(57 days)
The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also indicated for short-term improvement in the appearance of cellulite.
The Pure Impact module is indicated to be used for:
· Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
· Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.
The SofWave System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage.
The SofWave System consists of three main functional components: 1) console: 2) applicator: and 3) Electrical Muscle Stimulation (EMS) Module (Pure Impact). The console includes power sources, cooling unit, electrical components, IoT, BLE, and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves at 10-12 MHz and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console. The EMS module is wirelessly connected to and controlled by the SofWave console. It functions independently from the ultrasound system. The user selects either the ultrasound treatment or the EMS treatment, but not both, at the beginning of the treatment.
This FDA 510(k) K241685 summary describes the SofWave System, which includes an ultrasound system and an Electrical Muscle Stimulation (EMS) module (Pure Impact). The 510(k) submission is for minor changes to the existing SofWave System (K240687) and an updated software for the Pure Impact module to include the arms in its indications for use.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" for performance in a quantitative sense for this 510(k) submission. Instead, it focuses on demonstrating substantial equivalence to predicate devices for the modified SofWave system and the Pure Impact module. The performance data section primarily discusses validation of the changes.
However, based on the context of a 510(k) and the information provided, we can infer the acceptance criteria were that the device performs as intended and that the changes do not raise new questions of safety or effectiveness.
| Acceptance Criteria (Inferred from 510(k)) | Reported Device Performance |
|---|---|
| Minor changes in SofWave module do not raise different questions of safety or effectiveness. | "Performance testing, including design verification testing and electrical safety testing, confirmed the minor changes in the SofWave module did not raise different questions." |
| Software modifications for Pure Impact module are successfully implemented without major issues. | "The software modifications were evaluated through software verification testing, which was completed successfully with no major issues found." |
| Overall, the device performs as intended. | "In all instances, the subject SoftWave System performed as intended." |
| Pure Impact module has similar output waveform specifications as predicate/reference devices. | "Notably, the subject Pure Impact module has very similar output waveform specifications as the accufit predicate device and the HIVOX reference device. As shown in the detailed comparison below, all parameters are similar between the devices. Differences are minor and not clinically relevant." (Detailed table 3 on pages 9-10 supports this.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
This indicates that there was no clinical test set in the traditional sense for evaluating the device's clinical performance against an acceptance criterion in this particular 510(k) submission. The evaluation focused on engineering and software verification and validation. Therefore, information about sample size and data provenance for a "test set" in the context of clinical performance is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications:
Since "No clinical test data was used," there was no "ground truth" establishment by experts in the context of a clinical test set. The evaluation was based on engineering and software testing against predefined specifications and comparisons to predicate devices.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test data was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The submission explicitly states, "No clinical test data was used."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device described is a physical medical device (ultrasound system and electrical muscle stimulator) with software components, not an AI/algorithm-only device. Therefore, the concept of "standalone (algorithm only)" performance as typically applied to AI medical devices is not applicable. The software modifications were validated through software verification testing.
7. The Type of Ground Truth Used:
For the evaluation described in this summary, the "ground truth" for demonstrating substantial equivalence was effectively:
- Engineering specifications and standards: The device's electrical safety, design, and waveform output (for the Pure Impact module) were compared against established engineering principles and relevant voluntary standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971).
- Predicate device characteristics: The technological characteristics and performance of the modified SofWave module and the Pure Impact module were compared directly to already cleared predicate devices (K240687 for SofWave module and Pure Impact, and K233926 for accufit as another EMS predicate). The "ground truth" was that the subject device's performance fell within acceptable ranges or was equivalent to these legally marketed devices.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that involves a "training set" in the conventional sense. The software modifications mentioned were validated through verification testing, not a machine learning training process.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as no training set was used.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 7, 2024
Sofwave Medical Ltd. Ruthie Amir Chief Medical Officer 1 Ha-Otsma St. Yokneam Ilit, 2069200 Israel
Re: K241685
Trade/Device Name: SofWave System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, OHV Dated: June 11, 2024 Received: June 11, 2024
Dear Ruthie Amir:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices
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Enclosure
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Indications for Use
Submission Number (if known)
Device Name
SofWave System
Indications for Use (Describe)
The SofMave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also indicated for short-term improvement in the appearance of cellulite.
The Pure Impact module is indicated to be used for:
· Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
· Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Sofwave Medical's SofWave System, K241685
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared
Sofwave Medical Ltd. 1 Ha-Otsma St. Yokneam Ilit, Israel 2069200
Contact Person: Ruthie Amir, MD, Chief Medical Officer ruthie@sofwave.com +972543003164
Date Prepared: June 11, 2024
Name of Device:
SofWave System
Classification Name:
21 CFR 890.5850 (Powered Muscle Stimulator), Class II, product code NGX
21 CFR 878.4590 (Focused Ultrasound Stimulator System for Aesthetic Use), Class II, product code OHV
Predicate Devices
Sofwave Medical's SofWave System (K240687) (Predicate Device)
Mettler Electronics Corporation's accufit (K233926) (Predicate Device)
Hivox Biotek Inc.'s HIVOX Spopad EMS SP-911, SP-921 (K192264) (Reference Device)
Intended Use / Indications for Use
The SofMave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also indicated for short-term improvement in the appearance of cellulite.
