(249 days)
No reference devices were used in this submission.
No
The summary describes a simple microcurrent stimulator with manual controls and basic feedback mechanisms (LEDs, Flow light). There is no mention of AI, ML, or any complex data processing or learning capabilities.
No
The device's intended use is for "aesthetic purposes" and it stimulates "facial tissues for aesthetic purposes," which does not align with a therapeutic intent.
No
Explanation: The "Intended Use / Indications for Use" states that the device is "to stimulate facial tissues for aesthetic purposes." There is no mention of diagnosing any condition or disease.
No
The device description clearly outlines hardware components such as pushbuttons, LED indicators, a rechargeable battery, and probes, indicating it is a physical device that delivers electrical stimulation. While it mentions software verification and validation, this is for the software controlling the hardware, not a standalone software device.
Based on the provided information, the TAMA BEMS Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "to stimulate facial tissues for aesthetic purposes." This is a direct application to the human body for a non-diagnostic outcome.
- Device Description: The device description focuses on electrical stimulation and its parameters, not on analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic results.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The TAMA BEMS Device does not fit this description.
N/A
Intended Use / Indications for Use
The TAMA BEMS Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes
Product codes
NFO
Device Description
The TAMA BEMS Device is a microcurrent stimulator producing electrical currents up to 800 microamps. It is intended for aesthetic purposes. It has built-in pushbuttons to allow the user to adjust the output current from 0 to 800 micro-amps, as well as changing the modality (output frequency). The BEMS device is a battery-operated device that uses a rechargeable battery. When the device is plugged into the AC outlet for charging, it becomes disabled and no treatments can be performed. The BEMS device also has LED indicators to show output intensity, battery level, and output mode. A Flow light shows when probes contact the skin, and current is flowing through the patient. If the measured current through the probes does not match the set point selected by the user, the Flow LED turns off to indicate insufficient current flow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Biocompatibility Testing: A biocompatibility certification statement was provided indicating that the components with patient contact are fabricated from biocompatible metal that is also used for other TENS devices legally marketed in the USA. In addition, cytotoxicity testing was performed to demonstrate that there are no residuals present that negatively impact biocompatibility.
Electrical safety and electromagnetic compatibility (EMC) testing:
- IEC 60601-1 Electrical Safety Testing
- IEC 60601-1-2 EMC Testing
- IEC 60601-2-10 Medical Electrical Equipment Safety Standard for Nerve and Muscle Stimulators
Software Verification and Validation Testing: Verification and validation testing of the software was conducted in accordance with IEC 62304.
Mechanical and acoustic Testing: A risk analysis was completed and risk controls were implemented in accordance with ISO 14971. Human factors testing was conducted in accordance with IEC 60601-1-6, ISO 62366 and the FDA guidance on human factors engineering to demonstrate that the ergonomics of patient and user interfaces for the subject device are substantially equivalent to the predicate device.
Animal Study: Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Clinical Studies: Clinical testing was not required to demonstrate the safety and effectiveness of the TAMA BEMS Device. Instead, substantial equivalence is based upon benchtop performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains two logos. The first logo on the left is the Department of Health & Human Services-USA logo. The second logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
June 5, 2018
TAMA Research Corporation % Robert Packard President Medical Devices Academy, Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05728
Re: K173093
Trade/Device Name: TAMA BEMS device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: May 7, 2018 Received: May 7, 2018
Dear Robert Packard:
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
1
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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 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,
VivekJ. 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
2
Indications for Use
510(k) Number (if known) K173093
Device Name TAMA BEMS Device
Indications for Use (Describe)
The TAMA BEMS Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
1. SUBMITTER TAMA Research Corporation 7600 North 16th Street. Suite 205 Phoenix, AZ, 85020 USA Tel: +1 (602) 354-8185
| Contact Person: | Ali Shambayati |
|---|---|
| Date Prepared: | June 4, 2018 |
| Name of Device: | TAMA BEMS Device |
|---|---|
| Classification Name: | Neurological Therapeutic Device |
| Regulation: | 21 CFR §882.5890 |
| Regulatory Class: | Class II |
| Product Classification Code: | NFO |
PREDICATE DEVICE 111
| Predicate Manufacturer: | Biosonic Technologies, LLC |
|---|---|
| Predicate Trade Name: | Beautiful Image Model 900 Facial Toning Device |
| Predicate 510(k): | K130065 |
No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
The TAMA BEMS Device is a microcurrent stimulator producing electrical currents up to 800 microamps. It is intended for aesthetic purposes. It has built-in pushbuttons to allow the user to adjust the output current from 0 to 800 micro-amps, as well as changing the modality (output frequency). The BEMS device is a battery-operated device that uses a rechargeable battery. When the device is plugged into the AC outlet for charging, it becomes disabled and no treatments can be performed. The BEMS device also has LED indicators to show output intensity, battery level, and output mode. A Flow light shows when probes contact the skin, and current is flowing through the patient. If the measured current through the probes does not match the set point selected by the user, the Flow LED turns off to indicate insufficient current flow.
V. INDICATIONS FOR USE
The TAMA BEMS Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
4
- Indications for Use
- Materials of Construction ●
- Design Features
- . Energy Source
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
A biocompatibility certification statement was provided indicating that the components with patient contact are fabricated from biocompatible metal that is also used for other TENS devices legally marketed in the USA. In addition, cytotoxicity testing was performed to demonstrate that there are no residuals present that negatively impact biocompatibility.
