(117 days)
Intended for facial stimulation and indicated for over-the-counter cosmetic use.
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.
This document is a 510(k) premarket notification for the PureLift Pro Edition device. It states that no new performance data was required to establish substantial equivalence for the main device. However, performance data was generated for the PureLift Activator Serum, an accessory conductive gel, to demonstrate its equivalence to a predicate conductive gel.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
For the PureLift Pro Edition device itself, the document explicitly states: "No new or repeat design verification or design validation was required to support the substantial equivalence of the PureLift Pro Edition stimulator." This implies that the acceptance criteria for the device itself were based on its identity to the predicate device in terms of intended use and primary technological characteristics, and no new performance data was thus generated in this submission.
For the PureLift Activator Serum (accessory conductive gel), the acceptance criteria and performance are indicated in the "Performance Testing" section.
| Acceptance Criteria (for PureLift Activator Serum) | Reported Device Performance (PureLift Activator Serum) |
|---|---|
| Similar Conductivity to Predicate Gel | "The analysis demonstrated that the PureLift Activator Serum has similar conductivity as the Lectron II conductive gel." |
| Biocompatibility (Non-cytotoxic) | "Biocompatibility evaluations confirmed that the PureLift Activator Serum is non-cytotoxic..." (based on ISO 10993-5) |
| Biocompatibility (Non-sensitizing) | "...non-sensitizing..." (based on ISO 10993-10) |
| Biocompatibility (Non-irritating) | "...and non-irritating." (based on ISO 10993-10) |
| Max Voltage (similar to predicate) | Listed as "Comparisons to the Predicate Gel: • Maximum Voltage" in the performance testing section, indicating it was compared, but no specific value or "acceptance criteria" for similarity is explicitly stated as a numerical threshold in this document. The conclusion is that differences "did not raise new questions of safety or effectiveness." |
| Max Current (similar to predicate) | Listed as "Comparisons to the Predicate Gel: • Maximum Current" in the performance testing section, indicating it was compared, but no specific value or "acceptance criteria" for similarity is explicitly stated as a numerical threshold in this document. |
| Frequency (similar to predicate) | Listed as "Comparisons to the Predicate Gel: • Frequency" in the performance testing section, indicating it was compared, but no specific value or "acceptance criteria" for similarity is explicitly stated as a numerical threshold in this document. |
| Pulse Width (similar to predicate) | Listed as "Comparisons to the Predicate Gel: • Pulse Width" in the performance testing section, indicating it was compared, but no specific value or "acceptance criteria" for similarity is explicitly stated as a numerical threshold in this document. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not provide details on sample sizes for the conductivity analysis or biocompatibility testing of the PureLift Activator Serum. It broadly states "An analysis of the conductivity testing... was performed" and "Biocompatibility evaluations... were conducted."
The data provenance is not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The performance data for the PureLift Activator Serum (conductivity and biocompatibility) would typically be generated through laboratory testing, not through expert consensus on a test set in the way a diagnostic AI product might be evaluated.
4. Adjudication Method for the Test Set
Not applicable. This type of adjudication (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation or expert scoring, which is not the case for the reported performance data for this device or its accessory.
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. An MRMC comparative effectiveness study is not mentioned. This type of study is relevant for AI-powered diagnostic or assistive technologies, which the PureLift Pro Edition (a transcutaneous electrical nerve stimulator for cosmetic facial stimulation) is not. The submission is a 510(k) for a physical device, and the "AI" or "firmware" mentioned is likely internal control software, not an AI for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not applicable or performed, as this device is a physical stimulator and not an AI algorithm for data interpretation. The software/firmware is for controlling the device's electrical impulses.
7. The Type of Ground Truth Used
For the PureLift Activator Serum:
- Conductivity: The ground truth would be the measured conductivity values themselves, compared against the predicate gel's measured conductivity.
- Biocompatibility: The ground truth is established through standardized biological evaluations (ISO 10993-5 for cytotoxicity, ISO 10993-10 for sensitization and irritation), producing objective results based on cellular or tissue responses.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that undergoes a training phase with a "training set" of data in the common machine learning sense. The device is a hardware product.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this device.
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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
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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
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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)
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Submitter
| Applicant: | Xtreem Pulse353 W. 29 St. Suite 3New York, NY 10001United States |
|---|---|
| Contact Persons: | Primary CorrespondentJacqueline SchmaindaRegulatory ConsultantP: 763.269.2069E: jaschmainda@gmail.comAlternative CorrespondentAndrew Barile, CEOXtreem Pulse LLCP: 917.597.5436E: 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:
| PredicateType | 510(k) | Device Name | Manufacturer |
|---|---|---|---|
| Primary | K221443 | PureLift Pro Plus | Xtreem Pulse, LLC |
| Secondary | K933804 | Lectron II Conductive Gel | Cadwell Laboratories, Inc. |
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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 ofComparison | PureLift Pro PlusK221443 | PureLift Pro Plus EditionK230506 – this submission |
|---|---|---|
| Clearance Date | 21-Oct-2022 | TBD |
| Indications for Use | Intended for facial stimulation andindicated for over-the-countercosmetic use. | Intended for facial stimulation andindicated for over-the-countercosmetic 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 regulatedvoltage? | Regulated current | Regulated current |
| Software/ Firmware/MicroprocessorControl? | 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 ES60601-1IEC 60601-1-2IEC 60601-2-10IEC 60601-1-11 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10IEC 60601-1-11 |
| Biocompatibility | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 |
| Waveform | Pulses Monophasic, alternatingpolarity | Pulses Monophasic, alternatingpolarity |
| 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) | 1.37kHz~1.73kHz | 1.37kHz~1.73kHz |
| 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 PhaseCharge (µC) | 5.81µC@500Ω | 4.97µC@500Ω |
| Maximum current Density(mA/cm2) | 8.8mA/cm2@500Ω | 7.5mA/cm2@500Ω |
| Maximum PowerDensity | 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 |
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A comparison of the PureLift Activator Serum accessory to the predicate conductive gel is provided in the following table:
| Element ofComparison | PureLift Activator Serum (accessory)K230506 – this submission | Lectron II Conductive GelK933804 |
|---|---|---|
| Intended Use | NA – the PureLift Activator Serum is onlyintended for use with PureLift devices inaccordance with the intended use for thesedevices. | NA – a 510(k) summary is not publiclyavailable. |
| Ingredients | Water, glycerin, chondus crispus extract(seaweed), phenoxyethanol, sodiumhyaluronate, propylene glycol,chrophenesin, ethylhexyglycerin, disodiumEDTA, sodium dehyroacetate, palmityltripeptide-5, citric acid | NA – a 510(k) summary is not publiclyavailable. |
| PerformanceTesting | Comparisons to the Predicate Gel:• Conductivity• Maximum Voltage• Maximum Current• Frequency• Pulse Width | Unknown |
| Biocompatibility | ISO 10993-5ISO 10993-10 | NA - a 510(k) summary is not publiclyavailable. |
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.
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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.
§ 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).