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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

K011935

AUG = 8 2001

510(k) SUMMARY REJUVENIQUE® FACIAL TONING SYSTEM

Applicant/Address

Salton, Inc., 1955 W. Field Court, Lake Forest, IL 60045 ם

Contact Person/Telephone

Leon Dreimann, Chief Executive Officer, (PH) 847-803-4600 ext. 1200; (FAX) 847-803-1211

Preparation Date

2001 August 7, 2001

Device Trade Name

Rejuvenique® o

Classification Name

TENS Device(21 CFR 882.5890)

Legally Marketed Predicate Devices

a TENS devices.

Device Description

The Rejuvenique facial toning system consists of three connected components a face ם 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.

{1}------------------------------------------------

Intended Use

ロ Rejuvenique® is indicated for cosmetic use.

Substantial Equivalence Summary

O Rejuvenique® is substantially equivalent to legally marketed TENS devices.

Technological Characteristics

Basic Unit Characteristics

	1. Power Source(s):	Single 9V Battery
	2. Number of Output Modes:	1
3.	Number of Output Channels:	1 channel
	- Synchronous or Alternating?	Alternating into 12 electrode groups
	- Method of Channel Isolation	Electrode group selected by relays
	4. Regulated Current or Voltage?	Regulated Voltage
5.	Software/Firmware/Microprocessor Control?	Yes
	6. Automatic Overload Trip?	No
7.	Automatic No-Load Trip?	No
	8. Automatic Shut Off?	Yes
9.	Patient Override Control?	Yes
10. Indicator Display:
	- On/Off Status?	Yes
	- Low Battery?	Yes
	- Voltage/Current Level?	Yes, Uncalibrated Knob
	11. Timer Range (minutes)	Fixed 16 minutes
	12. Compliance with 21 CFR 898	Yes
	13. Weight	80 grams
	15. Dimensions (in.) [WxHxD]	4-1/2" x 3" x 1-1/4
	16. Housing Materials and Construction	ABS Plastic, snap latch assembly

Output Specifications

1. Waveform:	Pulsed Biphasic
2. Shape:	Rectangular (+ phase), Spike (- phase)
3. Maximum Output Voltage:	18.8V @ 500 Ohms
4. (+/- 10 %)	24.8V @ 2k Ohms
5.	28.0V @ 10k Ohms
6. Maximum Output Current:	37.6mA @ 500 Ohms
7. (+/- 10 %)	12.4mA @ 2k Ohms
8.	2.8mA @ 10k Ohms
9. Pulse Width	300 microseconds fixed
10. Frequency (Hz)	8 Hz fixed
11. Beat Frequency (Hz)	N/A
12. Symmetrical Phases	No

{2}------------------------------------------------

1. Phase Duration: (both phases, if asymmetrical)
Net Charge (microC per pulse) 14. (if zero, state method to achieve)
ાં રેં. Maximum Phase Charge, (microC)
Maximum Current Density 16.

300 microseconds (+ phase) 124.7 milliseconds (- phase, exponential) 0 @ 500 Ohms Transformer Coupling 11.3 microCoulombs @ 500 Ohms 46.4 mA/cm2 @ 500 Ohms

Sample Calculation:

Jmax = Imax/(pi * D2/4) = 37.6 mA/(3.1416 * (1.016 cm)^2 / 4) = 46.4 mA/cm2 Assumes only one electrode pair contacting. If both pairs make contact, Jmax is 23.2 mA/cm-

Maximum Power Density, (W/cm2) 17.

2.31 mW/cm2

Sample Calculation:

Pmax = Jmax * Vmax * 0.3 ms/125 ms + V- * J- * 2.8 ms/125 ms Pmax = 46.4 mA/cm2 * 18.8 * 0.0024 + 2.0V * 4.93 mA/cm2 * 0.0224 Pmax = 2.093 mW/cm2 + 0.221 mW/cm2 = 2.31 mW/cm2 First portion is positive phase, second is negative phase. Assumes negative Phase is square shaped with constant amplitude equal to initial negative spike. This slightly overestimates the power density of the negative phase.

Burst Mode: 18. 160 pulses a. Pulses per burst 1/240 (per electrode group) b. Bursts per second c. Burst duration 20 seconds d. Duty Cycle 1/12
On Time (Seconds) 19.

20 seconds/electrode group

Testing

Clinical efficacy and safety data was submitted in the application.

Conclusion

o Based on the foregoing, Salton believes the Rejuvenique® facial toning system is substantially equivalent to legally marketed predicate TENS devices.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Georgia C. Ravitz Counsel for Salton, Inc. Arent Fox Kinter Plotkin & Kahn, PLLC 1050 Connecticut Avenue, NW Washington, DC 20036-5339

Re: 510(k) Number K011935 Trade/Device Name: Rejuvenique® System, Model RJV-10 Regulation Numbers: 21 CFR 882.5890 and 21 CFR 882.1275 Regulatory Class: II Product Codes: NFO and GYB Dated: June 20, 2001 Received: June 21, 2001

Dear Ms. Ravitz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

AUG - 8 2001

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2 - Georgia C. Ravitz

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (2T CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

David C. Schultz, M.D.

Daniel G. Schultz, M.D. Deputy Director for Clinical and Review Policy Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page__1 __of__1

510(k) Number (if known): ___K011935

Device Name: Rejuvenique® System, Model RJV-10

Indications For Use:

The Rejuvenique System is indicated for cosmetic use.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Mullens

Collig35

Division Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number _

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).