(287 days)
The nu-beca Transcutaneous Electrical Nerve Stimulation is indicated for temporary relief of pain associated with sore and aching muscles in the lower back and upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
The nu-beca Transcutaneous Electrical Nerve Stimulation consists of following components and accessories: TENS Stimulator, Electrode Pad, nu-beca Gel Pad, Charging Cable, Storage Pad. The device releases electrical current with adjustable frequencies and voltages to temporarily relief sore and aching muscles. It has only one model: TN0001. The treatment time for one session use is 15 minutes.
The provided document is a 510(k) summary for the nu-beca Transcutaneous Electrical Nerve Stimulation device. It details a comparison to predicate and reference devices and summarizes non-clinical testing. However, it does not contain a specific study that proves the device meets predefined acceptance criteria for clinical performance, nor does it include information about human reader studies or ground truth establishment in the context of clinical efficacy for pain relief.
The document primarily focuses on demonstrating substantial equivalence through technological characteristics and safety testing (e.g., electrical safety, EMC, biocompatibility, performance of electrical current specifications). The "acceptance criteria" discussed in the document refer to the criteria for these technical and safety tests, which the device met.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
The document discusses various performance tests with general statements that "All test results met acceptance criteria." However, it does not present a single consolidated table of quantitative acceptance criteria and corresponding device performance values for all parameters. Instead, these are mentioned in the "11. Non-Clinical Testing Summary" section for specific tests.
Here's an attempt to extract some of the performance criteria and reported outcomes based on the text:
| Characteristic / Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety (Overall) | Compliance with IEC 60601-1:2012, IEC 60601-1-11:2015, IEC 60601-2-10:2016 | Met (passed all tests) |
| EMC | Compliance with IEC 60601-1-2:2014 | Met (passed all tests) |
| Waveform and Shape | - | Verified (met acceptance criteria) |
| Pulse Duration | Electrical pulse outputted within claimed time interval (same as predicate) | Verified (met acceptance criteria, same as predicate) |
| Net Charge per Pulse | - | Verified (met acceptance criteria; 7.50 µC, similar to reference K160052 at 7.16µC) |
| Maximum Average Power Density | Less than 0.25 Watts/cm² (per FDA Guidance) | 0.062 Watts/cm² (within safe range) |
| Intensity Verification (Output Voltage) | Compliance with IEC 60601-2-10:2016 | Verified (met acceptance criteria) |
| Frequency and Output Current Verification | Compliance with IEC 60601-2-10:2016 | Verified (met acceptance criteria) |
| Biocompatibility (Cytotoxicity) | Compliance with ISO 10993-5:2009 | Performed (results met acceptance criteria) |
| Biocompatibility (Sensitization) | Compliance with ISO 10993-10:2021 | Performed (results met acceptance criteria) |
| Biocompatibility (Irritation) | Compliance with ISO 10993-23:2021 | Performed (results met acceptance criteria) |
| Storage Stability | Safety and effectiveness suitable for shelf life | Performed (ensured suitable for use) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document describes non-clinical bench tests. These tests typically do not involve human subjects or "test sets" in the clinical sense. Therefore, there is no mention of sample size for a clinical test set or data provenance in terms of country of origin or retrospective/prospective nature. The tests are benchtop evaluations of device specifications and safety standards.
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. This document pertains to the regulatory clearance of a Transcutaneous Electrical Nerve Stimulation device, which is based on demonstrating substantial equivalence to existing devices through engineering and safety testing, not on diagnostic accuracy evaluated by experts. The "ground truth" here is the adherence to established engineering standards and safety limits.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for clinical studies where there are multiple interpretations or classifications to resolve, or for reviewing adverse events. This document describes technical product testing.
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. MRMC studies are used for evaluating diagnostic devices, particularly those involving human interpretation of images or other data, often in the context of AI assistance. The nu-beca Transcutaneous Electrical Nerve Stimulation is a therapeutic device for pain relief, not a diagnostic one. No AI component is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical TENS unit for direct patient use, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to established engineering standards and safety limits (e.g., IEC 60601 series, ISO 10993 series, FDA Guidance Document for Powered Muscle Stimulator 510(k)s). The device's performance was compared against these predefined technical benchmarks, not clinical outcomes or expert consensus on a disease state.
8. The sample size for the training set
Not applicable. The device is a hardware product, and the document describes its manufacturing specifications and testing against standards, not the development of a trained AI model.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned, as this is not an AI/ML-based device.
