(48 days)
The Rejuvenique® System is indicated for cosmetic use.
The Rejuvenique facial toning system consists of three connected components a face mask, connecting cable and control unit. The mask is a PBC mask that is shaped to fit over the user's face. It is held on the user's face by an adjustable headband. It contains 26 fixed-position, gold plated, brass electrodes. The connecting cable is an 8-conducter cable in a PVC jacket. It connects the face mask to the control unit by modular, phone jack-style plugs on each end. The Control Unit contains the power-source ( a nine-volt battery), and the microprocessor control. When the Rejuvenique® system is activated, it provides a stimulus to the first pair of electrodes for 20 seconds, and then the microprocessor automatically switches to the next pair of electrodes in the sequence. The Facial Point Location Display indicates which pair of electrodes are currently activated (1-12). A full cycle through the 12 pairs of electrodes requires approximately 4 minutes. Unless stopped by the user the product will go through four complete cycles (approximately 20 minutes), and then automatically shuts off.
Acceptance Criteria and Device Performance for Rejuvenique® Facial Toning System (K011935)
The provided document describes the Rejuvenique® Facial Toning System, a device indicated for cosmetic use. It seeks substantial equivalence to existing Transcutaneous Electrical Nerve Stimulation (TENS) devices. The document does not present specific performance-based acceptance criteria for a clinical claim to improve the appearance of the face (e.g., reduction in wrinkles, toning effects). Instead, it focuses on demonstrating that the device's technological characteristics and safety profile are substantially equivalent to legally marketed TENS devices.
The "clinical efficacy and safety data" mentioned is briefly stated as "submitted in the application" but no details of the study design, results, or acceptance criteria met by this data are provided within the publicly available document. Therefore, a comprehensive table of acceptance criteria and device performance based on a cosmetic efficacy claim cannot be constructed from this submission.
However, based on the principle of substantial equivalence to TENS devices, the implicit "acceptance criteria" revolved around adherence to the technological and safety characteristics commonly associated with TENS devices and demonstrating that the Rejuvenique® system operated within those established parameters.
Here are the details derived from the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) submission, the "acceptance criteria" are implied by the technological specifications presented for comparison against predicate TENS devices, and the "reported device performance" refers to the Rejuvenique® system's measured characteristics. There are no explicit performance targets for cosmetic efficacy stated.
| Acceptance Criterion (Implicit for TENS Equivalence) | Reported Device Performance (Rejuvenique® System) |
|---|---|
| Power Source: Single 9V Battery compatible | Single 9V Battery |
| Number of Output Modes: Typical for TENS | 1 |
| Number of Output Channels: Typical for TENS | 1 channel, alternating into 12 electrode groups |
| Channel Isolation: Method for TENS | Electrode group selected by relays |
| Regulated Output: Current or Voltage | Regulated Voltage |
| Software/Firmware/Microprocessor Control: Yes/No | Yes |
| Automatic Overload Trip: Common safety feature | No |
| Automatic No-Load Trip: Common safety feature | No |
| Automatic Shut Off: Common safety feature | Yes (after ~20 minutes/4 cycles) |
| Patient Override Control: Common safety feature | Yes |
| Indicator Displays: On/Off, Low Battery, Level | Yes (On/Off, Low Battery, Uncalibrated Knob) |
| Timer Range: Typical for TENS sessions | Fixed 16 minutes (implied operational session) |
| Compliance with 21 CFR 898: Yes | Yes |
| Waveform: Pulsed Biphasic | Pulsed Biphasic |
| Shape: Typical Rectangular/Spike | Rectangular (+ phase), Spike (- phase) |
| Maximum Output Voltage: Within TENS range | 18.8V @ 500 Ohms, 24.8V @ 2k Ohms, 28.0V @ 10k Ohms |
| Maximum Output Current: Within TENS range | 37.6mA @ 500 Ohms, 12.4mA @ 2k Ohms, 2.8mA @ 10k Ohms |
| Pulse Width: Typical for TENS | 300 microseconds fixed |
| Frequency: Typical for TENS | 8 Hz fixed |
| Symmetrical Phases: Not necessarily | No |
| Phase Duration: Reported | 300 microseconds (+ phase), 124.7 milliseconds (- phase, exponential) |
| Net Charge per pulse: Zero for TENS | 0 @ 500 Ohms (Transformer Coupling) |
| Maximum Phase Charge: Reported | 11.3 microCoulombs @ 500 Ohms |
| Maximum Current Density: Calculated | 46.4 mA/cm2 @ 500 Ohms |
| Maximum Power Density: Calculated | 2.31 mW/cm2 |
| Burst Mode characteristics: If applicable | Pulses per burst: 160; Bursts per second: 1/240; Burst duration: 20 seconds; Duty Cycle: 1/12 |
| On Time: Reported for duty cycle | 20 seconds/electrode group |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical efficacy and safety data was submitted in the application."
- Sample Size: This detail is not provided in the summary.
- Data Provenance: This detail is not provided in the summary. It is unknown if the data was retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the summary. The type of "clinical efficacy and safety data" submitted is not detailed, nor is the method by which ground truth for any cosmetic claim might have been established. Given the device seeks equivalence as a TENS device for "cosmetic use," the ground truth for safety would likely be against established TENS safety profiles and general electrical safety standards, rather than expert evaluation of a cosmetic outcome.
4. Adjudication Method for the Test Set
This information is not provided in the summary. Without details on the "clinical efficacy and safety data," it's impossible to know if an adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or implied in the document. This type of study is typically used for diagnostic or screening devices where human readers interpret results (e.g., radiology images). The Rejuvenique® System is a therapy/toning device, not a diagnostic one.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The concept of a "standalone" performance study (algorithm only) is not applicable to this device in the traditional sense, as it is a physical electrical stimulation device intended for direct user application, not an AI algorithm generating interpretations. Its performance relates to its electrical output parameters and user experience, not an algorithmic assessment.
7. The Type of Ground Truth Used
The document indicates "clinical efficacy and safety data was submitted." However, the specific type of ground truth used for "efficacy" related to cosmetic use is not detailed. For safety, the ground truth would typically be based on adverse event reporting and compliance with electrical safety standards. For "cosmetic use," without further detail, it's speculative but could involve:
- Subjective User Surveys/Self-assessment: Common in cosmetic product evaluations.
- Expert Consensus (e.g., dermatologists): Evaluation of before/after images for visible improvements.
- Objective Measurements: Skin elasticity, wrinkle depth measurements, etc.
However, the provided summary does not specify which, if any, of these methods were used. The primary ground truth for its regulatory clearance seems to be its substantive equivalence to existing TENS devices in terms of electrical output characteristics and intended mechanism of action (electrical stimulation) for non-medical cosmetic purposes, thereby inheriting the established safety and general efficacy profile of TENS.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI/ML algorithm that requires a separate "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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).