(201 days)
PureLift is intended for facial stimulation and indicated for over-the-counter cosmetic use.
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 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.
The provided document is a 510(k) summary for the PureLift device, a transcutaneous electrical nerve stimulator for aesthetic purposes. However, it does not contain a study that directly proves the device meets specific acceptance criteria for its intended cosmetic use (facial stimulation for over-the-counter cosmetic use).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (NuFace K072260 and reference device Rejuvenique K011935) by comparing technological characteristics and presenting results of various safety and performance tests. These tests are primarily designed to ensure the device is safe and functions as intended from an engineering and biocompatibility standpoint, rather than proving its cosmetic efficacy against specific clinical acceptance criteria.
Therefore, many of the requested details, such as sample size for test sets directly assessing cosmetic efficacy, expert-established ground truth for cosmetic outcomes, MRMC studies, or standalone performance for cosmetic claims, are not present in this regulatory submission.
Here's an attempt to answer the questions based only on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for cosmetic efficacy experiments or performance directly related to its "facial stimulation" claim. Instead, it details various engineering and safety tests and states that the device "passed or met the requirements of all testing." The table below will reflect the tests conducted and their outcomes as reported.
| Acceptance Criteria (Stated as "Requirements") | Reported Device Performance |
|---|---|
| Biocompatibility | |
| - Cytotoxicity (passed) | Not cytotoxic |
| - Sensitization (passed) | Not sensitizing |
| - Irritation (passed) | Not irritating |
| Electrical Safety | |
| - Compliance with IEC 60601-1 | Complied |
| - Compliance with IEC 60601-1-11 | Complied |
| - Compliance with IEC 60601-2-10 | Complied |
| Electromagnetic Compatibility (EMC) | |
| - Compliance with IEC 60601-1-2 | Complied |
| Software Verification & Validation | |
| - Per FDA Guidance (moderate level of concern) | Testing conducted and documentation provided as recommended. |
| Additional Physical/Mechanical Tests | |
| - Oscilloscope tracings | Passed/Met requirements |
| - Vibration | Passed/Met requirements |
| - Temperature | Passed/Met requirements |
| - Push | Passed/Met requirements |
| - Mold Stress | Passed/Met requirements |
| - Markings | Passed/Met requirements |
| - Mechanical Strength | Passed/Met requirements |
| - Drop | Passed/Met requirements |
| - Ball | Passed/Met requirements |
| - Acoustic | Passed/Met requirements |
| - Accessible Parts | Passed/Met requirements |
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 mentions various tests (biocompatibility, electrical safety, EMC, software V&V, and other physical/mechanical tests) but does not specify the sample size for these tests. For biocompatibility, it states "The subject device is considered tissue contacting for a duration of less than 24 hours," which refers to the classification of contact, not a sample size.
The data provenance (country of origin, retrospective/prospective) is not provided. These are typically laboratory tests performed on device units.
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 provided as the regulatory submission focuses on engineering, safety, and performance standards rather than clinical efficacy studies requiring expert evaluation of "ground truth" for cosmetic outcomes. The "ground truth" for the tests mentioned (e.g., biocompatibility or electrical safety) would be established by the testing standards themselves and laboratory measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for clinical studies with subjective endpoints, which are not detailed in this 510(k) summary for engineering and safety tests.
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 MRMC comparative effectiveness study was done and therefore no effect size for human improvement with AI assistance is reported. This device is a direct-to-consumer electrical stimulator, not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the PureLift device is a physical electromedical device for facial stimulation, not an AI algorithm. Software verification and validation were performed for the device's control software, but this is distinct from AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the reported performance data:
- Biocompatibility: The ground truth is established by adherence to ISO 10993 standards and the results of laboratory tests (cytotoxicity, sensitization, irritation) which provide objective measures against established biological criteria.
- Electrical safety and EMC: The ground truth is established by compliance with IEC 60601 series standards, using objective measurements against specified electrical and electromagnetic limits.
- Software Verification and Validation: The ground truth is established by adherence to FDA guidance for software in medical devices, typically involving testing against software requirements and design specifications.
- Other physical/mechanical tests: The ground truth is established by meeting engineering specifications and performance limits for durability, function, etc.
