NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use. Four (4) spherical electrodes, fixed on the NuBODY device main body, deliver low level electrical impulses (microcurrent) to targeted locations on the body.

AI/ML Overview

This document describes a 510(k) premarket notification for the NuBODY Skin Toning Device, claiming substantial equivalence to the NuFACE Plus device. As such, the study focuses on characterizing the new device's technical specifications and safety standards rather than a clinical efficacy trial.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a separate section. Instead, the performance is demonstrated by comparing the new device (NuBODY) to a legally marketed predicate device (NuFACE Plus) based on their technological characteristics, basic unit characteristics, and output specifications. The assertion is that NuBODY meets the predicate's performance by being "the same, or similar," and that "differences do not alter the clinical utility."

Therefore, the "acceptance criteria" are implied to be that the NuBODY device should have comparable performance characteristics and meet the same safety standards as the NuFACE Plus predicate device.

Acceptance Criteria (Implied: Comparable to NuFACE Plus Predicate)	Reported NuBODY Device Performance
Technological Characteristics:
- Power Source	Rechargeable, non-replaceable, lithium-ion battery (Same as predicate)
- Microcurrent Delivery	Four (4) smooth, chrome-plated, spherical electrodes (Predicate has two spheres, but both deliver microcurrent)
- Waveform	Continuous alternating microcurrent delivered in a burst of positive pulses followed by a burst of negative pulses (Same as predicate)
Basic Unit Characteristics:
- Power Source	Internal rechargeable Lithium ion battery (Same as predicate)
- Method of Line Current Isolation	Type BF (Same as predicate)
- Patient Leakage Current	N/A - Battery operated (Same as predicate)
- Number of Output Channels	1 (Same as predicate)
- Regulated Current or Voltage	Both (Same as predicate)
- Software/Firmware/Microprocessor Control	Yes (Same as predicate)
- Automatic Overload Trip	Not required due to circuit design (Same as predicate)
- Automatic No-Load Trip	Yes (Same as predicate)
- Automatic Shut Off	Yes (Same as predicate)
- Patient Override Control	Yes (Same as predicate)
- Indicator Display (On/Off, Low Battery, Voltage/Current Level)	All Yes (Same as predicate)
- Automatic Shut-Off (minutes)	Yes (5 minutes) (Predicate is 20 minutes; this difference is presented without an explicit "acceptance criterion" but is deemed not to alter clinical utility from the overall conclusion)
- Compliance with Voluntary Standards	IEC 60601-1, IEC 60601-1-2, IEC 60529, IEC 60601-2-10, ISO 14971, IEC 60601-1-6, IEC 62366 (More comprehensive than predicate which listed IEC 60601-1, IEC 60601-1-2, demonstrating compliance with relevant standards.)
- Compliance with 21 CFR 898	Yes (Same as predicate)
- Housing Materials and Construction	Thermoplastic (Same as predicate)
Output Specifications:
- Waveform (e.g., pulsed monophasic, biphasic)	Monophasic waveform that is delivered in a burst of pulses (Same as predicate)
- Shape (e.g., rectangular, spike, rectified sinusoidal)	Voltage Modulated Square (Same as predicate)
- Maximum Output Voltage	28 VDC (Same as predicate)
- Output Current when not stimulating	< 1 µA (Same as predicate)
- Output Tolerance	+/- 10% (Same as predicate)
- Pulse Width	60 ms (Same as predicate)
- Frequency (Hz)	Approximately 8.3 Hz (Same as predicate)
- For interferential modes	No Beat Frequency (Same as predicate)
- For multiphasic waveforms	Not Multiphasic (Same as predicate)
- Pulses per burst	20 (Same as predicate)
- Pulses per second	8.3 (Same as predicate)
- Burst duration (seconds)	2.4 s (Same as predicate)
- Duty Cycle [Line (b) x Line (c)] (on time per burst)	20.2 s (Same as predicate)
- ON Time (seconds)	60 msec (Same as predicate)
- OFF Time (seconds)	60 msec (Same as predicate)
Differences noted but deemed acceptable:
- Anatomic Sites (Intended Use)	Body (NuBODY) vs. Face (NuFACE Plus) - This is the primary intended use difference for which equivalence is sought.
- Number of Electrodes	4 Spheres (NuBODY) vs. 2 Spheres (NuFACE Plus)
- External Power Adapter	NuFACE 5-volt power adapter (NuBODY) vs. NuFACE 7-volt power adapter (NuFACE Plus)
- Maximum Output Current	900 µA @ 500Ω (NuBODY) vs. 400 µA @ 500Ω (NuFACE Plus)
- Maximum Output Current Density	0.468 mA/cm² (NuBODY) vs. 0.419 mA/cm² (NuFACE Plus)
- Net Charge (µC per pulse)	54 µC (NuBODY) vs. 24 µC (NuFACE Plus)
- Maximum Average Power Density (mW/cm²)	4.18 (NuBODY) vs. 1.12 (NuFACE Plus)
- Maximum Phase Charge (µC/Burst)	1.08 (NuBODY) vs. 0.48 (NuFACE Plus)
- Automatic Shut-Off	5 minutes (NuBODY) vs. 20 minutes (NuFACE Plus)
- Weight	Approximately 10-14 oz. (NuBODY) vs. 9 oz. (NuFACE Plus)
- Dimensions	Approximately 2.75" x 6.5" x 6.0" (NuBODY) vs. 2.8" x 5.1" x 1.3" (NuFACE Plus)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes bench testing for nonclinical performance and safety. It tests "a production equivalent of the NuBODY, and a commercial unit of the predicate."

