(103 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on electrical impulses (microcurrent) delivered via electrodes, with no mention of data processing or learning algorithms.
No.
The device is indicated for over-the-counter cosmetic use for facial stimulation, not for treating any medical condition or disease.
No
Explanation: The device is intended for facial stimulation and cosmetic use, not for diagnosing medical conditions.
No
The device description explicitly states it has "Two (2) spherical electrodes, fixed on the NuFACE FIX device main face, deliver low level electrical impulses". This indicates a hardware component is integral to the device's function.
Based on the provided information, the NuFACE FIX™ Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "facial stimulation" for "over-the-counter cosmetic use." This clearly indicates a cosmetic purpose applied externally to the body, not for testing samples of human origin (like blood, urine, or tissue) to diagnose or monitor a medical condition.
- Device Description: The description details the delivery of electrical impulses to the face for stimulation, which aligns with a cosmetic or therapeutic device, not an IVD.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the NuFACE FIX™ Device falls under the category of a cosmetic or potentially a low-risk therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The NuFACE FIX™ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
Product codes
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination.
- ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY (EMC) tests according to IEC 60601-1-2: 2014-02, IEC 60601-1-6: 2010 + AMD1:2013 TRF, IEC 60601-2-10: 2012, IEC 60601-1-11 2015/01/20 Ed. 2, IEC 60601-1:2005Ed.3+A1, ANSI/AMI ES60601-1:2005/(R)2012, CAN/CSA-C22.2 No. 60601-1:2014-03.
- INGRESS PROTECTION test according to EC 60529.
- USABILITY ENGINEERING test according to IEC 62366:2007Ed.1+A1.
- BATTERY TESTING according to IEC 62133 Edition 2.0 2012-12 and EN 62133: 2013.
- SOFTWARE VERIFICATION AND VALIDATION TESTING according to IEC 62304:2006 Ed. 1 +A1 and ISO 14971. Human factors testing was conducted in accordance with IEC 60601-1-6, ISO 62366 and the FDA guidance on human factors engineering. A prospective Usability Study was conducted.
- BIOCOMPATIBILITY TESTING: Not needed because materials and manufacturing processes are not significantly different from the predicate.
- ANIMAL STUDY: Not required.
- CLINICAL STUDIES: Not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 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
1
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
2
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)
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 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.
4
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) .
5
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.
6
PREDICATE COMPARISON
| Device Descriptions | NUFACE® FIX DEVICE
(NEW DEVICE) | NUFACE® TRINITY ELE
DEVICE (PREDICATE) | SAME OR DIFFERENT
TECHNOLOGICAL
CHARACTERISTICS |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| 1. 510(k) Number | K182424 | K131251 | |
| 2. Regulation
Number | 21 C.F.R. §
882.5890 | 21 C.F.R. § 882.5890 | Same |
| 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 FIX Device
is intended for
facial stimulation
and is indicated
for over-the-
counter cosmetic
use. | NuFACE Trinity ELE is
intended for facial
stimulation and is
indicated for over-
the-counter
cosmetic use | Same |
| 9. Indications for
Use | Over-the-Counter
Cosmetic Use | Over-the-Counter
Cosmetic Use | Same |
| 10. Anatomic Sites | Face | Face | Same |
| 11. Technological
Characteristics | The NuFACE FIX is
an over-the-
counter facial
stimulation device.
Its outer case is
injection molded
thermoplastic
resin. The output
contacts consist of
chrome-plated
spherical | The NuFACE Trinity
ELE is an over-the-
counter facial
stimulation device.
Its outer case is
injection molded
thermoplastic resin.
The output
contacts consist of
chrome-plated
spheres. The | Same |
| Device Descriptions | NUFACE® FIX DEVICE
(NEW DEVICE) | NUFACE® TRINITY ELE
DEVICE (PREDICATE) | SAME OR DIFFERENT
TECHNOLOGICAL
CHARACTERISTICS |
| | electrodes. The
NUFACE FIX device
is powered by a
rechargeable
lithium ion battery.
NUFACE FIX device
produces | device is powered
by a rechargeable
lithium ion battery
and produces a
microcurrent that is
discharged through
two fixed, smooth | |
| | microcurrent that
is discharged
through two fixed,
smooth spherical
electrodes. To turn
the NUFACE FIX | electrode spheres.
To turn the device
on, the on/off
button is pressed.
