(139 days)
Nu Skin RenuSpa iO is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
Nu Skin RenuSpa iO is a hand-held, portable, rechargeable microcurrent device used to stimulate certain parts of the body for aesthetic purposes. It is used with a conductive medium. It contains a rechargeable Lithium-ion battery that is recharged with a USB-enabled inductive charger. Nu Skin RenuSpa iO is inductively charged by the supplied Nu Skin RenuSpa iO charging stand. Nu Skin RenuSpa iO is designed to mechanically rest on the charging stand in a manner that ensures proper alignment for charging. The charging stand connects to an external AC/DC USB Power supply adapter via a short length of cable terminated with USB-A Male connection. Nu Skin RenuSpa iO is indicated for use only on healthy, unbroken skin. Nu Skin RenuSpa iQ uses a combination of LED lights and audio feedback. Nu Skin RenuSpa iO is sold in the United States in a kit with the conductive medium (510k cleared conductive GEL K022006). In all cases the Nu Skin RenuSpa iO and Charger user manual are provided to the user.
The provided text describes the 510(k) summary for the Nu Skin RenuSpa iO device, which is intended for body skin stimulation for over-the-counter cosmetic use. This document focuses on demonstrating substantial equivalence to a predicate device (NuBODY Skin Toning Device) rather than presenting a study proving that the device meets specific clinical acceptance criteria in terms of performance on patients.
Therefore, a significant portion of the requested information regarding clinical studies, sample sizes, expert ground truth, adjudication methods, and MRMC studies, is explicitly stated as "Not applicable" or is not present in the provided document, as the submission relies on nonclinical (bench) testing to demonstrate substantial equivalence.
Here's the information that can be extracted and a clear indication where the requested information is not available:
1. A table of acceptance criteria and the reported device performance
The document provides a table of "Design Verification" tests with a "Conclusion" column indicating "Acceptance criteria met." However, the specific numerical acceptance criteria for each test (e.g., what constitutes meeting "dimensional specifications" or "electrical functionality") are not detailed, only the qualitative conclusion. The reported device performance is similarly described qualitatively as meeting these unspecified criteria.
| Test | Test Method Summary | Reported Device Performance / Conclusion |
|---|---|---|
| Dimension verification | Confirms the units meet all dimensional specifications | Acceptance criteria met |
| Visual Inspection | Confirms the product meets all visual specifications | Acceptance criteria met |
| Design Verification | Confirms functionality of units using a clinically relevant bench top model | Acceptance criteria met |
| Software (SW) V&V | Confirms the units meet all SW specifications | Acceptance criteria met |
| Electrical Testing | Confirms electrical functionality of units using a clinically relevant bench top model | Acceptance criteria met |
| Biocompatibility | Confirms the units meet all biocompatibility requirements for this type of device | Acceptance criteria met |
| Cleaning Method Validation | Confirms the units meet all cleaning method expectations for this device | Acceptance criteria met |
| Packaging Distribution Simulation and accelerated aging Testing | Confirms the units meet all packaging distribution simulation and aging requirements | Acceptance criteria met |
| Output Waveform Characteristics | Nonclinical testing against predicate (NuBODY) | Substantially equivalent |
| Output Energy Characteristics | Nonclinical testing against predicate (NuBODY) | Substantially equivalent |
| Electrical and Constructional Safety (IEC 60601-1) | Nonclinical testing of the Nu Skin device | Conformed to standard |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | Nonclinical testing of the Nu Skin device | Conformed to standard |
| Specifics for Maximum Output Voltage (22 VDC) | Bench testing | 22 VDC |
| Specifics for Maximum Output Current (640 uA) | Bench testing (at 0Ω impedance, 620uA at 500Ω) | 640 uA |
| Specifics for Maximum Output Current Density (0.320 mA/cm²) | Calculated using the same methodology as predicate | 0.320 mA/cm² |
| Specifics for Net Charge per pulse (38.4 uC) | Calculated using the same methodology as predicate | 38.4 µC |
| Specifics for Maximum Average Power Density (3.52 mW/cm²) | Calculated using the same methodology as predicate | 3.52 mW/cm² |
| Specifics for Maximum Phase Charge (0.768 mC/Burst) | Calculated using the same methodology as predicate | 0.768 mC/Burst |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document explicitly states "Clinical Testing: Not applicable." The nonclinical "test set" for the bench testing is described as a "production equivalent of the Nu Skin" and a "commercial unit of the predicate." The exact number of units tested is not specified, but it implies a small number for bench validation.
