(645 days)
The Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device is indicated for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.
Candidate device is a handheld, AA battery-operated portable device for use in the home or clinic. It has pre-set modes and is for over-the-counter use in the home or a clinical setting. The candidate device uses transcutaneous electrical stimulation (TENS) for aesthetic use for facial, neck, and body stimulation. The EZZI-LIFT device has built-in electrodes. Accessories, listed below, are also available to be used with the device.
The Avazzia OTC TENS for Aesthetics, model BEST-AV1: EZZI-LIFT Device did not have a clinical study that proves the device meets acceptance criteria for a specific clinical outcome. Instead, the device's substantial equivalence was established through non-clinical bench testing, performance testing, and a comparison of its technical characteristics to predicate devices.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal "acceptance criteria" table with specific quantitative thresholds for clinical performance. Instead, it demonstrates substantial equivalence by comparing the technical specifications of the candidate device (EZZI-LIFT) to its predicate devices (NuFACE Trinity and NuBODY Skin Toning Device) and by confirming compliance with relevant safety standards.
The comparison table provided in the document highlights the following characteristics:
| Characteristic | Units | Candidate (EZZI-LIFT) | Primary Predicate (NuFACE Trinity) | Secondary Predicate (NuBody) |
|---|---|---|---|---|
| Device Name | EZZI-LIFT | NuFACE Trinity | NuBody | |
| 510K | K191951 | K181008 | K171588 | |
| Manufacturer | Avazzia, Inc. | Carol Cole Company (dba NuFACE) | Carol Cole Company (dba NuFACE) | |
| Indications for Use | Over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation. | Facial and neck stimulation; over-the-counter cosmetic use. | Body skin stimulation; over-the-counter cosmetic use. | |
| Anatomic Sites | Face, neck, and body | Face and neck | Body | |
| Number of Output Modes | number | 4 | 1 | 1 |
| Low Battery Indicator | Yes | Yes | Yes | |
| Automatic shut off | (minutes) | 60 | 20 | 5 |
| Compliance with Voluntary Standards | Yes/No | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 62366 | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60529, ISO 14971, IEC 60601-1-6, IEC 62366 |
| Compliance with 21 CFR 898 | Yes / No | Yes | Yes | Yes |
| Weight | ounces | 5.4 | 9 | 10 to 14 |
| Dimensions [W x H x D] | (in.) | 2.6" X 4.7" X 1.35" | 2.8" x 5.1" x 1.3" | 2" x 6.5" x 6.0" |
| Housing Materials and Construction | PCBs inside plastic case housing | Thermoplastic | Thermoplastic | |
| User Interface Display | LEDs and switches | not publicly available | not publicly available | |
| Energy type | Electric stimulation | Electric stimulation | Electric stimulation | |
| Number, Size, and Type of Batteries | Two 1.5 V AA batteries | Internal rechargeable Lithium-ion battery | Internal rechargeable Lithium-ion battery | |
| Stimulation Output Specifications | ||||
| Waveform Shape | positive square wave followed by a damped sinusoidal waveform of variable duration | pulsed biphasic modulated square wave | monophasic voltage modulated square wave | |
| Max output voltage (+/- 20%) at 500 Ω | V | -42 | 28 | 28 |
| Max output voltage (+/- 20%) at 2,000 Ω | V | -122 | not publicly available | not publicly available |
| Max output voltage (+/- 20%) at 10,000 Ω | V | -348 | not publicly available | not publicly available |
| Max output current (+/-20%) at 500 Ω | μA | 363 | 400 | 900 |
| Max output current (+/-20%) at 2,000 Ω | μA | 117 | not publicly available | not publicly available |
| Max output current (+/-20%) at 10,000 Ω | μA | 38 | not publicly available | not publicly available |
| Duration of primary (depolarizing phase) | mSec | 0.5 | 60 | 60 |
| Pulse Duration | mSec | 1.1 | 60 | 60 |
| Frequency | Hz | 15 to 121 | 8.3 | 8.3 |
| Net Charge per pulse at 500 Ω | μC | 4 | not publicly available | 54 |
| Max phase charge | μC | 10 | not publicly available | not publicly available |
| Max current density at 500 Ω (Built-in, Y, Brush) | μΑ/cm² | 800 | 419 | 468 |
