(136 days)
The device is indicated for aesthetic use, including facial and neck stimulation or body skin stimulation.
The subject device, the MyoLight Microcurrent Handpieces are intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the device. There are two MyoLight Microcurrent Handpieces that connect to the main unit. The small handpiece (diameter: 3.9 cm, Length: 14 cm) is generally used on the face and the large handpiece (diameter: 6.2 cm, Length: 15 cm) is generally used on the body. The handpieces are different in dimensions but not function. The handpieces contain the electrodes that deliver microcurrent for aesthetic use. The subject device is intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the handpieces. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about therapy type, remaining therapy time and main therapy parameters on the screen.
The provided context does not offer information about the acceptance criteria or a study proving that the device meets specific acceptance criteria in the typical format of a clinical or performance study with metrics like sensitivity, specificity, or AUC.
The document is a 510(k) summary for a medical device (MyoLight Microcurrent Handpiece) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study with acceptance criteria.
However, based on the non-clinical testing section, we can infer some "acceptance criteria" through compliance with recognized standards.
Here's the breakdown of the information that can be extracted, and where the requested information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating compliance with recognized standards and similarity to predicate devices. The "reported device performance" is essentially the device's conformance to these standards and its specifications aligning with the predicate devices.
| Acceptance Criterion (Inferred from Standards & Equivalence) | Reported Device Performance (MyoLight Microcurrent Handpiece) |
|---|---|
| Electrical Safety and Essential Performance (IEC 60601-1:2005/A1:2012) | Compliant with IEC 60601-1 leakage current requirements and isolation requirements. |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2:2014/EN 60601-1-2:2015) | Compliant with IEC 60601-1-2 (implied by listing the standard as tested). |
| Particular Requirements for Nerve and Muscle Stimulators (IEC 60601-2-10 Edition 2.1 2016-04) | Compliant with IEC 60601-2-10 (implied by listing the standard as tested). |
| Biocompatibility (ISO 10993 and FDA Guidance) | Biocompatibility tests performed (exact results not detailed, but implied to be acceptable). |
| Software Validation & Verification | Software V&V tests performed (exact results not detailed, but implied to be acceptable). |
| Bench Testing for Performance | Bench testing performed to verify performance (exact details not provided, but used to support substantial equivalence). |
| Specifications within Acceptable Range of Predicate Devices (e.g., Max output voltage, current, power density, net charge, phase charge, pulse duration, frequency) | Max output voltage (30V @ 500 Ω, 33V @ 1,000 Ω, 35V @ 10,000 Ω), Max output current (60 mA @ 500 Ω, 33 mA @ 1000 Ω, 3.5 mA @ 10,000 Ω), Max current density (82 µA/mm² @ 500 Ω), Max average power density (0.012W/cm² @ 500 Ω), Net Charge (0 µC), Max phase charge (23 µC), Duration of primary (128, 256, 384 µs), Pulse Duration (128, 256, 384 µs), Frequency (1 ~ 63 Hz). These are compared to predicate devices and deemed "substantially equivalent." |
| Safety - Automatic Shut Off | YES |
| Safety - Patient Contact Material | Stainless Steel 304, PMMA (biocompatibility validated). |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set in terms of patient samples. The testing described is non-clinical (bench testing, software V&V, and compliance with electrical safety and EMC standards). Therefore, there is no information on sample size or data provenance in the context of a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set using expert-established ground truth is described.
4. Adjudication method for the test set
Not applicable, as no clinical test set with adjudication is described.
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. The device is a microcurrent handpiece, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the device is not an algorithm for diagnostic or prognostic purposes. It is a physical device delivering electrical stimulation, with software controls for operation.
7. The type of ground truth used
For non-clinical testing:
- Electrical Safety, EMC, and Nerve/Muscle Stimulator Standards: Compliance is based on objective measurements against defined limits in the respective IEC standards.
- Biocompatibility: Likely based on laboratory assays and tests according to ISO 10993 standards.
- Software Validation & Verification: Based on predefined software requirements specification and test protocols.
- Bench Testing: Based on objective measurements of physical and electrical parameters against design specifications.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device. The "training set" concept doesn't apply.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 10, 2025
Raja Trading Company, Inc. % Yolando Smith Smith Assoicates 1469 Harwell Ave Crofton, Maryland 21114
Re: K243063
Trade/Device Name: Myolight Microcurrent Handpiece Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: January 15, 2025 Received: January 15, 2025
Dear Yolando Smith:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Heather L. Dean -S
Heather Dean, PhD
Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Myolight Microcurrent Handpiece
Indications for Use (Describe)
The device is indicated for aesthetic use, including facial and neck stimulation or body skin stimulation.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of 21CFR Section 807.92.
