(117 days)
Not Found
No
The device description and performance studies do not mention any AI or ML capabilities. The device appears to be a simple electrical stimulator with adjustable intensity.
No
The intended use explicitly states "over-the-counter cosmetic use," which does not fall under the definition of a therapeutic device.
No
The "Intended Use / Indications for Use" section states that the device is "Intended for facial stimulation and indicated for over-the-counter cosmetic use," which are not diagnostic purposes. The device description also focuses on applying electrical impulses for cosmetic use, not for detecting or identifying a medical condition.
No
The device description clearly details a physical, hand-held device with probes, a battery, and an outer case, indicating it is a hardware device, not software-only.
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 "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) to provide diagnostic information about a person's health or condition.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, diagnose, monitor, or predict any disease or medical condition.
- Performance Studies: The performance studies mentioned focus on conductivity of a serum and biocompatibility, which are relevant to a cosmetic device, not an IVD. There are no studies related to diagnostic accuracy or clinical performance in a diagnostic context.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function and intended use clearly fall outside of that definition.
N/A
Intended Use / Indications for Use
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 Pro Edition device is a hand-held device intended to apply electrical impulses to strategic locations on the face. The device probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allow 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 20.7cm (H) x 4.8cm (W) x 4.5cm (D). The outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device is powered by a 3.7-volt battery which produce a 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 of conductive gel.
The PureLift Pro Edition 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.
PureLift Pro Edition is provided with PureLift Activator Serum, a conductive gel.
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)
No new or repeat design verification or design validation was required to support the substantial equivalence of the PureLift Pro Edition stimulator.
An analysis of the conductivity testing of the PureLift Activator Serum was performed. The analysis demonstrated that the PureLift Activator Serum has similar conductivity as the Lectron II conductive gel.
Biocompatibility evaluations confirmed that the PureLift Activator Serum is non-cytotoxic, non-sensitizing, and non-irritating.
No new or repeat EMC or electrical safety testing was required to support the substantial equivalence of the PureLift Pro Edition.
No new or repeat software verification or validation testing was required to support the substantial equivalence of the PureLift Pro Edition.
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.
Not Found
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 21, 2023
Xtreem Pulse Jacqueline Schmainda Regulatory Consultant 353 W. 29th St., Suite 3 New York, New York 10001
Re: K230506
Trade/Device Name: PureLift Pro Edition Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: June 20, 2023 Received: June 21, 2023
Dear Jacqueline Schmainda:
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 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 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,
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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) K230506
Device Name PureLift Pro Edition
| Indications for Use (Describe) |
|---|
| -------------------------------- |
| Intended for facial stimulation and indicated for over-the-counter cosmetic use. |
|---|
| ---------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Submitter
| Applicant: | Xtreem Pulse
353 W. 29 St. Suite 3
New York, NY 10001
United States |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Persons: | Primary Correspondent
Jacqueline Schmainda
Regulatory Consultant
P: 763.269.2069
E: jaschmainda@gmail.com
Alternative Correspondent
Andrew Barile, CEO
Xtreem Pulse LLC
P: 917.597.5436
E: andrew@xtreempulse.com |
| Date Prepared: | June 21, 2023 |
| Device | |
| Trade Names: | PureLift Pro Edition |
| Classification Name: | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| FDA Panel: | Neurology |
| Regulatory Class: | Class II |
| Product Code: | NEO |
21 CFR 882.5890
Predicate Device
Regulation Number:
| Predicate
| Type | 510(k) | Device Name | Manufacturer |
|---|---|---|---|
| Primary | K221443 | PureLift Pro Plus | Xtreem Pulse, LLC |
| Secondary | K933804 | Lectron II Conductive Gel | Cadwell Laboratories, Inc. |
4
Device Description
PureLift Pro Edition
The PureLift Pro Edition device is a hand-held device intended to apply electrical impulses to strategic locations on the face. The device probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allow 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 20.7cm (H) x 4.8cm (W) x 4.5cm (D). The outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device is powered by a 3.7-volt battery which produce a 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 of conductive gel.
The PureLift Pro Edition 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.
Accessory
PureLift Pro Edition is provided with PureLift Activator Serum, a conductive gel.
Indications for Use
Intended for facial stimulation and indicated for over-the-counter cosmetic use.