Ascending tonal
beeps indicate the | |
| | device on, the
on/off button is
pressed. The two
spheres gently
glide over the skin | device is on. One
to five red LED lights
illuminate
indicating the
output intensity | |
| | to deliver low-level
electrical impulses
to targeted
locations on the
face. The NuFACE | level and the unit is
ready for use. Users
then follow the
instructions for use.
The two spheres | |
| | FIX device spheres
are designed for
optimal contact
with facial skin.
The NuFACE FIX
device delivers | gently glide over
the skin to deliver
low-level electrical
impulses to
targeted locations
on the face. | |
| | microcurrent as a
constant biphasic
square wave
comprised of (10) | NUFACE Trinity ELE
spheres are
designed for
optimal contact | |
| | positive pulses
followed by (10)
negative pulses.
The microcurrent
output | with the face. The
NUFACE Trinity ELE
delivers
microcurrent as a
constant biphasic | |
| | continuously
alternates
between the | square wave
comprising a (10)
positive pulses | |
| Device Descriptions | NuFACE® FIX DEVICE
(NEW DEVICE) | NuFACE® TRINITY ELE
DEVICE (PREDICATE) | SAME OR DIFFERENT
TECHNOLOGICAL
CHARACTERISTICS |
| | positive and
negative spherical
electrodes.
The NuFACE FIX
device requires
the use of a
conductive gel.
To promote proper
use and provide
feedback to the
user, the NuFACE
FIX Device
increases tactile
feedback to cue
the user to
relocate the
NuFACE FIX device
approximately
every 5 seconds. | 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 ELE
requires the use of
a conductive gel.
To promote proper
use and provide
feedback to the
user, the NuFACE
Trinity ELE beeps to
cue the user to
relocate the
device
approximately
every 5 seconds. | |
| Basic Unit
Characteristics | NUFACE® FIX DEVICE
(NEW DEVICE) | NUFACE® TRINITY
ELE DEVICE
(PREDICATE) | SAME OR DIFFERENT
TECHNOLOGICAL
CHARACTERISTIC |
| 1. 510(k) Number | K182424 | K131251 | |
| 2. Device Name,
Model | NUFACE FIX Device | NUFACE Trinity ELE
Device | |
| 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
(updated in
K181008) | 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 | User supplied
standard 5-volt USB
port | 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/Firmware/
Microprocessor
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 |
| Basic Unit
Characteristics | NUFACE® FIX DEVICE
(NEW DEVICE) | NUFACE® TRINITY
ELE DEVICE
(PREDICATE) | SAME OR DIFFERENT
TECHNOLOGICAL
CHARACTERISTIC |
| 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/Current
Level | Yes | Yes | Same |
| 14. Automatic Shut-Off
(minutes) | Yes (3 minutes) | Yes (20 minutes) | Different |
| 15. 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
IEC 60601-1-11
ANSI/AMI ES60601-1
CAN/CSA-C22.2 No.
60601-1
IEC 62133 | IEC 60601-1
IEC 60601-1-2 | Same |
| 16. Compliance with
21 CFR 898 | Yes | Yes | Same |
| 17. Weight | Approximately 2 oz. | 9 oz. without
charging base | Different |
| 18. Dimensions of
device(inch)
[WxLxD] | Approximately 5.7" x
0.82" | 2.8" x 5.1" x 1.3" | Different |
| 19. Housing Materials
and Construction | Thermoplastic | Thermoplastic | Same |
Table 1: General Comparison Table
7
8
9
Table 2: Basic Unit Characteristic Comparison
10
Table 3: Output Specification Comparison Table
| OUTPUT SPECIFICATIONS | NuFACE FIX
New DEVICE | NuFACE TRINITY + ELE
DEVICE
(PREDICATE) | SAME OR
DIFFERENT
TECHNOLOGICAL
CHARACTERISTIC |
|-----------------------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------------------------|---------------------------------------------------------|
| 1. 510(k) Number | K182424 | K131251 | |
| 2. Waveform (e.g.,
pulsed
monophasic, | Pulsed Biphasic | Pulsed Biphasic | Same |
| OUTPUT SPECIFICATIONS | NUFACE FIX
NEW DEVICE | NUFACE TRINITY + ELE
DEVICE
(PREDICATE) | SAME OR
DIFFERENT
TECHNOLOGICAL
CHARACTERISTIC |
| biphasic) | | | |
| 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 | 200 μΑ @ 500Ω | 208 μΑ @ 500Ω | Same |
| 6. Maximum Output
Current Density | 0.418 μΑ/cm² | 0.800 μΑ/cm² | Same |
| 7. Output Current
when not
stimulating |