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Image /page/0/Picture/0 description: The image contains 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.
July 19, 2023
Nu-Beca & Maxcellent Co. % Diana Sung, MS Assistant Manager of Regulatory Department TaiDoc Technology Corporation B1-7F, No.127, Wugong 2nd Rd. New Taipei City, Wugu District 24888 Taiwan
Re: K223151
Trade/Device Name: nu-beca Transcutaneous Electrical Nerve Stimulation Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: July 19, 2023 Received: July 19, 2023
Dear Diana Sung:
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/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 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).
Sincerely,
Robert Kang -S
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) K223151
Device Name
nu-beca Transcutaneous Electrical Nerve Stimulation
Indications for Use (Describe)
The nu-beca Transcutaneous Electrical Nerve Stimulation is indicated for temporary relief of pain associated with sore and aching muscles in the lower back and upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
| 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
In accordance with the requirements of 21 CFR 807.92, this summary is being provided to serve as the basis for the substantial equivalence determination.
| Company Name | TaiDoc Technology Corporation |
|---|---|
| Address | B1-7F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, |
| Taiwan 24888 | |
| Contact Person | Diana Sung |
| Title | Assistant Manager of Regulatory Department |
| Phone | 886-2-6625-8188 #1158 |
| Ra.Cert.Groupone@taidoc.com.tw |
1. Regulatory Consultant:
2. 510(k) Owner Information:
| Company Name | Nu-Beca & Maxcellent Co. |
|---|---|
| Address | 3F-1, No. 45, Dexing W. Rd., Taipei, Taiwan, 111046. |
| Contact Person | David Tsai |
| Title | President |
| Phone | 886-2-2836-3617 #6000 |
| david.tsai@nu-beca.com | |
| Date Prepared | September 30, 2022 |
3. Candidate Device Information:
| Proprietary Name | nu-beca Transcutaneous Electrical Nerve Stimulation |
|---|---|
| Common Name | Transcutaneous Electrical Nerve Stimulation |
| Product Code | NUH |
| Review Panel | Neurology |
| Classification | 2 |
| Regulation Number | 21 CFR §882.5890 |
4. Predicate device Information
| Proprietary Name | HIVOX OTC Electrical Stimulator |
|---|---|
| Mode Name | FT610-B |
| Manufacturer | HIVOX BIOTEK INC. |
| Product Code | NUH |
| 510(k) Number | K211403 |
| Review Panel | Neurology |
| Classification | 2 |
| Regulation Number | 21 CFR §882.5890 |
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| Proprietary Name | Cur Model 1 |
|---|---|
| Mode Name | Mode A (Default Mode) |
| Manufacturer | Thimble Bioelectronics |
| Product Code | NUH, NGX |
| 510(k) Number | K160052 |
| Review Panel | Neurology |
| Classification | 2 |
| Regulation Number | 21 CFR §882.5890 |
5. Reference Device
6. Intended Use
The nu-beca Transcutaneous Electrical Nerve Stimulation is indicated for temporary relief of pain associated with sore and aching muscles in the lower back and upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
7. Intended Use Population
The nu-beca Transcutaneous Electrical Nerve Stimulation is indicated for different patient populations and is intended for use in Adults Only (22 years of age and older).
8. Device Description
The nu-beca Transcutaneous Electrical Nerve Stimulation consists of following components and accessories:
| Components | Functions | Surface Material |
|---|---|---|
| TENS Stimulator | The main unit contains buttons and indicators thatrelease adjustable electrical current. | ABS |
| Electrode Pad | Combine with TENS Stimulator to fix it on user'sskin surface. | PET and STEEL |
| nu-beca Gel Pad | Stick the electrode pad connected with TENSStimulator on user's skin surface. | ST Gel SR |
| Charging Cable | Charge the TENS Stimulator. | PVC |
| Storage Pad | Protect the sticky surface of used nu-beca Gel Pad. | ABS |
Image /page/4/Figure/9 description: The image shows a TENS stimulator and electrode pads. The TENS stimulator is a small device with a power button and plus and minus buttons. The electrode pads are oval-shaped and are attached to the skin. There are two electrode pads on the left and two nu-beca gel pads on the right.
The nu-beca Transcutaneous Electrical Nerve Stimulation release electrical current with adjustable frequencies and voltages to temporarily relief sore and aching muscles. It has only one model: TN0001. The treatment time for one session use is 15 minutes. User can operate the nu-beca Transcutaneous Electrical Nerve Stimulation by following use interfaces.