510(k) Number: K243063
1. Date of Preparation
2/7/2025
2.
| Name: | RAJA Trading Company Inc. |
|---|---|
| Address: | 2801 Juniper Street, Suite 2, Fairfax, VA 22031 |
| Contact Person: | Robert J. Adipietro |
| Title: | Vice President |
| Telephone: | 561-868-4600 |
| Fax: | 561-258-0207 |
| Email: | rja@rajamedical.com |
3. Identification of the Proposed Device
| Trade Name: | MyoLight Microcurrent Handpiece |
|---|---|
| Common Name: | Microcurrent Stimulator |
| Classification Name: | Stimulator, Transcutaneous Electrical, Aesthetic Purpose |
| Classification: | Class II |
| Product Code: | NFO |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |
| Attachment | Regulation Name | Regulation No. | Productcode | Class |
|---|---|---|---|---|
| MyoLight MicrocurrentHandpieces | Stimulator, TranscutaneousElectrical, Aesthetic Purposes | 882.5890 | NFO | 2 |
Identification of Predicate Devices 4.
| PrimaryPredicate Device | Manufacturer | Trade Name | Product Code | 510KNumber |
|---|---|---|---|---|
| Aesthetic TENSDevice | BTL Industries, Inc. | BTL-785BNF Handpiece | NFO | K232172 |
| Reference PredicateDevice #1 | Manufacturer | Trade Name | 510KNumber | |
| Aesthetic TENSDevice | Salton, Inc. | Rejuvenique Facial ToningSystem | NFO | K011935 |
| Reference PredicateDevice #2 | Manufacturer | Trade Name | 510KNumber | |
| Aesthetic TENSDevice | Avazzia, Inc. | EZZI-LIFT | NFO | K191951 |
5. Product Description
The subject device, the MyoLight Microcurrent Handpieces are intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the device. There are two MyoLight Microcurrent Handpieces that connect to the main unit. The small handpiece (diameter: 3.9 cm, Length: 14 cm) is generally used on the face and the large handpiece (diameter: 6.2 cm, Length: 15 cm) is generally used on the body. The handpieces are different in dimensions but not function. The handpieces contain the electrodes that deliver microcurrent for aesthetic use.
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The subject device is intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the handpieces. The on-screen information guides the user step-bystep through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about therapy type, remaining therapy time and main therapy parameters on the screen.
The product is only sold to professionals licensed to administer the treatments including aestheticians, med spas, plastic surgeons and dermatologists and other licensed professionals. It is not intended to be sold to the consumer or for home use.
6. Indications for Use
The device is indicated for aesthetic use, including facial and neck or body skin stimulation.
| Specifications | Subject Device | PrimaryPredicate Device | ReferencePredicateDevice # 1 | ReferencePredicateDevice # 2 |
|---|---|---|---|---|
| 510(k) Number | K243063 | K232172 | K011935 | K191951 |
| Manufacturer | RAJA TradingCompany | BTL Industries, Inc | Salton, Inc. | Avazzia, Inc. |
| Device Name | MyoLightMicrocurrentHandpiece | BTL-785BNFHandpiece | RejuveniqueFacial ToningSystem | EZZI-LIFT |
| Classification &Subsequent ProductCodes | NFO | NFO | NFO | NFO |
| Regulation Number | 882.5890 | 882.5890 | 882.5890 | 882.5890 |
| Classification Name: | TranscutaneousElectrical NeverStimulator for PainRelief | TranscutaneousElectrical NeverStimulator for PainRelief | TranscutaneousElectrical NeverStimulator forPain Relief | TranscutaneousElectrical NeverStimulator forPain Relief |
| Common Name | Esthetic TENS Device | Esthetic TENSDevice | Esthetic TENSDevice | Esthetic TENSDevice |