Sample Size for Test Set: One "production equivalent" NuBODY device and one "commercial unit" of the NuFACE Plus predicate device were used for the performance testing.
Data Provenance: Not explicitly stated, but the testing would have been conducted by or for the manufacturer (Carol Cole Company/NuFACE) in the USA (Vista, CA is the address). This is non-clinical, prospective bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a microcurrent stimulator for cosmetic use, and the submission is a 510(k) based on substantial equivalence demonstrated through bench testing and compliance with recognized standards. There is no mention of clinical studies using human subjects or expert clinical panels to establish "ground truth" for the performance criteria in this document. The "ground truth" for this type of submission is typically derived from established engineering and safety standards and comparison to a predicate device's specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As described above, there was no clinical study involving human readers or assessment that would require an adjudication method. The evaluation was based on non-clinical bench testing against engineering specifications and predicate device characteristics.

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. This device is a transcutaneous electrical nerve stimulator for cosmetic purposes, not an AI-powered diagnostic device or a system designed to assist human readers. Therefore, an MRMC comparative effectiveness study or AI-related performance metrics are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical electronic device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) submission is primarily the technical specifications and safety standards as defined by regulatory bodies (e.g., FDA regulations, IEC standards) and demonstrated by the performance of the predicate device (NuFACE Plus). The "study" (bench testing) aims to confirm that the new device's technical output and safety parameters are comparable and compliant.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 31, 2017

Carol Cole Company dba NuFACE Donald Ellis Regulatory Affairs / Ouality Assurance Manager 1325 Sycamore Ave, Suite A Vista, California 92081

Re: K171588

Trade/Device Name: NuBODY 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: May 31, 2017 Received: May 31, 2017

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. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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) K171588

Device Name NuBODY Skin Toning Device

Indications for Use (Describe)

NuBODY Skin Toning Device is intended for body skin 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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Image /page/3/Picture/0 description: The image shows the logo for NuFace. The logo is in gray and features the brand name in a simple, sans-serif font. The "U" in NuFace has a horizontal line above it.

SECTION 5. 510(K) SUMMARY

DATE PREPARED: July 27, 2017

510(K) SUBMITTER/OWNER

Carol Cole Company 1325 Sycamore Ave, Suite A Vista, CA 92081, USA

CONTACT INFORMATION:

Donald Ellis, Requlatory Affairs/Quality Assurance Phone: (760) 509-1264 Facsimile: (760) 650-3667 DELLIS@mynuface.com Email:

DEVICE NAMES

Device Trade/ Proprietary Name: Device Common or Usual Name: Classification Name:

NuBODY Skin Toning Device NuBODY stimulator, transcutaneous electrical, aesthetic purposes 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:

510(k) Number:	K103472
Manufacturer:	Carol Cole Company dba NuFACE
Trade Name:	NuFACE® Plus
Product Code:	NFO

DEVICE DESCRIPTION

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NUFACE

1325 Sycamore Avenue, Suite A, Vista, CA 92081

INTENDED USE

NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.

Technological Characteristics

The proposed NuBODY device has the same, or similar, technological characteristics as the NuFACE Plus predicate device. The differences do not alter the clinical utility of our proposed NuBODY device relative to the cleared NuFACE Plus predicate device listed below.

NuBODY device is powered by a rechargeable, nonreplaceable, battery i) which uses a lithium ion chemistry.
Microcurrent is discharged through four (4) smooth, chrome-plated, ii) spherical electrodes.
iii) Comparable to the NuFACE Plus predicate device, the NuBODY device generates continuous alternating microcurrent delivered in a burst of positive pulses followed by a burst of negative pulses.

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Image /page/5/Picture/0 description: The image shows the word "NUFACE" in a sans-serif font. The letters are gray and evenly spaced. There is a horizontal line above the "U" in "NUFACE", and a small circle above and to the right of the "E".