- Data Provenance: Not specified for nonclinical testing.
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)
Not applicable, as no clinical studies with expert-established ground truth were performed for this submission. The "ground truth" for the nonclinical tests would be the established engineering specifications and compliance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies requiring adjudication were performed.
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
Not applicable. This device is a transcutaneous electrical nerve stimulator for cosmetic use, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithmic device. The device itself is a standalone product (without human-in-the-loop performance in terms of interpretation, but obviously requires human application). The performance was evaluated through nonclinical laboratory tests.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the nonclinical testing, the "ground truth" is implied to be the engineering design specifications, established industry standards (e.g., IEC 60601 series), and the characteristics of the legally marketed predicate device.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
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 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
November 21, 2023
NSE Products, Inc % Jack Slovick President Methodize Inc. 24813 Cty 18 Nevis, Minnesota 56467
Re: K232001
Trade/Device Name: Nu Skin RenuSpa iO Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: October 26, 2023 Received: November 1, 2023
Dear Jack Slovick:
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.
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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 Rehabilitation Devices
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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) K232001
Device Name Nu Skin RenuSpa iO
Indications for Use (Describe)
Nu Skin RenuSpa iO is intended for body skin 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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510(k) Summary
K232001
This 510(k) Summary was prepared in accordance with 21 CFR 807.92.
Date Prepared: 10/26/23
| Submitter/Manufacturer | Nu Skin Enterprises, Inc |
|---|---|
| 75 W. Center St. | |
| Provo, UT 84601 | |
| Establishment Registration # 3001236514 | |
| SubmissionCorrespondent | Jack SlovickRegulatory Consultant |
| Telephone: 763-639-0238 | |
| Email: jlslovick@gmail.com | |
| Trade Name | Nu Skin RenuSpa iO |
| Regulation Name | Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| Regulation Number | 21 CFR 882.5890 |
| Product Code | NFO |
| Device Class | Class II |
| Classification Panel | Division of Neurological and Physical Medicine Devices |
| Predicate Devices | NuBODY Skin Toning Device 510(k)#: K171588 |
| Reason for Submission | New Device |
Note: There were no previous submissions for this device.
Device Description
Nu Skin RenuSpa iO is a hand-held, portable, rechargeable microcurrent device used to stimulate certain parts of the body for aesthetic purposes. It is used with a conductive medium. It contains a rechargeable Lithium-ion battery that is recharged with a USBenabled inductive charger.
Nu Skin RenuSpa iO is inductively charged by the supplied Nu Skin RenuSpa iO charging stand. Nu Skin RenuSpa iO is designed to mechanically rest on the charging stand in a manner that ensures proper alignment for charging. The charging stand connects to an external AC/DC USB Power supply adapter via a short length of cable terminated with USB-A Male connection.
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Nu Skin RenuSpa iO is indicated for use only on healthy, unbroken skin.
Nu Skin RenuSpa iQ uses a combination of LED lights and audio feedback.
Nu Skin RenuSpa iO is sold in the United States in a kit with the conductive medium (510k cleared conductive GEL K022006). In all cases the Nu Skin RenuSpa iO and Charger user manual are provided to the user.
Product Overview
The Nu Skin RenuSpa iO system (as pictured below) will consist of a topical and handheld device used together approximately once a day, three days a week on thighs, arms, buttocks and/or abdomen. Suggested treatment duration will be up to five minutes for each area. When treatment has concluded, the device should be gently rinsed with warm water and towel dried.
Image /page/5/Picture/5 description: The image shows a medical device. The top portion of the image shows three different views of the device. The bottom portion of the image shows the device sitting on a charger.
