(378 days)
The Facial Spa is intended for the stimulation of healthy facial skin.
The Facial Spa is indicated for facial stimulation for over-the-counter cosmetic use.
The Facial Spa is a hand-held, battery-powered device used with conductive treatment gel to stimulate the face with microcurrents.
Here's a breakdown of the acceptance criteria and study information for the Nu Skin Facial Spa, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission is for substantial equivalence, meaning the device does not have explicit "acceptance criteria" for performance in the typical sense of a novel device. Instead, the "acceptance criteria" are compliance with relevant standards and demonstrating equivalence to a predicate device. The "reported device performance" is a direct comparison of its technical specifications to the predicate.
| Feature / Criterion | Acceptance (Predicate Standard) | Reported Nu Skin Facial Spa Performance | Meets Criteria? |
|---|---|---|---|
| General Compliance | |||
| IEC 60601-1 (Basic Safety) | Conforms | Conforms | Yes |
| IEC 60601-1-2 (EMC) | Conforms | Conforms | Yes |
| IEC 60601-2-10 (Nerve Stim. Safety) | Conforms | Conforms | Yes |
| IEC 60601-1-4 (PEMS Safety) | Conforms | Conforms | Yes |
| ISO 10993-10 (Irritation/Sens.) | Conforms | Conforms | Yes |
| ISO 10993-12 (Sample Prep) | Conforms | Conforms | Yes |
| 21 C.F.R. § 898 (Radiation Safety) | Conforms | Conforms | Yes |
| Substantial Equivalence (Comparison to Predicate: NuFace® Plus) | |||
| Regulation Number | 21 C.F.R. § 882.5890 | 21 C.F.R. § 882.5890 | Yes |
| Regulation Name | Transcutaneous Electrical Nerve Stimulator | Transcutaneous Electrical Nerve Stimulator | Yes |
| Regulatory Class | Class II | Class II | Yes |
| Product Code | NFO | NFO | Yes |
| Intended Use | Stimulate the face | Stimulate the face | Yes |
| Indications for Use | Over-the-counter Cosmetic Use | Over-the-counter Cosmetic Use | Yes |
| Power Source | Battery operated | Battery operated | Yes |
| Average DC current (No pulse) | 0 | 0 | Yes |
| Number of output channels | 1 | 1 | Yes |
| Microprocessor controlled | Yes | Yes (PLC) | Yes |
| Automatic no-load trip | Yes | Yes | Yes |
| Automatic shut off | Yes | Yes | Yes |
| User over-ride control | Yes | Yes | Yes |
| Indicator Display (On/off) | Yes | Yes | Yes |
| Indicator Display (Low-battery) | Yes | Yes | Yes |
| On Time (seconds) | Constant | Constant | Yes |
| Off Time (seconds) | None | None | Yes |
| Maximum Output Voltage (@ 500 Ω) | 137 mV | Mode 1: 188 mV (214 mV), Mode 2: 189 mV (225 mV), Mode 3: 185 mV (220 mV), Mode 4: 184 mV (212 mV), Mode 5: 184 mV (213 mV) (Higher than predicate, but within expected variation for a similar device) | Likely Yes |
| Maximum Output Voltage (@ 2k Ω) | 769 mV | Mode 1: 722 mV (1527 mV), Mode 2: 746 mV (812 mV), Mode 3: 735 mV (815 mV), Mode 4: 740 mV (802 mV), Mode 5: 741 mV (801 mV) (Varied, some higher, some lower, likely acceptable for equivalence) | Likely Yes |
| Maximum Output Voltage (@ 10k Ω) | 3.82 V | Mode 1: 2.626 V (2.978 V), Mode 2: 3.787 V (4.011 V), Mode 3: 3.747 V (4.014 V), Mode 4: 3.503 V (3.980 V), Mode 5: 3.729 V (3.980 V) (Varied, some higher, some lower, likely acceptable for equivalence) | Likely Yes |
| Maximum Output Current (@ 500 Ω) | 274 uA | Mode 1: 376 uA (427 uA), Mode 2: 379 uA (449 uA), Mode 3: 371 uA (440 uA), Mode 4: 368 uA (424 uA), Mode 5: 369 uA (427 uA) (Higher than predicate, but within expected variation for a similar device) | Likely Yes |
| Maximum Output Current (@ 2k Ω) | 387 uA | Mode 1: 361 uA (763 uA), Mode 2: 373 uA (406 uA), Mode 3: 367 uA (407 uA), Mode 4: 370 uA (401 uA), Mode 5: 370 uA (400 uA) (Varied, some higher, some lower, likely acceptable for equivalence) | Likely Yes |
| Maximum Output Current (@ 10k Ω) | 383 uA | Mode 1: 362 uA (398 uA), Mode 2: 379 uA (401 uA), Mode 3: 375 uA (401 uA), Mode 4: 350 uA (398 uA), Mode 5: 373 uA (398 uA) (Varied, some higher, some lower, likely acceptable for equivalence) | Likely Yes |
| Waveform | Pulsed Monophasic | Direct Current | Difference |
| Weight | 9 oz | 120 g (approx. 4 oz) | Difference |
| Dimensions | 3" x 5.25" x 1.25" | Facial Spa with Large Conductor: 143 x 31.2 x 67.5 mm (5.6" x 1.2" x 2.7") Facial Spa with Small Conductor: 136 x 31.2 x 67.5 mm (5.4" x 1.2" x 2.7") | Difference |
| Housing material and construction | Thermo Plastic | ABS, Chrome plated ABS, rubber (elastomer) | Difference |
Note on "Meets Criteria?": For 510(k)s, "meeting criteria" often means being acceptably similar or having differences that don't raise new questions of safety or effectiveness. The FDA conclusion states that the technological differences do not raise new questions of safety or effectiveness, thus deeming it substantially equivalent.
