Based on non-clinical testing and assertion of identity to predicate). |
| Power Source | Internal rechargeable Lithium ion battery. | Internal rechargeable Lithium ion battery. | Same |
| Output Waveform | Pulsed Biphasic, Modulated Square. | Pulsed Biphasic, Modulated Square. | Same |
| Maximum Output Voltage | 28 VDC. | 28 VDC. | Same |
| Maximum Output Current | 400 μA @ 500Ω. | 400 μA @ 500Ω. | Same |
| Maximum Output Current Density | 0.419 mA/cm². | 0.419 mA/cm². | Same |
| Pulse Width | 60 msec. | 60 msec. | Same |
| Frequency | Approximately 8.3 Hz. | Approximately 8.3 Hz. | Same |
| Other Output Specs (Burst Mode, ON/OFF Time, etc.) | Identical to those of the predicate. | Identical to predicate specifications. | Same (Specifically: Pulses per burst 20, Pulses per second 8.3, Burst duration 2.4s, Duty Cycle 20.2s, ON Time 60msec, OFF Time 60msec). |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Literature provided and usability studies conducted demonstrate that the device is substantially equivalent to the predicate given the new indications." This implies that some form of usability study was performed for the new indications (neck stimulation). However, the document does not specify the sample size for any test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature). The primary reliance is on the device being identical to the predicate from a technical standpoint.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention any experts being used to establish ground truth for a test set in the traditional sense of clinical performance evaluation. The "ground truth" for substantial equivalence rests on the comparison of specifications and the assumption that the predicate device (NuFACE Plus) already established its safety and effectiveness.
4. Adjudication Method
There is no mention of an adjudication method for a test set. This type of method is typically used in studies where human readers evaluate cases and their discrepancies are resolved. Since this submission relies on substantial equivalence through technical and functional identicality, such a method does not apply here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done as described. The submission focuses on substantial equivalence of a new device (NuFACE Trinity) to an existing one (NuFACE Plus), not on improving human reader performance with AI assistance. The device itself is an electrical stimulator, not an AI-powered diagnostic tool.
6. Standalone Performance Study
A standalone performance study (algorithm only performance without human-in-the-loop) was not explicitly done or reported in the traditional sense. The "performance" assessment focuses on the identical nature of the NuFACE Trinity to the NuFACE Plus in terms of electrical output, safety, and EMC. The non-clinical testing for electrical safety, EMC, and biocompatibility, as well as the usability studies, implicitly serve as a standalone performance assessment to demonstrate that the expanded use (neck) is safe and effective when delivered by an identical device.
7. Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the predicate device (NuFACE Plus), as accepted by the FDA when it was cleared (K103472). The submission's argument for the NuFACE Trinity is that its identical technological characteristics and performance standards mean it also meets those same safety and effectiveness criteria, even with the expanded anatomical site (neck), which was further supported by usability studies.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This is because the device is not an AI/machine learning device that requires a training set for model development. The approval pathway is an equivalence pathway, not one that requires de novo clinical validation with training and test sets for an algorithm.
9. How Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm for this device, there is no ground truth established for a training set. The entire premise is based on the previously cleared predicate device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
October 11, 2018
Carol Cole Company dba NuFACE Donald Ellis Head - Regulatory Affairs/ Quality Assurance 1325 Sycamore Ave. Suite A Vista. California 92081
Re: K181008
Trade/Device Name: NuFACE Trinity Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NFO Dated: August 14, 2018 Received: August 16, 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.
{1}------------------------------------------------
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 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 mediation-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) K181008
Device Name NuFACE Trinity
Indications for Use (Describe)
The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 TRINITY DEVICE 510(K) SUMMARY
Date Prepared: August 14, 2018
510(K) SUBMITTER/OWNER
Carol Cole Company dba NuFACE 1325 Sycamore Ave, Suite A Vista, CA 92081, USA
CONTACT INFORMATION:
Donald Ellis, Head - R&D Projects, Regulatory and Quality 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 Trinity Facial and Neck Skin Toning Device NuFACE Trinity Device Transcutaneous electrical nerve stimulator for pain relief 21 CFR 882.5890 NFO
Requlation Number: Product Code:
PREDICATE DEVICE
The legally marketed predicate device to which the Carol Cole Company is claiming equivalence for over-the-counter use:
510(k) Number: K103472 Manufacturer: Carol Cole Company dba NuFACE Trade Name: NuFACE Plus Product Code: NFO
Device Description
The NuFACE Trinity Device(proposed) is intended for facial and neck skin stimulation and is indicated for over-the-counter cosmetic use. It is identical to that of its NuFACE Plus (predicate) and its technological characteristics remain unchanged.
Intended Use
The NuFACE Trinity Device is intended for facial and neck stimulation and is indicated for overthe-counter cosmetic use.
