(98 days)
Not Found
No
The summary describes a basic electrical muscle stimulation (EMS) device with simple controls and safety features, with no mention of AI or ML in the device description, performance studies, or key metrics.
No.
The 'Intended Use / Indications for Use' section explicitly states, "Not intended for use in any therapy or for the treatment of any medical conditions or diseases."
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Not intended for use in any therapy or for the treatment of any medical conditions or diseases," and it does not mention any diagnostic capabilities. The device is described as an EMS device for improving muscle tone and firmness.
No
The device description explicitly states it is comprised of a treatment unit (applicator), a belt, and a cradle unit for charging, all of which are hardware components. It also mentions generating an electrical signal and transferring it via electrodes.
Based on the provided information, the Silk'n Model H5003 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the improvement of muscle tone and firmness, and strengthening muscles. This is a physical effect on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an EMS (Electrical Muscle Stimulation) device that generates electrical signals to stimulate muscles. This is a therapeutic or cosmetic function, not a diagnostic one.
- No mention of biological samples: IVD devices typically involve testing biological samples like blood, urine, tissue, etc. There is no mention of any such samples being used with this device.
- No diagnostic claims: The device does not claim to diagnose any medical condition or disease. Its purpose is purely related to muscle function and appearance.
Therefore, the Silk'n Model H5003 falls under the category of a physical therapy or cosmetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Silk'n Model H5003 is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
Product codes (comma separated list FDA assigned to the subject device)
NGX
Device Description
The Silk'n MODEL H5003 device is an over-the-counter home use EMS device intended for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. The Silk'n Model H5003 system is comprised of a treatment unit - "applicator", a belt for placing and holding the applicator and a cradle unit for charging of the applicator's battery. The device generates an electrical signal. which is required for muscle stimulation and is transferred to the muscles via the device electrodes.
The Silk'n MODEL H5003 device is easily operated by a single mode push-button, two operational buttons for selection of EMS level, and a set of light indicators informing the lay-user on the device current operation mode (i.e., EMS level treatment, standby or error), all are located on the applicator user interface board.
The Silk'n MODEL H5003 device is equipped with a safety proximity sensor, which initiates the signal only upon full contact between the electrodes and the skin, and disconnects the power in case of no contact during the device operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arms, abdomen, thighs and buttocks areas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A set of performance tests were conducted to demonstrate that the Silk'n MODEL H5003 device performs as expected under anticipated conditions of use and to verify that the device performance meets the device design requirements. The device was tested for validation of output waveform, basic unit characteristics, and output specifications.
Furthermore, the Silk'n MODEL H5003 device underwent software validation testing, electrical and mechanical safety testing according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2, safety and essential performance of nerve and muscle stimulators testing according to IEC 60601-2-10, and medical electrical equipment testing according to IEC 60601-1-11.
The results of these tests demonstrated that all the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 9, 2018
Home Skinovations Ltd. % Amit Goren Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 Il
Re: K180279
Trade/Device Name: Silk'n MODEL H5003 device Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: May 2, 2018 Received: May 7, 2018
Dear Amit Goren:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -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) K180279
Device Name Silk'n MODEL H5003
Indications for Use (Describe)
The Silk'n Model H5003 is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
| 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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3
Silk'n MODEL H5003 Device 510(k) File 510(k) Summary
510(K)SUMMARY SILK'N MODEL H5003
510(k) Number K180279
Applicant Name:
| Company Name: | |
|---|---|
| Address: |
Home Skinovations Ltd. Tavor Building, POB 533 Yokneam Iillit 2069206 Israel Tel: +972(4)9097440 Fax: +972(4)9097471 E-mail: amit@asteinrac.com
Contact Person:
| Official Correspondent: | Amit Goren |
|---|---|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| Address: | 20 Hata'as Str., Suite 102 |
| Kfar Saba 44425 Israel | |
| Tel: +972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-mail: amit@asteinrac.com | |
| Date Prepared: | May 09, 2018 |
| Trade Name: | Silk'n MODEL H5003 |
| Classification Name: | Powered muscle stimulator |
| Regulation Number: | CFR Classification sections 890.5850 |
| Product Code: | NGX |
| Classification: | Class II Medical Device |
Predicate Device:
The Silk'n MODEL H5003 device is substantially equivalent to the previously cleared, Body Control System "4M", manufactured by Sport-Elec S.A.
