(266 days)
Portable Electro-Stimulation Therapy Device, model LGT-235 is indicated for the Symptomatic relief of chronic intractable pain, Post-traumatic pain and Post-surgical pain of the arms and legs.
The Portable Electro-Stimulation Therapy Device, model LGT-235 is a stimulator which sends gentle electrical current to underlying nerves via electrodes (Knee brace or self-adhesive electrode) applied on the skin with two operational modes and powered by rechargeable lithium battery; the device system is made up of mobile app MStim Arth, main unit and electrodes (Knee brace and self-adhesive electrode).
The Mobile App MStim Arth provides access to treatment controls for Portable Electro-Stimulation Therapy Device from a compatible mobile device for selecting a pre-programmed output mode and treatment time.
The main unit provides access to adjust the intensity up or down, put ON/OFF the main unit.
The two modes that Portable Electro-Stimulation Therapy Device, model LGT-235 employs are transcutaneous electrical stimulation (TENS) and Microcurrent (MCR).
TENS and MCR are both specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. TENS and MCR use tiny electrical impulses sent through the skin to nerves to modify the pain perception. TENS and MCR do not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. Knee brace is placed on the leg or arm close to the area of pain.
The provided text describes the Portable Electro-Stimulation Therapy Device, model LGT-235, and its substantial equivalence to a predicate device (Sonicator Plus 920, Model ME 920), which implies that it meets certain performance criteria. However, the document does not explicitly list quantitative acceptance criteria for the device's performance in terms of clinical efficacy or diagnostic accuracy. Instead, it focuses on demonstrating equivalence through technical specifications and compliance with recognized safety standards.
Therefore, many of the requested fields cannot be filled as they relate to clinical studies or performance metrics that are not detailed in this 510(k) summary.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria for clinical performance (e.g., pain reduction percentage, accuracy). Instead, it compares the technical characteristics and output specifications of the subject device to the predicate device, with the implicit acceptance criterion being "similar" or "same," meaning the differences do not raise new questions of safety or effectiveness.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Subject Device) |
|---|---|---|
| Classification | Same as Predicate | 21 CFR 882.5890 (Same) |
| Product Code | Same as Predicate | GZJ (Same) |
| FDA Class | Same as Predicate | 2 (Same) |
| Intended Use | Same as Predicate | Symptomatic relief of chronic intractable pain, Post-traumatic pain, Post-surgical pain (Same) |
| Principle of operation | Same as Predicate | Sends gentle electrical current to muscle group via electrodes applied on the skin (Same) |
| Target Population | Same as Predicate | Adults (Same) |
| Anatomical Site | Same as Predicate | Arm and legs (Same) |
| Waveform | Same as Predicate | Symmetrical biphasic (Same) |
| Maximum Output Voltage | Similar to Predicate, acceptable differences | TENS: 50V @ 500 Ω, 115 V @ 2 kΩ, 125 V @ 10 kΩ; MCR: 0.45 V@ 500 Ω, 1.8 V@ 2 kΩ, 7.4 V @ 10 kΩ (Similar, acceptable error in MCR) |
| Maximum Output Current | Similar to Predicate, acceptable differences | TENS: 100 mA@ 500 Ω, 58 mA@ 2 kΩ, 13 mA@ 10 kΩ; MCR: 0.92 mA@ 500 Ω, 0.90 mA@ 2 kΩ, 0.74 mA@ 10 kΩ (Similar, acceptable error in MCR) |
| Pulse Width (TENS) | Similar to Predicate | 100 ~ 600 µs (Similar, within safe/effective range of predicate) |
| Pulse Width (MCR) | Similar to Predicate | 1.25 ms ~ 1.67 s (Similar, within safe/effective range of predicate) |
| Frequency (TENS) | Similar to Predicate | 0.5 ~ 250 Hz (Similar, predicate range overriding proposed device suggests safety) |
| Frequency (MCR) | Similar to Predicate | 0.3 ~ 400 Hz (Similar, predicate range overriding proposed device suggests safety) |
| Maximum Intensity | Same as Predicate | 100 mA (Same) |
| Net Charge (µC/pulse) | Same as Predicate | 0 µC @ 500Ω (Same) |
| Maximum Phase Charge | Similar to Predicate | TENS: 60 (µC) @ 500Ω; MCR: 75 (µC) @ 500Ω (Similar, predicate range overriding proposed device suggests safety) |
| Maximum Current Density | Similar to Predicate, acceptable differences | TENS: 1.97 (mA/cm²) @ 500Ω; MCR: 0.026 mA/cm² @ 500Ω (Similar, TENS proposed device is overriding predicate; for MCR, slightly larger but proven safe by IEC 60601-2-10) |
| Maximum Power Density | Similar to Predicate, acceptable differences | TENS: 8.26 mW/cm² @ 500Ω; MCR: 0.016 W/cm² @ 500Ω (Similar, TENS proposed device is overriding predicate; MCR within acceptable limits per guidance) |
| Biocompatibility | Pass ISO 10993-5 and 10 | Knee brace demonstrated safety by passing ISO 10993-5 and -10. (Meets) |
