(177 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as identical to its predicate with unchanged technological characteristics, focusing on microcurrent discharge.
No
The device is indicated for "over-the-counter cosmetic use" for "facial and neck stimulation," which does not constitute a therapeutic purpose.
No
The device is described as being for "facial and neck stimulation" and "cosmetic use," with no mention of diagnosing a disease or condition. Its intended use is to produce "microcurrent discharged through the two spherical probes," which is a therapeutic or cosmetic action, not a diagnostic one.
No
The device description explicitly states it produces microcurrent discharged through two spherical probes, indicating a hardware component that delivers energy.
Based on the provided information, the NuFACE Trinity device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "facial and neck stimulation" for "over-the-counter cosmetic use." This clearly describes a device used on the body for cosmetic purposes, not for testing samples of human origin (like blood, urine, or tissue) outside the body to diagnose or monitor a medical condition.
- Device Description: The description focuses on "skin stimulation" using "microcurrent discharged through the two spherical probes." This aligns with a device for external application to the skin.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases.
- Using reagents or calibrators.
The information provided strongly indicates that the NuFACE Trinity is a cosmetic or aesthetic device used externally on the body.
N/A
Intended Use / Indications for Use
The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.
Product codes
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.
The NuFACE Trinity 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 button is pressed. Ascending tonal beeps indicate the device is on. One to five red LED lights illuminate indicating the output intensity level and the unit is ready for use. Users then follow the instructions for use. The two spheres gently glide over the skin to deliver low-level electrical impulses to targeted locations. The NuFACE Trinity spheres are designed for optimal contact with the skin. The NuFACE Trinity Device delivers microcurrent as a constant biphasic square wave comprising a (10) positive pulses followed by (10) negative pulses. The microcurrent output continuously alternates between the positive and negative electrode spheres, and allows the user to adjust the output for a personalized comfort level. The NuFACE Trinity Device requires the use of a conductive gel. To promote proper use and provide feedback to the user, the NuFACE Trinity Device beeps to cue the user to relocate the device approximately every 5 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial and neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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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 OR
DIFFERENT | |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------|
| 1. 510(k) Number | K181008 | K103472 | | |
| 2. Regulation
Number | 21 C.F.R. § 882.5890 | 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 | Same | |
| 4. Regulatory Class | Class II | Class II | Same | |
| 5. Device
Classification
Name | Stimulator,
Transcutaneous
Electrical, Aesthetic
Purposes | Stimulator,
Transcutaneous
Electrical, Aesthetic
Purposes | Same | |
| 6. Product Code | NFO | NFO | Same | |
| 7. Regulation
Medical
Specialty | Neurology | Neurology | Same | |
| 8. Intended Use | NuFACE Trinity Device is
intended for facial and
neck skin stimulation and
is indicated for over-the-
counter cosmetic use. | NuFACE Plus is
intended for facial
stimulation and is
indicated for over-
the-counter cosmetic
use. | Different | |
| 9. Indications for
Use | Over-the-Counter
Cosmetic Use | Over-the-Counter
Cosmetic Use | Same | |
| 10. Anatomic Sites | Face and Neck | Face | Different | |
| 11. Technological
Characteristics | The NuFACE Trinity
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
button is pressed.
Ascending tonal beeps
indicate the device is
on. One to five red LED
lights illuminate
indicating the output
intensity level and the
unit is ready for use.
Users then follow the
instructions for use. The
two spheres gently glide
over the skin to deliver
low-level electrical
impulses to targeted
locations. The NuFACE
Trinity spheres are
designed for optimal
contact with the skin.
The NuFACE Trinity
Device delivers
microcurrent as a
constant biphasic | 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 button is
pressed. Ascending
tonal beeps indicate
the device is on. One
to five red LED lights
illuminate indicating
the output intensity
level and the unit is
ready for use. Users
then follow the
instructions for use.