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| Sport-Elec S.A. | Body Control System "4M" | K092476 |
4
Device Description:
The Silk'n MODEL H5003 device is an over-the-counter home use EMS device intended for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. The Silk'n Model H5003 system is comprised of a treatment unit - "applicator", a belt for placing and holding the applicator and a cradle unit for charging of the applicator's battery. The device generates an electrical signal. which is required for muscle stimulation and is transferred to the muscles via the device electrodes.
The Silk'n MODEL H5003 device is easily operated by a single mode push-button, two operational buttons for selection of EMS level, and a set of light indicators informing the lay-user on the device current operation mode (i.e., EMS level treatment, standby or error), all are located on the applicator user interface board.
The Silk'n MODEL H5003 device is equipped with a safety proximity sensor, which initiates the signal only upon full contact between the electrodes and the skin, and disconnects the power in case of no contact during the device operation.
Device Specifications:
Output voltage: 30v±2.00v Output current@500Ω: 60mA±4mA Pulse rate: 40Hz±10Hz Pulse width: 400usec±50usec
Intended Use/Indication for Use:
The Silk'n Model H5003 is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
Performance Standards:
The Silk'n MODEL H5003 device has been tested and complies with the following voluntary recognized standards:
60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 ● AAMI/ANSI And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601- 1:2005, Mod).
IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General . Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
5
. IEC 60601-2-10 (Second Edition, 2012): Medical electrical equipment part 2: particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
. IEC 60601-1-11:2010, Medical electrical equipment Part 1-11 - Requirements for the medical electrical equipment and medical electrical systems used in the home healthcare environment.
Non-Clinical (Bench) Performance Data:
A set of performance tests were conducted to demonstrate that the Silk'n MODEL H5003 device performs as expected under anticipated conditions of use and to verify that the device performance meets the device design requirements. The device was tested for validation of output waveform, basic unit characteristics, and output specifications.
Furthermore, the Silk'n MODEL H5003 device underwent software validation testing, electrical and mechanical safety testing according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2, safety and essential performance of nerve and muscle stimulators testing according to IEC 60601-2-10, and medical electrical equipment testing according to IEC 60601-1-11.
The results of these tests demonstrated that all the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Animal Performance Data / Histology Data:
Not Applicable
Clinical Performance Data:
Not Applicable
Substantial Equivalence:
The below table presents a comparison of the technological characteristics of the subject device and the predicate device:
6
| Device Characteristics | Subject Device –
Silk'n Model H5003 Device
Home Skinovations Ltd. | Predicate Device –
Body Control System
"4M" Device
SPORT-ELEC S. A.
K092476 |
|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication For Use | The Silk'n Model H5003 is
indicated for the
improvement of muscle tone
and firmness, for
strengthening muscles in
arms, abdomen, thighs and
buttocks areas.
Contraindicated use on
injured or otherwise impaired
muscles
Not intended for use in any
therapy or for the treatment of
any medical conditions or
diseases. | The Body Control System
"4M" is indicated for the
improvement of muscle
tone and firmness, for
strengthening muscles in
arms, abdomen, thighs, and
buttocks areas.
Contraindicated use on
injured or otherwise
impaired muscles
Not intended for use in any
therapy or for the treatment
of any medical conditions
or diseases. |
| Power | 1 rechargeable Li-Ion
battery, 3.7 V | 3 batteries, 1.5V |
| Patient leakage current | NA for battery powered device | NA for battery powered
device |
| Single fault condition (μΑ) | NA for battery powered device | NA for battery powered
device |
| Number of output
channels | 1 | 1 |
| Average DC
current through
electrodes when
device is on but
no pulses are
being applied | 0 μA | 0 μA |
| Number of outputs modes | 1 | 1 |
| Regulated current or
regulated voltage? | Voltage | Voltage |
| Software / firmware /
microprocessor control? | Yes | Yes |
| Automatic overload trip | No | No |
| Automatic no load trip | No | No |
| Automatic shut-off | Yes | Yes |
| Device Characteristics | Subject Device –
Silk'n Model H5003 Device | Predicate Device –
Body Control System
"4M" Device |
| | Home Skinovations Ltd. | SPORT-ELEC S. A.