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of clinical performance or algorithm evaluation with a specific sample size. This is a 510(k) submission based on substantial equivalence to a predicate device, primarily through engineering and technical comparisons and compliance with recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The submission focuses on technical specifications and adherence to safety standards, not on evaluating diagnostic accuracy requiring expert consensus on a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in this 510(k).
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
Not applicable. This device is a transcutaneous electrical nerve stimulator for cosmetic facial stimulation, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware device, not an algorithm, and its performance is evaluated based on its physical properties and adherence to electrical safety and biocompatibility standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this submission, the "ground truth" implicitly refers to:
- Recognized Standards: The published requirements of standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-4, ISO 10993-10, ISO 10993-12, and 21 C.F.R. § 898.
- Predicate Device Specifications: The established design and performance parameters of the legally marketed predicate device, NuFace® Plus (K103472), which serves as the benchmark for substantial equivalence.
8. The sample size for the training set
Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
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Page 1
| 510(k) Summary | |
|---|---|
| Submission Date: | Prepared September 4, 2012, updated September 17, 2013 |
| Submitter Information: | |
| Company Name: | Nu Skin Enterprises, Inc. |
| Company Address: | 75 West Center StreetProvo, UT 84601 |
| Contact Person: | Tyler Whitehead |
| SEP 17 2013 | |
| Device Information: | |
| Trade Name: | Facial Spa |
| Common Name: | Facial Toning Device |
| Classification Name: | Transcutaneous electrical nerve stimulator 21 CFR 882.5890 |
| Regulation Class: | Class II |
| Product Code: | NFO |
| Predicate Devices: | NuFace® Plus (K103472)Carol Cole CompanyClass II |
| Device Description: | The Facial Spa is a hand-held, battery-powered device used withconductive treatment gel to stimulate the face with microcurrents. |
| Intended Use: | The Facial Spa is intended for the stimulation of healthy facialskin. |
| Indications for Use: | The Facial Spa is indicated for facial stimulation for over-the-counter cosmetic use. |
| Compliance Data: | The Facial Spa conforms to the applicable requirements of thefollowing standards: |
| • IEC 60601-1 Issued: 1998/01/01 Ed: 2 Medical electricalequipment - Part 1: General requirements for basic safetyand essential performance; Amendment 1-1991,Amendment 2-1995, Corrigendum - 1995 |
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- . IEC 60601-1-2 Issued 2012/06/01 Ed: 3 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-2-10 Issued:1987/01/01 Ed:1 Medical Electrical . Equipment Part 2: Particular Requirements for the Safety of Nerve and Muscle Stimulators
- IEC 60601-1-4 Issued: 2000/04/01 Ed:1.1 Medical . Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems Consolidated with Amd. 1:1999
- ISO ISO10993-10 / Ed.3, Biological evaluation of medical . devices - Part 10: Tests for irritation and skin sensitization
- . ISO 10993-12 Biological evaluation of medical devices -Part 12: Sample Preparation and Reference Material
Comparison to Predicate Device:
The Facial Spa is identical to its predicate device in intended use and indications for use. It uses the same technological principle as the predicate device to accomplish its intended use, namely transcutaneous electrical stimulation. Both are hand-held, batterypowered devices. The present device raises no new questions of safety or effectiveness. A technical comparison of the two devices has been completed and supports a substantial equivalence determination.
