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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the PureLift Pro Plus, based on the provided FDA 510(k) summary:

This device is an electrical stimulator for aesthetic purposes, not an AI/ML device, so many of the requested fields (like those pertaining to AI model performance, human reader studies, or training sets) are not applicable (N/A) in this context. The acceptance criteria and performance data described relate to the safety and electrical/mechanical integrity of the physical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Standards Met	Reported Device Performance	Comments
Mechanical/Physical	Established design specifications	Met specifications	Verified through oscilloscope tracings, vibration, temperature, push, mold stress, markings, mechanical strength, drop, ball, and acoustic testing.
Biocompatibility	ISO 10993-1 (Cytotoxicity)	Passed	Not cytotoxic.
	ISO 10993-1 (Sensitization)	Passed	Not sensitizing.
	ISO 10993-1 (Irritation)	Passed	Not irritating.
Electrical Safety	ANSI/AAMI ES60601-1	Compliant
	IEC 60601-1-11	Compliant
	IEC 60601-2-10	Compliant
Electromagnetic Compatibility (EMC)	IEC 60601-1-2	Compliant
Software	Established design specifications	Met specifications	Verified through software verification and validation testing, assigned "moderate" level of concern.
Output Electrical Parameters (Comparison to Predicate/Reference)	Maximum output voltage/current within acceptable safety margins compared to predicate and reference, and below IEC standards for energy per second.	Verified as safe	Differences in voltage/current, phase charge, current density, and power density were evaluated and found not to adversely impact safety or effectiveness, remaining below thresholds for harm (e.g., 0.25 W/cm² for burn risk).

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated regarding a "test set" in the context of an algorithm. The testing described (mechanical, biocompatibility, electrical, software) would typically apply to representative device units from production, not a dataset of patient cases. The document implies performance testing was done on the device itself.
- Data Provenance: N/A for data provenance as it's not a data-driven device; the results are from laboratory testing of the physical hardware and software.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable, as this is not an AI/ML diagnostic or predictive device requiring expert interpretation of results to establish ground truth. The "ground truth" here is compliance with engineering standards and safety limits, which is assessed through defined testing procedures performed by qualified engineers/technicians.
- Qualifications of Experts: N/A.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. The "test set" in this context refers to physical device units undergoing compliance and safety testing, not a dataset requiring human adjudication of labels or interpretations.
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:
- MRMC Study: No. This device is a transcutaneous electrical nerve stimulator for aesthetic purposes, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. While the device has software/firmware control, its function is direct electrical stimulation, and it's not an algorithm providing a diagnostic or predictive output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: The ground truth for this device's performance is adherence to established engineering standards (e.g., IEC 60601 series, ISO 10993 series), design specifications, and safety limits. This is determined through objective measurements and validated test methods, not clinical outcomes or expert consensus on a disease state.
The sample size for the training set:
- Training Set Sample Size: Not applicable. This device does not use machine learning, so there is no "training set."
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. No training set is used.

Summary

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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

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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

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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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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

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V. INDICATIONS FOR USE

Intended for facial stimulation and indicated for over-the-counter cosmetic use.

Elements ofComparison	Subject DevicePureLift Pro PlusK221443	Predicate DevicePureLiftK190269	Reference DeviceRejuveniqueK011935
Indications for Use	Intended for facial stimulation and indicatedfor over-the-counter cosmetic use.	PureLift is intended for facial stimulation andindicated for over-the-counter cosmetic use.	Rejuvenique System isIndicated 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 outputmodes	2	1	1
Number of outputchannels	1 output channel	1 output channel	1 output channel
Regulated current orregulated voltage?	Regulated current	Regulated current	Regulated Voltage
Software/ Firmware/MicroprocessorControl?	Yes	Yes	Yes
Automatic Shut off?	Yes	Yes	Yes
Patient overridecontrol?	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 IEC60601-1-2IEC 60601-2-10IEC 60601-1-11	IEC 60601-1 IEC 60601-1-2IEC 60601-2-10IEC 60601-1-11	Not publicly available
Biocompatibility	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 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 outputvoltage	20Vpp(@500Ω)32Vpp(@2kΩ)44Vpp(@10kΩ)	15Vpp(@500Ω)23Vpp(@2kΩ)34Vpp(@10kΩ)	18.8V @ 500Ω24.8V @ 2kΩ28.0V @ 10kΩ
Maximum outputcurrent	9mA(@500Ω)4.4mA(@2kΩ)1.2mA(@10kΩ)	7mA(@500Ω)3.2mA(@2kΩ)0.9mA(@10kΩ)	37.6mA @ 500Ω12.4mA @ 2kΩ2.8mA @ 10kΩ
Output tolerance	+/- 1mA	+/- 1mA	+/- 10%
Pulse Width	4μs	4μs	300μs
Frequency (Hz)	1.37kHz~1.73kHz	1.37kHz~1.73kHz	8Hz fixed
Symmetrical phases	Not multiphasic	Not multiphasic	No
Phase duration	4μs	4μs	300µs (+phase)124.7ms (-phase,exponential)
Net Charge (µC perpulse train)	0µC per pulse train	0µC per pulse train	0μC @500Ω
Elements ofComparison	Subject Device	Predicate Device	Reference Device
	PureLift Pro Plus	PureLift	Rejuvenique
	K221443	K190269	K011935
Maximum PhaseCharge (μC)	5.81μC@500Ω	4.52μC@500Ω	11.3μC @500Ω
Maximum currentDensity (mA/cm²)	8.8mA/cm²@500Ω	6.8mA/cm²@500Ω	46.4mA/cm² @500Ω
Maximum PowerDensity	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

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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.

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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.

Regulation Number and Section

§ 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).