The Galvanic Spa (Model: SKB-1405) is intended for facial stimulation and is indicated for over-the-counter cosmetic use. The anatomical site for application of the Galvanic Spa is the face.

Device Description

Galvanic Spa, Model: SKB-1405 is a non-invasive facial toning device intended for facial stimulation. It produces micro-current discharged through the dual probes that are designed for optimal contact with faces of all shapes and sizes.Micro-current is an aesthetic modality providing electric current in millionths of an ampere and has the ability to increase facial contour and firm the skin and muscles by supplying 0-390 μΑ.

Galvanic Spa, Model: SKB-1405 is not for use on injured or otherwise impaired skin or muscles, and in any therapy for the treatment, or prevention of any disease. This device is not for use near any devices with Electromagnetic Interference (EMI). This device must only be used for the purpose stated - namely for the stimulation of facial muscles as indicated in the instruction manual for personal beauty purposes. All other uses shall be deemed improper.

AI/ML Overview

The provided text is a 510(k) summary for the "Galvanic Spa, Model: SKB-1405" device. It focuses on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific acceptance criteria through a clinical study or performance study with a test set, ground truth, or expert readers in the context of AI/machine learning.

Therefore, most of the information requested in your prompt (acceptance criteria, details of a study using a test set, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, training set information) is not present in this type of regulatory submission for this particular device.

This document primarily addresses:

Device Description and Intended Use: The Galvanic Spa is a non-invasive facial toning device intended for facial stimulation for over-the-counter cosmetic use.
Comparison to a Predicate Device: The core of the submission is to show substantial equivalence to the NūFACE® Plus device (K103472).
Bench Testing and Compliance with Standards: The document mentions various bench tests conducted to ensure safety and performance, such as electrical safety tests (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility tests (IEC 60601-1-2), software verification and validation, and waveform tests.
Biocompatibility Testing: Details are provided for cytotoxicity, skin sensitization, and skin irritation tests for patient-contacting materials (electrodes made of stainless steel).

The prompt's questions are designed for a situation where a new AI/ML-driven medical device is being evaluated for its diagnostic or prognostic performance against a ground truth, often involving human readers. This document describes a physical electrical stimulation device that does not perform such functions, and as such, the type of "study" described in the prompt is not applicable here.

Here's a breakdown of why the requested information is largely absent or not applicable:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (as would be understood for an AI/ML device): Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" for this device are demonstrated by compliance with general safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2), biocompatibility standards (ISO 10993-5, ISO 10993-10), and substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety.
- Reported Device Performance: The performance is reported in terms of physical characteristics (e.g., maximum output current, voltage, pulse duration, frequency), and compliance with the aforementioned safety and biocompatibility standards. There are no performance metrics related to diagnostic accuracy or AI/ML output.
Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of AI/ML evaluation. The safety and performance are evaluated through bench testing (measuring electrical characteristics, checking biocompatibility, etc.) and comparison to a known safe and effective predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts in the sense of image interpretation or clinical diagnosis for this device type.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is not an AI-assisted diagnostic device requiring human reader comparison studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrical stimulator, not an algorithm. Its "standalone" performance is its electrical output and safety, which is evaluated through bench testing.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device is compliance with engineering specifications, safety standards, and observed physical/electrical properties of the device, attested through various lab tests.
The sample size for the training set: Not applicable. This device does not use machine learning, so there is no training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (Transcutaneous Electrical Nerve Stimulator for Pain Relief, specifically for cosmetic facial stimulation) seeking 510(k) clearance by demonstrating substantial equivalence. It is not an AI/ML device, and therefore the framework of questions you've posed is not suitable for describing its "acceptance criteria" and "study" in the way you intend for AI/ML products.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 2, 2017

ShenZhen Siken 3D Technology Development Co., Ltd. % Mr. Jet Li Manager Guangzhou LETA Testing Technology Co., Ltd 6f, No.1 TianTai Road, Science City, LuoGang District GuangZhou, CN

Re: K163470

Trade/Device Name: Galvanic Spa, Model: SKB-1405 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NFO Dated: May 9, 2017 Received: May 15, 2017

Dear Mr. Jet Li:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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

Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163470

Device Name Galvanic Spa, Model: SKB-1405

Indications for Use (Describe)

The Galvanic Spa (Model: SKB-1405) is intended for facial stimulation and is indicated for over-the-counter cosmetic use. The anatomical site for application of the Galvanic Spa is the face.

Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Chapter 6. 510(k) Summary

Date of the summary prepared: May 1, 2017

510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

� Company Name: ShenZhen Siken 3D Technology Development Co.,Ltd.
� Address: Siken Industrial Park, East Avenue No.33 Songgang Street,Baoan District,Shenzhen,Guangdong,China
Phone: 0755-27697523 �
Fax: 0755-27697514 �
Contact Person (including title): Kimi xue �
E-mail: sales06@siken3d.com �

Subject Device Information 2.

Galvanic Spa, Model: SKB-1405 � Trade Name:
Galvanic Spa � Common Name:
Stimulator, Transcutaneous Electrical, Aesthetic Purposes Classification name: �
Neurology, Physical Medicine Review Panel: �
NFO Product Code: �
2 Regulation Class: �
882.5890 Regulation Number: �

Predicate Device Information 3.

Sponsor	Carol Cole Company
Device Name	NūFACE® Plus
510(k) Number	K103472
Product Code	NFO
Regulation Number	882.5890

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Sponsor:	ShenZhen Siken 3D Technology Development Co.,Ltd.
Subject Device:	Galvanic Spa,Model: SKB-1405
File No.:	510(k) submission report (V1.0), Chapter 6 510(k) Summary
Regulation Class	2

4. Device Description

5. Intended Use / Indications for Use

The Galvanic Spa (Model: SKB-1405) is intended for facial stimulation and is indicated for over thecounter cosmetic use. The anatomical site for application of the Galvanic Spa is the face.

6.Design

Galvanic Spa, Model: SKB-1405 is intended for facial stimulation.It has one treatment mode which is micro-current mode.It produces micro-current discharged through the dual probes.The device measures 3.2" L x 6.5" W x 2.2" D. Its two output contacts are made by stainless steel. The device is powered by 3.7V Li-battery,and there are 4 output intensity levels which can be indicated by four LED lamps in the head of device.

7. Materials

There is one kind of patient directly contracting component in the subject device as the following list.

Component of DeviceRequiringBiocompatibility	Material ofComponent	Body ContactCategory(ISO 10993-1)	Contact Duration(ISO 10993-1)
Electrodes	Stainless steel	Surface-contactingdevice: skin	Maximum 2 hours(< 24hours)

(Note: The "Massage Head" described in the biocompatibility test reports is mean the electrodes, they are the same part of the device.)

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Sponsor: ShenZhen Siken 3D Technology Development Co.,Ltd. Galvanic Spa,Model: SKB-1405 Subject Device: File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

The Nature of body contact is surface, skin contact. And the contact duration is less than 24 hours. According to Table 1 - Initial evaluation tests for consideration in ISO 10993-1, the applicable biological effect is:

� Cytotoxicity
� Sensitization
� Irritation or intracutaneous reactivity

1. Cytotoxicity Test

(1) Test Method

MTT Method in ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for In Vitro

cytotoxicity, Edition 3.0, 2009;

(2) Passing Criteria

As our subject device is only for limited skin contacting, we set the criteria for NON-TOXIC to be "no more than Grade 2" according to United States Pharmacopoeia.

(3) Test Result

The Cytotoxicity test result showed the device had no toxicity to L929 cell. The test result is passed the criteria.

2. Skin Sensitization Test

(1) Test Method
Guinea Pig Maximization Test in ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, Edition 3.0, 2010;

(2) Passing Criteria

As our subject device is for limited skin contacting, we set the criteria to be "Grade 0" according to United States Pharmacopoeia.

(3) Test Result
The Skin Sensitization test result for device is Grade 0. The test result is passed the criteria.

3. Skin Irritation Test

(1) Test Method

0.9% Sodium Chlorid Injection and Sesame oil Extract in ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, Edition 3.0, 2010;

(2) Passing Criteria

As our subject device is for limited skin contacting, we set the criteria to be "0-0.4 for Irritation Index" according to United States Pharmacopoeia.

(3) Test Result

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The Skin Irritation test results for Component is 0 for Irritation Index. The test result is passed the criteria.

