(163 days)
Prescription Use:
The Strive™ TENS device is used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment for post-surgical and post-trauma acute pain.
As a TENS device, indications are for the following conditions:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
Over the Counter Use:
The Strive™ TENS device is used for:
-temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
-the symptomatic relief and management of chronic, intractable pain associated with arthritis.
The Strive device is a handheld Transcutaneous Electrical Nerve Stimulation (TENS) unit which delivers electrical pulses transmitted by electrodes to cutaneous (surface) and afferent (deep) nerves of the body for pain management. The device provides simple user interface and programming, and is aimed to be used with lead wires and electrodes. Strive will be marketed as either Prescription (RX for U.S. Only) or Over-the-Counter (OTC), with each configuration having its own set of labeling, as appropriate.
The Strive device utilizes electrodes which are single patient use only. The device embeds a rechargeable battery that cannot be removed. The device is inoperable while the battery is charging.
This document is a 510(k) summary for the Strive™ Transcutaneous Electrical Nerve Stimulator (TENS) device. It details the device's characteristics and compares them to predicate devices to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" paired with "reported device performance" in a single table format. Instead, it presents performance testing results against recognized standards and claims substantial equivalence to predicate devices. The comparisons provided in Tables 1a, 1b, 2, 3, and 4 effectively serve as the device's reported performance against established benchmarks (predicate devices' specifications and general standards for TENS devices).
Here's a synthesized table based on the information provided, focusing on the Strive device's performance against relevant standards and the finding of substantial equivalence:
| Acceptance Criteria (Standards/Benchmarks) | Reported Device Performance (Strive™) |
|---|---|
| Electrical Safety & Electromagnetic Compatibility (EMC) | Compliance demonstrated with: |
| - IEC 60601-1 (Basic safety and essential performance) | Met |
| - IEC 60601-1-2 (EMC) | Met |
| - IEC 60601-1-11 (Use in home healthcare environment) | Met |
| - IEC 60601-2-10 (Performance of nerve and muscle stimulators) | Met |
| Software Verification | In accordance with FDA guidance "General Principles of Software Validation, January 11, 2002": |
| - Software meets design requirements | Met (software testing demonstrated that requirements were met) |
| Usability/Human Factors | In accordance with IEC 60601-1-6: |
| - Established usability requirements met | Met |
| - Design appropriate for intended users and use environment | Met (substantiated acceptability of use-related risks) |
| Coexistence Testing | Performance evaluated in environments with other devices (Bluetooth, Wi-Fi, Microwave Oven, clinical devices): |
| - Meets specified requirements in presence of other devices | Met all specified requirements |
| Substantial Equivalence to Predicate Devices (EMPI Select, EMPI Phoenix, SmartRelief) | Conclusion based on performance testing and similarities of Indications for Use and technological characteristics: |
| - Similar Indications for Use | Similar |
| - No new questions of safety or effectiveness raised by differences | Concluded to be as safe and effective as, and substantially equivalent to, predicate devices. |
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 does not specify the sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for any of the performance tests (Electrical Safety and EMC, Software Verification, Usability/Human Factors, Coexistence Testing). These types of tests typically involve testing the device itself or a representative number of devices, rather than a clinical dataset of patients.
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)
The document does not mention the use of experts to establish a "ground truth" for any test sets in the way that would apply to diagnostic imaging or clinical trials. The tests performed are primarily engineering and simulated user environment tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is mentioned or implied, as the nature of the tests (electrical safety, software verification, usability, coexistence) does not typically involve human adjudication of results in the way a clinical study or expert review of images would.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a TENS unit for pain relief, not an AI-assisted diagnostic or interpretation device that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Strive™ device is a medical device (TENS unit) that delivers electrical stimulation. It does not employ an "algorithm" in a diagnostic or interpretive sense that would operate "standalone" versus "human-in-the-loop." Its performance is about its physical outputs and safety, not an interpretive algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus, pathology, outcomes data) is not applicable here. The "truth" for the performance tests mentioned (electrical safety, software, usability, coexistence) is conformance to the specified standards or design requirements.
8. The sample size for the training set
This question is not applicable. The Strive™ device is a TENS unit, not an AI/machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of a human figure in profile, with three overlapping faces representing the department's focus on health and human well-being. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2016
DJO, LLC Rand Daoud Regulatory Affairs Specialist III 1430 Decision St. Vista, CA 92081
Re: K153704
Trade/Device Name: Strive™ Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ, NUH, NYN Dated: April 21, 2016 Received: April 22, 2016
Dear Rand Daoud:
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. 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 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
{1}------------------------------------------------
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -A
- for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153704
Device Name
Strive™M
Indications for Use (Describe)
Prescription Use:
The Strive™ TENS device is used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment for post-surgical and post-trauma acute pain.
