(156 days)
No
The 510(k) summary does not mention AI or ML, and the device description focuses on basic electrical stimulation and user-adjustable settings.
No.
The intended use explicitly states "over-the-counter cosmetic use," not therapeutic use.
No
The device is intended for facial stimulation and cosmetic use, not for diagnosing medical conditions.
No
The device description explicitly details physical components like probes, a battery, an outer case, and mentions hardware testing (vibration, temperature, drop, etc.) in the performance studies section. While software verification and validation are mentioned, the device is clearly a physical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "Intended for facial stimulation and indicated for-over-the counter cosmetic use." This describes a device used on the body for cosmetic purposes, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a hand-held device that applies electrical impulses to the face. This aligns with a cosmetic or therapeutic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
Therefore, the PureLift Pro Plus, as described, falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended for facial stimulation and indicated for over-the-counter cosmetic use.
Product codes
NFO
Device Description
The PureLift Pro Plus is a hand-held device intended to apply electrical impulses to strategic locations on the face. The PureLift Pro Plus 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 (10).
The device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (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 the green LED light will illuminate 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 with the use of conductive gel.
The PureLift Pro Plus 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 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 testing was conducted. The test results confirmed that the device met established design specifications.
Biocompatibility evaluations for the subject device were conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA, and included:
- 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 not be cytotoxic, sensitizing, or irritating.
Electrical safety and EMC testing were conducted on the subject device. It was found to comply with the ANSI/AAMI ES60601-1, 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 was conducted and confirmed that the device met established design specifications and conforms to the user needs. The software was assigned a "moderate" level of concern.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States.
October 21, 2022
Xtreem Pulse LLC Andrew Barile CEO 353 W. 29 St. Suite 3 New York, New York 10001
Re: K221443
Trade/Device Name: PureLift Pro Plus Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: September 22, 2022 Received: September 23, 2022
Dear Andrew Barile:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation 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) K221443
Device Name PureLift Pro Plus
Indications for Use (Describe) 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
| I. SUBMITTER | |
|---|---|
| Applicant: | XTREEM PULSE LLC |
| 353 W. 29 ST. SUITE 3 | |
| NEW YORK, NY 10001 | |
| UNITED STATES | |
| Contact Persons: | Jacqueline Schmainda |
| Regulatory Consultant | |
| P: 763.269.2069 | |
| E: jaschmainda@gmail.com | |
| Andrew Barile, CEO | |
| Xtreem Pulse LLC | |
| P: 917.597.5436 | |
| E: andrew@xtreempulse.com | |
| Date Prepared: | October 20, 2022 |
| II. DEVICE | |
| Name of Device: | PureLift Pro Plus |
| Classification Name: | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Regulatory Class: | Class II |
| Product Code: | NFO |
| Regulation Number: | 21 CFR 882.5890 |
| III. PREDICATE DEVICE | |
| Primary Predicate Device: | PureLift |
| Manufacturer: | Xtreem Pulse LLC |
| 510(k) Number: | K190269 |
| Reference Device: | Rejuvenique Model (RJV-10) |
| Manufacturer: | Salton, Inc. |
| 510(k) Number: | K011935 |
IV. DEVICE DESCRIPTION
The PureLift Pro Plus is a hand-held device intended to apply electrical impulses to strategic locations on the face. The PureLift Pro Plus 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 (10).
The device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (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 the green LED light will illuminate 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 with the use of conductive gel.
The PureLift Pro Plus 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.
4
V. INDICATIONS FOR USE
Intended for facial stimulation and indicated for over-the-counter cosmetic use.
| Elements of
Comparison | Subject Device
PureLift Pro Plus
K221443 | Predicate Device
PureLift
K190269 | Reference Device
Rejuvenique
K011935 |
|---------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Indications for Use | Intended for facial stimulation and indicated
for over-the-counter cosmetic use. | PureLift is intended for facial stimulation and
indicated for over-the-counter cosmetic use. | Rejuvenique System is
Indicated for cosmetic use. |
| Dimensions (HxWxD) | 20.7cm x 4.8cm x 4.5cm | 13.4in x 4.8in x 4.3in | 3in x 4½in x 1½in |
| Power Source | One 3.7V Battery | One 3.7V Battery | One 9V Battery |
| Number of output
modes | 2 | 1 | 1 |
| Number of output
channels | 1 output channel | 1 output channel | 1 output channel |
| Regulated current or
regulated voltage? | Regulated current | Regulated current | Regulated Voltage |
| Software/ Firmware/
Microprocessor
Control? | Yes | Yes | Yes |
| Automatic Shut off? | Yes | Yes | Yes |
| Patient override
control? | No | No | Yes |
| Indicator Display | Yes | Yes | Yes |
| Timer range | 10 minutes only | 10 minutes only | 16 min fixed |
| Type of protection | Type BF | Type BF | Not publicly available |