Figure 1: Nu Skin RenuSpa iO device and charger
Nu Skin RenuSpa iQ will include an internal (non-removable) lithium-ion battery system that will be charged (inductively) from a low-profile charging base. The user will control
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the device via a single button interface. Seven LED indicator positions and an audible alert speaker system will provide user feedback concerning the state of the device (charge, treatment, duration, etc.).
Image /page/6/Picture/1 description: The image shows a tube of Nu Skin Conductive Gel. The tube is white with gray text. The text on the tube reads "Nu Skin Conductive Gel For external use only 150ml e (5.0 fl.oz.)".
Figure 2: Cleared Conductive Gel
This is an already FDA cleared substance supplied with the kit (K022006).
The Nu Skin RenuSpa iO device contains a rechargeable Lithium-ion battery that is recharged with a USB-enabled inductive charger. Key battery characteristics are shown in the following table:
| Characteristic | Specification |
|---|---|
| Capacity | Typical: 750 mAh |
| Open Circuit Voltage | 3.68~3.92V |
| State of Charge | 50%-80% |
| Weight | 22g |
| Max Voltage | 4.2V |
| Nominal Voltage | 3.6V |
| Fully Discharge Voltage | 3.0V |
| Standard Charge Current | 0.5C |
| Charge time | 3.5 Hours |
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Indications for Use.
Nu Skin RenuSpa iO is intended for body skin stimulation and is indicated for over-thecounter cosmetic use.
Comparison of Technological Characteristics with the Predicate Device
The Nu Skin RenuSpa iO device is substantially equivalent to the predicate device based on comparison of indications for use and technological characteristics. The indications are identical to that of the predicate device NuBODY Skin Toning Device. There are minor differences but mostly similarities between the subject and the predicate device. These differences will be further explained subsequent to the following table.
| GeneralComparison Table | Nu Skin RenuSpa iO(New Device) | NuBODY (Predicate) | Remark |
|---|---|---|---|
| 510k # | K232001 | K171588 | N/A |
| Indication | Nu Skin RenuSpa iO isintended for body skinstimulation and isindicated for over-the-counter cosmetic use. | NuBODY Skin ToningDevice is intended forbody skin stimulation andis indicated for over-the-counter cosmetic use. | Same |
| Anatomic Sites | Areas of the body otherthanthe face | Areas of the body otherthanthe face | Same |
| TechnologicalCharacteristics | The Nu Skin RenuSpa iODevice is a body skintoning device. Its outercase is injection moldedthermoplastic resin. Theoutput contacts consist ofchrome-plated elongatedspherical electrodes. TheRenuSpa iO device ispowered by arechargeable lithium-ionbattery. RenuSpa iOdevice producesmicrocurrent that isdischarged through four | The NuBODY SkinToning Device is a bodyskin toning device. Itsouter case is injectionmolded thermoplasticresin. The outputcontacts consist ofchrome-plated sphericalelectrodes. The NuBODYdevice is powered by arechargeable lithium-ionbattery. NuBODY deviceproduces microcurrentthat is dischargedthrough four fixed, | DifferenceNote 1 |
| fixed, smooth elongated | smooth spherical | ||
| spherical electrodes. | electrodes. | ||
| To turn the RenuSpa iO | To turn the NuBODY | ||
| device on, the on/off | device on, the on/off | ||
| button is pressed. | button is pressed. | ||
| Ascending tonal beeps | Ascending tonal beeps | ||
| indicate the RenuSpa iO | indicate the NuBODY | ||
| device is on. Five LED | device is on. One to | ||
| lights illuminate indicating | three LED lights | ||
| the treatment time | illuminate indicating the | ||
| duration and the unit is | output intensity level and | ||
| ready for use. | the unit is ready for use. | ||
