(321 days)
The TOPTENS-01 can be used for the Symptomatic relief of chronic intractable pain, Post traumatic pain adjunctive treatment, Post-surgical pain adjunctive treatment.
The proposed device is transcutaneous electrical nerve stimulator for pain relief. this is a device used to apply an electrical current to electrodes on a patient's skin to treat pain. It only has one model: TOPTENS-01. TOPTENS-01 is mainly composed: host, built-in power supply, output lead and electrode. TOPTENS-01 power supply is DC4.5V, using built-in removable 3 AAA batteries. TOPTENS-01 comes with 2 independent output channels (A&B). Users can be adjust independently the two output channels Intensity by pressing the Left and right sides Intensity adjustment key. LCD screen display the remaining stimulation time in the top left corner. The default stimulation time is 30 minutes. TOPTENS-01 has 9 types stimulation modes: Mode1, Mode2, Mode 3, Mode 4, Mode 5, Mode6, Mode 7, Mode 8, Mode 9.
This is a 510(k) premarket notification for a medical device called the Transcutaneous Electrical Nerve Stimulator (TOPTENS-01) manufactured by Top-Rank Health Care Co., Ltd. The document aims to demonstrate that the TOPTENS-01 device is substantially equivalent to a legally marketed predicate device (K152374, also a Transcutaneous Electrical Nerve Stimulator).
This document does not contain acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy. Instead, it demonstrates substantial equivalence based on a comparison to a predicate device, focusing on technical specifications and safety standards.
Therefore, many of the requested sections (acceptance criteria related to clinical performance, sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, and ground truth types) are not applicable or cannot be extracted from this specific 510(k) summary, as these types of studies were not conducted or reported for this submission.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
This document does not establish performance acceptance criteria in terms of clinical outcomes or accuracy. Instead, it demonstrates substantial equivalence based on compliance with harmonized electrical safety and EMC standards, and a comparison of the device's technical specifications to a predicate device. The "performance" being evaluated is its adherence to these standards and the similarity of its operational parameters to the predicate.
| Acceptance Criteria Category (from 510(k) Summary) | Description of Criteria / Standard | Reported Device Performance and Compliance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1: Medical electrical equipment Part 1: General Requirements For Basic Safety And Essential Performance; and IEC 60601-2-10: Medical electrical equipment Part 2-10: Particular requirements for the safety of nerve and muscle stimulators. | The device complies with IEC 60601-1 and IEC 60601-2-10. The 510(k) states: "The new device passed Safety testing, so these differences will not cause any safety and effectiveness issues." (Difference 4). "The pulse parameters meet the maximum current density <2mA/cm² And the maximum average power density <0.25W/cm² safety standard requirements, and passed the safety test." (Difference 6). "But they all meet the safety standard requirements of maximum current density < 2mA/cm² and maximum average power density <0.25W/cm², and the new device has passed the safety test." (Difference 7). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic disturbances-Requirements and tests. | The device complies with IEC 60601-1-2. "The EMC property meets the requirements." (Section 6) |
| Home Healthcare Environment | Compliance with 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. | The device complies with IEC 60601-1-11:2015. (Section 6) |
| Additional Safety Standards | Compliance with ANSI/AAMI/ES 60601-1: 2005/(R)2012 and A1:2012, C1:2009/(r)2012 and a2:2010/(r)2012. | The device complies with ANSI/AAMI/ES 60601-1. (Section 6) |
| Functional Equivalence | Substantial equivalence in intended use, principle of operation, and performance specifications to the predicate device K152374. | The document provides detailed comparisons (Table 3 and Table 4) highlighting similarities in product code, regulation, indications for use, principle of operation, type of use, user interface, number of output channels, anatomical locations, regulated voltage, software control, automatic shut-off features, and display indications. Differences (e.g., power source, synchronous/alternating output, time range, dimensions, max output voltage/current, pulse parameters) were individually assessed and argued not to raise new questions of safety or effectiveness, often by referencing successful safety testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for clinical data. This 510(k) submission does not include clinical studies.
- For non-clinical (engineering/safety) tests: No specific "sample size" is mentioned for these tests, as they are typically performed on a limited number of manufactured units to verify design compliance with standards. The provenance of this non-clinical testing data is implied to be from the manufacturer (Top-Rank Health Care Co., Ltd. in China) or a certified testing laboratory. The tests are prospective in the sense that they were performed on the device after its manufacture.
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)
- Not applicable. No clinical test set or ground truth established by experts is mentioned in this 510(k) submission, as no clinical studies were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication is mentioned.