The two spheres
gently glide over the
skin to deliver low-
level electrical
impulses to targeted
locations. The
NuFACE Plus spheres
are designed for
optimal contact with | Same | |
| | | | | |
| BASIC UNIT
CHARACTERISTICS | square wave comprising
a (10) positive pulses
followed by (10)
negative pulses. The
microcurrent output
continuously alternates
between the positive
and negative electrode
spheres, and allows the
user to adjust the output
for a personalized
comfort level. The
NuFACE Trinity Device
requires the use of a
conductive gel. To
promote proper use and
provide feedback to the
user, the NuFACE Trinity
Device beeps to cue the
user to relocate the
device approximately
every 5 seconds. | the skin. The NuFACE
Plus device delivers
microcurrent as a
constant biphasic
square wave
comprising a (10)
positive pulses
followed by (10)
negative pulses. The
microcurrent output
continuously
alternates between
the positive and
negative electrode
spheres, and allows
the user to adjust the
output for a
personalized comfort
level. The NuFACE
Plus device requires
the use of a
conductive gel. To
promote proper use
and provide
feedback to the user,
the NuFACE Plus
beeps to cue the user
to relocate the
device approximately
every 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 rechargeable
Lithium ion battery | Internal rechargeable
Lithium ion battery | Same | |
| a. Method of
Line Current
Isolation | Type BF | Type BF | Same | |
| b. Patient
Leakage
Current | | | | |
| 1). Normal
condition | N/A - Battery operated | N/A - Battery operated | Same | |
| 2). Single
fault condition | N/A - Battery operated | N/A - Battery operated | Same | |
| 5. External power
adapter | NuFACE 7-volt power
adapter | NuFACE 7-volt power
adapter | Same | |
| 6. Number of
Output
Channels | 1 | 1 | Same | |
| a. Synchronous
or Alternating | N/A - 1 Output channel | N/A - 1 Output channel | Same | |
| b. Method of
Channel
Isolation | N/A - 1 Output channel | N/A - 1 Output channel | Same | |
| 7. Regulated
Current or
Regulated
Voltage | Both | Both | Same | |
| 8. Software/Firmwa
re/Microproces
sor Control | Yes | Yes | Same | |
| 9. Automatic
Overload Trip | Not required due to
circuit design | Not required due to
circuit design | Same | |
| 10. Automatic No-
Load Trip | Yes | Yes | Same | |
| 11. Automatic Shut
Off | Yes | Yes | Same | |
| 12. Patient
Override
Control | Yes | Yes | Same | |
| 13. Indicator
Display | | | | |
| a. On/Off
Status | Yes | Yes | Same | |
| b. Low Battery | Yes | Yes | Same | |
| | c. Voltage/Curr
ent Level | Yes | Yes | Same |
| | 14. Automatic
Shut-Off
(minutes) | Yes (20 minutes) | Yes (20 minutes) | Same |
| | 15. Compliance
with Voluntary
Standards | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 | Same |
| | 16. Compliance
with 21 CFR 898 | Yes | Yes | Same |
| | 17. Weight | 9 oz. without charging
base | 9 oz. without charging
base | Same |
| | 18. Dimensions of
device(inch)
[W x L x D] | 2.8" x 5.1" x 1.3" | 2.8" x 5.1" x 1.3" | Same |
| | 19. Housing
Materials and
Construction | Thermoplastic | Thermoplastic | Same |
| | OUTPUT
SPECIFICATIONS | | | |
| | | | K103472 | Unknown |
| 1. | 510(k) Number | | | |
| 2. | Waveform (e.g.,
pulsed
monophasic,
biphasic) | Pulsed Biphasic | Pulsed Biphasic | Same |
| 3. | Shape (e.g.,
rectangular,
spike, rectified
sinusoidal) | Modulated Square | Modulated Square | Same |
| 4. | Maximum
Output Voltage | 28 VDC | 28 VDC | Same |
| 5. | Maximum
Output Current | 400 μA @ 500Ω | 400 μA @ 500Ω | Same |
| 6. | Maximum
Output Current
Density | 0.419 mA/cm2 | 0.419 mA/cm2 | Same |
| Output
8.
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 interferential
modes, only | | | | |
| 12. Beat Frequency
(Hz) | No Beat Frequency | No Beat Frequency | Same | |
| 13. For multiphasic
waveforms, only | | | | |
| 14. Symmetrical
phases | Not Multiphasic | Not Multiphasic | Same | |
| 15. Phase Duration
(include units) | Not Multiphasic | Not Multiphasic | Same | |
| 16. Net Charge (µC
per pulse) | N/A - Battery operated | N/A - Battery
operated | Same | |
| 17. Burst Mode (i.e.,
pulse trains) | | | | |
| a. Pulses per burst | 20 | 20 | Same | |
| b. Pulses per
second | 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 per
burst) | 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.