(201 days)
No
The description focuses on electrical stimulation and user-adjustable settings, with no mention of AI or ML capabilities.
No
The device is intended for "over-the-counter cosmetic use" and "facial stimulation," which are not considered therapeutic purposes.
No
The device is described as being "intended for facial stimulation and indicated for over-the-counter cosmetic use" and applies "electrical impulses to strategic locations on the face" for cosmetic purposes, not for diagnosing any medical condition.
No
The device description clearly outlines physical hardware components including probes, an outer case, a battery, and an LCD screen, and mentions hardware-specific testing like mechanical strength and biocompatibility.
Based on the provided information, the PureLift device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "facial stimulation and indicated for over-the-counter cosmetic use." This is a cosmetic application, not a diagnostic one.
- Device Description: The device applies electrical impulses to the face for stimulation. It does not analyze biological samples (like blood, urine, or tissue) which is the core function of an IVD.
- Lack of Diagnostic Claims: There are no mentions of diagnosing, monitoring, or treating any disease or condition. The focus is on cosmetic improvement.
- Predicate Device: The predicate device (NuFace) and reference device (Rejuvenique) are also devices used for facial stimulation and cosmetic purposes, not IVDs.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The PureLift device does not fit this description.
N/A
Intended Use / Indications for Use
PureLift is intended for facial stimulation and indicated for over-the-counter cosmetic use.
Product codes (comma separated list FDA assigned to the subject device)
NFO
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter cosmetic use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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): Electrical safety 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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.
1
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
2
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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3
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
4
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
Comparison | PureLift | Predicate Device
NuFace
(K072260) | Reference Device
Rejuvenique
(K011935) |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Device Name, Model | PureLift | NuFace® | Rejuvenique® |
| Indications for Use | PureLift is intended for
facial stimulation and
indicated for over-the-
counter cosmetic use. | The NuFace® Facial
Toning Device is
intended for facial
stimulation and is
indicated for over-the-
counter cosmetic use. | The Rejuvenique System
is indicated for cosmetic
use. |
| Technological
Characteristics | The PureLift is a
handheld device
intended for facial
stimulation. Its outer
case is injection molded
of thermoplastic resin
and the two probes
consist of chrome-plated
spheres. The device,
powered by a 3.7V
battery, produces
electrical impulses that
is transmitted through
the two fixed, smooth
spherical probes.
To turn the device on,
the push the on/off
button. An LCD screen
will be displayed,
indicating the unit is
ready for use. Users
then follow the
instructions for use. The
two probes gently glide | NuFace® is a Facial
Toning Device intended
for facial stimulation.
The device measures 7"
L x 2.5" W x 1" D. Its
outer case is injection
molded of thermoplastic
resin, ABS UL 94 HB, and
the output contacts
(probes) consist of
chrome-plated spheres.
The device, powered by
a 9-volt battery,
produces microcurrent
that is Discharged
through the two fixed,
smooth spherical
probes. To turn the
device on, the
thumbwheel is pushed
upwards. A Green LED
light will Then
illuminate, indicating the
unit is ready for use. | |
| Elements of
Comparison | PureLift | Predicate Device
NuFace
(K072260) | Reference Device
Rejuvenique
(K011935) |
| | over the skin to deliver
low-level electrical
impulses to strategic
locations on the face. | 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. | |
| Power Source | One 3.7 V Battery | One 9V Battery | Single 9V Battery |
| Number of output
modules | 1 | 1 | 1 |
| Number of output
channels | 1 output channel | 1 output channel | 1 output channel |
| Regulated current or
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
IEC 60601-1-2
IEC 60601-2-10
IEC 60601-1-11 | IEC 60601-1
IEC 60601-1-2
IEC 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 output
voltage | 15Vpp (@500Ω)
23Vpp (@2kΩ)
34Vpp(@10kΩ) | 158 Mv @ 500Ω
780 Mv @ 2ΚΩ
2.6 V @ 10ΚΩ | 18.8V @ 500Ω
24.8V @ 2kΩ
28.0V @ 10kΩ |
| Maximum output
current | 7mA (@500Ω)
3.2mA(@2kΩ)
0.9mA(@10kΩ) | 0.223mA @ 500Ω | 37.6mA @ 500Ω
12.4mA @ 2ΚΩ
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),
124.7ms (-phase,
exponential) |
| Elements of
Comparison | PureLift | Predicate Device
NuFace
(K072260) | Reference Device
Rejuvenique
(K011935) |
| Net Charge (μC per
pulsetrain) | 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 current
Density (mA/cm²) | 6.8mA/cm² @ 500Ω | 0.341mA/cm² @ 500Ω | 46.4mA/cm² |
| Maximum Power
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
(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
group |
| OFF Time (Seconds) | None | None | None |
5
6
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.
7
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.