(119 days)
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No
The document does not mention AI, ML, or any related concepts like training sets, test sets, or image processing, which are typically associated with AI/ML applications in medical devices. The description focuses on the device's hardware components and electrical stimulation capabilities.
No.
The device is indicated for "over-the-counter cosmetic use" and "facial stimulation," which are not considered therapeutic purposes. Furthermore, the absence of animal or clinical studies, with substantial equivalence based on performance specifications to a predicate device, indicates it's not intended for medical treatment.
No
The device is described as a "microcurrent stimulator for facial skin stimulation" intended for cosmetic use, and the performance studies focus on safety and technical specifications, not on diagnosing any medical conditions.
No
The device description explicitly details hardware components such as a main unit, USB power cable, housing made from Acrylonitrile Butadiene Styrene, chrome-plated spherical probes, and an integrated rechargeable lithium-ion battery. It also mentions electrical safety and EMC testing, which are related to hardware.
Based on the provided information, the NuFACE FIX+ Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "facial stimulation" and "over-the-counter cosmetic use." This clearly indicates a purpose related to cosmetic appearance and not the diagnosis of diseases or conditions.
- Device Description: The description focuses on the physical characteristics and function of a microcurrent stimulator for facial skin. There is no mention of analyzing biological samples (like blood, urine, or tissue) which is a core characteristic of IVD devices.
- Lack of IVD-related information: The document does not contain any information typically associated with IVD devices, such as:
- Analysis of biological samples.
- Detection or measurement of analytes.
- Diagnostic claims.
- Performance metrics like sensitivity, specificity, PPV, NPV, which are crucial for evaluating the accuracy of diagnostic tests.
In summary, the NuFACE FIX+ Device is a cosmetic device for facial stimulation, not a device used for in vitro diagnostic purposes.
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
- FIX+ is a portable hand-held microcurrent stimulator for facial skin stimulation indicated for over-the-counter cosmetic use.
- -Main components: Main unit, USB power cable, and NuFACE Line Smoothing FIX Serum conductivity gel.
- Housing of the device made from Acrylonitrile Butadiene Styrene, with chrome-plated spherical probes.
- Inclusion of three microcurrent output frequency levels. -
- Integrated rechargeable lithium-ion battery -
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
facial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter cosmetic use / home use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
a. Safety Testing: NūFACE® FIX+ device was tested and has demonstrated compliance with applicable IEC standards concerning electrical safety and EMC.
b. Common EM Emitters: The FIX+ was tested to all applicable clauses of the IEC 60601-1-2: Edition 4.1, IEC 60601-4-2 Edition 1.0, and IEC 55014-2:2021 standards. In addition, a Common Emitter evaluation, for some of the most common electromagnetic emitters a home user could encounter, was conducted per FDA guidance document "Electromagnetic Compatibility (EMC) of Medical Devices" (06/06/2022).
c. Bench Testing: Extensive bench testing was conducted to ensure the output waveform characteristics and the microcurrent output performance levels met the established product requirements within the designed tolerances. These tests are addressed in detail in the Performance Testing Section of this premarket notification. Performance bench testing was conducted using production equivalent devices of the NūFACE® FIX Plus device. The testing was comprised of: Output Waveform Characteristics, Output Energy Characteristics. Both internal performance bench testing and laboratory testing conducted concluded that the subject FIX+ device waveform and energy characteristics fall within their intended specifications and are substantially equivalent to the predicate device.
d. Software Verification and Validation Testing: Certification and validation testing for the subject device were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." All test requirements are considered as Passed and the user interface features, functions, and output of the FIX+ devices meet the specified design input criteria.
e. Animal Study and Clinical Studies: The provided documentation asserts that the determination of substantial equivalence for the device in question will not involve animal or clinical studies; hence, no such studies have been conducted to support this claim. Instead, a comparison of performance specifications with a predicate device will be used for the assessment.
f. Biocompatibility: The FIX+ device was evaluated for Biocompatibility as a Surface Device with contact with intact skin with a long-term contact duration of greater than 30 days.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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). On the left is the Department of Health & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 27, 2024
Carol Cole Company dba NuFACE® Robert Castro Director of Quality and Regulatory 1325 Sycamore Ave Suite A Vista, California 92081
Re: K240564
Trade/Device Name: NuFACE® FIX+ Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: April 15, 2024 Received: April 16, 2024
Dear Robert Castro:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices
2
OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
s for Use
Submission Number (if known)
Device Name
NuFACE® FIX+
Indications for Use (Describe)
The NuFACE FIX+ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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1. SUBMITTER
| Submitter: | Carol Cole Company dba NūFACE® |
|---|---|
| Address: | 1325 Sycamore Ave., Suite A Vista, CA 92081 |
| Phone: | 818-468-3752 |
| Fax: | 760-650-3037 |
| Email: | rcastro@nuface.com |
| Contact Person: | Robert C. Castro |
| Date Prepared: | April 15, 2024 |
2. DEVICE
| Name of Device: | NūFACE® FIX+ |
|---|---|
| Common or | |
| Usual Name: | FIX+ |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Regulation Number: | 21 CFR 882.5890 |
| Regulatory Class: | Class II |
| Product Code: | NFO |
3. PREDICATE DEVICE
| Name of Device: | NūFACE® FIX Skin Toning Device |
|---|---|
| 510(k) Number: | K182424 |
| This predicate device has not been subject to a design-related recall. |
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4. DEVICE DESCRIPTION
- FIX+ is a portable hand-held microcurrent stimulator for facial skin stimulation indicated for over-the-counter cosmetic use.