Predicate Comparison

Table1: General Comparison Table

DEVICE DESCRIPTIONS	NuBODY(NEW DEVICE)	NuFACE Plus Device(PREDICATE)
1. 510(k) Number	K171588	K103472
2. Regulation Number	21 C.F.R. § 882.5890	21 C.F.R. § 882.5890
3. Regulation Name	Transcutaneous electrical nerve stimulator for pain relief	Transcutaneous electrical nerve stimulator for pain relief
4. Regulatory Class	Class II	Class II
5. Device Classification Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Stimulator, Transcutaneous Electrical, Aesthetic Purposes
6. Product Code	NFO	NFO
7. Regulation Medical Specialty	Neurology	Neurology
8. Intended Use	NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.	NuFACE Plus Facial Toning Device is intended for facial stimulation and is indicated for over the counter cosmetic use.
9. Indications for Use	Over-the-Counter Cosmetic Use	Over-the-Counter Cosmetic Use
10. Anatomic Sites	Areas of the body other than the face	Face
11. Technological Characteristics	The NuBODY Skin Toning Device is a body skin toning device. Its outer case is injection molded thermoplastic resin. The output contacts consist of chrome-plated spherical electrodes. The NuBODY device is powered by a rechargeable lithium ion battery. NuBODY device produces microcurrent that is discharged through four fixed, smooth spherical	The NuFACE Plus is a facial toning device. Its outer case is injection molded thermoplastic resin. The output contacts consist of chrome-plated spheres. The device is powered by a rechargeable lithium ion battery and produces a microcurrent that is discharged through two fixed, smooth electrode spheres. To turn the device on the on/off
DEVICE DESCRIPTIONS	NuBODY(NEW DEVICE)	NUFACE PLUS DEVICE(PREDICATE)
	electrodes. To turn theNuBODY device on, theon/off button is pressed.Ascending tonal beepsindicate the NuBODY deviceis on. One to three LED lightsilluminate indicating theoutput intensity level and theunit is ready for use. The fourspheres gently glide over theskin to deliver low-levelelectrical impulses totargeted locations on thebody. The NuBODY devicespheres are designed foroptimal contact with bodyskin. The NuBODY devicedelivers microcurrent as aconstant monophasicsquare wave comprised of aburst of (10) positive pulsesfollowed by a burst of (10)negative pulses. Themicrocurrent outputcontinuously alternatesbetween the positive andnegative sphericalelectrodes, and allows theuser to adjust the output fora personalized comfort level.The NuBODY device requiresthe use of a conductive gel.To promote proper use andprovide feedback to theuser, the NuBODY devicebeeps to cue the user torelocate the NuBODY deviceapproximately every 5seconds.	button is pressed.Ascending tonal beepsindicate the device is on.One to five red LED lightsilluminate indicating theoutput intensity level andthe unit is ready for use.Users then follow theinstructions for use. Thetwo spheres gently glideover the skin to deliverlow-level electricalimpulses to targetedlocations on the face. TheNuFACE Plus spheres aredesigned for optimalcontact with the face.The NuFACE Plus devicedelivers microcurrent as aconstant monophasicsquare wave comprisedof a burst of (10) positivepulses followed by a burstof (10) negative pulses.The microcurrent outputcontinuously alternatesbetween the positive andnegative electrodespheres, and allows theuser to adjust the outputfor a personalized comfortlevel. The NuFACE Plusdevice requires the use ofa conductive gel. Topromote proper use andprovide feedback to theuser, the NuFACE Plusbeeps to cue the user torelocate the deviceapproximately every 5seconds.
BASIC UNITCHARACTERISTICS	NuBODY(NEW DEVICE)	NuFACE Plus Device(PREDICATE)
1. 510(k) Number	K171588	K103472
2. Device Name,Model	NuBODY Skin ToningDevice	NuFACE Plus FacialToning Device
3. Manufacturer	Carol Cole Company(dba NuFACE)	Carol Cole Company(dba NuFACE)
4. Power Source(s)	Internal rechargeableLithium ion battery	Internal rechargeableLithium ion battery
a. Method ofLine CurrentIsolation	Type BF	Type BF
b. PatientLeakageCurrent
1). Normalcondition	N/A - Batteryoperated	N/A - Batteryoperated
2). Singlefaultcondition	N/A - Batteryoperated	N/A - Batteryoperated
5. External poweradapter	NuFACE 5-volt poweradapter	NuFACE 7-volt poweradapter