| The four elongated | The four spheres gently | ||
| spheres gently glide over | glide over the skin to | ||
| the skin to deliver low- | deliver low-level | ||
| level electrical impulses | electrical impulses to | ||
| to targeted locations on | targeted locations on the | ||
| the body. | body. | ||
| The RenuSpa iO device | The NuBODY device | ||
| elongated spheres are | spheres are designed for | ||
| designed for optimal | optimal contact with body | ||
| contact with body skin. | skin. The NuBODY | ||
| The RenuSpa iO device | device delivers | ||
| delivers microcurrent as a | microcurrent as a | ||
| constant monophasic | constant monophasic | ||
| square wave comprised | square wave comprised | ||
| of a burst of (10) positive | of a burst of (10) positive | ||
| pulses followed by a | pulses followed by a | ||
| burst of (10) negative | burst of (10) negative | ||
| pulses. | pulses. | ||
| The microcurrent output | The microcurrent output | ||
| continuously alternates | continuously alternates | ||
| between the positive and | between the positive and | ||
| negative elongated | negative spherical | ||
| spherical electrodes. | electrodes and allows the | ||
| The RenuSpa iO device | user to adjust the output | ||
| requires the use of a | for a personalized | ||
| conductive gel. | comfort level. | ||
| To promote proper use | The NuBODY device | ||
| and provide feedback to | requires the use of a | ||
| the user, the RenuSpa iO | conductive gel. | ||
| device provides | |||
| continuous white noisewhen the device is inproper contact with theskin. | To promote proper useand provide feedback tothe user, the NuBODYdevice beeps to cue theuser to relocate theNuBODY deviceapproximately every 5seconds. |
Table 1 – General Comparison Table
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Table 2 – Basic Unit Comparison
| Basic UnitComparison Table | Nu Skin RenuSpa iO(New Device) | NuBODY (Predicate) | Remark |
|---|---|---|---|
| Power Source | Internal rechargeableLithium-ion battery | Internal rechargeableLithium-ion battery | Same |
| a. Method ofLine CurrentIsolation | Type BF | Type BF | Same |
| b. PatientLeakageCurrent | (See 1) and 2) below) | - | - |
| 1) Normalcondition | N/A- Battery Operated | N/A- Battery Operated | Same |
| 2) Single FaultCondition | N/A- Battery Operated | N/A- Battery Operated | Same |
| External poweradapter | Nu Skin 5-volt USB-AWireless Charger. | NuFACE 5-volt poweradapter | DifferenceNote 2 |
| Number ofOutputChannels | 1 | 1 | Same |
| a) Synchronousor Alternating | N/A - 1 Outputchannel | N/A - 1 Outputchannel | Same |
| b) Method ofChannelIsolation | N/A - 1 Outputchannel | N/A - 1 Outputchannel | Same |
| RegulatedCurrent orRegulatedVoltage | Both | Both | Same |
| Software/Firmware/MicroprocessorControl | Yes | Yes | Same |
| AutomaticOverload Trip | Not required due tocircuit design | Not required due tocircuit design | Same |
| AutomaticNon load Trip | Yes | Yes | Same |
| Automatic ShutOff | Yes | Yes | Same |
| PatientOverrideControl | Yes | Yes | Same |
| Indicator Display | |||
| a) On-Off status | Yes | Yes | Same |
| b) Low Battery | Yes | Yes | Same |
| c) Voltage/Current Level | Yes | Yes | Same |
| Automatic Shut-Off(minutes) | Yes (5minutes) | Yes (5minutes) | Same |
| Compliancewith VoluntaryStandards | IEC 60601-1IEC 60601-1-2IEC 60601-2-10ISO 14971IEC 60601-1-6IEC 62366IEC 60601-1-11 | IEC 60601-1IEC 60601-1-2IEC 60529IEC 60601-2-10ISO 14971IEC 60601-1-6IEC 62366 | DifferenceNote 2 |
| Weight | Approximately 6.7 oz.Without power adapter | Approximately 10-14oz. without poweradapter | DifferenceNote 3 |
| Dimensions ofdevice(inch) [Wx L x D] | Approximately 5.1" x2.9" x 2.9" | Approximately 2.75" x6.5" x 6.0" | DifferenceNote 3 |
