(317 days)
The Nutra Face LIFT Model PE8050 device is intended for facial stimulation and indicated for over-the-counter cosmetic use.
The Nutra Face Lift is a hand-held device intended to apply low level electrical impulses to strategic locations on the face. The Nutra Face Lift probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings from 0 to 400 microamps for personalized comfort level by pressing the up/down button. The Nutra Face Lift requires the use of a conductive derma gel.
The Nutra Face Lift unit contains a power supply and internal Ni-MH rechargeable battery. The enclosure is made of medical grade biocompatibility plastics and the output contacts (Probes) consist of chrome-plated spheres. The on/off button on the unit directly allows the user to immediately remove all power from the unit.
The provided document, a 510(k) summary for the "Nutra Face LIFT Model PE8050", primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about the acceptance criteria for a specific performance study in the way a clinical trial might, nor does it present the study for proving those criteria.
However, it does describe a "Usability and Product Self Selection Study" and states that "All four goals of the Study were met." This implies that the 'acceptance criteria' for this specific study were the successful achievement of these stated goals. The document also mentions nonclinical performance data related to compliance with FDA performance standards and electrical safety.
Here's an analysis based on the provided text, addressing your questions where possible:
Description of Acceptance Criteria and Study
The primary study mentioned, the "Usability and Product Self Selection Study," had four goals that served as its acceptance criteria. The document states that all four goals were met, thereby proving the device met these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Goals) | Reported Device Performance |
|---|---|
| 1. To attract participants that represented the "intended users" of the device. | Met |
| 2. To determine if consumers could correctly self-select using the Packaging labeling only. | Met |
| 3. To test consumer knowledge of the Packaging labeling and Instruction Manual. | Met |
| 4. To have consumers demonstrate their ability to adhere to what they had read in the Instruction Manual and actually operate and care for the device correctly. | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 80 participants
- Data Provenance: Not explicitly stated, but the submission is to the US FDA, suggesting the study was likely conducted in the United States. The study is referred to as a "Usability and Product Self Selection Study," indicating a prospective design where data was collected specifically for this evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish a 'ground truth' in the context of this Usability and Product Self Selection Study. The study focused on consumer interaction, self-selection, and knowledge, not on expert medical evaluation of outcomes.
4. Adjudication Method for the Test Set
Not applicable for this type of self-selection and usability study. The criteria were based on participants' actions and knowledge, which would likely have been directly observed or assessed.
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
No, an MRMC comparative effectiveness study was not done. The device is a "Transcutaneous electrical nerve stimulator for pain relief" (classified as such, but indicated for "facial stimulation and is indicated for-over-the counter cosmetic use"), not an AI-powered diagnostic tool requiring human reader interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done
This is not applicable, as the device is a physical electrostimulation device for cosmetic use, not an algorithm. Its performance is evaluated through its physical and electrical characteristics, and user interaction.
7. The Type of Ground Truth Used
For the "Usability and Product Self Selection Study," the "ground truth" was essentially the observed behavior and stated understanding of the participants regarding the device's packaging and instruction manual, and their ability to operate the device correctly. This is a form of behavioral or self-reported data against pre-defined success metrics for usability and comprehension.
The document also mentions compliance with various engineering and electrical safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993) for which the "ground truth" would be the successful adherence to the requirements of these published technical standards, verified through objective laboratory testing.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2016
Nutra Luxe MD, LLC Gloria Avendano Regulatory Affairs Manager 12801 Commonwealth Dr. Units 2-6 Fort Myers, FL 33913
Re: K150826 Trade/Device Name: Nutra Face LIFT Model PE8050 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NFO Dated: January 4, 2016 Received: January 13, 2016
Dear Gloria Avendano:
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 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
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the quality systems (OS) 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 yours,
Michael J. Hoffmann -A
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) K150826
Device Name Nutra Face LIFT Model PE8050
Indications for Use (Describe)
The Nutra Face LIFT Model PE8050 device is intended for facial stimulation and 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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FDA 510K Summary
The Nutra Face LIFT
1. General Information
Submitter:
Nutra Luxe MD, LLC 12801 Commonwealth Dr. Units 2-6 Fort Myers, FL 33913
| Contact Person: | Gloria Avendano |
|---|---|
| Nutra Luxe MD | |
| 12801 Commonwealth Dr. Units 2-6 | |
| Fort Myers, FL 33913 | |
| gloria@nutraluxemd.com |
Summary Preparation Date:
February 9, 2016.