Battery charging
The TENS stimulator is charged by inserting the charging cable into USB charging port, and then plugging the adaptor connected with charging cable into electrical outlet.
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Assembling
The TENS stimulator, electrode pad and nu-beca Gel Pad should be assembled before application. The nu-beca Gel Pad is stick on the electrode pad to fix the electrode pad in conjunction with TENS stimulator on skin surface. The TENS stimulator is connected with electrode pad by magnet.
Application
Apply the assembled nu-beca Transcutaneous Electrical Nerve Stimulation on pain associated sites: lower back, upper and lower extremities (arm and/or leg).
Operation
The TENS stimulator is switched-on and switched-off by long pressing the power button. The 13 frequencies of electrical current are configured into mode 6. User can adjust the 6 modes by short pressing the power button. There are 1 to 10 adjustable intensity levels, which represent 10 levels of output voltage. User can adjust level 10 of intensity by pressing the "+" button to increase the output voltage or pressing "—" button to decrease the output voltage.
Indicator light display
The TENS stimulator displays indicator lights in green and/or orange color under different conditions.
Green light shows under following conditions:
- · The TENS stimulator is switched-on.
- · The battery is fully charged.
Twinkling green light flashes under following conditions:
- The intensity level is adjusted to the maximum or minimum level. ●
- Twinkling green and orange light flashes under following conditions:
- . The electrode pad is not adhered firmly on skin surface.
Twinkling orange light flashes under following conditions:
- The TENS stimulator is charging.
- . The electricity is about to deplete.
No light shown: The TENS stimulator is switched-off.
9. Principle of Operation
The nu-beca Transcutaneous Electrical Nerve Stimulation device can generate small pulses of electrical current. Delivered these pulses pass through the skin and activated underlying nerves.
The nu-beca Transcutaneous Electrical Nerve Stimulation outputs electrical pulses to specific nerves via gel pad fixed on the intact skin of lower back, upper and lower extremities and powered by rechargeable lithium battery. The purpose is to temporarily relief the pain associated with sore and aching muscles.
The BOOST circuit controls the voltage amplitude by modifying the Pulse Width Modulation (PWM) circuit while the user pressed the "+" or "-" button to adjust the voltage from 1 to 10 intensities. The frequency of output voltage is controlled by modifying the frequency of Pulse Width Modulation (PWM) circuit while the user short pressed the power button to select the 1 to 6 mode, which consists of different frequency combinations.
10. Comparison to Predicate device
- 10.1 Intended Use Comparison
The intended use of the nu-beca Transcutaneous Electrical Nerve Stimulation is the same as the predicate device, it is for temporary relief of pain associated with sore and aching muscles in the lower back and upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
10.2 Technological Comparison
The nu-beca Transcutaneous Electrical Nerve Stimulation is substantially equivalent to the predicate device in terms of technological characteristics, including their use environment and function.
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| Characteristic | Predicate Device | Reference Device | Candidate Device | Remark | |
|---|---|---|---|---|---|
| K211403 | K160052 | K223151 | |||
| HIVOX OTC Electric Stimulator | Cur Model 1, Mode A(Default Mode) | nu-beca Transcutaneous Electrical NerveStimulation | |||
