(321 days)
Not Found
No
The device description and performance studies focus on standard electrical stimulation and compliance with electrical safety standards. There is no mention of AI, ML, or any data processing that would suggest intelligent algorithms are used.
Yes
The device is a transcutaneous electrical nerve stimulator (TENS) for pain relief, which is explicitly used to treat medical conditions (chronic intractable pain, post-traumatic pain, post-surgical pain).
No
The device is described as a transcutaneous electrical nerve stimulator (TENS) for pain relief, used for symptomatic relief of chronic intractable pain, post-traumatic pain, and post-surgical pain. It applies electrical currents to treat pain, rather than diagnose it.
No
The device description explicitly states it is composed of a host, built-in power supply, output lead, and electrode, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The TOPTENS-01 is a transcutaneous electrical nerve stimulator (TENS). It applies electrical current to the skin for pain relief. It does not analyze any biological specimens.
- Intended Use: The intended use is for symptomatic relief of pain, not for diagnosing or monitoring a condition based on in vitro analysis.
- Lack of IVD-related information: The description does not mention any components or processes related to handling or analyzing biological samples.
Therefore, the TOPTENS-01 falls under the category of a therapeutic device, specifically a TENS device, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TOPTENS-01 can be used for the Symptomatic relief of chronic intractable pain, Post traumatic pain adjunctive treatment, Post-surgical pain adjunctive treatment.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
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. These stimulation modes can be selected by pressing the key.
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, key interaction |
| Built-in power supply | Energy Supply |
| Pads | Is responsible for sending electrical signals to the skin |
| Set of Lead Wires | Is responsible for transmitting electrical signals to the Pads |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Back of Neck, Shoulder, Lumbar pain, Elbow, Knee, Hip
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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) | Max | ||||
| Amplitude | |||||
| (V)(Vpeak, | |||||
| @500 Ω) | Output Mode | Position for Use | |||
| Mode 1 | 60~100 | 100~150 | 33 | Frequency | |
| Modulation & | |||||
| 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 | Frequency | |
| Modulation | Shoulder | ||||
| Mode 3 | 100~150 | 100 | 33 | Frequency | |
| Modulation | Lumbar pain | ||||
| Mode 4 | 100 | 100 | 23 | Continuous wave | Elbow |
| Mode 5 | 120 | 100~150 | 33 | Pulse Width | |
| Modulation | Knee | ||||
| Mode 6 | 100~150 | 200 | 23 | Frequency | |
| Modulation | 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 | Frequency | |
| Modulation & | |||||
| Pulse Width | |||||
| Modulation | 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, key |
| interaction | |
| Built-in power | |
| supply | Energy Supply |
| Pads | Is responsible for sending electrical |
| signals to the skin | |
| Set of Lead Wires | Is responsible for transmitting electrical |
| signals 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
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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 Electrical | ||
| Nerve Stimulator (T.E.N.S) | |||
| Product | |||
| Code | 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 Electrical | ||
| Nerve Stimulator (T.E.N.S) | |||
| Number | |||
| Indications | |||
| for 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 of | |||
| Operation | 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 Electrical | ||
| Nerve 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 AAA | |||
| batteries | DC 3.0V, 2 AAA | |||
| batteries | Difference 1 | |||
| - Method of Line | ||||
| Current Isolation | Type BF | Type BF | Same | |