| HousingMaterials andConstruction | Thermoplastic | Thermoplastic | Same |
| OutputSpecificationComparison Table | Nu Skin RenuSpa iO(New Device) | NuBODY (Predicate) | Remark |
| Waveform (e.g.,Pulsed monophasic, biphasic) | Monophasicwaveform that isdelivered in a burst ofpulses | Monophasicwaveform that isdelivered in a burst ofpulses | Same |
| Shape (e.g.,rectangular, spike,rectified sinusoidal) | Voltage ModulatedSquare | Voltage ModulatedSquare | Same |
| MaximumOutput Voltage | 22 VDC | 28 VDC | DifferenceNote 4 |
| MaximumOutput Current | 640 μΑ | 900 µA @ 500Ω | DifferenceNote 4 |
| Maximum OutputCurrent Density | 0.320 mA/cm2 | 0.468 mA/cm2 | DifferenceNote 4 |
| Output Currentwhen not stimulating | < 1 µA | < 1 µA | Same |
| Output Tolerance | +/- 10% | +/- 10% | Same |
| Pulse Width | 60 ms | 60 ms | Same |
| Frequency (Hz) | Approximately 8.3 Hz | Approximately 8.3 Hz | Same |
| For interferentialmodes, onlya) BeatFrequency(Hz) | No Beat Frequency | No Beat Frequency | Same |
| For multiphasicwaveforms, onlya) Symmetricalphases | Not Multiphasic | Not Multiphasic | Same |
| b) PhaseDuration(includeunits)c) (state range,if applicable)d) (both phases,ifasymmetrical) | Not Multiphasic | Not Multiphasic | Same |
| Net Charge (μCper pulse) | 38.4 µC | 54 µC | DifferenceNote 4 |
| Burst Mode (i.e.,pulse trains) | |||
| a) Pulses perburst | 20 | 20 | Same |
| b) Pulses persecond | 8.3 | 8.3 | Same |
| c) Burstduration(seconds) | 2.4 s | 2.4 s | Same |
| d) Duty Cycle[Line (b) xline (c)] (ontime perburst) | 20.2 s | 20.2 s | Same |
| ON Time (seconds) | 60 msec | 60 msec | Same |
| OFF Time (seconds) | 60 msec | 60 msec | Same |
| MaximumAverage PowerDensity(mW/cm2) | 3.52 | 4.18 | DifferenceNote 4 |
| Maximum PhaseCharge (mC/Burst) | 0.768 | 1.08 | DifferenceNote 4 |
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Table 3 – Output Specification Comparison Table
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Nonclinical testing was performed to demonstrate that the Nu Skin product met design specifications and is substantially equivalent to the NUBODY Plus predicate device. This performance testing was conducted using a production equivalent of the Nu Skin, and a commercial unit of the predicate. The testing consisted of the evaluation of output waveform characteristics and output energy characteristics.
Additionally, Product Safety and EMC testing of the Nu Skin was conducted in accordance with IEC 60601-1 and IEC 60601-1-2. The Nu Skin device conformed to ANSI/AAMI IEC 60601-1: 2005 / A2:2010 for Electrical and Constructional Safety and to IEC 60601-1-2 for Electromagnetic Compatibility (EMC) and IEC 60601-2-10.
All nonclinical test results for output waveform, output energy, Electrical and Constructional Safety and EMC confirm the Nu Skin device is substantially equivalent to the NUBODY predicate device.
As such, any differences between the new device and the predicate do not raise any new issues related to safety and efficacy.
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General Comparisons
Technological Characteristics
The new device is similar but slightly different than the predicate in that:
-
The predicate has smooth spherical electrodes as opposed to smooth elongated spherical electrodes in the new device.
-
The predicate LED lights indicate output intensity modification and are not present in the new device. The new device LED lights indicate treatment time elapsed.
-
The predicate allows the user to change intensity and is not present in the new device.
-
The predicate provides feedback of proper use via beep cues every 5 seconds; the new device provides feedback of proper use via continuously emitting white noise. Therefore, these differences don't raise any new issues related to safety and efficacy.