| Electrical Safety | Pass ANSI AAMI ES60601-1 | Demonstrated electrical safety by passing ANSI AAMI ES60601-1 and meeting relevant chapters. (Meets) |
| Electromagnetic Compatibility (EMC) | Pass IEC 60601-1-2 | Demonstrated EMC by passing IEC 60601-1-2. (Meets) |
| Safety of Nerve & Muscle Stimulators | Pass IEC 60601-2-10 | Demonstrated safety by passing IEC 60601-2-10. (Meets) |
| Home Healthcare Environment Safety | Pass IEC 60601-1-11 | Demonstrated safety by passing IEC 60601-1-11. (Meets) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission focuses on non-clinical (engineering, safety, and performance) testing, and does not describe a clinical test set or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. The document describes non-clinical testing and equivalency to a predicate device, not a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. There is no described clinical test set with ground truth requiring adjudication.
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
This information is not applicable/not provided. The device is an electro-stimulation therapy device for pain relief, not an AI-assisted diagnostic or interpretative device that would typically involve human "readers" or MRMC studies for AI improvement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device is a therapy device, not an algorithm, and its performance is assessed against electrical and safety standards, not standalone diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided. The "ground truth" for the non-clinical tests involved comparing the device's measured electrical outputs and safety characteristics against established international standards (ISO, ANSI, IEC) and the specifications of the predicate device.
8. The sample size for the training set
This information is not applicable/not provided. As this is a 510(k) for a physical medical device (electro-stimulation therapy), not an AI/ML algorithm, there is no "training set" in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable/not provided. See response to point 8.
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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 & 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.
April 26, 2018
Guangzhou Longest Science & Technology Co., Ltd. % You Yijie Manager Oimmig Medical Consulting Service Co., Ltd RM.1711, Building K, NO.101 Science Ave International Creative Valley Guangzhou, 510663 Cn
Re: K182108
Trade/Device Name: Portable Electro-Stimulation Therapy Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: March 29, 2019 Received: March 29, 2019
Dear You Yijie:
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. 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 located 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.
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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; 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,
Pamela D. Scott -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) K182108
Device Name Portable Electro-Stimulation Therapy Device
Indications for Use (Describe)
Portable Electro-Stimulation Therapy Device, model LGT-235 is indicated for the Symptomatic relief of chronic intractable pain, Post-traumatic pain and Post-surgical pain of the arms and legs.
| 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
Date: April 24, 2019
1. Submitter's Information
Establishment Registration Information
Name: Guangzhou Longest Science & Technology Co., Ltd. Address: 5&6f, Building B4, No.11, Kaiyuan Avenue Science City, Hi-Tech Industrial Zone Guangzhou, Guangdong CHINA
Contact Person of applicant
Name: Xiaobinq Luo Address: 5&6f, Building B4, No.11, Kaiyuan Avenue Science City, Hi-Tech Industrial Zone Guangzhou, Guangdong CHINA TEL: +86 020-66353999 FAX: +86 020-66353999 Email: qzlongest@126.com
Contact Person of the Submission:
Name: You Yijie Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: +86 020-8224 5821 FAX: +86 020-8224 5821 Email: Jet.you@gimmiq-med.com
2. Device Information
Type of 510(K) submission: Traditional Trade Name: Portable Electro-Stimulation Therapy Device Model: LGT-235 Regulation name: Transcutaneous electrical nerve stimulator for pain relief. Review panel: Neurology Product code: GZJ Requlation Class: II Regulation Number: 21 CFR 882.5890
3. Predicate Device Information
510(k) submitter/holder: Mettler Electronics Corp. 510(K) Number: K111482 Regulation Class: 2 Device: Sonicator Plus 920 Sonicator Plus 920, Model ME 920 Trade name:
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4. Device description
The Portable Electro-Stimulation Therapy Device, model LGT-235 is a stimulator which sends gentle electrical current to underlying nerves via electrodes (Knee brace or self-adhesive electrode) applied on the skin with two operational modes and powered by rechargeable lithium battery; the device system is made up of mobile app MStim Arth, main unit and electrodes (Knee brace and self-adhesive electrode).