| Indications for use | The device is indicatedfor aesthetic useincluding facial andneck or body skinstimulation. | The device isindicated foraesthetic useincluding facial andneck or body skinstimulation. | Indicates forCosmetic Use | The AvazziaOTC TENS foraesthetics,model BEST-AVI™ : EZZI-LIFTTM Deviceis indicated forover-the-counteraesthetic useincluding facialand neckstimulation orbody skinstimulation. |
| Specifications | Subject Device | PrimaryPredicate Device | ReferencePredicateDevice # 1 | ReferencePredicateDevice # 2 |
| Anatomic Sites | Face, Neck, and Body | Face, Neck, andBody | Face | Face, Neck, andBody |
| Principal of Operation | Handpieces withelectrodes that deliverelectrical stimulationattached to a mainbody that contains thepower supplies, themicroprocessor controlunit, and the touch-screen user interface. | Handpieces withelectrodes thatdeliver electricalstimulation attachedto a main body thatcontains the powersupplies, themicroprocessorcontrol unit, and thetouch-screen userinterface. | Face Mask withelectrodes that fitover users facethat deliverselectricalstimulationconnected to acontrol unit. | Handheldportable devicewith electrodes,batteries anduser controls. |
| User Interface | LCD Touch Screen onmain Control Unit withPower Source andMicroprocessorcontrolled | LCD Touch Screenon main ControlUnit with PowerSource andMicroprocessorcontrolled | Control Unitwith PowerSource andMicroprocessorcontrolled. | LEDs andswitches |
| Compliance withVoluntary Standards | IEC 60601-1IEC 60601-1-2IEC 60601-2-10ISO 14971IEC 62366 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10ISO 14971IEC 62366 | Not Available | IEC 60601-1IEC 60601-1-2IEC 60601-2-10ISO 14971IEC 62366 |
| Compliance with 21CFR 898 | YES | YES | YES | YES |
| Power Sources | Mains Power 110 -120, 220 - 240 VAC,50- 60 Hz | Mains Power100-240V, 50-60Hz | 9V battery | Two 1.5 V AAbatteries |
| Patient leakagecurrent: NormalCondition | Compliant with IEC60601-1 leakagecurrent requirements | Compliant with IEC60601-1 leakagecurrentrequirements | Not Available | Compliant withIEC 60601-1leakage currentrequirements |
| Method of ChannelIsolation | Compliant with IEC60601-1 isolationrequirements | Compliant with IEC60601-1 isolationrequirements | Electrode Groupselected byrelays | Compliant withIEC 60601-1isolationrequirements |
| Synchronous orAlternating Output | Both | Both | Alternating | Not Available |
| Software / Firmware/ Micro-ProcessorControl? | Yes | Yes | Yes | Yes |
| Number of OutputModes | 1 | 1 | 1 | 4 |
| Specifications | Subject Device | PrimaryPredicate Device | ReferencePredicateDevice # 1 | ReferencePredicateDevice # 2 |
| Regulated Current orRegulated Voltage | Regulated Voltage | Regulated Voltage | RegulatedVoltage | RegulatedVoltage |
| Housing Materialsand Constructions | Molded PC-ABSplastic material withscrew assemblyconstruction. | PCBs and leadsinside plastic, orfoam case housing. | ABS Plastic,latch assembly | PCBs insideplastic casehousing |
| Energy Type | Electrical Stimulation | ElectricalStimulation | ElectricalStimulation | ElectricalStimulation |
| Voltage Current Level | Yes - UncalibratedKnob | Yes | Yes -UncalibratedKnob | Not Available |
| HandpieceDimensions | Handpiece #1: 62mm x147 mmHandpiece #2: 39mm x139.5 mm | 38.98" x 53.94" x34.65" | 4.5" X 3" X1.25" | 2.6" X 4.7" X1.35" |
| Handpiece Weight | Handpiece #1: 1100 gHandpiece #2: 720 g | 2500 g | 80 grams | 5.4 oz. |
| RecommendedTreatment Time/Timer range | 20 MinutesRecommendedTreatment Time | 20 Minutes Timerrange | 20/16 minutesTimer Range | Not Available |
| Output Modes | 1 | 1 | 1 | 4 |
| Automatic Shut Off | YES | Unknown | YES | YES |
| Patient Contact | YES | YES | YES | YES |
| Contact Material | Stainless Steel 304PMMA | Conductive Ink(Silver) | PCB Mask withGold PlatedBrass Electrodes | Stainless Steel316 |