| Max current density at 500 Ω (Pencil) | μΑ/cm² | 19,000 | ||
| Max average power density at 500 Ω (Built-in, Y, Brush) | μW/cm² | 500 | not publicly available | 4,180 |
| Max average power density at 500 Ω (Pencil) | μW/cm² | 3,500 | ||
| Burst mode (a) pulse per burst | number | 1 | 20 | 20 |
| Burst mode (b) burst per second | number | n/a | 8.3 | 8.3 |
| Burst mode (c) burst duration | (sec) | n/a | 2.4 | 2.4 |
| Burst mode (d) duty cycle | n/a | 20.2sec | 20.2sec | |
| On Time (per second) | seconds | 0.1 | not publicly available | not publicly available |
| Off Time (per second) | seconds | 0.9 | not publicly available | not publicly available |
| Electrodes (a) materials | Stainless steel 316 | Chrome-plated | Chrome-plated | |
| (b) electroconductive media | n/a | Conductive gel | Conductive gel | |
| (c) electrode-to-skin impedance range | less than 15 | not publicly available | not publicly available | |
| (d) max duration of use (same as device shut off) | (minutes) | 60 | 20 | 20 |
| (e) conductive surface area (built in rectangular) | cm2 | 1.94 | - | - |
| (e) conductive surface area (spherical) | cm2 | 5.60 | not publicly available | not publicly available |
| (e) conductive surface area (brush/comb) | cm2 | 0.56 | not publicly available | not publicly available |
| (e) conductive surface area (small circular, pencil-like) | cm2 | 0.023 | not publicly available | not publicly available |
The acceptance criterion, though not explicitly stated as a pass/fail threshold, is implied to be that the device's technical characteristics, particularly regarding stimulation output and safety features, fall within the range of equivalence to predicate devices and comply with accepted safety standards (e.g., ANSI/AAMI NS4:2013/(R)2017). The document explicitly states: "The candidate devices fall within the same range of equivalence for performance and energy output for meeting the ANSI/AAMI NS4:2013/(R)2017 standard requirements for safety; and therefore, they do not raise new questions of safety."
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 primarily describes non-clinical bench testing and usability studies, not traditional clinical trials with patient test sets. Therefore, terms like "sample size for the test set" (in a clinical context) and "data provenance" (country of origin, retrospective/prospective) are not directly applicable.
- Test Set (Non-clinical): The "test set" for performance testing consisted of "a production equivalent of the candidate device." The specific number of devices tested is not mentioned.
- Usability Study: A usability study was performed, but the number of participants or their demographics are not provided.
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 information is not applicable as the clearance was based on substantial equivalence to predicate devices and non-clinical testing, rather than a study requiring expert consensus on clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the clearance was based on non-clinical testing and comparison to predicate devices, which do not involve adjudication by multiple experts on a clinical test set.
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
There was no MRMC comparative effectiveness study done. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for aesthetic use, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is not an algorithm or AI-based system. It's a hardware device (TENS stimulator). Its "standalone performance" refers to its electrical output, safety, and functionality as evaluated in non-clinical bench tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device and submission, the "ground truth" is primarily established by compliance with recognized electrical and medical device safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 62366, ANSI/AAMI NS4:2013/(R)2017) and the established safety and effectiveness of the legally marketed predicate devices for their intended uses. The document states that "The Avazzia device technological specifications are similar; therefore, they do not pose new questions regarding safety and effectiveness." The usability study also confirmed that the device and instructions "met requirements for usability factors for over-the-counter use."