The Mobile App MStim Arth provides access to treatment controls for Portable Electro-Stimulation Therapy Device from a compatible mobile device for selecting a pre-programmed output mode and treatment time.
The main unit provides access to adjust the intensity up or down, put ON/OFF the main unit.
The two modes that Portable Electro-Stimulation Therapy Device, model LGT-235 employs are transcutaneous electrical stimulation (TENS) and Microcurrent (MCR).
TENS and MCR are both specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. TENS and MCR use tiny electrical impulses sent through the skin to nerves to modify the pain perception. TENS and MCR do not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. Knee brace is placed on the leg or arm close to the area of pain.
5. Principle of operation:
The Portable Electro-Stimulation Therapy Device, model LGT-235 sends gentle electrical current to underlying nerves and muscle group via electrodes (Knee brace or self-adhesive electrode) applied on the skin and powered by rechargeable lithium battery. When used in TENS or MCR mode, it specifically targets the sensory nerves, which are responsible for sending pain signals to the brain; and it uses tiny electrical impulses sent through the skin to nerves to modify pain perception and finally helps control the pain.
6. Indications for Use
Portable Electro-Stimulation Therapy Device, model LGT-235 is indicated for the Symptomatic relief of chronic intractable pain, Post-traumatic pain and Post-surgical pain of the arms and legs..
7. Summary of technological characteristics of device compared to the predicate devices (K111482)
| Characteristic | Subject device | Predicate device | Discussion of difference | |
|---|---|---|---|---|
| Present application(PortableElectro-StimulationTherapy Device, model | (K111482, SonicatorPlus 920, Model ME920 (TENS andMicrourrent mode)) | |||
| LGT-235) | ||||
| Classification | 21 CFR 882.5890 | 21 CFR 890.5890 | Same | |
| Product Code | GZJ | GZJ | Same | |
| FDA Class | 2 | 2 | Same | |
| Intended Use | Symptomatic relief ofchronic intractable pain2. Post-traumatic pain3. Post-surgical pain | Symptomatic relief ofchronic intractable pain2. Post-traumatic pain3. Post-surgical pain | Same | |
| Principle of operation | sends gentle electricalcurrent to muscle groupvia electrodes appliedon the skin | sends gentle electricalcurrent to muscle groupvia electrodes appliedon the skin | Same | |
| target population | adults | adults | Same | |
| anatomical site | Arm and legs | Arm and legs | Same | |
| Material of Patientcontact components | Electrodes:Knee brace: OK cloth +SBR + dacronConductive fabric:Silver wire + nylonSelf-adhesive electrode:conductive hydrogel | Electrode: conductivehydrogel | DifferentKnee brace wasdemonstratedbiocompability safety bypassing ISO 10993-5 andISO 10993-10 tests. Thedifference does not raisethe issue of product'ssafety and effectiveness. | |
| where used | home | home | Same | |
| Design | Handheld | Desk type | DifferentThis difference existed willnot affect the safety andeffectiveness of theproposed device | |
| Power Source | Rechargeable lithiumbattery 3.7V | AC line | DifferentThe proposed device wasdemonstrated electricalsafety by passing ANSIAAMI ES60601-1. Thedifference does not raisethe issue of product'ssafety and effectiveness. | |
| Method of linecurrent isolation | N/A (3.7V rechargeablelithium battery operateddevice) | Double isolation | DifferentThis difference existed willnot affect the safety andeffectiveness of theproposed device. | |
| PatientLeakage | Normalcondition | < 1µA | Meet requirement ofANSI/AAMI ES60601-1 | SimilarThe proposed device was |
| Current | Single faultcondition | < 1μΑ | >50μΑ | demonstrated electricalsafety by meet therequirement of chapter8.7.4.7 of ANSI AAMIES60601-1. Thedifference does not raisethe issue of product'ssafety and effectiveness. |
| Numberof OutputChannels | Number | One | two | DifferentThis will not affect thesafety and effectivenessof the proposed device |
| Synchronouss orAlternating? | Synchronous | Synchronous | Same | |
| Number of OutputModes | two (TENS + MCR) | two (TENS + MCRmodes) | Same | |
| Regulated Current orRegulated Voltage? | Current | Current | Same | |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Same | |
| Automatic OverloadTrip? | Yes | Yes | Same | |