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. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is hardware and does not perform diagnostic algorithms in a standalone capacity that would require this type of evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For non-clinical tests: The "ground truth" for the non-clinical tests (electrical safety, EMC, etc.) is the adherence to the specified international and national standards (e.g., IEC 60601-x series). These standards define measurable parameters and acceptable limits.
- For clinical performance: No clinical ground truth was used as no clinical testing was performed or submitted. The statement of "Substantial Equivalence" relies on the device being technologically similar and equally safe and effective to the predicate device.
8. The sample size for the training set
- Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator and does not utilize a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device.
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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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
December 15, 2021
Top-Rank Health Care Co., Ltd. % Yuling Chen Official Correspondent Microkn Business Consulting (Shanghai) Co., Ltd. Room 1219, Block A, No3699, Gonghexin Road, Jingan District Shanghai, Shanghai 200040 China
Re: K210223
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: November 24, 2020 Received: January 28, 2021
Dear Yuling Chen:
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.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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).
Sincerely.
for Pamela Scott Assistant Director 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
510(k) Number (if known) K210223
Device Name
Transcutaneous Electrical Nerve Stimulator
Indications for Use (Describe)
The TOPTENS-01 can be used for the Symptomatic relief of chronic intractable pain, Post traumatic pain adjunctive treatment, Post-surgical pain adjunctive treatment.
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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510(k) Summary
| Product name | Transcutaneous Electrical Nerve Stimulator |
|---|---|
| Model | TOPTENS-01 |
| Applicants | Top-Rank Health Care Co.,Ltd. |
| Document Name | 510(k) Summary |
| Objective | 510 (k) Application |
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510(k) Summary
1. Contact information
1.1. Applicant
Applicant Name: Top-Rank Health Care Co.,Ltd.
Address: CHECUN VILLAGE, DONGGUAN ST.
Shang-Yu District Shaoxing city, Zhejiang province, China CN 312352
Contact Person: Franck Lou
Title: Manager
Telephone: +0575-82563666
E-mail: info@etop-rank.com
1.2. Consultant
Company: Microkn Business Consulting (Shanghai) Co., Ltd.
Address: Room 1219, Block A, No 3699, Gonghexin Road, Jingan District,
Shanghai, China
Contact Person: Yuling.Chen
Telephone: +86 15021397762
Email: yuling.chen@microkn.com
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2. Device information
- . Trade Name: Transcutaneous Electrical Nerve Stimulator
- Model(s): TOPTENS-01 ●
- Classification: II ●
- Product Code: NUH ●
- Regulation Number: 21 CFR 882.5890 ●
- 510(K)Number: K210223 .
3. Indications for Use
- Symptomatic relief of chronic intractable pain ●
- Post traumatic pain adjunctive treatment ●
- . Post surgical pain adjunctive treatment
4. Legally Marketed Predicate Device
Product name:Transcutaneous Electrical Nerve Stimulator (T.E.N.S)
510(k) Number: K152374
Product Code: NUH
Manufacture: Fuji Dynamics Ltd
5.Description of the device
The proposed device is transcutaneous electrical nerve stimulator for pain
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relief. this is a device used to apply an electrical current to electrodes on a patient's skin to treat pain. It only has one model: TOPTENS-01.
TOPTENS-01 is mainly composed: host, built-in power supply, output lead and electrode.
TOPTENS-01 power supply is DC4.5V, using built-in removable 3 AAA batteries.
TOPTENS-01 comes with 2 independent output channels (A&B). Users can be adjust independently the two output channels Intensity by pressing the Left and right sides Intensity adjustment key.
LCD screen display the remaining stimulation time in the top left corner. The default stimulation time is 30 minutes
TOPTENS-01 has 9 types stimulation modes: Mode1, Mode2, Mode 3, Mode 4, Mode 5, Mode6, Mode 7, Mode 8, Mode 9. These stimulation modes can be selected by pressing the key.The detailed difference shown in Table 1.