| Intended use | The FT610-B is designed for symptomaticrelief and management of chronic pain, andfor temporary relief of pain associated withsore and aching muscles in the shoulder,waist, back, neck, upper extremities andlower extremities due to strain from exerciseor normal household work activities. It isalso indicated for temporary relief of painassociated with dysmenorrhea (menstrualcramps) when used with over-the-counterpain medication. In addition, it also providesa heat function intended to temporarilyrelieve minor aches and pains. | A transcutaneous electrical nerve stimulation(TENS) Mode which is indicated for thesymptomatic relief andmanagement of chronic intractable pain, andfor temporary relief of pain associated withsore and aching muscles in theshoulder, waist, back, neck, upperextremities (arm) and lower extremities (leg)due to strain from exercise or normalhousehold work activities, andA powered muscle stimulation (PMS) modewhich is indicated to improve and facilitatemuscle performance in healthymuscles.The CUR Model 1 should be applied tonormal, healthy, dry and clean skin of adultpatients. | The nu-beca Transcutaneous Electrical NerveStimulation is indicated for temporary reliefof pain associated with sore and achingmuscles in the lower back and upper andlower extremities (arm and/or leg) due tostrain from exercise or normal household andwork activities. | Refer to #D1 | |
| Classification | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | Same | |
| Product code | NUH | NUH, NGX | NUH | Same | |
| Type of use | OTC | OTC | OTC | Same | |
| EMC | IEC 60601-1-2 Edition 4.0 | IEC 60601-1-2 | IEC 60601-1-2: 2014 | Same | |
| Electrical safety | ANSI/AAMI ES60601-1:2015/(R)2012IEC 60601-1-11 Edition 2.0IEC 60601-2-10 Edition 2.1 | IEC 60601-1IEC 60601-2-10 | IEC 60601-1: 2012IEC 60601-2-10: 2016IEC 60601-1-11: 2015 | Same | |
| Dimension | 113 mm x 70 mm x 9.7 mm | 36mm x 36mm x 8.5mm | 60.5 mm x 44 mm x 11.4 mm | Refer to #D2 | |
| Operation environment | 10 °C ~ 40 °C, 30% ~ 85% R.H. | Not publicly available | 5°C ~ 40 °C (41 °F~104 °F), 15% ~ 90% R.H. | ||
| Storage environment | -10 °C ~ 50 °C, 10%~95% R.H. | Not publicly available | -25 °C | Refer to #D3 | |
| Transport environment | -10 °C~ 50°C, 35%~85% ~ 85% R.H. | Not publicly available | -25 °C | ||
| Power supply | Lithium battery 3V | 3.7V Lithium-Polymer battery (rechargeable) | Lithium battery 3.7 V | Refer to #D4 | |
| Treatment time | 20 minutes fixed | 60 minutes | 15 minutes fixed | Refer to #D5 | |
| Indicator light display | No | Yes | Yes | Refer to #D6 | |
| Parameter | Predicate Device | Reference Device | Candidate Device | Remark | |
| K211403 | K160052 | K223151 | |||
| HIVOX OTC ElectricStimulator | Cur Model 1, Mode A(Default Mode) | nu-beca TranscutaneousElectrical Nerve Stimulation | |||
| Waveform | Symmetrical Biphasic | Biphasic, Asymmetrical | Asymmetrical Biphasic | Similar to K160052Refer to #D7 | |
| Shape | Rectangular | Rectangular | Rectangular | ||
| Maximum OutputVoltage | @500Ω | 72 ±10% V | 42.6V | 35.0 V | |
| @2ΚΩ | 112 ±10% V | 85.2V | 55.0 V | ||
| @10ΚΩ | 120 ±10% V | 87.0V | 70.0 V | ||
| Maximum OutputCurrent | @500Ω | 144 ±10% mA | 85.1 mA | 75.0 mA | Similar to K160052Refer to #D8 |
| @2ΚΩ | 56 ±10% mA | 43.1 mA | 27.5 mA | ||
| @10KΩ | 12 ±10% mA | 8.8 mA | 7.0 mA | ||
| Pulse Duration | 100 µSec | 91.7 usec | 100 µSec | Same | |
| Frequency | 100 Hz | 40-130 Hz | 2.0 Hz | Similar to K160052Refer to #D9 | |
| 4.0 Hz | |||||
| 5.0 Hz | |||||
| 6.0 Hz | |||||
| 8.0 Hz | |||||
| 10.0 Hz | |||||
| 16.0 Hz | |||||
| 20.0 Hz | |||||
| 32.0 Hz | |||||
| 40.0 Hz | |||||
| 50.0 Hz | |||||
| 64.0 Hz | |||||
| 80.0 Hz | |||||
| Net Charge per pulse | @500Ω | Not publicly available | 7.16uC | 7.50 µC | Similar to K160052Refer to #D10 |
| Maximum Charge | @500Ω | 7.2 μC | 7.16uC | 7.50 µC | Refer to #D11 |
| Maximum CurrentDensity | @500Ω | 0.364 mA/cm², r.m.s. | 0.35 mA/cm² | 1.77 mA/cm², r.m.s. | Refer to #D12 |
| Maximum Average PowerDensity | @500Ω | 0.00185 W/cm² | 1.50 mW/cm² | 0.062 W/cm² | |
| Burst Mode | Pulse per burst | N/A | N/A | N/A | Same |
| Burst per second | N/A | N/A | N/A | ||
| Burst duration | N/A | N/A | N/A | ||
| Duty Cycle | N/A | N/A | N/A |
Table 1. Summary of intended use and basic characteristics compared to predicate device and reference device
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Table 2. Summary of technological characteristics compared to predicate device and reference device
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11. Discussion of Differences
10.1 #D1 (Intended use)
The intended use of candidate device is different from predicate device due to the following reasons:
- · The predicate device can be applied on shoulder and neck.