| Automatic No-LoadTrip? | Yes | Yes | Same | |
| Automatic Shut Off? | "On/Off" button | "On/Off" button | Same | |
| User Override Control? | No, On/Off | No, On/Off, Hold or Stop | Same | |
| IndicatorDisplay | On/OffStatus? | Yes | Yes | Same |
| Low Battery? | Yes | N/A | DifferentThis difference existed willnot affect the safety andeffectiveness of theproposed device | |
| Voltage/CurrentLevel? | Yes (on app) | Yes | SameSystem validationtesting scenarioscovering mitigation ofwireless risks inaccordance withRED were added to ourfull system testingprotocol to ensure safeand effective use. | |
| Timer Range (minutes) | 1~60 minutes | 0~60 minutes | Same | |
| ANSI AAMI ES60601-1 | Yes | Yes | Same | |
| IEC 60601-1-2 | Yes | Yes | Same | |
| IEC 60601-2-10 | Yes | Yes | Same | |
| Weight | main unit: 120gCharging case: 150g | 11(lbs.) | DifferentThe Weight will not affectthe safety andeffectiveness of theproposed device | |
| Dimensions(W x H x D) | 59mm (W) × 59mm (L) ×22mm (H) (mm) | 4.9 x 13.6 x10.5(in.) | DifferentThe dimensions will notaffect the safety andeffectiveness of theproposed device | |
| Operatingcondition | Temperature: 5 to 40°C;Rel. humidity: ≤80%;Atmosphere Pressure:86.0 to 106.0kPa. | Temperature of use from10°C to 40°CMax. relative humidityfrom 30% to 75%Atmospheric pressurefrom 700 hPa to1060 hPa | SimilarThe operating condition ofsubject device has passedthe safety test, and theInstructions for Useprovides the operatingcondition, so thedifference between theoperating conditions ofsubject device andpredicate device will notaffect the safety andeffectiveness of subjectdevice |
Basic Device Characteristics - Comparison with Predicate Device
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Output Specifications – Comparison with Predicate Device
| Characteristic | Subject devicePresent application(PortableElectro-StimulationTherapy Device, modelLGT-235) | Predicate device(K111482, SonicatorPlus 920, Model ME920 (TENS andMicrourrent mode)) | Discussion of difference | |
|---|---|---|---|---|
| Waveform | Symmetrical biphasic | Symmetrical Biphasic | Same | |
| Maximum OutputVoltage (± 20%) | TENS:50V @ 500 Ω115 V @ 2 kΩ125 V @ 10 kΩMCR:0.45 V@ 500 Ω1.8 V@ 2 kΩ7.4 V @ 10 kΩ | TENS:50 V @ 500 Ω115 V @ 2 kΩ125 V @ 10 kΩMCR:0.37 V @ 500 Ω1.5 V @ 2 kΩ7.4 V @ 10 kΩ | SimilarThe error existed in MCRmode between proposeddevice and predicatedevice are acceptable.The difference does notraise the issue ofproduct's safety andeffectiveness. | |
| Maximum Output | TENS: | TENS: | ||
| Current (± 20%) | 100 mA@ 500 Ω58 mA@ 2 kΩ13 mA@ 10 kΩMCR:0.92 mA@ 500 Ω0.90 mA@ 2 kΩ0.74 mA@ 10 kΩ | 100 mA@ 500 Ω58 mA@ 2 kΩ13 mA@ 10 kΩMCR:0.74 mA@ 500 Ω0.75 mA@ 2 kΩ0.74 mA@ 10 kΩ | The error existed in MCRmode between proposeddevice and predicatedevice are acceptable.The difference does notraise the issue ofproduct's safety andeffectiveness. | |
| Pulse Width | TENS: 50 to 500 μs | TENS: 100 ~ 600us | Similar | |
| MCR: 4.16 ms ~ 0.5s | MCR: 1.25ms ~ 1.67s | The predicate device issafe and effective in pulsewidth range 100 ~ 600usfor TENS mode and1.25ms ~ 1.67s for MCRmode, since the pulsewidth range of proposeddevice are in the range ofpredicate device, theproposed device is alsosafe and effective with itspulse width, therefore, thedifference does not raisethe issue of product'ssafety and effectiveness. | ||
| Frequency | TENS: 1 ~ 120 Hz | TENS: 0.5 ~ 250 Hz | Similar | |
| MCR: 1 ~ 120 Hz | MCR: 0.3 ~ 400 Hz | The frequency range ofpredicate device isoverriding the range ofproposed device, sincethe predicate device issafe and effective,therefore the proposeddevice is also safe andeffective, the differencedoes not raise the issue ofproduct's safety andeffectiveness. | ||
| Maximum intensity | 100mA | 100 mA | Same | |
| Formultiphasic | Symmetricalphases? | Yes | Yes | Same |
| waveformsonly | PhaseDuration(includeunits)(staterange, ifapplicable) (bothphases, ifasymmetrical) | TENS: 50 to 500 µsMCR: 4.16 ms ~ 0.5s | TENS: 100 ~ 600usMCR: 1.25ms ~ 1.67s | Similar |
| The predicate device issafe and effective in pulsewidth range 100 ~ 600usfor TENS mode and1.25ms ~ 1.67s for MCRmode, since the pulsewidth range of proposeddevice are in the range ofpredicate device, theproposed device is alsosafe and effective with itspulse width, therefore,difference existed doesnot raise the issue ofproduct's safety andeffectiveness. | ||||