As a TENS device, indications are for the following conditions:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
Over the Counter Use:
The Strive™ TENS device is used for:
-temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
-the symptomatic relief and management of chronic, intractable pain associated with arthritis.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5:
510(k) Summary
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Section 5. 510(k) Summary
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is K153704.
| Submitted by: | DJO, LLC1430 Decision StreetVista, CA 92081 |
|---|---|
| Contact Person: | Rand DaoudRegulatory Specialist III760-734-3037 |
| Date Summary Prepared: | December 23, 2015 |
| Trade Name: | Strive™ |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief(21 CFR 882.5890) |
| Product Code: | GZJ (primary code)NUH (primary code)NYN (subsequent code) |
| Regulatory Class: | Class II |
| Predicate Device: | EMPI Select (K061650)EMPI Phoenix (K124016)SmartRelief (K131159) |
Device Description:
The Strive device is a handheld Transcutaneous Electrical Nerve Stimulation (TENS) unit which delivers electrical pulses transmitted by electrodes to cutaneous (surface) and afferent (deep) nerves of the body for pain management. The device provides simple user interface and programming, and is aimed to be used with lead wires and electrodes. Strive will be marketed as either Prescription (RX for U.S. Only) or Over-the-Counter (OTC), with each configuration having its own set of labeling, as appropriate.
The Strive device utilizes electrodes which are single patient use only. The device embeds a rechargeable battery that cannot be removed. The device is inoperable while the battery is charging.
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Indications for Use:
Prescription Use:
The Strive device is used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment for post-surgical and post- trauma acute pain.
As a TENS device, indications are for the following conditions: -Symptomatic relief and management of chronic, intractable pain -Adjunctive treatment for post-surgical and post-trauma acute pain -Relief of pain associated with arthritis
Over-the-Counter Use:
The Strive TENS device is used for:
-Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
-The symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Programs:
Strive provides two different TENS programs (P1 and P2) based on the same waveform: a balanced asymmetrical biphasic waveform that has nominally constant current in the positive phase and a second logarithmic waveform which decreases current in the negative phase. These programs are pre-installed in the Strive device and can be used interchangeably based on physician prescription (under RX use) and/or provided device program selection instructions (under OTC use).
The following is a description of programs P1 and P2:
SMP program (P1)
The SMP program combines two pain relief principals, High Frequency TENS and Low Frequency TENS. P1 delivers a group of pulses as a repeating 12-second cycle varies from low frequencies to high frequencies. Within each cycle, the rate and duration of the pulses vary as shown in Figure 11.2 below. The frequency varies from 5Hz to 122Hz and the pulse duration varies from 300us (at low frequencies) to 70us (at high frequencies).
The program is built to provide at the time high frequency TENS (during 9.5s of total period) and low frequency TENS (during 2.5s of total period). The pulse duration variation is done to avoid strong contraction during 12s cycle and thus increase usage comfort.
Frequency modulated TENS program (P2)
The modulated TENS program relies solely on the first principle of pain relief, High Frequency TENS, for the treatment of post-surgical or chronic pain.
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This program has a frequency modulation range of 90 to 120pps, and a period of 4s cycle times, with a fixed pulse duration of 80us.
Comparison to the Predicate Devices:
The indications for use for Strive are identical to those of the predicate devices, EMPI Select, EMPI Phoenix and SmartRelief.
The technological characteristics of the device to the predicate devices are very similar, although there are a few minor differences.