- · The predicate device is indicated for dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.
- · The predicate device has the heat function.
The claimed intended use of candidate device is narrower than predicate device, and the electrical safety of candidate device has passed IEC 60601-1:2012, IEC 60601-1-11:2015 and IEC 60601-2-10:2016, which demonstrated that the different intended use doesn't affect safety and effectiveness of candidate device.
10.2 #D2 (Dimension)
The performance tests verified the claimed specifications of electrical current between candidate device and predicate device. All test results met acceptance criteria, which demonstrated that the different dimension of candidate device meet the intended use, and doesn't affect safety and effectiveness.
10.3 #D3 (Operation, storage and transportation conditions)
The storage, transportation and operation environment of candidate device has been verified to comply with the requirements of IEC 60601-1-11:2015.
According to the test results, the basic safety and performance of candidate device were maintained under transport and storage condition and under operation condition, which demonstrated that the different operation, storage and transportation conditions of candidate device meet the intended use, and doesn't affect safety and effectiveness.
10.4 #D4 (Power source)
The candidate device uses Lithium battery 3.7V as power source. For predicate device, Lithium battery 3V is used as power source. The electromagnetic compatibility and electrical safety of candidate device has been verified to comply IEC 60601-1-2:2014 and IEC 60601-1:2012. All test results met acceptance criteria, which demonstrated that the different power source of candidate device meet the intended use, and doesn't affect safety and effectiveness.
10.5 #D5 (Treatment time)
Although the treatment time is different from the predicate device, the treatment time 15 minutes (automatically switch-off in 15 minutes) of candidate device was verified in software validation tests. All test results met acceptance criteria, which demonstrated that the different treatment time of candidate device meet the intended use, and doesn't affect safety and effectiveness.
10.6 #D6 (Indicator light display)
The candidate device displays indicator lights in green and/or orange color under different conditions. For the predicate device, there is no indicator light. The software validation tests were performed to verify the indicator lights correctly display under each state of device, and the EMC and safety test were performed to verify the electromagnetic compatibility and electrical safety of candidate device. All test results met acceptance criteria. which demonstrated that the design of indicator lights of candidate device meet the intended use, and doesn't affect safety and effectiveness.
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10.7 #D7 (Output waveform and shape)
The candidate device outputs asymmetrical biphasic and rectangular waveform, and the predicate device outputs symmetrical biphasic and rectangular waveform. The candidate device has demonstrated the electrical safety by passing IEC 60601-1:2012, IEC 60601-1-11:2015 and IEC 60601-2-10:2016, therefore, the different output waveform shape will not affect the electrical safety of the candidate device.
We have found 510(k) cleared reference device K160052 has identical waveform and shape with the candidate device, which demonstrate that the design of waveform and shape on the candidate device doesn't impact safety and effectiveness.
10.8 #D8 (Maximum output voltage and Maximum output current)
The maximum output voltage and maximum output current under 500Ω, 2KΩ and 10KΩ resistance of candidate device are different from predicate device due to different design. The performance test was conducted to verify the maximum output voltage and maximum output current of candidate device under the acceptance criteria followed IEC 60601-2-10:2016, section 201.12.1.102.
The candidate device has also demonstrated the electrical safety by passing IEC 60601-1:2012, IEC 60601-1-11:2015 and IEC 60601-2-10:2016, therefore, the different output waveform shape will not affect the electrical safety of the candidate device.
We have found 510(k) cleared reference device K160052 has similar maximum output voltage and maximum output current with the candidate device, which demonstrate that the design of candidate device doesn't impact safety and effectiveness.
10.9 #D9 (Frequency and Output current)
The frequencies (2-80Hz) of electrical current generated from candidate device are configured into 6 modes. For predicate device, there is only one mode with fixed frequency 100 Hz. The candidate device has demonstrated the electrical safety by passing IEC 60601-1:2012, IEC 60601-1-11:2015 and IEC 60601-2-10:2016, therefore, the different frequency range will not affect the electrical safety of the candidate device.
We have found 510(k) cleared reference device K160052 has 40-130 Hz frequency range similar to 2-80 Hz of candidate device, which demonstrate that the frequency design of candidate device doesn't impact safety and effectiveness.