Electrical safety and electromagnetic compatibility (EMC)
The following electrical safety and EMC tests have been performed:
- . IEC 60601-1 Electrical Safety Testing
- IEC 60601-1-2 EMC Testing ●
- . IEC 60601-2-10 Medical Electrical Equipment Safety Standard for Nerve and Muscle Stimulators
Software Verification and Validation Testing
Verification and validation testing of the software was conducted in accordance with IEC 62304.
Mechanical and acoustic Testing
A risk analysis was completed and risk controls were implemented in accordance with ISO 14971. Human factors testing was conducted in accordance with IEC 60601-1-6. ISO 62366 and the FDA guidance on human factors engineering to demonstrate that the ergonomics of patient and user interfaces for the subject device are substantially equivalent to the predicate device.
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the TAMA BEMS Device. Instead, substantial equivalence is based upon benchtop performance testing.
5
| | TAMA BEMS Device –
Subject Device | Beautiful Image Model
900 Facial Toning Device – K130065 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The TAMA BEMS
Device uses microcurrent
electrical to stimulate
facial tissues for aesthetic
purposes | The Beautiful Image
Model 900 Facial Toning
Device uses microcurrent
electrical energy to
stimulate facial tissues for
aesthetic
purposes. |
| Design | | |
| Power Source | Internal 4.3V
rechargeable Lithium
Polymer battery | One 6V Battery |
| Method of Line Current Isolation | N/A | N/A |
| Patient Leakage Current | N/A | N/A |
| Normal Condition (μΑ) | N/A | N/A |
| Single Fault Condition (µA) | N/A | N/A |
| Average DC current through electrodes when
device is on but no pulses are being applied (μΑ) | None | None |
| Number of Output Modes | Four | One |
| Number of Output Channels | One | One |
| Synchronous or Alternating? | N/A | N/A |
| Method of Channel Isolation | N/A | N/A |
| Manufacturer | TAMA Research
Corporation | Biosonic Technologies,
LLC |
| Regulated Current or Regulated Voltage? | Both | Both |
| Software/Firmware/Microprocessor Control? | Yes | Yes |
| Automatic Overload Trip? | Yes | Yes |
| Automatic No-Load Trip? | Yes | Yes |
| Automatic Shut Off? | Yes | Yes |
| User Override Control? | Yes | Yes |
| Indicator Display Status | | |
| On/Off Display Status? | Yes | Yes |
| Low Battery? | Yes | Yes |
| Voltage/Current Level? | Yes | Yes |
| Timer Range (minutes) | 0-30 minutes | None |
| Compliance with Voluntary Standards? | IEC60601-1 | IEC 60601-1 |
| Compliance with 21 CFR 989? | Yes | Yes |
| Weight (lbs., oz.) | 9.5 ounces | 10 lbs |
| Dimensions (in.) [WxHxD] | 3x5x0.7 | 5.5x15.3x11.3 |
| Housing Materials and Construction | Anodized aluminum 6061 | Thermoplastic |
| Waveform (e.g., pulsed monophasic, biphasic) | Biphasic | Biphasic |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Rectangular | Rectangular |
| Maximum Output Voltage (volts) (+/-5%) | ±0.400 @500Ω
±1.600 @2 k Ω
±8.00 @10k Ω | 0.347 @500Ω
1.242 @2 k Ω
5.780 @10k Ω |
| Maximum Output Current (mA) (+/-5%) | ±0.800 @500 Ω
±0.800 @2 k Ω
±0.800 @10k Ω | 0.647 @500 Ω
0.625 @2 k Ω
0.584 @10k Ω |
| Duration of primary (depolarizing) phase (msec) | 26.3 – 1200 | 0.648 – 322 |
| Pulse Duration (msec) | 52.6 – 2400 | 3.24 – 1610 |
| Frequency (Hz) [or Rate (pps)] | 0.045 – 2560 | 0.621 – 308.6 |
| For multiphasic waveforms only:
Symmetrical phases?
Phases Duration (msec), (state range, if applicable), (both phases, if asymmetrical) | Yes
26.3 – 1200 | Yes
0.324-161 |
| Net Charge (micro coulombs (µC) per pulse) (If zero, state method of achieving zero net charge.) | 0µC @500 Ω | 0µC @500 Ω |
| Maximum Phase Charge, (µC) | 400 µC positive phase,
400 µC positive phase,
(50% duty cycle), all loads | 190 @500 Ω |
| Maximum Current Density (mA/cm², r.m.s.) | 1.591 @500 Ω (1) | 1.486 @500 Ω |
| Maximum Average Current (average absolute value), mA | 0.800 @500 Ω | 0.493 @500 Ω |
| Maximum Average Power Density, (W/cm²), (using smallest electrode conductive surface area) | 318E-6 @500Ω (2)
0.012 @18.75 KΩ (3) | 366E-6 @500 Ω |
| Burst Mode (i.e., pulse trains)
(a) Pulses per burst
(b) Bursts per second
(c) Burst duration (seconds)
(d) Duty Cycle: Line (b) x Line (c) | 5 - 20
10 - 40
0.00195 - 0.0078
0.0195 – 0.1719 (4) | N/A
N/A
N/A
N/A |
| ON Time (seconds) | Constant | 10-30 |
| OFF Time (seconds) | None | 1-6 |
| Additional Features (specify if applicable) | None | None |
The following table provides a Substantial Equivalence Comparison of TAMA BEMS with Beautiful Image Model 900 Facial Toning Device (K130065):
6
VIII. CONCLUSIONS
Based on a comparison of indications for use, technological characteristics and performance data; it can be concluded that the TAMA BEMS Device is substantially equivalent to the predicate device.