The following tables summarize the similarities and differences between the technological characteristics of the devices.
| Table 1a: Basic Device Characteristics - Comparison with Predicate Rx Devices | |
|---|---|
| ------------------------------------------------------------------------------- | -- |
| Characteristic | New Device | Predicate Device | Predicate Device | Same / Different |
|---|---|---|---|---|
| 510(k) Number | K153704 | K061650 | K124016 | NA |
| Device Name | Strive | EMPI Select | EMPI Phoenix | NA |
| -Symptomaticrelief andmanagement ofchronic, intractablepain. | -Symptomatic relief andmanagement of chronic,intractable pain. | As a TENS device,indications are forthe followingconditions: | ||
| Indications for Use | -Adjunctivetreatment for post-surgical and post-trauma acute pain. | -Adjunctive treatment forpost-surgical and post-trauma acute pain | -Symptomatic reliefand management ofchronic, intractablepain-Adjunctivetreatment for post-surgical and post-trauma acute pain | Similar |
| -Relief of painassociated witharthritis. | -Relief of pain associatedwith arthritis. | -Relief of painassociated witharthritis |
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| Prescription/OTC | Prescription | Prescription | Prescription | Same |
|---|---|---|---|---|
| TENS Programs | SMP Mode(SMP) | Strength Duration (SD) | FrequencyModulatedTENS (FM) | Similar |
| FrequencyModulation(FM) | Alternating RampedBurst (ARB), | SMP forStriveandSelect arethe same. | ||
| SMP Mode (SMP) | ||||
| Modulation Amplitude(MA), | FM forStriveandPhoenixare same. | |||
| Continuous (C),Cycled Burst (B),Modulation (M). | ||||
| Connection of deviceto electrodes | Lead wires | Lead wires | Leadwires andgarment | Same |
| Power Source(s) | LiPo 250[mAh](3.7[V]), notremovable | Alkaline orRechargeable (3 AAA) | 2 AA LR06Batteries, 1.5 VAlkaline or 1.2V NiMhrechargeable | Different |
| - Method of linecurrent isolation | N/A(battery operateddevice) | N/A(battery operateddevice) | N/A(batteryoperated device) | Same |
| - Patient LeakageCurrent | N/A(battery operateddevice) | N/A(battery operateddevice) | N/A(batteryoperated device) | Same |
| ● Normal condition | N/A(battery operateddevice) | N/A(battery operateddevice) | N/A(batteryoperated device) | Same |
| • Single faultcondition | N/A(battery operateddevice) | N/A(battery operateddevice) | N/A(batteryoperated device) | Same |
| Number of OutputModes | 2(2xTENS) | 7 (7xTENS) | 4 (1xTENS,2xNMES,1xPulsedCurrent DC) | Different |
| Number of OutputChannels | 1, split | 2 | 2 | Similar |
| - Synchronous orAlternating? | NA | Program dependent | Synchronousbut never twochannelsactivated at thesame time | Different |
| - Method of ChannelIsolation | NA | Transformer | Each channel isthe middle of anH Bridge.Except when itis activated,each channel isin highimpedance state. | Different |
| Regulated Current orRegulated Voltage? | RegulatedCurrent | Constant voltage pulse,constant currentundershoot | RegulatedCurrent | Different |
| Software/Firmware/MicroprocessorControl? | Yes,Microcontroller | Yes, Microprocessor | Yes. | Same |
| Automatic OverloadTrip? | No | No | No | Same |
| Automatic No-LoadTrip? | Yes | Yes | Yes | Same |
| Automatic Shut Off? | Yes | Yes | Yes | Same |
| Patient OverrideControl? | No | No | Yes (On/Offswitch) | Different |
| Indicator Display- On/Off Status? | Yes (P1 & P2,OutputIndicators) | Yes (LCD) | Yes | Same |
| - Low Battery? | No | Yes. Battery icon onLCD. | Yes | Different |
| - Voltage/CurrentLevel? | Active/inactiveoutput | Yes, numeric value onLCD | Yes | Different |
| Timer Range(minutes) | Unlimited | Unlimited | 20 minutes (P1and P2),30 minutes (P4),Unlimited (P3) | Similar |
| Compliance with 21CFR 898? | Yes | Yes | Yes | Same |
| Weight | 0.99 oz | 4.9 oz with batteries | 170 g withbatteries | Different |
| Dimensions [W x H xD] | 49 mm x 64mm x14 mm | 109mm x 61mm 36 mm | 67mm x 135mmx 30mm | Different |