| Table 1 the Difference of Models | |||||
|---|---|---|---|---|---|
| Mode | Frequency(Hz) | Pulse Width(μs) | MaxAmplitude(V)(Vpeak,@500 Ω) | Output Mode | Position for Use |
| Mode 1 | 60~100 | 100~150 | 33 | FrequencyModulation &Pulse Width | Back of Neck |
| Table 1 the Difference of Models | |||||
| Mode | Frequency(Hz) | Pulse Width(μs) | Max amplitude(V)(Vpeak,@500 Ω) | Output Mode | Position for Use |
| Modulation | |||||
| Mode 2 | 80~100 | 260 | 23 | FrequencyModulation | Shoulder |
| Mode 3 | 100~150 | 100 | 33 | FrequencyModulation | Lumbar pain |
| Mode 4 | 100 | 100 | 23 | Continuous wave | Elbow |
| Mode 5 | 120 | 100~150 | 33 | Pulse WidthModulation | Knee |
| Mode 6 | 100~150 | 200 | 23 | FrequencyModulation | Hip |
| Mode 7 | 100 | 260 | 23 | Continuous wave | Elbow 2 |
| Mode 8 | 100 | 100 | 33 | Continuous wave | Knee 2 |
| Table 1 the Difference of Models | |||||
| Mode | Frequency(Hz) | Pulse(μs) | Max amplitude(V) (Vpeak,@500 Ω) | Output Mode | Position for Use |
| Mode 9 | 60~100 | 100~160 | 33 | FrequencyModulation &Pulse WidthModulation | Back of Neck 2 |
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Note 1: Do not place the electrodes on the Spine.
Note 2: Do not place the electrodes directly over joints.
The main components of proposed device shown in Table 2.
| Table 2 Main Components of Proposed Device | |
|---|---|
| Components | Function Description |
| Host | Control circuit signal, user interface, keyinteraction |
| Built-in powersupply | Energy Supply |
| Pads | Is responsible for sending electricalsignals to the skin |
| Set of Lead Wires | Is responsible for transmitting electricalsignals to the Pads |
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6.Non-Clinical Test conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-2-10:2016, Medical electrical equipment Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
- ANSI/AAMI/ES 60601-1: 2005/(R)2012 and A1:2012, C1:2009/(r)2012 and a2:2010/(r)2012. Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
- 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.
- IEC 60601-1-2: General requirements for basic safety and essential . performance-Collateral standard: Electromagnetic disturbances-Requirements and tests. The EMC property meets the requirements.
7.Clinical Test Conclusion
6
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No clinical study is included in this submission.
8.Predicate Devices
Product name:Transcutaneous Electrical Nerve Stimulator (T.E.N.S)
510(k) Number: K152374
Product Code: NUH
Manufacture: Fuji Dynamics Ltd
9.Substantially Equivalent (SE) Comparison
The Transcutaneous Electrical Nerve Stimulator has been carefully compared to legally marketed devices with respect to intended use, configuration, principle of operation (Table 3), and performance specifications (Table 4).
| Table 3 General Comparison | |||
|---|---|---|---|
| Item | Proposed Device | Predicate Device | Remark |
| TOPTENS-01 | Transcutaneous ElectricalNerve Stimulator (T.E.N.S) | ||
| ProductCode | NUH | NUH | Same |
| 510(k)Number | K210223 | K152374 | -- |
| Regulation | 21 CFR 882.5890 | 21 CFR 882.5890 | Same |
| Table 3 General Comparison | |||
| Item | Proposed Device | Predicate Device | Remark |
| TOPTENS-01 | Transcutaneous ElectricalNerve Stimulator (T.E.N.S) | ||
| Number | |||
| Indicationsfor Use | Symptomatic relief of chronic intractable pain Post traumatic pain adjunctive treatment Post surgical pain adjunctive treatment | Used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain. | Same |
| Principle ofOperation | The device applies low-frequency current to human tissue through the body surface skin, and treats specific parts of the human body through the generated electrochemical and electrophysiological reactions. | The device applies low-frequency current to human tissue through the body surface skin, and treats specific parts of the human body through the generated electrochemical and electrophysiological reactions. | Same |
| Table 3 General Comparison | |||
| Item | Proposed Device | Predicate Device | Remark |
| TOPTENS-01 | Transcutaneous ElectricalNerve Stimulator (T.E.N.S) | ||
| Type of use | OTC | OTC | Same |
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Table 4 Performance Comparison
| Table 4 Performance Comparison | ||||
|---|---|---|---|---|
| Item | Proposed Device | Predicate Device | Remark | |
| Power source | DC 4.5V, 3 AAAbatteries | DC 3.0V, 2 AAAbatteries | Difference 1 | |
| - Method of LineCurrent Isolation | Type BF | Type BF | Same | |