10.10 #D10 (Net charge per pulse)
The candidate device has demonstrated the electrical safety by passing IEC 60601-1:2012, IEC 60601-1-11:2015 and IEC 60601-2-10:2016. It can be concluded that the net charge per pulse design of candidate device doesn't affect the safety and effectiveness. We have found 510(k) cleared reference device K160052 has 7.16μC net charge similar to 7.5µC of candidate device, which demonstrate that the net charge per pulse design of candidate device doesn't impact safety and effectiveness.
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10.11 #D11 (Maximum charge)
The 7.5uC maximum charge under 500Ω resistance of candidate device is similar to 7.2uC of predicate device. The performance test was conducted to verify the maximum charge of candidate device under the acceptance criteria followed IEC 60601-2-10:2016, section 201.12.1.102. The EMC and safety test were performed to verify the electromagnetic compatibility and electrical safety of candidate device. All test results were within acceptance criteria, which demonstrated that the candidate device with similar maximum charge can meet the intended use, and doesn't affect the safety and effectiveness.
10.12#D12 (Maximum current density and Maximum average power density)
The maximum current density and maximum average power density under 500Ω resistance of candidate device are different from predicate device due to different design.
According to FDA Guidance Document for Powered Muscle Stimulator 510(k)s, page 16, section 3: "Maximum current density and power density values should be calculated using the conductive surface area of the smallest electrodes provided/recommended for use with the unit; sample calculations should be provided. The maximum power density should be based on the maximum duty cycle and should be averaged over an output duration of one second. The maximum power density should be less than 0.25 Watts/cm² to reduce the risk of thermal burns.", the maximum average power density less than 0.25 Watts/cm² under maximum current density is safe, which demonstrated that the 0.062 Watts/cm² maximum average power density of candidate device under 1.77 mA/cm², r.m.s. maximum current density is within safe range. It can be concluded that the different maximum current density and maximum average power density of candidate device doesn't affect safety and effectiveness.
12. Non-Clinical Testing Summary
11.1 Performance test
The electric current specifications of candidate device were verified by bench tests.
-
11.1.1 Waveform and shape
The waveform and shape were verified for the candidate device. All test results were demonstrated to meet the acceptance criteria. -
11.1.2 Pulse duration
The pulse duration was verified for the candidate device to ensure the electrical pulse of candidate device was outputted within the claimed time interval. All test results were within acceptance criteria, which demonstrate that the pulse duration of candidate device is the same to predicate device and doesn't affect the safety and effectiveness. -
11.1.3 Net charge per pulse
The net charge per pulse was verified for the candidate device. All test results were demonstrated to meet the acceptance criteria, which demonstrate that the net charge per pulse of candidate device doesn't affect the safety and effectiveness. -
11.1.4 Maximum average power density
The maximum average power density was verified for the candidate device to ensure the maximum energy (Watt) transmitted to the user skin surface for each square centimeter is below the maximum level 0.25 Watts/cm² in accordance with FDA Guidance Document for Powered Muscle Stimulator 510(k)s, page 16. Section 3. All test results were within acceptance criteria, which demonstrated that the maximum average power density of candidate device is within safe range and doesn't affect the safety and effectiveness.
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11.1.5 Intensity verification
The output voltage of intensity level was verified for candidate to ensure the output voltage of candidate device meet IEC 60601-2-10:2016. All test results were within acceptance criteria, which demonstrate that each intensity level of candidate device output voltage doesn't affect the safety and effectiveness.
11.1.6 Frequency and output current verification
The frequency and output current were verified for candidate device. All test results were demonstrated to meet the acceptance criteria followed IEC 60601-2-10:2016.
11.2 Biocompatibility
The nu-beca Gel Pad contacts the skin surface of users. The following biocompatibility test were conducted for of patient-contacting material ST Gel SR:
- The cytotoxicity test was performed in accordance with ISO 10993-5:2009.
- The sensitization test was performed in accordance with ISO 10993-10:2021
- The irritation test was performed in accordance with ISO 10993-23:2021
11.3 Storage stability test
Storage stability test of nu-beca Transcutaneous Electrical Nerve Stimulation is performed to ensure the safety and effectiveness are suitable for use over the shelf life of device.
Nonclinical tests were performed in accordance with 21 CFR §882.5890.
Clinical Testing is not applicable. Risks are analyzed to confirm that all identified risks were effectively mitigated. There were no special concerns of safety and effectiveness identified.
13. Conclusions
According to results of nonclinical tests, the nu-beca Transcutaneous Electrical Nerve Stimulation has a substantially equivalent safety and effectiveness profile to the predicate device (K211403) and reference device (K160052).
§ 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).