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Table 1b: Basic Device Characteristics – Comparison with Predicate OTC Device
| Characteristic | New Device | Predicate Device | Same /Different |
|---|---|---|---|
| 510(k) Number | K153704 | K131159 | NA |
| Device Name | Strive | SmartRelief | NA |
| Manufacturer | DJO, LLC. | Chattem, Inc. | NA |
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| Indications for Use | -Temporary relief of painassociated with sore andaching muscles due tostrain from exercise ornormal household andwork activities.-The symptomatic reliefand management ofchronic, intractable painand relief of painassociated with arthritis. | -Temporary relief of painassociated with sore andaching muscles due tostrain from exercise ornormal household andwork activities.-The symptomatic reliefand management ofchronic, intractable painand relief of painassociated with arthritis. | Same |
|---|---|---|---|
| Prescription/OTC | OTC | OTC | Same |
| TENS Programs | SMP Mode (SMP)Frequency Modulation(FM) | TENS (SMP) | Similar |
| Connection of deviceto electrodes | Lead wires | Snaps on the device | Different |
| Power Source(s) | LiPo 250[mAh] (3.7[V]),not removable | Lithium BatteryCoin cell CR2032 3V | Different |
| - Method of linecurrent isolation | N/A(battery operated device) | N/A (batteryoperated device) | Same |
| - Patient LeakageCurrent | N/A(battery operated device) | N/A (batteryoperated device) | Same |
| ● Normal condition | N/A(battery operated device) | N/A (batteryoperated device) | Same |
| ● Single faultcondition | N/A (battery operateddevice) | N/A (batteryoperated device) | Same |
| Number of OutputModes | 2(2xTENS) | 1 (TENS) | Different |
| Number of OutputChannels | 1, split | 1 | Similar |
| - Synchronous orAlternating? | NA | NA | Same |
| - Method of ChannelIsolation | NA | NA | Same |
| Regulated Current orRegulated Voltage? | Regulated Current | Regulated Current | Same |
| Software/Firmware/MicroprocessorControl? | Yes, Microcontroller | Yes, micro controller | Same |
| Automatic OverloadTrip? | No | No | Same |
| Automatic No-LoadTrip? | Yes | No | Different |
| Automatic Shut Off? | Yes | Yes | Same |
| Patient OverrideControl? | No | No | Same |
| Indicator Display- On/Off Status? | Yes (P1 & P2, OutputIndicators) | Yes | Same |
| - Low Battery? | No | No | Same |
| Voltage/CurrentLevel? | Active/inactive output | Active/inactiveoutput | Same |
| Timer Range(minutes) | Unlimited | Yes (30min) | Different |
| Compliance with 21 CFR 898? | Yes | Yes | Same |
| Weight | 0.99 oz | 20g (0.7oz) | Different |
| Dimensions [W x H x D] | 49 mm x 64mm x 14 mm | 64x38x13[mm] (2.5x1.5x0.5["]) | Different |
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Table 2: Output Specifications – Comparison with EMPI Select Predicate Device
| Characteristic | New Device | Predicate Device(EMPI Select) | Same/Different |
|---|---|---|---|
| Output mode / Program | P1 (SMP) | SMP | Same |
| Waveform | Balanced,Asymmetrical Biphasic | Balanced, AsymmetricalBiphasic | Same |
| Shape | Square positive pulse,current controlledLogarithmic negativepulse, decrease current. | AC, constant currentundershoot; constant voltagepulse | Different |
| Maximum OutputVoltage (± 10%) | 110[V] peak on 10[kΩ]110[V] peak on 2[kΩ]60[V] peak on 1[kΩ]30[V] peak on 500[Ω] | 0[V] (open lead) peak on10[kΩ]40[V] peak on 2[kΩ]30[V] peak on 1[kΩ]30[V] peak on 500[Ω] | Different |
| Maximum OutputCurrent (± 10%) | 11[mA] peak on10[kΩ]55[mA] peak on 2[kΩ]60[mA] peak on 1[kΩ]60[mA] peak on500[Ω]Max rms current6.28[mA]rms(divided by 2 per outputwhen split) | 0[mA] (open lead) peak on10[kΩ]20[mA] peak on 2[kΩ]30[mA] peak on 1[kΩ]60[mA] peak on 500[Ω]Max rms current 11[mA]rms | Same |
| Pulse Width | 70 to 300[μs](measured at 50% ofpositive pulse) | 0-400 μs at 50%of peakamplitude | Similar |
| Frequency | 5 to 122[Hz] | 2, 5-150 Hz, 5Hz increments | Similar |