| - Normal condition | 2μΑ | - | Difference 1 | |
| - Single fault | ||||
| condition | N/A | N/A | Same | |
| User interface | By LCD display | By LCD display | Same | |
| Table 4 Performance Comparison | ||||
| Item | Proposed Device | |||
| TOPTENS-01 | Predicate Device | |||
| Transcutaneous | ||||
| Electrical Nerve | ||||
| Stimulator (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 | Transcutaneous | ||
| Electrical Nerve | ||||
| Stimulator (T.E.N.S) | Remark | |||
| Regulated Current or | ||||
| Regulated Voltage? | Regulated Voltage | Regulated Voltage | Same | |
| Software/Firmware/ | ||||
| Microprocessor | ||||
| Control? | Software | Software | Same | |
| Automatic overload | ||||
| trip | NO | NO | Same | |
| Automatic No Load | ||||
| Trip? | Yes | Yes | Same | |
| Automatic shut off? | Yes | Yes | Same | |
| User Override | ||||
| Control? | NO | NO | Same | |
| Indication Display | - | - | - | |
| -On/off status? | Yes | Yes | Same | |
| -Low battery? | Yes | Yes | Same | |
| Table 4 Performance Comparison | ||||
| Item | Proposed Device | |||
| TOPTENS-01 | Predicate Device | |||
| Transcutaneous | ||||
| Electrical Nerve | ||||
| Stimulator (T.E.N.S) | Remark | |||
| -Voltage/ | ||||
| current | ||||
| level? | Yes | Yes | Same | |
| Time range (min) | 5~60 minutes | |||
| (5,10,15,20,25,30,35,40, | ||||
| 45,50,55and 60 min | ||||
| selectable) | Continuous, 15 min, | |||
| 30 min, 45 min and | ||||
| 60 min selectable. | Difference 3 | |||
| Compliance with | ||||
| Voluntary | ||||
| Standards? | Yes. | |||
| AAMI/ANSI ES | ||||
| 60601-1, | ||||
| IEC 60601-1-2, | ||||
| IEC 60601-2-10, | ||||
| IEC 62133, | ||||
| IEC 60601-1-11 | Yes. | |||
| AAMI/ANSI ES | ||||
| 60601-1, IEC | ||||
| 60601-1-2, | ||||
| IEC 60601-2-10, | ||||
| IEC 62133, | ||||
| IEC 60601-1-11 | Same | |||
| Compliance with 21 | ||||
| CFR 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 | Transcutaneous | |||
| Electrical Nerve | ||||
| Stimulator (T.E.N.S) | ||||
| construction | ||||
| Waveform | biphasic symmetrical | |||
| Square waveform | biphasic symmetrical | |||
| Rectangular | ||||
| waveform | Same | |||
| Shape | Square | Square | Same | |
| Maximum | ||||
| output | ||||
| voltage | ||||
| (Vp) | 33 @500Ω | |||
| 60 @2kΩ | ||||
| 100 @10kΩ | 70 @500Ω | |||
| 98 @2kΩ | ||||
| 108 @10kΩ | ||||
| Max Output | ||||
| Current (mA) | 66 @500Ω | |||
| 30 @2kΩ | ||||
| 10 @10kΩ | 140 @500Ω | |||
| 49 @2kΩ | ||||
| 10.8 @10kΩ | Difference 5 | |||
| Pulse Width | ||||
| Range(uS) | 100~260 | 104 | Difference 6 | |
| Frequency (Hz) | 60~150 | 90 | Difference 6 | |
| Table 4 Performance Comparison | ||||
| Item | Proposed Device | |||
| TOPTENS-01 | Predicate Device | |||
| Transcutaneous | ||||
| Electrical Nerve | ||||
| Stimulator (T.E.N.S) | Remark | |||
| For | ||||
| multi-prog | ||||
| ram | ||||
| waveforms | ||||
| only | Symmetrical | |||
| phases? | Yes | Yes | Same | |
| Phase | ||||
| Duration | 100~260 | 208 | Difference 6 | |
| Net Charge (mC per | ||||
| pulse) | 0@500Ω, | |||
| Method: Balanced | ||||
| waveform | 0@500Ω, | |||
| Method: Balanced | ||||
| waveform | Same | |||
| Maximum Average | ||||
| Current (mA) | 2.22@500Ω | 0.9@500Ω | Difference 7 | |
| Maximum Phase | ||||
| Charge, (µC) | 17.16@500Ω | 18.1@500Ω | Difference 7 | |
| Maximum Current | ||||
| Density | ||||
| (mA/cm², 500Ω, | ||||
| r.m.s) | 0.14@500Ω | 2.28mA/cm²@500Ω | Difference 7 | |
| Maximum Power | ||||
| Density | 0.00015@500Ω | |||
| (using smallest | 0.00225@500Ω | |||
| (using smallest | Difference 7 | |||
| Table 4 Performance Comparison | ||||
| Item | Proposed Device | Predicate Device | Remark | |
| TOPTENS-01 | Transcutaneous | |||
| Electrical Nerve | ||||
| Stimulator (T.E.N.S) | ||||
| , (W/cm²) | ||||
| (using smallest | ||||
| electrode conductive | ||||
| surface 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
19
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
20
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