8. The sample size for the training set
This information is not applicable as the device is a hardware TENS stimulator and does not involve AI/machine learning models with training sets.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 27, 2021
Avazzia, Inc Ms. Tammy Lahutsky Regulatory Affairs 13140 Coit Road, Suite 515 Dallas, Texas 75240
Re: K191951
Trade/Device Name: Avazzia OTC TENS for Aesthetics, model BEST-AV1: EZZI-LIFT Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: March 25, 2021 Received: March 26, 2021
Dear Ms. Lahutsky:
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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,
Jitendra Virani Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191951
Device Name
Avazzia OTC TENS for Aesthetics, model BEST-AV1™: EZZI-LIFT™ Device
Indications for Use (Describe)
The Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device is indicated for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.
| 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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510(k) Summary
| Submitted by: | |
|---|---|
| Manufacturer and Sponsor: | Avazzia, Inc.13140 Coit RoadSuite 515Dallas, TX 75240 USA |
| Telephone: | 214-575-2820 |
| Contact Person: | Tammy Lahutsky |
| Date of Summary Preparation: | April 26, 2021 |
| Trade Names of Candidate Devices: | Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™Device |
| Device names: | |
| Device Trade Proprietary name:Device Common or Usual Name:Classification Name:Regulation Number:Regulation Class | Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ DeviceAesthetic TENS DeviceTranscutaneous Electrical Nerve Stimulator for Pain Relief21 CFR 882.5890Class II |
| Product code: | NEO |
Predicate Devices
- . NuFACE Trinity Facial and Neck Skin Toning Device, K181008, 08/14/2018, TENS Class II 21 CFR 882.5890 NFO (primary predicate)
- . NuBODY Skin Toning Device, K171588, 07/27/2017, TENS Class II 21 CFR 882.5890 NFO (secondary predicate)
Reference Device used to support scientific methodology
- o Avazzia OTC TENS Model Best-AV1™: Med-Best™, Med-Sport™, Avazzia Blue™, Avazzia Star™, K162392, 05/12/2017, TENS Class II 21 CFR 882.5890 NUH is identical in manufacturing to the candidate device and is used to support biocompatibility, electromagnetic compatibility and electrical safety testing.
Indications for Use
The Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device is indicated for over-thecounter aesthetic use including facial and neck stimulation or body skin stimulation.
Description of Candidate Device
Candidate device is a handheld, AA battery-operated portable device for use in the home or clinic. It has pre-set modes and is for over-the-counter use in the home or a clinical setting.
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510k Aesthetic TENS, K191951
The candidate device uses transcutaneous electrical stimulation (TENS) for aesthetic use for facial, neck, and body stimulation.
How the Device Works
Candidate device uses TENS applied to the skin surface with cutaneous electrodes to stimulate the skin of the face, neck and body for aesthetic use.
The EZZI-LIFT device has built-in electrodes. Accessories, listed below, are also available to be used with the device.
Available Accessories
- . Cutaneous electrodes:
- o Spherical Soft tissue electrodes with common name: Y electrodes
- o Brush electrode
- Small Circular Electrode with common name: Pencil electrode o
- Lead wires .
The user can apply the built-in electrodes or place accessory electrodes where indicated and apply stimulation for a recommended period of time. The user manual contains recommended treatment methods and times.
The user controls the output by selecting the mode and power setting.
Scientific Concepts
Various modes in the candidate device are suited for TENS applications. Very short duration high voltage pulsed current (HVPC) stimulates the skin of the face, neck and body for aesthetic use.
Predicate Comparison
Significant physical and performance characteristics of the device including Stimulation Output Specifications & Summary of the Technological Characteristics Compared to the Predicates are shown in the table below.
The candidate device has similar technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices as summarized in the technological characteristics.