- -Main components: Main unit, USB power cable, and NuFACE Line Smoothing FIX Serum conductivity gel.
- Housing of the device made from Acrylonitrile Butadiene Styrene, with chrome-plated spherical probes.
- Inclusion of three microcurrent output frequency levels. -
- Integrated rechargeable lithium-ion battery -
5. INTENDED USE
The NuFACE® FIX+ Device is intended for facial stimulation.
6. INDICATIONS FOR USE
The NuFACE FIX+ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
7. DEVICE COMPONENTS
The following materials are expected to contact the user in normal use:
| Device
| Component | Composition |
|---|---|
| Two (x2) Spheres | Chromium plating |
| Handheld Unit | |
| Enclosure | Acrylonitrile Butadiene Styrene (ABS). |
8. ACCESSORIES
| Accessories | Description |
|---|---|
| FIX+ device | NūFACE® FIX+ |
| Power Cord | USB-to-DC Power cable (Charge only) |
| Conductivity Gel | NūFACE® Line Smoothing FIX Serum |
| Sizes: 2 fl. oz. or 5 fl. oz. | |
| To be applied before treatments |
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9. DESIGN AND TECHNOLOGICAL SPECIFICATIONS
FIX+ is based on the design of the established NūFACE® FIX Skin Toning Device (predicate device - K182424). The primary distinction from the predicate device involves a slight modification in the shape and dimensions of the device housing, the inclusion of three (3) adjustable microcurrent output frequencies, and an increased microcurrent output intensity.
10. TECHNOLOGICAL CHARACTERISTICS COMPARISON
| Technological Characteristics Comparison | ||
|---|---|---|
| Category | NUFACE FIX+ | |
| (SUBJECT DEVICE) | NUFACE FIX | |
| Line Smoothing Device (PREDICATE) | ||
| Type of Energy | ||
| Output | Microcurrent | Microcurrent |
| Energy Delivery | Microcurrent is delivered via two fixed, | |
| smooth spherical electrodes | Microcurrent is delivered via two fixed, | |
| smooth spherical electrodes | ||
| Energy Flow | Microcurrent continuously alternates | |
| between the positive and negative | ||
| electrode spheres | Microcurrent continuously alternates between | |
| the positive and negative electrode spheres | ||
| Energy Output | Constant biphasic square | |
| wave | Constant biphasic square | |
| wave | ||
| Energy Power | ||
| Source | Internal rechargeable battery | Internal rechargeable |
| battery | ||
| Battery Type | Lithium Ion | Lithium Ion |
| Charging | ||
| Circuitry | Internal to Device | Internal to Device |
| Charging Method | USB Power Cable | USB Power Cable |
| Waveform | Pulsed Biphasic | Pulsed Biphasic |
| Shape | Modulated Square | Modulated Square |
| Maximum Output | ||
| Voltage | 28 VDC | 28 VDC |
| Software | Yes | Yes |
| Firmware | Yes | Yes |
| Technological Characteristics Comparison | ||
| Category | NuFACE FIX+ | |
| (SUBJECT DEVICE) | NuFACE FIX | |
| Line Smoothing Device (PREDICATE) | ||
| Microprocessor Control | Yes | Yes |
| Output Frequency | Variable frequency | |
| ranging from 8.3 Hz to | ||
| 50.0 Hz | Approximately 8.3 Hz | |
| Range of Output Frequency (Hz) | Range of 2-50 Hz | 8.3 Hz |
| Wireless Technologies | None | None |
| Wireless Capability | None | None |
| Output Intensity (μA) | 225 μA | 200 μA |
| Maximum Output Current Density | 0.480 mA/cm2 | 0.418 mA/cm2 |
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510(k) SUMMARY NūFACE® FIX+
| Table 4: Performance Specifications Comparison | ||
|---|---|---|
| Category | NuFACE FIX+ | |
| (Subject Device) | NuFACE FIX Line Smoothing Device | |
| (Predicate) | ||
| Maximum Output | ||
| Current | 225 $ μ $ A @ 10000Ω | 208 $ μ $ A @ 500Ω |
| Output Current when | ||
| not stimulating | 30 day) repeated contact with human tissue. Biocompatibility evaluation endpoints were assessed in accordance with the "Evaluation of Endpoints for Consideration" detailed in Attachment A of the FDA's quidance document titled "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process." The FIX+ device was evaluated for Biocompatibility as a Surface Device with contact with intact skin with a long-term contact duration of greater than 30 days. |
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12. CONCLUSION
The NuFACE® FIX+ is found to be substantially equivalent to its predicate, the NūFACE® FIX Line Smoothing Device (K182424). This determination is based on the similarity in intended use, indications for use, and the majority of the technological characteristics between the two devices. Although there are some differences in output characteristics like pulse width and frequency range, these do not affect the devices' clinical efficacy or intended cosmetic functions. The detailed analysis provided in the Substantial Equivalence Section of the premarket notification confirms that the observed technological differences do not introduce new safety and effectiveness concerns.