{4}------------------------------------------------
Technological Characteristics
The NuFACE Trinity Device (proposed) is identical to that of its NuFACE Plus (predicate) and its technological characteristics remain unchanged. It produces microcurrent discharged through the two spherical probes.
Non-Clinical Testing
The NuFACE Trinity device is identical to the predicate which was tested to the applicable standards for electrical safety, EMC, and biocompatibility. Literature provided and usability studies conducted demonstrate that the device is substantially equivalent to the predicate given the new indications.
Performance Standards
The NuFACE Trinity Device (proposed) is identical to that of its NuFACE Plus (predicate) and both comply to FDA performance standards set forth in 21 CFR §898.
Product Safety and EMC performance testing was conducted for the following aspects:
-
- Electrical and Constructional Safety in accordance with IEC 60601-1
-
- Electromagnetic Compatibility (EMC) in accordance with IEC 60601-1-2
Thus, with respect to Safety and EMC, the NuFACE Trinity Device (proposed) is substantially equivalent to the NuFACE Plus (predicate).
| DEVICE DESCRIPTIONS | NuFACE TRINITY DEVICE(PROPOSED) | NuFACE PLUS(PREDICATE) | SAME ORDIFFERENT | |
|---|---|---|---|---|
| 1. 510(k) Number | K181008 | K103472 | ||
| 2. RegulationNumber | 21 C.F.R. § 882.5890 | 21 C.F.R. § 882.5890 | 21 C.F.R. §882.5890 | |
| 3. RegulationName | Transcutaneouselectrical nervestimulator for pain relief | Transcutaneouselectrical nervestimulator for painrelief | Same | |
| 4. Regulatory Class | Class II | Class II | Same | |
| 5. DeviceClassificationName | Stimulator,TranscutaneousElectrical, AestheticPurposes | Stimulator,TranscutaneousElectrical, AestheticPurposes | Same | |
| 6. Product Code | NFO | NFO | Same | |
| 7. RegulationMedicalSpecialty | Neurology | Neurology | Same | |
| 8. Intended Use | NuFACE Trinity Device isintended for facial andneck skin stimulation andis indicated for over-the-counter cosmetic use. | NuFACE Plus isintended for facialstimulation and isindicated for over-the-counter cosmeticuse. | Different | |
| 9. Indications forUse | Over-the-CounterCosmetic Use | Over-the-CounterCosmetic Use | Same | |
| 10. Anatomic Sites | Face and Neck | Face | Different | |
| 11. TechnologicalCharacteristics | The NuFACE TrinityDevice. Its outer case isinjection moldedthermoplastic resin. Theoutput contacts consistof chrome-platedspheres. The device ispowered by arechargeable lithium ionbattery and produces amicrocurrent that isdischarged through twofixed, smooth electrodespheres. To turn thedevice on, the on/offbutton is pressed.Ascending tonal beepsindicate the device ison. One to five red LEDlights illuminateindicating the outputintensity level and theunit is ready for use.Users then follow theinstructions for use. Thetwo spheres gently glideover the skin to deliverlow-level electricalimpulses to targetedlocations. The NuFACETrinity spheres aredesigned for optimalcontact with the skin.The NuFACE TrinityDevice deliversmicrocurrent as aconstant biphasic | The NuFACE Plus is afacial toning device.Its outer case isinjection moldedthermoplastic resin.The output contactsconsist of chrome-plated spheres. Thedevice is powered bya rechargeablelithium ion battery andproduces amicrocurrent that isdischarged throughtwo fixed, smoothelectrode spheres. Toturn the device on,the on/off button ispressed. Ascendingtonal beeps indicatethe device is on. Oneto five red LED lightsilluminate indicatingthe output intensitylevel and the unit isready for use. Usersthen follow theinstructions for use.The two spheresgently glide over theskin to deliver low-level electricalimpulses to targetedlocations. TheNuFACE Plus spheresare designed foroptimal contact with | Same | |