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| page | 3 |
|---|---|
| ------ | --- |
| Device Comparison Table(i.e., design, material, chemical composition, energy source) | ||||
|---|---|---|---|---|
| Characteristic | units | Candidate | Primary Predicate | Secondary Predicate |
| Device Name | EZZI-LIFT | NuFACE Trinity | NuBody | |
| 510K | K191951 | K181008 | K171588 | |
| Manufacturer | Avazzia, Inc. | Carol Cole Company(dba NuFACE) | Carol Cole Company(dba NuFACE) | |
| Indications for Use | The Avazzia OTC TENSfor aesthetics, modelBEST-AV1™: EZZI-LIFT™ Device isindicated for over-the-counter aesthetic useincluding facial andneck stimulation orbody skin stimulation. | The NuFACE TrinityDevice is intended forfacial and neckstimulation and isindicated for over-the-counter cosmeticuse. | NuBODY Skin ToningDevice is intended forbody skin stimulationand is indicated forover-the-countercosmetic use. | |
| Anatomic Sites | Face, neck, and body | Face and neck | Body | |
| Number of OutputModes | number | 4 | 1 | 1 |
| Low Battery Indicator | Yes | Yes | Yes | |
| Automatic shut off | (minutes) | 60 | 20 | 5 |
| Compliance withVoluntary Standards | Yes/No | IEC 60601-1IEC 60601-1-2IEC 60601-2-10ISO 14971IEC 62366 | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10IEC 60529, ISO 14971IEC 60601-1-6IEC 62366 |
| Compliance with 21CFR 898 | Yes / No | Yes | Yes | Yes |
| Weight | ounces | 5.4 | 9 | 10 to 14 |
| Dimensions[W x H x D] | (in.) | 2.6" X 4.7" X 1.35" | 2.8" x 5.1" x 1.3" | 2" x 6.5" x 6.0" |
| Housing Materials andConstruction | PCBs inside plasticcase housing | Thermoplastic | Thermoplastic | |
| User Interface Display | LEDs and switches | not publicly available | not publicly available | |
| Energy type | Electric stimulation | Electric stimulation | Electric stimulation | |
| Number, Size, and Typeof Batteries | Two 1.5 V AA batteries | Internal rechargeableLithium-ion battery | Internal rechargeableLithium-ion battery | |
| Stimulation Output Specifications | ||||
| Characteristic | units | Candidate | Predicate | Predicate |
| Device Name | EZZI-LIFT | NuFACE Trinity | NuBody | |
| Waveform Shape | positive square wavefollowed by a dampedsinusoidal waveformof variable durationdepending ondamping and bodyloading | pulsed biphasicmodulated squarewave | monophasic voltagemodulated squarewave | |
| Max output voltage(+/- 20%) | ||||
| - at 500 Ω | V | -42 | 28 | 28 |
| - at 2,000 Ω | V | -122 | not publicly available | not publicly available |
| - at 10,000 Ω | V | -348 | not publicly available | not publicly available |
| Max output current(+/-20%) | 500μA | |||
| - at 500 Ω | μA | 363 | 400 | 900 |
| - at 2,000 Ω | μΑ | 117 | not publicly available | not publicly available |
| - at 10,000 Ω | μΑ | 38 | not publicly available | not publicly available |
| Duration of primary(depolarizing phase) | mSec | 0.5 | 60 | 60 |
| Pulse Duration | mSec | 1.1 | 60 | 60 |
| Frequency | Hz | 15 to 121 | 8.3 | 8.3 |
| Net Charge per pulse at500 Ω | μC | 4 | not publicly available | 54 |
| Max phase charge | μC | 10 | not publicly available | not publicly available |
| Max current density at500 Ω | μΑ/cm² | Built-in, Y, Brush: 800Pencil: 19,000 | 419 | 468 |
| Max average powerdensity at 500 Ω | μW/cm² | Built-in, Y, Brush: 500Pencil: 3,500 | not publicly available | 4,180 |
| Burst mode | ||||
| (a) pulse per burst | number | 1 | 20 | 20 |
| (b) burst per second | number | n/a | 8.3 | 8.3 |
| (c) burst duration | (sec) | n/a | 2.4 | 2.4 |
| (d) duty cycle | n/a | 20.2sec | 20.2sec | |
| On Time (per second) | seconds | 0.1 | not publicly available | not publicly available |
| Off Time (per second) | seconds | 0.9 | not publicly available | not publicly available |
| Electrodes |
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| œpageD1A | |
|---|---|
| -------------------------- | -- |
| Stimulation Output Specifications | ||||
|---|---|---|---|---|
| Characteristic | units | Candidate | Predicate | Predicate |
| Device Name | EZZI-LIFT | NuFACE Trinity | NuBody | |
| (a) materials | Stainless steel 316 | Chrome-plated | Chrome-plated | |
| (b) electroconductivemedia | n/a | Conductive gel | Conductive gel | |
| (c) electrode-to-skinimpedance range | less than 15 | not publicly available | not publicly available | |
| (d) max duration ofuse (same as deviceshut off) | (minutes) | 60 | 20 | 20 |
| (e) conductivesurface area | ||||
| built in rectangular | cm2 | 1.94 | - | - |
| spherical | cm2 | 5.60 | not publicly available | not publicly available |
| brush/comb | cm2 | 0.56 | not publicly available | not publicly available |
| small circular,pencil-like | cm2 | 0.023 | not publicly available | not publicly available |
Comparison of technical characteristics with the predicate devices
Transcutaneous electric nerve stimulation (TENS) is the technological principle for both the subject and predicate devices. It is based on the use of electric stimulation to the skin for aesthetic use.