| - Normal condition | 2μΑ | - | Difference 1 | |
| - Single faultcondition | N/A | N/A | Same | |
| User interface | By LCD display | By LCD display | Same | |
| Table 4 Performance Comparison | ||||
| Item | Proposed DeviceTOPTENS-01 | Predicate DeviceTranscutaneousElectrical NerveStimulator (T.E.N.S) | Remark | |
| Number of output models | 4 | 4 | Same | |
| Output channel | Two channels | Two channels | Same | |
| Number of output models | 1 | 1 | Same | |
| Number of output channels | 2 | 2 | Same | |
| Number of anatomical locations | 6 | 6 | Same | |
| Anatomical locations | Back of Neck, Shoulder, Lumbar pain, Elbow, Knee, Hip | Back of Neck, Shoulder, Lumbar pain, Elbow, Knee, Hip | Same | |
| -Synchronous or Alternating? | Synchronous | Alternating | Difference 2 | |
| -Method of channel isolation | By enclosure | By enclosure | Same | |
| Table 4 Performance Comparison | ||||
| Proposed Device | Predicate Device | |||
| Item | TOPTENS-01 | TranscutaneousElectrical NerveStimulator (T.E.N.S) | Remark | |
| Regulated Current orRegulated Voltage? | Regulated Voltage | Regulated Voltage | Same | |
| Software/Firmware/MicroprocessorControl? | Software | Software | Same | |
| Automatic overloadtrip | NO | NO | Same | |
| Automatic No LoadTrip? | Yes | Yes | Same | |
| Automatic shut off? | Yes | Yes | Same | |
| User OverrideControl? | NO | NO | Same | |
| Indication Display | - | - | - | |
| -On/off status? | Yes | Yes | Same | |
| -Low battery? | Yes | Yes | Same | |
| Table 4 Performance Comparison | ||||
| Item | Proposed DeviceTOPTENS-01 | Predicate DeviceTranscutaneousElectrical NerveStimulator (T.E.N.S) | Remark | |
| -Voltage/currentlevel? | Yes | Yes | Same | |
| Time range (min) | 5~60 minutes(5,10,15,20,25,30,35,40,45,50,55and 60 minselectable) | Continuous, 15 min,30 min, 45 min and60 min selectable. | Difference 3 | |
| Compliance withVoluntaryStandards? | Yes.AAMI/ANSI ES60601-1,IEC 60601-1-2,IEC 60601-2-10,IEC 62133,IEC 60601-1-11 | Yes.AAMI/ANSI ES60601-1, IEC60601-1-2,IEC 60601-2-10,IEC 62133,IEC 60601-1-11 | Same | |
| Compliance with 21CFR 8988? | Yes | Yes | Same | |
| Weight (lbs.) | 0.18 (Battery Excluded) | 70g | ||
| Dimensions(in.) [W× H × D]For unit | 2.32x 4.96x1.18 | 38x127x20 | Difference 4 | |
| Housing materials | Plastic (ABS) enclosure | ABS | ||
| Table 4 Performance Comparison | ||||
| Item | Proposed Device | Predicate Device | Remark | |
| TOPTENS-01 | TranscutaneousElectrical NerveStimulator (T.E.N.S) | |||
| construction | ||||
| Waveform | biphasic symmetricalSquare waveform | biphasic symmetricalRectangularwaveform | Same | |
| Shape | Square | Square | Same | |
| Maximumoutputvoltage(Vp) | 33 @500Ω60 @2kΩ100 @10kΩ | 70 @500Ω98 @2kΩ108 @10kΩ | ||
| Max OutputCurrent (mA) | 66 @500Ω30 @2kΩ10 @10kΩ | 140 @500Ω49 @2kΩ10.8 @10kΩ | Difference 5 | |
| Pulse WidthRange(uS) | 100~260 | 104 | Difference 6 | |
| Frequency (Hz) | 60~150 | 90 | Difference 6 | |
| Table 4 Performance Comparison | ||||
| Item | Proposed DeviceTOPTENS-01 | Predicate DeviceTranscutaneousElectrical NerveStimulator (T.E.N.S) | Remark | |
| Formulti-programwaveformsonly | Symmetricalphases? | Yes | Yes | Same |
| PhaseDuration | 100~260 | 208 | Difference 6 | |
| Net Charge (mC perpulse) | 0@500Ω,Method: Balancedwaveform | 0@500Ω,Method: Balancedwaveform | Same | |
| Maximum AverageCurrent (mA) | 2.22@500Ω | 0.9@500Ω | Difference 7 | |
| Maximum PhaseCharge, (µC) | 17.16@500Ω | 18.1@500Ω | Difference 7 | |
| Maximum CurrentDensity(mA/cm², 500Ω,r.m.s) | 0.14@500Ω | 2.28mA/cm²@500Ω | Difference 7 | |
| Maximum PowerDensity | 0.00015@500Ω(using smallest | 0.00225@500Ω(using smallest | Difference 7 | |
| Table 4 Performance Comparison | ||||
| Item | Proposed Device | Predicate Device | Remark | |
| TOPTENS-01 | TranscutaneousElectrical NerveStimulator (T.E.N.S) | |||
| , (W/cm²)(using smallestelectrode conductivesurface area) | electrode 16cm²) | electrode 25cm²) |
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Difference 1:
The new device TOPTENS-01 is substantial equivalence as the predicate device K152374. The differences in Power source specification(value) and Patient Leakage Current are the differences Because of the difference in structure and circuit layout, which only affect the safety performance of the device, the device is an internal power device that only uses battery power, which has lowest safety risks and has passed the safety test, so these differences will not cause any safety and effectiveness issues. Considering the same Insulation method and power source, they are substantial equivalence.