| For multiphasic waveforms only:- Symmetrical phases?- Phase Duration (include units) (state range, if applicable) (both phases, if asymmetrical) | Biphasic:Asymmetrical70 to 300[µs] for positive pulse, logarithmic negative pulse, decrease current. | Biphasic:Asymmetrical0 to 400[µs] for positive pulse, constant current undershoot | Same |
| Net Charge [µC/pulse] | 18[µC] on 1[kΩ] | 12[µC] / output on 1 [kΩ] load(24[µC] CH1 & 2 together) | Different |
| Maximum Phase Charge [µC] | 0[µC] on 1[kΩ] | 0[µC] / output on 1 [kΩ] load | Same |
| Maximum Current (RMS) Density [mA/cm²] | 0.31[mA/cm²] (over 1[s] period) | 11 [mA] | Same |
| Maximum Power Density [mW/cm²] | 4.92[mW/cm²] (split on 2x1[kΩ] in //) | 44[mW/cm²] per output, on 1[kΩ] | Different |
| Burst Mode (i.e. pulse trains)a) Pulses per burstb) Bursts per secondc) Burst duration (seconds)d) Duty Cycle [Line (b) x Line (c)] | NA, no burst mode | a) 29[pulses/burst]b) 0.39[burst/s]c) 1.9[s] | Different |
| ON Time (seconds) | Once started, the output is active until user manually stops the unit | Depends on the selected program | Different |
| OFF Time (seconds) | NA, no OFF time | Depends on the selected program | Different |
| Additional Features (if applicable) | NA, no additional feature | NA, no additional feature | Same |
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| Characteristic | New Device | Predicate Device(EMPI Phoenix) | Similar/Different |
|---|---|---|---|
| Output mode / Program | P2 (Frequency ModulatedTENS) | Frequency ModulatedTENS (P3) | Same |
| Waveform | Balanced, AsymmetricalBiphasic | Symmetrical Biphasic | Similar |
| Shape | Square positive pulse,current controlledLogarithmic negativepulse, decrease current. | Rectangular | Different |
| Maximum OutputVoltage (± 10%) | 110[V] peak on 10[k[Ω]]110[V] peak on 2[k[Ω]]60[V] peak on 1[k[Ω]]30[V] peak on 500[Ω] | 150[V] peak on 10[k[Ω]]150[V] peak on 2[k[Ω]]100[V] peak on 1[k[Ω]]50[V] peak on 500[Ω] | Different |
| Maximum OutputCurrent (± 10%) | 11[mA] peak on 10[k[Ω]]55[mA] peak on 2[k[Ω]]60[mA] peak on 1[k[Ω]]60[mA] peak on 500[Ω]Max rms current6.28[mA]rms(divided by 2 per outputwhen split) | 15[mA] peak on10[k[Ω]]75[mA] peak on 2[k[Ω]]100[mA] peak on1 [k[Ω]]100[mA] peak on500[Ω]Max rms current21.2[mA]rms | Different |
| Pulse Width | 80[µs] (measured at50% of positive pulse) | 80µs | Same |
| Frequency | 90 to 120[Hz] | 90-120 Hz | Same |
| For multiphasicwaveforms only:Symmetrical phases?-Phase Duration-(include units) (staterange, if applicable)(both phases, ifasymmetrical) | Biphasic:Asymmetrical-70 to 300[us] for-positive pulse,logarithmic negativepulse, decreasecurrent. | NA | Different |
| Net Charge[µC/pulse] | 18[µC] @ 500[Ω] | 30 µC @ 500Ω | Different |
| Maximum Phase Charge[μC] | 0[µC] on 1[kΩ] | 0[µC] / output on 1[kΩ] load | Same |
| Maximum Current (RMS)Density [mA/cm²] | 0.33[mA/cm²](over 1[s] period) | 1.44 mA/ cm²@ 500Ω | Different |
| Maximum Power Density[mW/cm²] | 5.53[mW/cm²] @ 500[Ω] | 0.0111W/cm² @ 500Ω | Different |
| Burst Mode (i.e. pulsetrains)e) Pulses per burstf) Bursts per secondg) Burst duration (seconds)h) Duty Cycle [Line (b) xLine (c)] | NA, no burst mode | NA | Same |
| ON Time (seconds) | Once started, the outputis active until usermanually stops the unit | Constant (withouthandswitch) | Different |
| OFF Time (seconds) | NA, no OFF time | 0 (withouthandswitch) | Different |
| Additional Features (ifapplicable) | NA, no additional feature | NA | Same |
Table 3: Output Specifications – Comparison with EMPI Phoenix Predicate Device
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Table 4: Output Specifications – Comparison with Chattem SmartRelief Predicate Device
| Characteristic | New Device | Predicate Device(SmartRelief) | Similar/Different |
|---|---|---|---|
| Output mode /Program | P1 (SMP) | TENS (SMP) | Similar |
| Waveform | Balanced, AsymmetricalBiphasic | Balanced, AsymmetricalBiphasic | Similar |