Note 1:
The new device and predicate device have many similarities in technological characteristics except for electrodes, materials, and user interface functions. Both have passed the biocompatibility tests. For more stability and better contact, the proposed device uses fixed, elongated spherical electrodes, and provides user interface functions that differ from the predicate device (audible cues and LED lights). The proposed device has passed the IEC 60601-1, 60601-1-2 tests. Therefore, these differences don't raise any new issues related to safety and efficacy.
Basic Unit Comparisons
External Power Adapter
The predicate device provides a 5-volt power adapter that plugs in directly into the device via a barrel connection. This power adapter includes a built-in mains wall adapter that is included as part of the power adapter.
The new device provides a 5-volt USB-A power adapter that charges wirelessly. This power adapter does not include a built-in mains wall adapter and relies on a customer provided a certified USB-A mains wall adapter with appropriate electrical ratings. Like the predicate, the new device passes testing as part of AAMI/ANSI IEC 60601-1 for safety and to IEC 60601-1-2 for Electromagnetic Compatibility (EMC). Therefore, these differences don't raise any new issues related to safety and efficacy.
Compliance with Voluntary Standards
The predicate device does not list the IEC 60601-1-11 standard under voluntary compliance. The predicate also explicitly lists IEC 60529.
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The new device does list the IEC 60601-1-11 standard due to the use of the device in a home health care environment. The new device does not explicitly list IEC 60529 but rather includes the associated standard as a part of AAMI/ANSI IEC 60601-1 testing. Therefore, these differences don't raise any new issues related to safety and efficacy.
Note 2:
The tests performed by our proposed device are slightly different from those of the predicate device. IEC 60529 is the standard for device waterproof level testing, and the waterproof level of our device has been evaluated in the AAMI/ANSI IEC 60601-1 test. The predicate device provided a 5-volt plug in adapter while the new device provides a wireless adapter passed testing as part of AAMI/ANSI IEC 60601-1 for safety and to IEC 60601-1-2 for Electromagnetic Compatibility (EMC). Therefore, these differences don't raise any new issues related to safety and efficacy.
Weight (oz)
The predicate device weighs approximately 10-14 oz. without the power adapter due to older industrial design, internal components, and materials used.
The new device weighs approximately 6.7 oz. without the power adapter due to the newer smaller industrial design, internal components, and materials used to improve device handling. Therefore, these differences don't raise any new issues related to safety and efficacy.
Dimensions (Inches)
The predicate NuFACE device dimensions measure approximately 2.75" x 6.5" x 6.0" due to older industrial design, internal components, and materials used. The new device dimensions measure approximately 5.1" x 2.9" due to newer smaller industrial design, internal components, and materials used to improve device handling. Therefore, these differences don't raise any new issues related to safety and efficacy.
Note 3:
The proposed device is different from the predicate device in housing material, weight, dimensions, and appearance. Both have passed the biocompatibility tests, IEC 60601-1, 60601-1-2 tests. Therefore, these differences don't raise any new issues related to safety and efficacy.
Output Specification Comparison
Maximum Output Voltage (V)
The predicate device has a maximum output voltage of 28 VDC.
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The new device has a maximum output voltage of 22 VDC. This lowering of the maximum voltage output allows for similar efficacy and is optimal for an improved user experience. Therefore, these differences don't raise any new issues related to safety and efficacy.
Maximum Output Current (uA)
The predicate device has a maximum output current of 900uA at a measured resistance of 500 Ω. The exact maximum output current, regardless of impedance load, is estimated to be around 920 - 940 uA due to calculations around listed specifications and ratings.
The new device has a maximum output current of 640uA and is a true maximum output current with an impedance load approaching 0 Ω. Measurement of the current output at 500 Ω is 620uA. While capable of listing the output current of 620uA at 500 Ω, we believe that 640uA is the true maximum regardless of impedance load. Regardless, this lowering of the maximum voltage current allows for similar efficacy and is optimal for an improved user experience. Therefore, these differences don't raise any new issues related to safety and efficacy.
Maximum Current Density (mA/cm2)
The predicate device has a listed maximum current density of 0.468 mA/cm².
Using the same methodology, we calculate the new device as having a Maximum Output Current Density of 0.320 mA/cm². Therefore, these differences don't raise any new issues related to safety and efficacy.