| On/off status | Yes | Yes | Yes |
| Standards Compliance | ANSI/AAMI ES60601-1 IEC
60601-1-2
IEC 60601-2-10
IEC 60601-1-11 | IEC 60601-1 IEC 60601-1-2
IEC 60601-2-10
IEC 60601-1-11 | Not publicly available |
| Biocompatibility | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | Not publicly available |
| Waveform | Pulses Monophasic,
alternating polarity | Pulses Monophasic,
alternating polarity | Pulsed biphasic |
| Shape | Rectangular Pulses | Rectangular Pulses | Rectangular (+phase)
Spike (-phase) |
| Maximum output
voltage | 20Vpp(@500Ω)
32Vpp(@2kΩ)
44Vpp(@10kΩ) | 15Vpp(@500Ω)
23Vpp(@2kΩ)
34Vpp(@10kΩ) | 18.8V @ 500Ω
24.8V @ 2kΩ
28.0V @ 10kΩ |
| Maximum output
current | 9mA(@500Ω)
4.4mA(@2kΩ)
1.2mA(@10kΩ) | 7mA(@500Ω)
3.2mA(@2kΩ)
0.9mA(@10kΩ) | 37.6mA @ 500Ω
12.4mA @ 2kΩ
2.8mA @ 10kΩ |
| Output tolerance | +/- 1mA | +/- 1mA | +/- 10% |
| Pulse Width | 4μs | 4μs | 300μs |
| Frequency (Hz) | 1.37kHz1.73kHz | 1.37kHz1.73kHz | 8Hz fixed |
| Symmetrical phases | Not multiphasic | Not multiphasic | No |
| Phase duration | 4μs | 4μs | 300µs (+phase)
124.7ms (-phase,
exponential) |
| Net Charge (µC per
pulse train) | 0µC per pulse train | 0µC per pulse train | 0μC @500Ω |
| Elements of
Comparison | Subject Device | Predicate Device | Reference Device |
| | PureLift Pro Plus | PureLift | Rejuvenique |
| | K221443 | K190269 | K011935 |
| Maximum Phase
Charge (μC) | 5.81μC@500Ω | 4.52μC@500Ω | 11.3μC @500Ω |
| Maximum current
Density (mA/cm²) | 8.8mA/cm²@500Ω | 6.8mA/cm²@500Ω | 46.4mA/cm² @500Ω |
| Maximum Power
Density | 39600μW/cm² | 23800μW/cm² | 2.31 mW/cm² |
| Pulse per burst | 30 pulses | 30 pulses | 160 pulses |
| Bursts per second | 2740 ~ 3460 | 2740 ~ 3460 | 1/240 (per electrode group) |
| Burst duration | 230µs | 230µs | 20 seconds |
| Duty cycle | 0.63 ~ 0.80 | 0.63 ~ 0.80 | 1/12 |
| ON Time (seconds) | Constant | Constant | 20 seconds/electrode group |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
5
The following technological differences exist between the subject and predicate devices:
- Dimensions: As compared to the predicate PureLift device, the PureLift Pro Plus device has a increased height and depth; however, the shape and dimensions of the two fixed, smooth spherical probes located at the distal end of the device remain unchanged. These spheres represent the active part of the device that provides facial stimulation. The device's overall dimensional differences do not alter the manner in which the device is intended to be used nor does it introduce a usability issue. The device's hourglass shape is intended to aid in holding the device as opposed to the predicate PureLift device which was designed with a more oval shape. As such, the dimensional modification does not adversely impact the safety or effectiveness of the device.
- . Maximum output voltage/ current: The maximum output voltage and maximum output current values for the PureLift Pro Plus device are slightly higher than the predicate PureLift device; however, the energy per second, which is calculated by the output voltage and current for the PureLift Pro Plus device is much lower than the reference device as well as the value specified by the IEC standards. Additionally, the energy for total 10 minutes for the PureLift is slightly higher than the PureLift predicate device but much lower than the reference device. The difference of the maximum output voltage and maximum output current between the PureLift Pro Plus and both the predicate and reference devices does not adversely impact the safety or effectiveness of the device.
- Maximum phase charge (μC): Maximum phase charge is slightly different between the PureLift Pro Plus device and the predicate PureLift device; however, the value is much lower than the reference device indicating substantial equivalence. The difference in value does not increase the risk of skin burn or other injury nor does it raise new questions safety or effectiveness.
- Maximum current density (mA/cm²): The maximum current density of the PureLift Pro Plus device is much lower than the reference device and the difference does not adversely influence safety or effectiveness.
- . Maximum power density (μW/cm²): The maximum power density of the PureLift Pro Plus device is slightly larger than the PureLift predicate and reference devices. However, this value is slightly lower than 0.25W/cm² which is described as a threshold for reducing the risk of burn in FDA's guidance document for powered muscle stimulators. As such, there is no increased risk of injury or new questions of safety or effectiveness.
6
VII. PERFORMANCE DATA
Oscilloscope tracings, vibration, temperature, push, mold stress, markings, mechanical strength, drop, ball, acoustic, and accessible parts testing was conducted. The test results confirmed that the device met established design specifications.
Biocompatibility testing
Biocompatibility evaluations for the subject device were conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA, and included:
- 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 not be cytotoxic, sensitizing, orirritating.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject device. It was found to comply with the ANSI/AAMI ES60601-1, 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 was conducted and confirmed that the device met established design specifications and conforms to the user needs. The software was assigned a "moderate" level of concern.
VIII. CONCLUSIONS
The subject device is identical to the predicate in terms of intended use. The technological differences between the subject and predicate device were addressed using performance data and confirmed that differences did not raise new questions of safety or effectiveness. Thus, it is concluded that the PureLift Pro Plus is substantially equivalent to the predicate device.