Difference 2:
The new device TOPTENS-01 is substantial equivalence as the predicate device K152374. The difference between synchronous or alternating is that only the output method of the two channal is different, The final output
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waveform of the two channal is the same 。 They has passed the safety test, so these differences will not cause any safety and effectiveness issues. Considering the same output waveform and Output Shape, they are substantial equivalence.
Difference 3:
The new device TOPTENS-01 is substantial equivalence as the predicate device K152374.
The time range of the new device is same, and the options can be increased, in order to facilitate different use requirements. The new device has passed the safety test and the maximum time value is the same, so these differences will not cause any safety and effectiveness issues.
The new device is just an expansion of the time range and the maximum time value is the same, it can be considered that they are essentially equivalent.
Difference 4:
The new device TOPTENS-01 is substantial equivalence as the predicate device K152374. The differences in Dimensions, Weight and Housing materials construction are the differences in design requirements between different devices, which only affect the safety performance of the device, but the new device passed Safety testing, so these differences will not cause any safety and effectiveness issues. Considering the same intended use, working
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principle, output mode and output waveform, they are substantial equivalence.
Difference 5:
The new device TOPTENS-01 is basically equivalent to the predicate device K152374. The difference between the maximum output voltage and maximum output current of the new device is only in the output amplitude range. This can be achieved by adjusting the appropriate output intensity to achieve the same output effect and meet the requirements of use.
Based on the same intended use, output waveform, and the new equipment has passed safety tests, these differences will not cause any new safety and effectiveness issues, they are essentially equivalent.
Difference 6:
The new device TOPTENS-01 is basically equivalent to the predicate device K152374. The difference between of Pulse Width, Frequency, Phase Duration of the new device is only in the pulse parameter . As the new device adapts to the needs of different treatment sites, a wider parameter range is required, and the parameter range of the new device can cover the predicate device, Based on the same output waveform,it can be considered to have the same validity and the predicate device.
There are no safety difference in the pulse parameters themselves. The safety risks related to these parameters are mainly as follows: Frequency is higher,
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Pulse Width is wider, and Phase Duration is longer,The energy of the pulse per unit time is higher, but the pulse parameters meet the maximum current density <2mA/cm² And the maximum average power density <0.25W/cm² safety standard requirements, and passed the safety test.
Based on the same intended use, output waveform, and the new equipment has passed safety tests, these differences will not cause any new safety and effectiveness issues, they are essentially equivalent.
Difference 7:
The new device TOPTENS-01 is basically equivalent to the predicate device K152374. Maximum phase charge, maximum current density, and maximum power density are the main safety requirements. Although the some parameters of the new device is higher than that of the predicate device K152374, the value is close and at a low level. The maximum current density and the maximum power density are different because they are calculated by different electrodes, and the value is close and at a low level. But they all meet the safety standard requirements of maximum current density < 2mA/cm 2 and maximum average power density <0.25W/cm² ,and the new device has passed the safety test. These differences will not lead to any new safety and effectiveness issues. They are essentially equivalent.
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Safety comparison has been done to validate the electrical safety of the
device (Table 5).
| Table 5 Safety Comparison | |||
|---|---|---|---|
| Item | Proposed Device | Predicate Device | Remark |
| EMC, Electrical and Laser Safety | |||
| Electrical safety | Comply with IEC 60601-1,IEC 60601-2-10 | Comply with IEC60601-1, IEC60601-2-10 | SE |
| EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | SE |
| Homehealthcareenviroment | IEC 60601-1-11:2015 | IEC 60601-1-11:2015 | SE |
Table 5 Safety Comparison
11.Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is
determined to be Substantially Equivalent (SE) to the predicate device.
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§ 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).