| Shape | Square positive pulse,current controlledLogarithmic negative pulse,decrease current. | Square positive pulse,current controlledLogarithmic negativepulse, decrease current. | Similar |
| Maximum OutputVoltage (± 10%) | 110[V] peak on 10[kΩ]110[V] peak on 2[kΩ]60[V] peak on 1[kΩ]30[V] peak on 500[Ω] | 70[V] peak on 10[kΩ]70[V] peak on 2[kΩ]60[V] peak on 1[kΩ]30[V] peak on 500[Ω] | Different |
| Maximum OutputCurrent (± 10%) | 11[mA] peak on 10[kΩ]55[mA] peak on 2[kΩ]60[mA] peak on 1[kΩ]60[mA] peak on 500[Ω]Max rms current6.28[mA]rms(divided by 2 per outputwhen split) | 7[mA] peak on 10[kΩ]35[mA] peak on 2[kΩ]60[mA] peak on 1[kΩ]60[mA] peak on 500[Ω]Max rms current3[mA]rms | Similar |
| Pulse Width | 70 to 300[µs] (measuredat 50% of positive pulse) | 30-220 µs at50% of peakamplitude | Similar |
| Frequency | 5 to 122[Hz] | max 100[Hz] | Similar |
| For multiphasicwaveforms only:Symmetrical-phases?Phase Duration(include units)(state range, ifapplicable) (bothphases, ifasymmetrical) | Biphasic:Asymmetrical-70 to 300[µs] for-positive pulse,logarithmic negativepulse, decrease current. | Biphasic:Asymmetrical-30 to 220[µs] for positivepulse, constantcurrentundershoot | Similar |
| Net Charge[µC/pulse] | 18[µC] @ 1[kΩ] | 13.2[µC] | Different |
| Maximum PhaseCharge [µC] | 0[µC] on 1[kΩ] | 0[µC] | Similar |
| Maximum Current(RMS)Density [mA/cm2] | 0.31[mA/cm²](over 1[s] period) | 0.1[mA/cm²](2.06[mA]/20[cm²]) | Similar |
| Maximum PowerDensity [mW/cm²] | 4.92[mW/cm²](split on 2x1[kΩ] in //) | 1.5[mW/cm²](60mA70V2*40µs *90Hz) / 4.5²cm² | Different |
| Burst Mode (i.e. pulse trains)i) Pulses per burstj) Bursts per secondk) Burst duration (seconds)l) Duty Cycle [Line (b) x Line (c)] | NA, no burst mode | NA, no burst mode | Same |
| ON Time (seconds) | Once started, the output is active until user manually stops the unit | 30[min] | Different |
| OFF Time (seconds) | NA, no OFF time | NA, no OFF time | Same |
| Additional Features (if applicable) | NA, no additional feature | NA, no additional feature | Same |
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Although there are minor differences observed between the predicate devices and Strive, seen in the tables above, there are no differences in which raise any new questions of safety or effectiveness.
Performance Testing:
Electrical Safety and Electromagnetic Compatibility: Strive testing comprises of the following standards for electrical safety and electromagnetic compatibility:
- . IEC 60601-1 for basic safety and essential performance
- IEC 60601-1-2 for electromagnetic compatibility ●
- IEC 60601-1-11 for use in a home healthcare environment ●
- IEC 60601-2-10 for performance of nerve and muscle stimulators ●
Software Verification: The device's software was verified in accordance with the requirements of FDA's guidance document: General Principles of Software Validation, January 11, 2002. The software testing demonstrated that the software meets its design requirements.
Usability/Human Factors Testing: Usability/Human Factors testing was performed in accordance to standard IEC 60601-1-6, which demonstrated that the established requirements for usability were met, and the device's design is appropriate for the intended users and use environment. The result of this study substantiates the acceptability of the use-related risks identified during the risk assessment activities.
Coexistence Testing: The performance of Strive was evaluated in an environment with other devices (Bluetooth, Wi-Fi, Microwave Oven), as well as in an environment with clinical devices which intentionally and unintentionally emit RF frequencies. The device met all specified requirements.
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Conclusion:
Based on the performance testing and the similarities of the indications for use and the technological characteristics, it can be concluded that Strive is as safe and effective as, and substantially equivalent to, the predicate devices.
§ 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).