2. Device Name
| Trade Name: | Nutra Face Lift Model PE8050 |
|---|---|
| Common Name: | Facial Toning Device |
| Classification Name: | Transcutaneous electrical nerve stimulator 21 CFR 882.5890 |
| Product Code: | NFO |
3. Predicate Device
The Nutra Face Lift is substantially equivalent to the NuFace Facial Toning Device K072260
4. Device Description
The Nutra Face Lift is a hand-held device intended to apply low level electrical impulses to strategic locations on the face. The Nutra Face Lift probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings from 0 to 400 microamps for personalized comfort level by pressing the up/down button. The Nutra Face Lift requires the use of a conductive derma gel.
The Nutra Face Lift unit contains a power supply and internal Ni-MH rechargeable battery. The enclosure is made of medical grade biocompatility plastics and the output contacts (Probes) consist of chrome-plated spheres. The on/off button on the unit directly allows the user to immediately remove all power from the unit.
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Image /page/4/Picture/0 description: The image shows the words "nutra luxe MD" with a flower in between the words "nutra" and "luxe". The word "nutra" is in black, the flower is in black, and the words "luxe MD" are in pink. The words and flower are reflected below.
5. Intended Use and Indications:
The Nutra Face Lift device is ntended for facial stimulation and is indicated for-over-the counter cosmetic use.
Substantial Equivalency & Comparison of Technological Similarities and Differences 6.
The Nutra Face Lift is as safe and effective as the predicate device. The Nutra Face Lift has the same indications, as the predicate device.
The Nutra Face Lift is substantially equivalent in technological characteristics to the predicate device, including the positive and negative probes. The device powered by a 5V-500Ma AC/DC charger, produces microcurrent that is discharged through the two fixed, smooth probes.
The Nutra Face Lift has the following similarities to the NuFace
-
- Has the same indicated use
- Uses the same operating principle 2.
-
- Incorporates similar materials.
- Utilizes a same treatment duration (i.e. 5 seconds per step, repeat each step 3 times) 4.
- Utilizes a similar treatment regimen (i.e. 5 times a week for 90 days) న్.
One of the differences between the Nutra Face Lift and its predicate device is the predicate device uses a thumbwheel to adjust the desired intensity while the Nutra Face Lift uses an up/down button.
Any differences between The Nutra Face Lift and the predicates device are not significant to its safety or effectiveness for its intended use.
Section 1: Device Descriptions
| Elements of Comparison | Nutra Face Lift | Predicate Device |
|---|---|---|
| 510(k) Number | K150826 | K072260 |
| Regulation Number | 21 C.F.R 882.5890 | 21 C.F.R 882.5890 |
| Regulation Name | Transcutaneous Electrical NerveStimulator | Transcutaneous Electrical NerveStimulator |
| Regulatory Class | Class II | Class II |
| Product Code | NFO | NFO |
| Intended use | Stimulate the face; skin toning | Stimulate the face; skin toning |
| Indications for Use | Intended for facial stimulation and isindicated for-over-the countercosmetic use. | Intended for facial stimulationand is indicated for-over-the countercosmetic use. |
| Technological Characteristics | The Nutra Face Lift is a hand-helddevice intended to apply low levelelectrical impulses to strategic locationson the face. The Nutra Face Lift probesare designed for optimal contact withthe face. | NuFace® is a Facial Toning Deviceintended for facial stimulation. Thedevice measures 7" L x 2.5" W x 1"D. Its outer case is injection molded ofthermoplastic resin, ABS UL 94 HB,and the output contacts (probes)consist of chrome-plated spheres. The |
| The device continually alternatesbetween the positive and negativeprobes and allows the user to adjust thesettings from 0 to 400 microamps forpersonalized comfort level by pressingthe up/down button. The Nutra FaceLift requires the use of a conductivederma gel. | device, powered by a 9-volt battery,produces microcurrent that isDischarged through the two fixed,smooth spherical probes. To turn thedevice on, the thumbwheel is pushedupwards. A Green LED light willThen illuminate, indicating the unit isready for use. Users then follow theinstructions for use. The two probesgently glide over the skin to deliverlow-level electrical impulses tostrategic locations on the face. | |