At a high level, the subject and predicate devices are based on the following same technological elements:
- . Transcutaneous electric nerve stimulation (TENS) to the skin for aesthetic use
- . Quantity of electric stimulation applied to the skin resulting from short, pulsed electrical current that results in only microamperage applications per second, also known as microcurrent.
- . Meet the same medical device general safety requirements IEC 60601-1 and requirements EMC: IEC 60601-1-2.
There are variations between the subject and predicate devices for specific waveform shape, max voltage, phase charge, pulses per second, duty cycle and current.
Rationale that differences in technical performance specifications are within range of equivalence, and therefore, do not raise new questions.
The variations in technical characteristics fall within the range of Agency accepted differences for devices with the same principal of operation and the same intended use. This is consistent with the Agency accepted standard, ANSI/AAMI NS4:2013/ (R)2017 Transcutaneous electrical nerve stimulators, that references combination of current or charge over time for determining safety for Transcutaneous electrical stimulators.
The ANSI/AAMI document established a maximum charge to prevent serious injury or death.
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page 6
Peak instantaneous maximum voltage and pulse width are considered and included in determination of charge per pulse and the resulting current flow and determining safety.
The candidate devices fall within the same range of equivalence for performance and energy output for meeting the ANSI/AAMI NS4:2013/(R)2017 standard requirements for safety; and therefore, they do not raise new questions of safety.
Nonclinical Tests
Nonclinical bench testing was performed to demonstrate that the candidate device met design specifications and accepted safety standards and requirements.
Performance testing was conducted using a production equivalent of the candidate device. The testing consisted of the evaluation of output waveform and energy characteristics. Results were compared to predicate device performance characteristics.
Additionally, output energy, electrical and constructional safety and EMC testing of the candidate device was conducted in accordance with Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, IEC 60601-1:2005 MOD, Medical electrical equipment - Part 1-2 : General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, IEC 60601-1-2, Edition 4.0 2014-02, and Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators, IEC 60601-2-10, 2016.
The software development process and software verification is conducted according to Medical device software – Software life cycle processes, IEC 62304, 2015 and the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices – Guidance for Industry and FDA Staff – May 11, 2005.
Usability study was performed to assess the candidate device for aesthetic use. The candidate device and accompanying instructions for use met requirements for usability factors for over-the-counter use. No new questions of safety or efficacy were raised. No new risks were raised. The instructions for use support the safe and effective use of the EZZI-LIFT device and accessories for aesthetic use. Reference FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff", 2016 and IEC 62366, Medical devices - Part 1: Application of usability engineering to medical devices, 2015.
Results from bench testing and performance tests are compared to that of predicate devices in a comparison table format.
Nonclinical test results and studies, including the performance bench testing, product safety testing, software, usability studies, and risk management activities in conformance with Medical devices — Application of risk management to medical devices, ISO 14971, 2012 were reviewed and evaluated.
The candidate devices fall within the same range of equivalence for output energy characteristics and construction for meeting accepted safety standards for transcutaneous electrical nerve and muscle stimulators; and therefore, they do not raise new questions of safety.
Results confirmed that design and safety requirements were met, and that no new questions of safety or effectiveness were raised. This data was used to determine substantial equivalence.
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Safety and Effectiveness
The Avazzia device technological specifications are similar; therefore, they do not pose new questions regarding safety and effectiveness.
Indications for use for TENS OTC for aesthetic use have been established, therefore, indications for use do not pose new questions regarding safety and effectiveness.
Conclusion
The Avazzia EZZI-LIFT device has intended use and technological characteristics that are substantially equivalent to the 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).