6. Number ofOutputChannels	1	1
a. Synchronousor Alternating	N/A - 1 Outputchannel	N/A - 1 Outputchannel
b. Method ofChannelIsolation	N/A - 1 Outputchannel	N/A - 1 Outputchannel
7. RegulatedCurrent orRegulatedVoltage	Both	Both
8. Software/Firmware/MicroprocessorControl	Yes	Yes
9. AutomaticOverload Trip	Not required due tocircuit design	Not required due tocircuit design
BASIC UNITCHARACTERISTICS	NuBODY(NEW DEVICE)	NUFACE PLUS DEVICE(PREDICATE)
10. Automatic No-Load Trip	Yes	Yes
11. Automatic ShutOff	Yes	Yes
12. PatientOverrideControl	Yes	Yes
13. IndicatorDisplay
a. On/OffStatus	Yes	Yes
b. Low Battery	Yes	Yes
c. Voltage/Current Level	Yes	Yes
14. AutomaticShut-Off(minutes)	Yes (5 minutes)	Yes (20 minutes)
15. Compliancewith VoluntaryStandards	IEC 60601-1IEC 60601-1-2IEC 60529IEC 60601-2-10ISO 14971IEC 60601-1-6IEC 62366	IEC 60601-1IEC 60601-1-2
16. Compliancewith 21 CFR 898	Yes	Yes
17. Weight	Approximately 10-14oz. without poweradapter	9 oz. withoutcharging base
18. Dimensions ofdevice(inch) [Wx L x D]	Approximately 2.75" x6.5" x 6.0"	2.8" x 5.1" x 1.3"
19. HousingMaterials andConstruction	Thermoplastic	Thermoplastic
OUTPUT SPECIFICATIONS	NuBODY(NEW DEVICE)	NuFACE Plus DEVICE(PREDICATE)
1. 510(k) Number	K171588	K103472
2. Waveform (e.g.,pulsedmonophasic,biphasic)	Monophasicwaveform that isdelivered in a burst ofpulses	Monophasicwaveform that isdelivered in a burstof pulses
3. Shape (e.g.,rectangular,spike, rectifiedsinusoidal)	Voltage ModulatedSquare	Voltage ModulatedSquare
4. MaximumOutput Voltage	28 VDC	28 VDC
5. MaximumOutput Current	900 μA @ 500Ω	400 μA @ 500Ω
6. MaximumOutput CurrentDensity	0.468 mA/cm²	0.419 mA/cm²
7. Output Currentwhen notstimulating	< 1 µA	< 1 µA
8. OutputTolerance	+/- 10%	+/- 10%
9. Pulse Width	60 ms	60 ms
10. Frequency (Hz)	Approximately 8.3 Hz	Approximately 8.3 Hz
11. For interferentialmodes, only
a. BeatFrequency(Hz)	No Beat Frequency	No Beat Frequency
12. For multiphasicwaveforms, only
a. Symmetricalphases	Not Multiphasic	Not Multiphasic
b. Phase Duration(include units)c. (staterange, ifapplicable)d. (both	Not Multiphasic	Not Multiphasic
OUTPUT SPECIFICATIONS	NuBODY(NEW DEVICE)	NUFACE PLUS DEVICE(PREDICATE)
phases, ifasymmetrical)
13. Net Charge (µCper pulse)	54 µC	24 µC
14. Burst Mode (i.e.,pulse trains)
a. Pulses perburst	20	20
b. Pulses persecond	8.3	8.3
c. Burst duration(seconds)	2.4 s	2.4 s
d. Duty Cycle[Line (b) x Line(c)] (on timeper burst)	20.2 s	20.2 s
15. ON Time(seconds)	60 msec	60 msec
16. OFF Time(seconds)	60 msec	60 msec
17. MaximumAverage PowerDensity(mW/cm²)	4.18	1.12
18. Maximum PhaseCharge(µC/Burst)	1.08	0.48

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NUFACE

Table 2: Basic Unit Characteristic Comparison

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Table 3: Output Specification Comparison Table

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Bench Testing

Nonclinical testing was performed to demonstrate that the NuBODY product met design specifications and is substantially equivalent to the NuFACE Plus predicate device. This performance testing was conducted using a production equivalent of the NuBODY, and a commercial unit of the predicate. The testing consisted of the evaluation of Output Waveform Characteristics and Output Energy Characteristics.

Additionally, Product Safety and EMC testing of the NuBODY was conducted in accordance with IEC 60601-1 and IEC 60601-1-2. The NuBODY device conformed to ANSI/AAMI ES60601-1: 2005 / A2:2010 for Electrical and

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NUFACE

Constructional Safety and to IEC 60601-1-2 for Electromagnetic Compatibility (EMC) and IEC 60601-2-10.

All nonclinical test results for Output Waveform, Output Energy, Electrical and Constructional Safety and EMC confirm the NuBODY device is substantially equivalent to the NuFACE Plus predicate device.

Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR part 807 and based on all relative information provided in this premarket notification, we conclude the NuBODY Skin Toning Device is substantially equivalent to the NuFACE Plus predicate device with regards to safety and effectiveness.

Regulation Number and Section

§ 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).