| Waveform Shape | Pulsed Biphasicrectangular modulatedby trapezoidal | Pulsed Biphasicrectangularmodulated bytrapezoidal | Pulsed Biphasicrectangular | Positive squarewave followedby a dampedsinusoidalwaveform ofvariabledurationdepending ondamping andbody loading |
| Max output voltage[V] (±20%) at500 Ω2,000 Ω10,000 Ω | 30V @ 500 Ω33V @ 1,000 Ω | BTL-785-2, -8, -9Max. 48,5V @ 10 -373 Ω48,5V @ 500 Ω48,5V @ 2,000 Ω0 @ 10,000 Ω | 18V @ 500 Ω24V @ 1,000 Ω | 42V @ 500 Ω |
| Specifications | Subject Device | PrimaryPredicate Device | ReferencePredicateDevice # 1 | ReferencePredicateDevice # 2 |
| 35V @ 10,000 Ω | BTL-785-1, -7Max. 48,5V @ 10 -757 Ω48,5V @ 500 Ω48,5V @ 2,000 Ω0 @ 10,000 Ω | 28V @ 10,000 Ω | 122V @ 2,000 Ω348V @ 10,000 Ω | |
| Max output current(+/-20%) a500 Ω2,000 Ω10,000 Ω | 60 mA @ 500 Ω33 mA @ 1000 Ω3.5 mA @ 10,000 Ω | BTL-785-2, -8, -9Max. 130 mA @ 10- 373 Ohm97 mA @ 500 Ω24 mA @ 2000 Ω0 mA @ 10000 ΩBTL-785-1, -7Max. 64 mA @ 10 -757 Ω64 mA @ 500 Ω24 mA @ 2000 Ω0 mA @ 10000 Ω | 37.6 mA @ 500 Ω12.4 mA @ 1000 Ω2.8 mA @10,000 Ω | Max. 0.5 mA0.363 mA @500 Ω0.117 mA @2000 Ω0.038 mA @10000 Ω |
| Max current density at500 Ω [μA/mm²] | 82 µA/mm² | BTL-785-2 - 243μA/mm²BTL-785-8 - 335μA/mm²BTL-785-9 - 277μA/mm²BTL-785-1 - 168μA/mm²BTL-785-7 - 337μA/mm² | 464 μA/ mm² | Built-in, YBrush: 8μA/mm²Pencil: 190μA/mm² |
| Max average powerdensity at 500 Ω[W/cm²] | 0.012W/ cm² | BTL-785-2 - 0.047W/cm²BTL-785-8 - 0.065W/cm²BTL-785-9 - 0.054W/cm²BTL-785-1 - 0.033W/cm²BTL-785-7 - 0.065W/cm² | 0.0023 W/ cm² | Built-in, YBrush: 0.0005W/cm²Pencil: 0.0035W/cm² |
| Net Charge per pulse | 0 µC (Pulse is biphasicsymmetrical) | 0 µC (Pulse isbiphasicsymmetrical) | 0 µC | 4 µC |
| Max phase charge perpulse at 500 Ω [μC] | 23 µC | BTL-785-2, -8, -915 µC | 11.3 µC | 10 µC |
| Specifications | Subject Device | PrimaryPredicate Device | ReferencePredicateDevice # 1 | ReferencePredicateDevice # 2 |
| BTL-785-1, -710 μC | ||||
| Duration of primary[μs](depolarizing phase) | 128 μs, 256 μs, 384 μs | 80 μs | Not Available | 500 μs |
| Pulse Duration [μs] | 128 μs, 256 μs, 384 μs | 160 μs | 300 μs | 1100 μs |
| Frequency [Hz] | 1 ~ 63 Hz | 250 Hz | 8 Hz | 15-121 Hz |
7. Substantially Equivalent (SE) Comparison
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Similarities
The subject device is similar to the predicate product in:
- same classification information,
- same indications and intended use,
- same principle of operation
- same performance effectiveness and performance safety as the primary predicate device. ●
- same waveform shape
- . same maximum average power density
- substantially equivalent maximum output voltage
- substantially equivalent output current .
Differences
The differences do not affect the performance and effectiveness of the subject device. Differences in Maximum Voltage, Maximum Current, Frequency, Pulse Duration, Phase Charge, and Current Density do not affect the performance and safety of the subject device.
Therefore, the MyoLight Microcurrent Handpiece device is substantially equivalent to the predicate device.
8. Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:
-
IEC 60601-1:2005/A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
- IEC 60601-1-2:2014/EN 60601-1-2:2015, Medical electrical equipment- Part 1-2: General requirements for basic A safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
-
IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
-
Biocompatibility Tests per ISO 10993 and FDA Guidance.
-
Software Validation & Verification Test.
-
Bench Testing to verify the performance.
9. Clinical Testing
Not Applicable
10. Conclusion
Based on the comparison and analysis above, the proposed subject device is Substantially Equivalent (SE) to the predicate device.
§ 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).