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510(k) Data Aggregation
(102 days)
GESKE Beauty Tech GmbH
SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
SmartAppGuided™ MicroCurrent Face-Lift Pen| 6 in 1 is an over-the-counter stimulation device. Its enclosure is injection-molded thermoplastic resin with silicone embedded in it. The output contacts consist of an electrode composed of chrome-plated or titanium- gold plated sphere. The device is powered by a rechargeable lithium-ion battery and cannot be used while charging. The device produces microcurrent that is discharged through two fixed, smooth spherical electrodes, and it has 3 current intensity levels that can be adjusted by pressing the on/off button on the device. Press the on/off button to turn on the device, and two spherical electrodes provide low-level electrical pulses to the target position of the face, and when the EMS function is turned on, the vibration function is also turned on simultaneously; The device spheres are designed for optimal contact with facial skin. The device delivers microcurrent as a constant biphasic square wave comprised of 10 positive pulses followed by 10 negative pulses. The microcurrent output continuously alternates between the positive and negative spherical electrodes.
The provided FDA 510(k) clearance letter and summary for the SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 focuses on establishing substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. It does not contain information about acceptance criteria for performance related to its cosmetic claims, nor does it detail a study that proves the device meets such criteria.
The document confirms that clinical performance data and animal studies were not required for this submission. The assessments conducted were primarily for safety and electrical characteristics to ensure the device is as safe and effective as its predicate devices, rather than measuring the cosmetic effect of the device itself.
Therefore, the following information, based on the provided text, will reflect the absence of specific acceptance criteria or studies related to cosmetic performance, and will focus on the safety and technical compliance criteria.
Acceptance Criteria and Study Proving Device Meets Criteria for SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1
The provided FDA 510(k) submission primarily focuses on establishing the substantial equivalence of the SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 to predicate devices concerning safety and technical characteristics. The document does not specify acceptance criteria related to its cosmetic effects (e.g., face-lift efficacy) or include a clinical study designed to demonstrate performance against such cosmetic criteria.
The acceptance criteria mentioned are related to electrical and mechanical safety, electromagnetic compatibility, software validation, and biocompatibility, ensuring the device is safe for its intended use as an over-the-counter stimulation device for cosmetic use.
1. A table of acceptance criteria and the reported device performance
Since specific performance acceptance criteria for cosmetic "face-lift" efficacy are not detailed in the provided document, the table below focuses on the reported technical performance and compliance with relevant safety standards. The "Acceptance Criteria" are implied by the standards the device claims compliance with and the comparisons to predicate devices.
| Acceptance Criteria (Implied by Compliance Standards & Predicate Comparison) | Reported Device Performance |
|---|---|
| Electrical Safety & Basic Performance (IEC 60601-1) | Compliant. Bench testing and third-party accredited laboratory evaluation confirmed waveform and output energy characteristics meet intended specifications and national/international standards. |
| EMC (IEC 60601-1-2) | Compliant. Device tested and demonstrated compliance. |
| Home Use Medical Devices (IEC 60601-1-11) | Compliant. Device tested and demonstrated compliance. |
| Nerve & Muscle Stimulators (IEC 60601-2-10) | Compliant. Third-party accredited laboratory evaluated the device in accordance with this standard. Output current, voltage, and current density are within established safety limits and compared favorably to predicate devices. Max output current (760μA@500Ω) and Max current density (0.56mA/cm² @ 500Ω) are significantly lower than standard limits (50mA and 2 mA/cm² respectively). |
| Biocompatibility (ISO 10993-1, -5, -10, -12, -23) | Compliant. Biocompatibility evaluation performed for patient-contacting components (housing materials, spheres), showing no adverse skin reactions. |
| Ingress Protection (IEC 60529) | Compliant. Device tested and demonstrated compliance. |
| Usability Engineering (IEC 62366) | Compliant. Device tested and demonstrated compliance. Feedback mechanisms (tactile and sound) address lack of visual indicator. |
| Risk Management (ISO 14971) | Compliant. Device tested and demonstrated compliance. Substantial reduction in maximum power density compared to some predicates minimizes thermal/electrical injury risk. |
| Software Verification & Validation | All testing conducted as recommended by FDA guidance. Software classified as "basic" level of concern. |
| Maximum Output Voltage | 25.2VDC (No Load). Lower than some predicates (28VDC), considered safe. |
| Maximum Output Current | 760μA@500Ω. Falls between predicate devices (400 μA and 900 μA) and well below the IEC 60601-2-10 limit of 50mA. |
| Maximum Output Current Density | 0.56mA/cm² @ 500Ω. Slightly higher than some predicates but significantly lower than Predicate Device 3 (8.8 mA/cm²) and the IEC 60601-2-10 noted trigger level of 2 mA/cm². |
| Maximum Power Density | 151 μW/cm². Significantly lower than Predicate 2 (4.18 mW/cm²) and Predicate 3 (39,600 μW/cm²), considered a safety advantage. |
| Maximum Phase Charge | 45.6 μC@500Ω. Higher due to longer pulse width, but offset by lower output current and balanced biphasic waveform for zero net output, operating within safety limits. |
2. Sample size used for the test set and the data provenance
The document specifies "production-equivalent devices" were used for bench testing. It does not provide a specific sample size (N=?) for these test devices.
The data provenance is based on internal testing conducted by GESKE Beauty Tech GmbH and evaluation by a "third-party accredited laboratory." The country of origin for these tests is not explicitly stated, but the submitter is based in Berlin, Germany. The testing described is prospective in nature, as it involves newly conducted tests on the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish a "ground truth" for any performance claims related to cosmetic efficacy. The "ground truth" for the technical and safety performance is established by compliance with international standards (e.g., IEC, ISO) and comparison to legally marketed predicate devices, which are assessed by regulatory bodies. The qualifications of personnel conducting the internal and third-party laboratory tests are implied by their accreditation to perform such standards-based evaluations, but specific expert details are not provided.
4. Adjudication method for the test set
No adjudication method (e.g., 2+1, 3+1) is described, as the testing focuses on objective measurements against engineering specifications and compliance with recognized safety standards, rather than subjective interpretation or consensus-based clinical assessments.
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 MRMC comparative effectiveness study was conducted. The device is a direct-to-consumer electrical stimulation device, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improving with AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study focused on cosmetic efficacy (e.g., "face-lifting" ability) was not conducted or reported. The "standalone" performance here refers to the device's technical specifications and safety compliance, which were evaluated in bench tests and by a third-party laboratory without human interaction for performance claims beyond safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is primarily defined by:
- Compliance with international standards: (e.g., IEC 60601 series, ISO 10993 series, ISO 14971, IEC 60529, IEC 62366, etc.) for electrical safety, EMC, biocompatibility, usability, and risk management.
- Technical specifications: Measurements of output characteristics (voltage, current, density, waveform) against design tolerances.
- Substantial equivalence to predicate devices: Comparing its technical characteristics and safety profile to legally marketed devices.
There is no mention of ground truth established by expert consensus, pathology, or cosmetic outcomes data for the device's "face-lift" claims in this 510(k) summary.
8. The sample size for the training set
This device is not an AI/machine learning device that requires a "training set." Therefore, this information is not applicable.
9. How the ground truth for the training set was established
This information is not applicable as the device does not utilize a training set in the context of AI/machine learning.
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