| Stimulating surface areaof electrode (minimum) | 2500mm² (50mm,square) | 2015.80mm² (50.8mmdiameter, round) | SimilarThe smaller of the surfacearea the higher risk is, thedifference does not raisethe issue of product'ssafety and effectiveness. | |
| Net Charge (µC/pulse) | TENS:0µC @ 500ΩMCR: 0µC@ 500Ω | 0 µC @ 500Ω | Same. | |
| Maximum PhaseCharge (µC) | TENS: 48 (µC) @ 500ΩMCR: 34 (µC) @ 500Ω | TENS: 60 (µC) @ 500ΩMCR: 75 (µC) @ 500Ω | SimilarThe Maximum PhaseCharge of predicatedevice is overriding theproposed device, sincethe predicate device issafe and effective,therefore the proposeddevice is also safe andeffective, differenceexisted does not raise theissue of product's safetyand effectiveness. | |
| Maximum CurrentDensity,(mA / cm², r.m.s.) | TENS: 0.81mA/cm2 @500ΩMCR: 0.036mA/cm2@500Ω | TENS: 1.97 (mA/cm2)@ 500ΩMCR: 0.026mA/cm2 @500Ω | SimilarFor TENS mode, themaximum current densityof proposed device isoverriding the proposeddevice which means theproposed device is safeand effective. As for modeMCR, the maximumcurrent density ofproposed device is littlebigger than predicatedevice, however theproposed device wasdemonstrated safety by | |
| IEC 60601-2-10. Thedifference does not raisethe issue of product'ssafety and effectiveness. | ||||
| Maximum PowerDensity (W/cm²) | TENS: 8.26 mW/cm²@ 500ΩMCR: 0.016 W/cm²@ 500Ω | TENS: 39 mW/cm²@ 500ΩMCR: 0.007 mW/cm²@ 500Ω | SimilarFor TENS mode, themaximum power densityof proposed device isoverriding the proposeddevice which means theproposed device is safeand effective. As for modeMCR, the maximumpower density of proposeddevice is bigger thanpredicate device but farless than 0.25 W/cm²required by GuidanceDocument for PoweredMuscle Stimulator (June9, 1999), the differencedoes not raise the issue ofproduct's safety andeffectiveness. |
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8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Non-clinical verification testing of the Portable Electro-Stimulation Therapy Device, model: LGT-235 included electrical, mechanical, and software tests to show the device meets its design specifications. Validation and performance testing validates that the device meets its user needs. Verification and validation test results established that the device meets its intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new issues of safety and effectiveness were raised. The Portable Electro-Stimulation Therapy Device, model: LGT-235 was designed, verified, and validated according to the company's Design Control process and has been subjected to extensive safety and performance testing as shown in the test results provided in this submission. Verification and Validation testing data demonstrate that the device meets all of its specifications including compliance with the following standards:
-
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicityISO 10993-10:2010 Biological evaluation of medical devices. Tests for irritation and skin sensitization
-
- ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012 Medical electrical equipment. General requirements for basic safety and essential performance
-
- IEC 60601-1-2:2014 Medical electrical equipment part 1-2: general requirements for safety - collateral standard: electromagnetic compatibility - requirements and tests
-
- IEC 60601-2-10:2012 Medical Electrical equipment Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
-
- IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
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9. Conclusions
The electrical safety, EMC, biocompatibility, software verification and validation, basic unit characteristics, and output specifications information provided is sufficient to demonstrate substantial equivalence to the predicate device. As the Portable Electro-Stimulation Therapy Device, model: LGT-235 is nearly identical to the predicate device, differences in their characteristics do not raise any raise new questions regarding safety and effectiveness with identical indications for use and essentially identical technological characteristics, the Portable Electro-Stimulation Therapy Device, model: LGT-235 is substantially equivalent to the predicate device Sonicator Plus 920, Model ME 920 (TENS and MCR mode).
§ 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).