For the cosmetic use indication, the document does not describe any studies that would establish a specific "ground truth" for cosmetic outcomes like facial toning or appearance improvement. The 510(k) process focuses on substantial equivalence based on technical characteristics and safety, assuming the predicate's indications are well-established.
8. The sample size for the training set
This information is not applicable/not provided. The device is a physical electrical stimulator, not a machine learning model that requires a training set for an algorithm.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated in point 8.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 | |
| (757) 582-4337 | |
| ralexander@iuvoconsulting.com |
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 ofComparison | PureLift | Predicate DeviceNuFace(K072260) | Reference DeviceRejuvenique(K011935) |
|---|---|---|---|
| Device Name, Model | PureLift | NuFace® | Rejuvenique® |
| Indications for Use | PureLift is intended forfacial stimulation andindicated for over-the-counter cosmetic use. | The NuFace® FacialToning Device isintended for facialstimulation and isindicated for over-the-counter cosmetic use. | The Rejuvenique Systemis indicated for cosmeticuse. |
| TechnologicalCharacteristics | The PureLift is ahandheld deviceintended for facialstimulation. Its outercase is injection moldedof thermoplastic resinand the two probesconsist of chrome-platedspheres. The device,powered by a 3.7Vbattery, produceselectrical impulses thatis transmitted throughthe two fixed, smoothspherical probes.To turn the device on,the push the on/offbutton. An LCD screenwill be displayed,indicating the unit isready for use. Usersthen follow theinstructions for use. Thetwo probes gently glide | NuFace® is a FacialToning Device intendedfor facial stimulation.The device measures 7"L x 2.5" W x 1" D. Itsouter case is injectionmolded of thermoplasticresin, ABS UL 94 HB, andthe output contacts(probes) consist ofchrome-plated spheres.The device, powered bya 9-volt battery,produces microcurrentthat is Dischargedthrough the two fixed,smooth sphericalprobes. To turn thedevice on, thethumbwheel is pushedupwards. A Green LEDlight will Thenilluminate, indicating theunit is ready for use. | |
| Elements ofComparison | PureLift | Predicate DeviceNuFace(K072260) | Reference DeviceRejuvenique(K011935) |
| over the skin to deliverlow-level electricalimpulses to strategiclocations on the face. | Users then follow theinstructions for use. Thetwo probes gently glideover the skin to deliverlow-level electricalimpulses to strategiclocations on the face. | ||
| Power Source | One 3.7 V Battery | One 9V Battery | Single 9V Battery |
| Number of outputmodules | 1 | 1 | 1 |
| Number of outputchannels | 1 output channel | 1 output channel | 1 output channel |
| Regulated current orregulated 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 60601-1IEC 60601-1-2IEC 60601-2-10IEC 60601-1-11 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | IEC 60601-1 |
| Biocompatibility | ISO 10993-5,-10 | ISO 10993-5,-10 | ISO 10993-5,-10 |
| Waveform | Pulsed Monophasic,alternating polarity | Pulsed Monophasic | pulsed biphasic |
| Shape | Rectangular Pulses | Rectangular Pulses | Rectangular (+phase,Spike(-phase) |
| Maximum outputvoltage | 15Vpp (@500Ω)23Vpp (@2kΩ)34Vpp(@10kΩ) | 158 Mv @ 500Ω780 Mv @ 2ΚΩ2.6 V @ 10ΚΩ | 18.8V @ 500Ω24.8V @ 2kΩ28.0V @ 10kΩ |
| Maximum outputcurrent | 7mA (@500Ω)3.2mA(@2kΩ)0.9mA(@10kΩ) | 0.223mA @ 500Ω | 37.6mA @ 500Ω12.4mA @ 2ΚΩ2.8mA @ 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),124.7ms (-phase,exponential) |
| Elements ofComparison | PureLift | Predicate DeviceNuFace(K072260) | Reference DeviceRejuvenique(K011935) |
| Net Charge (μC perpulsetrain) | 0μC per pulse train | 0 µC per pulsetrain | 0µC per pulsetrain |
| Maximum Phase Charge(μC) | 4.52μC @ 500Ω | 18.13 µC @ 500Ω | 11.3μC @500Ω |
| Maximum currentDensity (mA/cm²) | 6.8mA/cm² @ 500Ω | 0.341mA/cm² @ 500Ω | 46.4mA/cm² |
| Maximum PowerDensity (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(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/electrodegroup |
| 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.
§ 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).