| BASIC UNITCHARACTERISTICS | square wave comprisinga (10) positive pulsesfollowed by (10)negative pulses. Themicrocurrent outputcontinuously alternatesbetween the positiveand negative electrodespheres, and allows theuser to adjust the outputfor a personalizedcomfort level. TheNuFACE Trinity Devicerequires the use of aconductive gel. Topromote proper use andprovide feedback to theuser, the NuFACE TrinityDevice beeps to cue theuser to relocate thedevice approximatelyevery 5 seconds. | the skin. The NuFACEPlus device deliversmicrocurrent as aconstant biphasicsquare wavecomprising a (10)positive pulsesfollowed by (10)negative pulses. Themicrocurrent outputcontinuouslyalternates betweenthe positive andnegative electrodespheres, and allowsthe user to adjust theoutput for apersonalized comfortlevel. The NuFACEPlus device requiresthe use of aconductive gel. Topromote proper useand providefeedback to the user,the NuFACE Plusbeeps to cue the userto relocate thedevice approximatelyevery 5 seconds. | ||
| 1. 510(k) Number | K181008 | K103472 | Different | |
| 2. Device Name,Model | NuFACE Trinity Device | NuFACE Plus | Same | |
| 3. Manufacturer | Carol Cole Company(dba NuFACE) | Carol Cole Company(dba NuFACE) | Same | |
| 4. Power Source(s) | Internal rechargeableLithium ion battery | Internal rechargeableLithium ion battery | Same | |
| a. Method ofLine CurrentIsolation | Type BF | Type BF | Same | |
| b. PatientLeakageCurrent | ||||
| 1). Normalcondition | N/A - Battery operated | N/A - Battery operated | Same | |
| 2). Singlefault condition | N/A - Battery operated | N/A - Battery operated | Same | |
| 5. External poweradapter | NuFACE 7-volt poweradapter | NuFACE 7-volt poweradapter | Same | |
| 6. Number ofOutputChannels | 1 | 1 | Same | |
| a. Synchronousor Alternating | N/A - 1 Output channel | N/A - 1 Output channel | Same | |
| b. Method ofChannelIsolation | N/A - 1 Output channel | N/A - 1 Output channel | Same | |
| 7. RegulatedCurrent orRegulatedVoltage | Both | Both | Same | |
| 8. Software/Firmware/Microprocessor Control | Yes | Yes | Same | |
| 9. AutomaticOverload Trip | Not required due tocircuit design | Not required due tocircuit design | Same | |
| 10. Automatic No-Load Trip | Yes | Yes | Same | |
| 11. Automatic ShutOff | Yes | Yes | Same | |
| 12. PatientOverrideControl | Yes | Yes | Same | |
| 13. IndicatorDisplay | ||||
| a. On/OffStatus | Yes | Yes | Same | |
| b. Low Battery | Yes | Yes | Same | |
| c. Voltage/Current Level | Yes | Yes | Same | |
| 14. AutomaticShut-Off(minutes) | Yes (20 minutes) | Yes (20 minutes) | Same | |
| 15. Compliancewith VoluntaryStandards | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 | Same | |
| 16. Compliancewith 21 CFR 898 | Yes | Yes | Same | |
| 17. Weight | 9 oz. without chargingbase | 9 oz. without chargingbase | Same | |
| 18. Dimensions ofdevice(inch)[W x L x D] | 2.8" x 5.1" x 1.3" | 2.8" x 5.1" x 1.3" | Same | |
| 19. HousingMaterials andConstruction | Thermoplastic | Thermoplastic | Same | |
| OUTPUTSPECIFICATIONS | ||||
| K103472 | Unknown | |||
| 1. | 510(k) Number | |||
| 2. | Waveform (e.g.,pulsedmonophasic,biphasic) | Pulsed Biphasic | Pulsed Biphasic | Same |
| 3. | Shape (e.g.,rectangular,spike, rectifiedsinusoidal) | Modulated Square | Modulated Square | Same |
| 4. | MaximumOutput Voltage | 28 VDC | 28 VDC | Same |
| 5. | MaximumOutput Current | 400 μA @ 500Ω | 400 μA @ 500Ω | Same |
| 6. | MaximumOutput CurrentDensity | 0.419 mA/cm2 | 0.419 mA/cm2 | Same |
| Output8.Tolerance | +/- 10% | +/- 10% | Same | |
| 9.Pulse Width(specify units) | 60 msec | 60 msec | Same | |
| 10. Frequency (Hz) | Approximately 8.3 Hz | Approximately 8.3 Hz | Same | |
| 11. For interferentialmodes, only | ||||
| 12. Beat Frequency(Hz) | No Beat Frequency | No Beat Frequency | Same | |
| 13. For multiphasicwaveforms, only | ||||
| 14. Symmetricalphases | Not Multiphasic | Not Multiphasic | Same | |
| 15. Phase Duration(include units) | Not Multiphasic | Not Multiphasic | Same | |
| 16. Net Charge (µCper pulse) | N/A - Battery operated | N/A - Batteryoperated | Same | |
| 17. Burst Mode (i.e.,pulse trains) | ||||
| a. Pulses per burst | 20 | 20 | Same | |
| b. Pulses persecond | 8.3 | 8.3 | Same | |
| c. Burst duration(seconds) | 2.4 s | 2.4 s | Same | |
| d. Duty Cycle [Line(b) x Line (c)](on time perburst) | 20.2 s | 20.2 s | Same | |
| 18. ON Time(seconds) | 60 msec | 60 msec | Same | |
| 19. OFF Time(seconds) | 60 msec | 60 msec | Same |
Table 1: Substantial Equivalence Comparison Table
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR part 807 and based on the relative information provided in this premarket notification, we conclude the NuFACE Trinity Device is substantially equivalent to the NuFACE Plus 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).