PureLift

K190269 · Xtreem Pulse, LLC · NFO · Aug 28, 2019 · Neurology

Device Facts

• Record ID: K190269
• Device Name: PureLift
• Applicant: Xtreem Pulse, LLC
• Product Code: NFO · Neurology
• Decision Date: Aug 28, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PureLift is intended for facial stimulation and indicated for over-the-counter cosmetic use.

Device Story

Hand-held facial stimulation device; applies low-level electrical impulses to strategic facial locations via two fixed, chrome-plated spherical probes. User-operated; powered by 3.7V rechargeable battery. Device features LCD screen, power button, and intensity adjustment (levels 1-10). Used with electroconductive media. Probes glide over skin to deliver impulses. Intended for OTC cosmetic use. Benefits include facial stimulation. Device includes automatic shut-off and timer (10 minutes).

Clinical Evidence

No clinical data. Bench testing only. Included oscilloscope tracings, vibration, temperature, mechanical strength, drop, ball, acoustic, and accessible parts testing. Biocompatibility testing (cytotoxicity, sensitization, irritation) per ISO 10993-5 and -10. Electrical safety and EMC testing per IEC 60601-1, 60601-1-2, 60601-1-11, and 60601-2-10.

Technological Characteristics

Handheld device; thermoplastic resin case; chrome-plated spherical probes. Powered by 3.7V battery. Output: Pulsed monophasic, alternating polarity, rectangular pulses. Frequency: 1.37-1.73 kHz. Pulse width: 4μs. Type BF protection. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11. Biocompatibility: ISO 10993-5, -10.

Indications for Use

Indicated for over-the-counter cosmetic facial stimulation.

Regulatory Classification

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.

Predicate Devices

• NuFace Nodel NU-4003 (K072260)

Reference Devices

• Rejuvenique Model RJV10 (K011935)

Submission Summary (Full Text)

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August 28, 2019

Xtreem Pulse. LLC % Rhonda Alexander, Ph.D. Sr. Consultant, Regulatory Strategy IUVO Consulting, LLC PO Box 56436 Virginia Beach, Virginia 23456

Re: K190269

Trade/Device Name: PureLift Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: August 26, 2019 Received: August 27, 2019

Dear Dr. Alexander:

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.

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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 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Vivek Pinto, Ph.D. 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) K190269

Device Name PureLift

Indications for Use (Describe)

PureLift 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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# 510(k) Summary

#### l. SUBMITTER

XTREEM PULSE LLC 353 W. 29 ST. SUITE 3 NEW YORK, NY 10001 UNITED STATES

| Contact Person: | Rhonda Alexander, DSL |
|-----------------|-------------------------------------|
| | Sr. Consultant, Regulatory Strategy |
| | IUVO Consulting, LLC |
| | [phone] |
| | [e-mail] |

Date Prepared: 27 August 2019

#### II. DEVICE

| Name of Device: | PureLift |
|----------------------|-----------------------------------------------------------|
| Classification Name: | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Regulatory Class: | Class II |
| Product Code: | NFO |
| Regulation Number: | 21 CFR 882.5890 |

#### III. PREDICATE DEVICE

NuFace Nodel NU-4003 Manufacturer: Carol Cole Company K Number: K072260

Reference Device: Rejuvenique Model RJV10 K Number: K011935 Manufacturer: Salton, Inc.

## IV. DEVICE DESCRIPTION

The PureLift is a hand-held device intended to apply electrical impulses to strategic locations on the face. The PureLift 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 for personalized comfort level by pressing the up/down button. The intensity starts at (1) and continues to (10).

The device measures 13.4″ L x 4.8″ W x 4.3″ D. Its outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device, powered by a 3.7-volt battery, produces low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device

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on, the power button is pushed. Then LCD screen will be displayed, indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face.

PureLift is intended to be used with a legally marketed electroconductive media.

The PureLift unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres.

## V. INDICATIONS FOR USE

PureLift is intended for facial stimulation and indicated for over-the-counter cosmetic use.

## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| Elements of<br>Comparison | PureLift | Predicate Device<br>NuFace<br>(K072260) | Reference Device<br>Rejuvenique<br>(K011935) |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Device Name, Model | PureLift | NuFace® | Rejuvenique® |
| Indications for Use | PureLift is intended for<br>facial stimulation and<br>indicated for over-the-<br>counter cosmetic use. | The NuFace® Facial<br>Toning Device is<br>intended for facial<br>stimulation and is<br>indicated for over-the-<br>counter cosmetic use. | The Rejuvenique System<br>is indicated for cosmetic<br>use. |
| Technological<br>Characteristics | The PureLift is a<br>handheld device<br>intended for facial<br>stimulation. Its outer<br>case is injection molded<br>of thermoplastic resin<br>and the two probes<br>consist of chrome-plated<br>spheres. The device,<br>powered by a 3.7V<br>battery, produces<br>electrical impulses that<br>is transmitted through<br>the two fixed, smooth<br>spherical probes.<br>To turn the device on,<br>the push the on/off<br>button. An LCD screen<br>will be displayed,<br>indicating the unit is<br>ready for use. Users<br>then follow the<br>instructions for use. The<br>two probes gently glide | NuFace® is a Facial<br>Toning Device intended<br>for facial stimulation.<br>The device measures 7"<br>L x 2.5" W x 1" D. Its<br>outer case is injection<br>molded of thermoplastic<br>resin, ABS UL 94 HB, and<br>the output contacts<br>(probes) consist of<br>chrome-plated spheres.<br>The device, powered by<br>a 9-volt battery,<br>produces microcurrent<br>that is Discharged<br>through the two fixed,<br>smooth spherical<br>probes. To turn the<br>device on, the<br>thumbwheel is pushed<br>upwards. A Green LED<br>light will Then<br>illuminate, indicating the<br>unit is ready for use. | |
| Elements of<br>Comparison | PureLift | Predicate Device<br>NuFace<br>(K072260) | Reference Device<br>Rejuvenique<br>(K011935) |
| | over the skin to deliver<br>low-level electrical<br>impulses to strategic<br>locations on the face. | Users then follow the<br>instructions for use. The<br>two probes gently glide<br>over the skin to deliver<br>low-level electrical<br>impulses to strategic<br>locations on the face. | |
| Power Source | One 3.7 V Battery | One 9V Battery | Single 9V Battery |
| Number of output<br>modules | 1 | 1 | 1 |
| Number of output<br>channels | 1 output channel | 1 output channel | 1 output channel |
| Regulated current or<br>regulated Voltage? | Regulated current | Both | Regulated Voltage |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes |
| Automatic Shut off? | Yes | No | Yes |
| Patient override control? | No | No | No |
| Indicator Display | Yes | Yes | Yes |
| Timer range | 10 minutes only | No Timer | Fixed 16 minutes |
| Type of protection | Type BF | Type BF | Type BF |
| On/off status | Yes | Yes | Yes |
| Standards Compliance | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>IEC 60601-1-11 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | IEC 60601-1 |
| Biocompatibility | ISO 10993-5,-10 | ISO 10993-5,-10 | ISO 10993-5,-10 |
| Waveform | Pulsed Monophasic,<br>alternating polarity | Pulsed Monophasic | pulsed biphasic |
| Shape | Rectangular Pulses | Rectangular Pulses | Rectangular (+phase,<br>Spike(-phase) |
| Maximum output<br>voltage | 15Vpp (@500Ω)<br>23Vpp (@2kΩ)<br>34Vpp(@10kΩ) | 158 Mv @ 500Ω<br>780 Mv @ 2ΚΩ<br>2.6 V @ 10ΚΩ | 18.8V @ 500Ω<br>24.8V @ 2kΩ<br>28.0V @ 10kΩ |
| Maximum output<br>current | 7mA (@500Ω)<br>3.2mA(@2kΩ)<br>0.9mA(@10kΩ) | 0.223mA @ 500Ω | 37.6mA @ 500Ω<br>12.4mA @ 2ΚΩ<br>2.8mA @ 10ΚΩ |
| Output tolerance | +/- 1mA | +/- 10% | +/- 10% |
| Pulse Width | 4μs | 112ms | 300μs |
| Frequency (Hz) | 1.37kHz~1.73kHz | 8.39Hz | 8Hz |
| Symmetrical phases | Not multiphasic | Not Multiphasic | No |
| Phase duration | 4μs | Not determined | 300µs (+phase),<br>124.7ms (-phase,<br>exponential) |
| Elements of<br>Comparison | PureLift | Predicate Device<br>NuFace<br>(K072260) | Reference Device<br>Rejuvenique<br>(K011935) |
| Net Charge (μC per<br>pulsetrain) | 0μC per pulse train | 0 µC per pulsetrain | 0µC per pulsetrain |
| Maximum Phase Charge<br>(μC) | 4.52μC @ 500Ω | 18.13 µC @ 500Ω | 11.3μC @500Ω |
| Maximum current<br>Density (mA/cm²) | 6.8mA/cm² @ 500Ω | 0.341mA/cm² @ 500Ω | 46.4mA/cm² |
| Maximum Power<br>Density (μW/cm²) | 23800μW/cm² @ 500Ω | 3.02μW/cm² @ 500Ω | 2310.0μW/cm² |
| Pulses per burst | 30 | 21 | 160 pulses |
| Bursts per second | 2740 ~ 3460 | 9.1 | 1/240<br>(per electrode group) |
| Burst duration | 230μs | 2.3 seconds | 20 seconds |
| Duty cycle | 0.63 ~ 0.80 | 20.9 | 1/12 |
| ON Time (seconds) | Constant | Constant | 20 seconds/electrode<br>group |
| OFF Time (Seconds) | None | None | None |

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#### VII. PERFORMANCE DATA

Oscilloscope tracings, Vibration, Temperature, Push, Mold Stress, Markings, Mechanical Strength, Drop, Ball, Acoustic, and Accessible Parts tests were also conducted. The device passed or met the requirements of all testing.

#### Biocompatibility testing

The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

- Cytotoxicity
- Sensitization
- . Irritation

The subject device is considered tissue contacting for a duration of less than 24 hours. The device passed each test, and was found to not be cytotoxic, sensitizing, or irritating.

#### Electrical safety and electromagnetic compatibility (EMC)

Electricalsafety and EMC testing were conducted on the subject device. It was found to comply with the IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.

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## Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

#### VIII. CONCLUSIONS

The subject device is identical to the predicate in terms of intended use. The technical differences between subject and predicate were addressed using performance data. Thus, it is concluded that the PureLift is substantially equivalent to the predicate device.