Net Charge per pulse (uC per pulse)
The predicate NuFACE device has a listed Net Charge per pulse of 54uC.
Using the same methodology, our maximum output current, and pulse width, we calculate the new device to have a net charge per pulse of 640uA (*) 60 ms = 38.4 uC per pulse. Therefore, these differences don't raise any new issues related to safety and efficacy.
Maximum Average Power Density (mW/cm²)
The predicate device has a listed maximum current density of 4.18 mW/cm².
Using the same methodology, our maximum output current density, and maximum output voltage, we calculate the new device as having a Maximum Average Power
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Density of 0.320 mA/cm² (*) 22 VDC (/) 2 = 3.52 mW/cm². Therefore, these differences don't raise any new issues related to safety and efficacy.
Maximum Phase Charge (mC/Burst)
The predicate device has a Maximum Phase Charge of 1.08 mC/Burst.
Using the same methodology, our Net Charge per pulse, and pulse duration, we calculate the new device to have a Maximum Phase Charge of 0.768 mC/Burst. Therefore, these differences don't raise any new issues related to safety and efficacy.
Note 4:
The maximum output voltage and maximum output current of the new device are lower than those of the predicate device to a similar level that allows for similar efficacy and is optimal for an improved user experience.
The net charge, maximum phase charge, maximum current density, and maximum average power density are calculated by different electrode areas and lower maximum ratings. Both meet IEC 60601-2-10 and other IEC 60601 tests. Therefore, these differences don't raise any new issues related to safety and efficacy.
Nonclinical testing was performed to demonstrate that the Nu Skin product met design specifications and is substantially equivalent to the NuBODY Skin Toning Device predicate. This performance testing was conducted using a production equivalent of the Nu Skin, and a commercial unit of the predicate. The testing consisted of the evaluation of Output Waveform Characteristics and Output Energy Characteristics.
Additionally, Product Safety and EMC testing of the Nu Skin was conducted in accordance with IEC 60601-1 and IEC 60601-1-2. The Nu Skin device conformed to IEC 60601-1-2 Edition 4.0 2014-02 for Electrical and Constructional Safety and to IEC 60601-1-2 Edition 4.0 2014-02 for Electromagnetic Compatibility (EMC) and IEC 60601-2-10.
All nonclinical test results for Output Waveform, Output Energy, Electrical and Constructional Safety and EMC confirm the Nu Skin device is substantially equivalent to the NUBODY predicate device.
Performance Data
To demonstrate the substantial equivalence of the subject Nu Skin RenuSpa iO Device to the selected predicate device, the performance and technological characteristics were evaluated by the completion of the following tests and assessments:
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- Design Verification .
- SW Verification/Validation ●
- Electrical Testing .
- Packaging Validation ●
- Bench Testing ●
Design Verification
The following design verification tests were performed on the subject device:
| Test | Test Method Summary | Conclusion |
|---|---|---|
| Dimension verification | Confirms the units meet alldimensional specifications | Acceptance criteria met |
| Visual Inspection | Confirms the product meets all visualspecifications | Acceptance criteria met |
| Design Verification | Confirms functionality of units using aclinically relevant bench top model | Acceptance criteria met |
| Software (SW) V&V | Confirms the units meet all SWspecifications | Acceptance criteria met |
| Electrical Testing | Confirms electrical functionality of unitsusing a clinically relevant bench topmodel | Acceptance criteria met |
| Biocompatibility | Confirms the units meet allbiocompatibility requirements for thistype of device | Acceptance criteria met |
| Cleaning MethodValidation | Confirms the units meet all cleaningmethod expectations for this device | Acceptance criteria met |
| PackagingDistributionSimulation andaccelerated agingTesting | Confirms the units meet all packagingdistribution simulation and agingrequirements | Acceptance criteria met |
Results of tests and assessments did not raise new safety or efficacy questions.
Clinical Testing
Not applicable
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR part 807 and based on all relative information provided in this premarket notification, we conclude the Nu Skin RenuSpa iO Device is substantially equivalent to the NuBODY device predicate with regards to safety and effectiveness.
§ 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).