| Power Source | One 3.6 V battery | One 8V Battery |
| Number of output modules | 1 | 1 |
| Number of output channels | 1 output channel | 1 output channel |
| Regulated current or regulatedVoltage? | Both | Both |
| Software/Firmware/MicroprocessorControl? | Yes | Yes |
| Automatic Overload Trip? | No | No |
| Automatic Shut off? | No | No |
| Patient override control? | Yes | Yes |
| Indicator Display | Yes | No |
| Timer range | No Timer | No timer |
| Type of protection | Type BF | Type BF |
| Number of output modules | 1 | 1 |
| Number of output channels | 1 | 1 |
| Software/Firmware | No | No |
| On/off status | No | No |
| Standards Compliance | IEC 60601-1IEC 60601-1-2IEC 60601-2-1060601-1-11 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 |
| Biocompatibility | ISO 10993-5, -10 | ISO 10993-5, -10 |
| Waveform | Pulsed Monophasic | Pulsed Monophasic |
| Shape | Modulated Square | Rectangular Pulses |
| Maximum output voltage | 50Vpp (No load condition)8Vpp (10kΩ) | 158 Mv @ 500Ω780 Mv @ 2kΩ2.6 V @ 10kΩ |
| Maximum output current | +/- 400μA @ (10kΩ) | 223 μA @ 500 Ω |
| Output tolerance | +/- 10% | +/- 10% |
| Pulse Width | 60ms | 112 ms |
| Frequency (Hz) | 8.34 Hz | 8.39 Hz |
| Symmetrical phases | Not Multiphasic | Not Multiphasic |
| Phase duration | Not determined | Not determined |
| Net Charge (µC per pulsetrain) | 0 µC per pulsetrain | 0 µC per pulsetrain |
| Maximum Phase Charge (µC) | 18.13 µC @ 500 Ω | 18.13 µC @ 500 Ω |
| Maximum current Density(Ma/Cm²) | 0.341mA/cm² @ 500 Ω | 0.341mA/cm² @ 500 Ω |
| Maximum Power Density(μW/cm²) | 3.02μW/cm² @ 500 Ω | 3.02μW/cm² @ 500 Ω |
| Pulses per burst | 20 | 20 |
| Burst duration | 2.4 | 2.3 |
| ON Time (seconds) | Constant | Constant |
| OFF Time (Seconds) | None | None |
Nutra Face Lift and NuFace Original Comparison Table
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Section 2: Basic Characteristics
| 510(k) Number | K150826 | K072260 |
|---|---|---|
| Device Name, Model | Nutra Face Lift | NuFace® |
| Manufacturer | NutraLuxe MD | Carol Cole Company |
| Power Source(s) | 2.4 | 2.4 |
| ON Time (seconds) | Constant | Constant |
| OFF Time (Seconds) | None | None |
7. Clinical Performance Data
A Usability and Product Self Selection Study was conducted utilizing 80 participants: with the following four goals:
(1) To attract participants that represented the "intended users" of the device;
- (2) To determine if consumers could correctly self-select using the Packaging labeling only:
- (3) To test consumer knowledge of the Packaging labeling and Instruction Manual;
- (4) To have consumers demonstrate their ability to adhere to what they had read in the Instruction Manual and actually operate and care for the device correctly. All four goals of the Study were met.
Nonclinical Performance Data 8.
Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied for each are listed in Section 17.
The Nutra Face Lift device was tested and found to be in compliance with FDA's performance standards set forth in 21 C.F.R. §898.
The Nutra Face Lift was also tested and complies with Electrical Safety and EMC testing, which include the requirements of IEC 60601-1:2012 3rd Edition "Medical Electrical Equipment Part 1 - General Requirements for Safety" IEC 60601-1-2 "Medical Electrical Equipment Part 1-2, General Requirements for Safety - Collateral Standard Electromagnetic Compatibility Requirements and Tests IEC 60601-1-11 Home healthcare medical equipment and IEC 60601-2-10:2012 2nd Edition "Medical Electrical equipment -- part 2-10: particular requirements for the basic safety and essential performance of nerve and muscle stimulators. (Neurology). In addition, testing and analysis have demonstrated compliance of the plastic within ISO 10993 (Biocompatibility).
9. Regulatory Requirements
NutraLuxe MD manufactures under strict quality assurance guidelines and US FDA Good Manufacturing Practice (GMP)
Nutra Luxe MD is fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations (QSR), Risk Analysis and Risk Management files (RMF) conforms to ISO 14971,
Conclusion: Nutra Luxe MD, Inc. found The Nutra Face Lift device to be substantially equivalent to the legally marketed predicate devices.
§ 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).