Table: Comparison of Nu Skin Facial Spa and Carol Cole NuFace® Plus
| Features | Nu Skin Facial Spa (Subject Device) | Carol Cole NuFace® Plus (Predicate Device) |
|---|---|---|
| Similarities | ||
| Regulation Number | 21 C.F.R. § 882.5890 | 21 C.F.R. § 882.5890 |
| Regulation Name | Transcutaneous ElectricalNerve Stimulator | Transcutaneous ElectricalNerve Stimulator |
| Regulatory Class | Class II | Class II |
| Product Code | NFO | NFO |
| Intended Use | Stimulate the face | Stimulate the face |
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Traditional 510(k) Premarket Notification Nu Skin Facial Spa
| Indications for Use | Over-the-Counter CosmeticUse | Over-the-Counter CosmeticUse |
|---|---|---|
| Power Source | Battery operated | Battery operated |
| Average DC current throughelectrodes when device is onbut no pulse being applied | 0 | 0 |
| Number of output channels | 1 | 1 |
| Microprocessor controlled | Yes (PLC) | Yes |
| Automatic no-load trip | Yes | Yes |
| Automatic shut off | Yes | Yes |
| User over-ride control | Yes | Yes |
| Indicator Display | ||
| On/off | Yes | Yes |
| Low-battery | Yes | Yes |
| On Time (seconds) | Constant | Constant |
| Off Time (seconds) | None | None |
| Compliance with VoluntaryStandards | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 |
| Compliance with21 C.F.R. § 898 | Yes | Yes |
| Differences |
| Differences . " | ﻟ | ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ | ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ | ﺎનું | : | |
|---|---|---|---|---|---|---|
| :� | 19 17, | ﻳr | 1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ysi | .7 |
| Modes | One to Five | One |
|---|---|---|
| Maximum Output Voltage | @ 500 Ω | @ 500 Ω |
| Mode 1: 188 mV (214 mV) | 137 mV | |
| Mode 2: 189 mV (225 mV) | ||
| Mode 3: 185 mV (220 mV) | ||
| Mode 4: 184 mV (212 mV) | ||
| Mode 5: 184 mV (213 mV) | ||
| @ 2k Ω | @ 2k Ω | |
| Mode 1: 722 mV (1527 mV) | 769 mV | |
| Mode 2: 746 mV (812 mV) | ||
| Mode 3: 735 mV (815 mV) | ||
| Mode 4: 740 mV (802 mV) | ||
| Mode 5: 741 mV (801 mV) | ||
| @ 10 k Ω | @ 10 k Ω | |
| Mode 1: 2.626 V (2.978 V) | 3.82 V | |
| Mode 2: 3.787 V (4.011 V) | ||
| Mode 3: 3.747 V (4.014 V) | ||
| Mode 4: 3.503 V (3.980 V) | ||
| Mode 5: 3.729 V (3.980 V) |
Page 3
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Traditional 510(k) Premarket Notification Nu Skin Facial Spa
Page 4
| Maximum Output Current | @ 500 ΩMode 1: 376 uA (427 uA)Mode 2: 379 uA (449 uA)Mode 3: 371 uA (440 uA)Mode 4: 368 uA (424 uA)Mode 5: 369 uA (427 uA)@ 2 kΩMode 1: 361 uA (763 uA)Mode 2: 373 uA (406 uA)Mode 3: 367 uA (407 uA)Mode 4: 370 uA (401 uA)Mode 5: 370 uA (400 uA)@ 10 kΩMode 1: 362 uA (398 uA)Mode 2: 379 uA (401 uA)Mode 3: 375 uA (401 uA)Mode 4: 350 uA (398 uA)Mode 5: 373 uA (398 uA) | @ 500 Ω274 uA@ 2 kΩ387 uA@ 10 kΩ383 uA |
|---|---|---|
| Waveform | Direct Current | Pulsed Monophasic |
| Weight | 120 g (approx. 4 oz) | 9 oz |
| Dimensions | Facial Spa with LargeConductor: 143 x 31.2 x 67.5 mm (5.6" x 1.2" x 2.7")Facial Spa with SmallConductor: 136 x 31.2 x 67.5 mm (5.4" x 1.2" x 2.7") | 3" x 5.25" x 1.25" |
| Housing material andconstruction | ABS, Chrome platedABS, rubber (elastomer) | Thermo Plastic |
Conclusion:
.
The Facial Spa is substantially equivalent to the predicate device, as the devices share a common intended use, and technological differences between the Facial Spa and the predicate do not raise new questions of safety or effectiveness.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
September 17, 2013
NuSkin Enterprises, Inc. C/O Paul D. Rubin Ropes & Gray LLP One Metro Center 700 12th Street, Suite 900 Washington, DC 20005
Re: K122711
Trade/Device Name: NuSkin Facial Spa Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator Regulatory Class: Class II Product Code: NFO Dated: September 4, 2013 Received: September 4, 2013
Dear Mr. Rubin,
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{5}------------------------------------------------
Page 2 -- Mr. Paul Rubin
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name:_ NuSkin Facial Spa
Indications For Use:
The Facial Spa is indicated for facial stimulation for over-the-counter cosmetic use.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M.J nd -S
Page 1 of _ 1
§ 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).