K092476 |
| User overrides control? | Yes | Yes |
| Indicator display - On/Off
Status | Yes | Yes |
| Indicator display – low
battery | Yes | Yes |
| Indicator display
voltage/current level | No | No |
| Time range (minutes) | 15 | Data not available |
| Compliance with standards? | AAMI/ANSI 60601-1
IEC 60601-2-10
IEC 60601-1-2
IEC 60601-1-11 | AAMI/ANSI 60601-1
IEC 60601-2-10
IEC 60601-1-2
IEC 60601-1-4 |
| Compliance with 21 CFR
898 | Yes | Yes |
| Housing material and
construction | ABS | ABS |
| Output waveform | Symmetrical biphasic | Monophasic |
| Shape | Rectangular | Rectangular |
| Duration of primary
(depolarizing) phase | 0 | 0 |
| Maximum output voltage
(voltage, +/-10%) at 500
ohms, 2 K ohms, and 10 k
ohms | 32V for 500, 2K and
10Kohms | Data not available |
| Maximum output current
(mA +/- 10%) at 500 ohms | 64 mA | Data not available |
| Maximum output current
(mA +/- 10%) at 2 K ohms | 16 mA | Data not available |
| Maximum output current
(mA +/- 10%) at 10 K ohms | 3.2 mA | Data not available |
| Pulse width (usec) | 1000±50 | Data not available |
| Phase duration (usec) | 400±50 | Data not available |
| Frequency (Hz) | 40±10 | Data not available |
| Maximum current density at
500 ohms (mA/cm²) | 4.9 | 3 |
| Device Characteristics | Subject Device -
Silk'n Model H5003 Device
Home Skinovations Ltd. | Predicate Device -
Body Control System
"4M" Device
SPORT-ELEC S. A.
K092476 |
| Maximum average power
density at 500 ohms
(W/cm²) | 0.005 | 0.092 |
| Symmetrical phases | Yes | No |
| Net charge per pulse | 0 $[$\mu$C]$ | Data not available |
| Maximum phase charge | 25.6 $[$\mu$C]$ | Data not available |
| Burst mode | a. Pulses per burst: 88
b. Bursts per second: 0.238
c. Burst duration: 2.1 [sec]
d. Duty Cycle: 50% | Data not available |
7
8
The Silk'n MODEL H5003 device shares many of characteristics and features with the predicate Body Control System "4M" device (cleared under K092476). Both Silk'n MODEL H5003 and Body Control System "4M" devices have a similar design, technological features, user interface and hardware components. Both devices share the basic technological principal of applying trans-cutaneous electrical muscle stimulation (EMS) through skin contact electrodes.
The Silk'n MODEL H5003 device for EMS technology has same low risk as was previously determined for the Body Control System "4M" predicate devices incorporate similar safety features, including automatic shut off of the energy source at the end of predetermined treatment time period, system abnormalities check, and safety proximity sensor. In addition to the safety features, compliance with safety standards of the Silk'n MODEL H5003 device is similar to the compliance with safety standards of the predicate device.
The only meaningful difference between the Silk'n MODEL H5003 and the Body Control System "4M" device is the electrode type. While the Body Control System "4M" utilizes Adhesive electrodes with hydrophilic gel, the Silk'n MODEL H5003 device utilizes conductive fabric electrodes. Both electrode materials are biocompatible with ISO 10993-5 and ISO 10993-10 requirements. A second difference between the two devices is the replacement of LCD display in the Body Control System "4M" with LED indicators in the Silk'n MODEL H5003. which raise no new safety or efficacy concerns. All other differences between the two devices are minor changes in the external design, which do not raise new safety or efficacy concerns. Consequently, it can be concluded that the Silk'n MODEL H5003 device is substantially
equivalent to its predicate Body Control System "4M" device (cleared under 510(k) K092473).