Comparison of Technological Characteristics with the Predicate Device
A comparison of the intended use and technological characteristics of the PureLift products to the predicate PureLift device is provided in the following table:
| Element of
Comparison | PureLift Pro Plus
K221443 | PureLift Pro Plus Edition
K230506 – this submission |
|---------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Clearance Date | 21-Oct-2022 | TBD |
| Indications for Use | Intended for facial stimulation and
indicated for over-the-counter
cosmetic use. | Intended for facial stimulation and
indicated for over-the-counter
cosmetic use. |
| Dimensions (HxWxD) | 20.7cm x 4.8cm x 4.5cm | 20.7cm x 4.8cm x 4.5cm |
| Power Source | One 3.7V Battery | One 3.7V Battery |
| Number of output modes | 2 | 1 |
| Number of output channels | 1 output channel | 1 output channel |
| Regulated current or regulated
voltage? | Regulated current | Regulated current |
| Software/ Firmware/
Microprocessor
Control? | Yes | Yes |
| Automatic Shut off? | Yes | Yes |
| Element of | PureLift Pro Plus | PureLift Pro Plus Edition |
| Comparison | K221443 | K230506 - this submission |
| Patient override control? | No | No |
| Indicator Display | Yes | Yes |
| Timer range | 10 minutes only | 10 minutes only |
| Type of protection | Type BF | Type BF |
| On/off status | 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 |
| Biocompatibility | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 |
| Waveform | Pulses Monophasic, alternating
polarity | Pulses Monophasic, alternating
polarity |
| Shape | Rectangular Pulses | Rectangular Pulses |
| Maximum output voltage | 20Vpp(@500Ω)
32Vpp(@2kΩ)
44Vpp(@10kΩ) | 16.6Vpp(@500Ω)
27.0Vpp(@2kΩ)
38.4Vpp(@10kΩ) |
| Maximum output current | 9mA(@500Ω)
4.4mA(@2kΩ)
1.2mA(@10kΩ) | 7.7mA(@500Ω)
3.6mA(@2kΩ)
1.0mA(@10kΩ) |
| Output tolerance | +/- 1mA | +/- 1mA |
| Pulse Width | 4µs | 4µs |
| Frequency (Hz) | 1.37kHz1.73kHz | 1.37kHz1.73kHz |
| Symmetrical phases | Not multiphasic | Not multiphasic |
| Phase duration | 4µs | 4µs |
| Net Charge
(µC per pulse train) | 0µC per pulse train | 0µC per pulse train |
| Maximum Phase
Charge (µC) | 5.81µC@500Ω | 4.97µC@500Ω |
| Maximum current Density
(mA/cm2) | 8.8mA/cm2@500Ω | 7.5mA/cm2@500Ω |
| Maximum Power
Density | 39600µW/cm2 | 29250µW/cm2 |
| Pulse per burst | 30 pulses | 30 pulses |
| Bursts per second | 2740 ~ 3460 | 2740 ~ 3460 |
| Burst duration | 230µs | 230µs |
| Duty cycle | 0.63 ~ 0.80 | 0.63 ~ 0.80 |
| ON Time (seconds) | Constant | Constant |
5
6
A comparison of the PureLift Activator Serum accessory to the predicate conductive gel is provided in the following table:
| Element of
Comparison | PureLift Activator Serum (accessory)
K230506 – this submission | Lectron II Conductive Gel
K933804 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Intended Use | NA – the PureLift Activator Serum is only
intended for use with PureLift devices in
accordance with the intended use for these
devices. | NA – a 510(k) summary is not publicly
available. |
| Ingredients | Water, glycerin, chondus crispus extract
(seaweed), phenoxyethanol, sodium
hyaluronate, propylene glycol,
chrophenesin, ethylhexyglycerin, disodium
EDTA, sodium dehyroacetate, palmityl
tripeptide-5, citric acid | NA – a 510(k) summary is not publicly
available. |
| Performance
Testing | Comparisons to the Predicate Gel:
• Conductivity
• Maximum Voltage
• Maximum Current
• Frequency
• Pulse Width | Unknown |
| Biocompatibility | ISO 10993-5
ISO 10993-10 | NA - a 510(k) summary is not publicly
available. |
Performance Data
No new or repeat design verification or design validation was required to support the substantial equivalence of the PureLift Pro Edition stimulator.
An analysis of the conductivity testing of the PureLift Activator Serum was performed. The analysis demonstrated that the PureLift Activator Serum has similar conductivity as the Lectron II conductive gel.
Biocompatibility
No new or repeat biocompatibility testing was required to substantial equivalence of the PureLift Pro Edition stimulator.
The following biocompatibility evaluations of the PureLift Activator Serum were conducted:
- . ISO 10993-5, Cytotoxicity
- ISO 10993-10, Sensitization
- ISO 10993-10, Irritation
Biocompatibility evaluations confirmed that the PureLift Activator Serum is non-cytotoxic, non-sensitizing, and non-irritating.
Electrical safety and electromagnetic compatibility (EMC)
No new or repeat EMC or electrical safety testing was required to support the substantial equivalence of the PureLift Pro Edition.
7
Software verification and validation
No new or repeat software verification or validation testing was required to support the substantial equivalence of the PureLift Pro Edition.
Conclusions
The subject PureLift Pro Edition device is identical to the predicate device in terms of intended use and primary technological characteristics. Any differences between these devices were reviewed and confirmed to raise no new questions of safety or effectiveness. Additionally, the PureLift Activator Serum was assessed using performance data which confirmed that any differences between it and the predicate conductive gel did not raise new questions of safety or effectiveness. Thus, it is concluded that the PureLift Pro Edition is substantially equivalent to the predicate device.