8.Physical characteristics

Basic Unit Characteristics
Power Source	3.7V Li-battery
Method of Line Current Isolation	Type BF Applied Part
Patient leakage current	Comply with IEC 60601-1 and IEC 60601-2-10
- Normal Condition	--
- Single Fault Condition	--
Average DC current through electrodes when device is on but no pulses are being applied	0A
Number of channels	1
Number of modes	1
Output Intensity Level	4
Regulated Current or Regulated Voltage?	Current Control
Software/Firmware/Microprocessor Control?	Yes
Automatic Overload Trip?	Yes
Automatic No-Load Trip?	Yes
Automatic Shut Off?	Yes
User Override Control?	Yes
Indicator	Indicates on/off status, low battery, LED of mode information, intensity level information.
Time Range (minutes)	No
Compliance with Voluntary Standards	YesComply with IEC 60601-1 and IEC 60601-2-10, IEC 60601-1-2
Compliance* with 21 CFR 898	Yes
Main Unit Weight	248g
Accessories Weight	Charger Adapter: 180g
Main Unit Dimension	3.2" L x 6.5" W x 2.2" D
Charger lead wire length	1.6m
Housing Materials of main unit	Electrodes made from stainless steel.
Accessories Materials	Plastic
Micro-Current Mode Specification
Waveform and Shape	Pulsed, symmetric biphasic, rectangular
Maximum Output Voltage (+/- 10%)	156mV @ 500Ω0.78V @ 2kΩ
	2.6V @ 10kΩ
Maximum Output Current (+/- 10%)	0.31mA @ 500Ω0.39mA @ 2kΩ0.26mA @ 10kΩ
Net Charge (per pulse)	0 mC @500Ω
Phase Charge	17.1 μC @ 500Ω
Maximum Current Density	0.274mA/cm²@500Ω (The Electrode Size: 1.13 cm²)
Maximum Power Density	42.5μW/cm²@500Ω(The Electrode Size:1.13cm²)
Pulse Width	55 ms
Pulse Duration	110 ms
Frequency	9.09 Hz±10 %
Contraction and Relaxation Time	Due to different modes. (See below "Program Specification Table")
Additional Features
Environment for operation	Temperature: 5 ~ 40°CHumidity: ≤ 80% RH
Environment for storage	Temperature: 0 ~ 45°CHumidity: ≤ 93% RH

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Sponsor: ShenZhen Siken 3D Technology Development Co.,Ltd. Subject Device: Galvanic Spa,Model: SKB-1405 File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

9. Test Summary

Galvanic Spa, Model: SKB-1405 has been evaluated the safety and performance by lab bench testing as following:

Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards �
� Electromagnetic compatibility test according to IEC 60601-1-2 standard
� Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
� The waveform test report has also been conducted to verify the output parameters of the device.

10. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, and intended use of Galvanic Spa, Model: SKB-1405 is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device	Remark
Device Name andModel	Galvanic Spa,Model: SKB-1405	NūFACE® Plus	--
510(k) Number	Applying	K103472	--
Elements ofComparison	Subject Device	Predicate Device	Remark
Manufacturer	ShenZhen Siken 3D TechnologyDevelopment Co.,Ltd.	Carol Cole Company	--
Intended Use	The Galvanic Spa (Model: SKB-1405) is intended for facialstimulation and is indicated for over-the-counter cosmetic use. Theanatomical site for application of theGalvanic Spa is the face.	The NūFACE® Plus Facial ToningDevice is intended for facial stimulationand is indicated forover-the-counter cosmetic use. (21CFR 801 Subpart C).The anatomical site for application ofthe NOFACE® Plus is the face.	SE
Power Source(s)	3.7V Li-battery	4 rechargeable AA NiMH batteries	SENote 1
Method of LineCurrent Isolation	Type BF Applied Part	Type BF Applied Part	SE
PatientLeakageCurrent	Comply with IEC 60601-1 and IEC60601-2-10	Comply with IEC 60601-1 and IEC60601-2-10	SE
	NCSFC
Average DCcurrent throughelectrodes whendevice is on butno pulses arebeing applied	0	0	SE
Number of OutputChannels	One channel	One channel	SE
Number of OutputModes	one mode	one mode	SE
Output IntensityLevel	4 levels	3 levels	SENote 3
Synchronous orAlternating?	Alternating	Alternating	SE
Regulated Currentor RegulatedVoltage?	Both	Both	SE
Elements ofComparison		Subject Device	Predicate Device	Remark
Software/Firmware/MicroprocessorControl?		Yes	Yes	SE
AutomaticOverload Trip		Yes	Not required due to circuit design	SENote 1
Automatic No-Load Trip		Yes	Yes	SE
Automatic ShutOff		Yes	Yes	SE
Patient OverrideControl		Yes	Yes	SE
IndicatorDisplay	On/OffStatus	Yes	Yes	SE
	LowBattery	No	Yes	SENote 1
	Voltage/CurrentLevel	Yes	Yes	SE
Timer Range		No	Yes(21 minutes)	SENote 3
LCD Display		No	No	SE
Compliance withVoluntaryStandards		YesComply with IEC 60601-1 and IEC60601-2-10, IEC 60601-1-2	YesComply with IEC 60601-1 and IEC60601-2-10, IEC 60601-1-2	SE
Compliance* with21 CFR 898		Yes	Yes	SE
Weight		248g	9 oz without charging base	SENote 2
Dimensions		3.2" L x 6.5" W x 2.2" D	3" x 5.25" x 1.25"(inch)	SENote 2
Housing Materialsand Construction		Thermo Plastic	Thermo Plastic	SE
Output Specifications
Elements ofComparison	Subject Device	Predicate Device	Remark
Waveform	Pulsed Biphasic	Pulsed Monophasic	SENote 3
Shape	Symmetric biphasic, rectangular	Modulated Square	SENote 3
Maximum OutputVoltage (+/- 10%)	156mV @ 500Ω0.78V @ 2kΩ2.6V @ 10kΩ	137mV @ 500Ω769mV @ 2kΩ3.82V @ 10kΩ	SENote 3
Maximum OutputCurrent (+/- 10%)	0.31mA @ 500Ω0.39mA @ 2kΩ0.26mA @ 10kΩ	274uA @ 500Ω387uA @ 2kΩ383uA @ 10kΩ	SENote 3
Pulse Duration	110ms	119 ms	SENote 3
Pulse Frequency	9.09 Hz±10 %	8.40 Hz	SENote 3
Maximum CurrentDensity	0.274mA/cm2@500Ω	0.419mA/cm2@500Ω	SENote 4
Maximum PowerDensity	42.5μW/cm2@500Ω	3.22μW/cm2@500Ω	SENote 4
Contraction andRelaxation Time	Adjustable, due to different levels.(See below "Program SpecificationTable")	Adjustable, due to different levels.	SE
Environment forOperating	Temperature: 5°C~40°CHumidity: ≤80 %	Temperature: 5 ~ 40° CHumidity: 20 ~ 65% RH	SENote 1
Environment forStorage	Temperature:0~45°CHumidity: ≤93%	Temperature: 0 ~ 40°CHumidity: 10 ~ 90% RH	SENote 1
Biocompatibility	All user directly contacting materialsare compliance with ISO10993-5and ISO10993-10 requirements.	All user directly contacting materialsare compliance with ISO10993-5 andISO10993-10 requirements.	SE
Electrical Safety	Comply with IEC 60601-1, IEC60601-2-10,	Comply with IEC 60601-1 and IEC60601-2-10	SE
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SE

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Sponsor: ShenZhen Siken 3D Technology Development Co.,Ltd. Subject Device: Galvanic Spa,Model: SKB-1405 File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

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Sponsor: ShenZhen Siken 3D Technology Development Co.,Ltd. Subject Device: Galvanic Spa,Model: SKB-1405 File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

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Sponsor: ShenZhen Siken 3D Technology Development Co.,Ltd. Subject Device: Galvanic Spa,Model: SKB-1405 File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

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Comparison in Detail(s):

Note 1:

"Power Source(s)", "Automatic Overload Trip", "Operating Environment", "Storage Environment","Housing Materials and Construction" and "Indicator Display of Low Battery and Voltage/ Current Level"are a little different from the predicate devices, it will not affect the main function and the intended use of the device. They all also comply with IEC 60601-1 requirements. So the differences will not raise any safety or effectiveness issue.

Note 2:

Although the "Weight", "Dimensions" of subject device are different from the predicate devices, they are all proved by waveform report and performance report. And they comply with IEC 60601-2-10 requirements. So the differences of the physics specifications will not raise any safety or effectiveness issue.

Note 3:

Although the "Waveform", "Maximum Output Current", "Maximum Output Voltage", "Pulse Duration", "Output Intensity Level","Timer Range","Shape", "Maximum Current Density", "Maximum Power Density"and "Pulse Frequency" of subject device are a little different from the predicate devices, they all comply with IEC 60601-1, IEC 60601-2-10 requirement, So the differences of function specification will not raise any safety or effectiveness issue.

Note 4:

The subject device and the predicate device has the same intended use and the similar technological characteristics of output waveform. And the power density of the subject device and predicate device both conform to FDA Guidance: Maximum Power Density < 0.25 (W/cm²), and they all comply with IEC60601-1, IEC60601-2-10, so the value of the subject device does not adversely impact safety and effectiveness compared to values of the predicate device.

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).