The Pure Impact module is indicated to be used for:
- Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
- Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and ● buttocks areas.
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Technological Characteristics
The SofWave System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage.
The SofMave System consists of three main functional components: 1) console: 2) applicator: and 3) Electrical Muscle Stimulation (EMS) Module (Pure Impact). The console includes power sources, cooling unit, electrical components, IoT, BLE, and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves at 10-12 MHz and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console. The EMS module is wirelessly connected to and controlled by the SofWave console. It functions independently from the ultrasound system. The user selects either the ultrasound treatment or the EMS treatment, but not both, at the beginning of the treatment.
Comparison of Technological Characteristics with the Predicate Devices
The SofWave module is almost identical to the previous SoftWave device that was cleared in K240687, other than a few minor changes made to the hardware of the cleared device. These minor modifications do not change the treatment parameters or energy specification, nor do they present any new questions of safety or effectiveness.
The subject Pure Impact module is very similar to the predicate SofMave device that was cleared in K240687. No hardware changes were made to the cleared SofWave device's Pure Impact module. The software has been updated to allow the previously cleared plyometric protocol to arms. The Pure Impact module also has similar technology to the accufit predicate device (K233926). Both devices are electrical muscle stimulators that generate electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. Both devices contract muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the arms, thighs, and buttocks. Both the Pure Impact module of SofMave system and accufit consist of a console with a touchscreen control panel and power supply module. For both devices, all system functions are controlled through the console. During a treatment session, one or more electrodes are secured to the patient, and electrical stimulation is delivered to the treatment area at the selected treatment mode and intensity.
The minor differences in the subject device's technological characteristics compared to the predicate devices do not raise different questions of safety or effectiveness.
| Subject Device | Predicate Device K240687 | |
|---|---|---|
| Product | SofWave (SofWave Module) | SofWave (SofWave Module) |
| Regulation Number | 21 CFR 878.4590 | 21 CFR 878.4590 |
| Product Code | OHV | OHV |
| Indications for Use | The SofWave System is indicated foruse as a non-invasive dermatologicalaesthetic treatment to improve facial | The SofWave System is indicated foruse as a non-invasive dermatologicalaesthetic treatment to improve facial |
Table 1: Substantial Equivalence Chart - SofWave Module
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| Subject Device | Predicate Device K240687 | |
|---|---|---|
| Product | SofWave (SofWave Module) | SofWave (SofWave Module) |
| lines and wrinkles, lift the eyebrow,and lift lax submental (beneath thechin) and neck tissue; which can alsoaffect the appearance of lax tissue inthe submental and neck regions forsubjects aged 22 and older. TheSofWave System is also intended forshort-term improvement in theappearance of cellulite. | lines and wrinkles, lift the eyebrow,and lift lax submental (beneath thechin) and neck tissue; which can alsoaffect the appearance of lax tissue inthe submental and neck regions forsubjects aged 22 and older. TheSofWave System is also intended forshort-term improvement in theappearance of cellulite. | |
| Device Technology | High Intensity non-focusedUltrasound | High Intensity non-focusedUltrasound |
| System Components | Console that includes the powersources, electrical componentsand user interface (touchscreen) Handpiece | Console that includes the powersources, electrical componentsand user interface (touchscreen) Handpiece |
| Energy Delivered perPZT | 3-5 Joule per PZT (Lift and Preciseapplicators)2.6-7 Joule per PZT (Smoothapplicator) | 3-5 Joule per PZT (Lift and Preciseapplicators)2.6-7 Joule per PZT (Smoothapplicator) |
| Epidermal Impact | Non-invasive | Non-invasive |
| Treatment Area | $15, 35, or 70 mm^2$ | $15, 35, or 70 mm^2$ |
| User Interface | LCD Touch Screen Graphic UserInterface | LCD Touch Screen Graphic UserInterface |
Table 2: Substantial Equivalence Chart – Pure Impact Module
| Subject Device | Predicate Device(K240687) | Predicate Device(K233926) | |
|---|---|---|---|
| Product | SofWave (Pure ImpactModule) | SofWave (Pure ImpactModule) | accufit |
| Regulation Number | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 |
| Classification Name | Powered musclestimulator | Powered musclestimulator | Powered musclestimulator |
| Product Code | NGX | NGX | NGX |
| Indication for Use | indicated to be usedfor:• Improvement ofabdominal tone, forstrengthening of theabdominal muscles,for development offirmer abdomen. | indicated to be usedfor:• Improvement ofabdominal tone, forstrengthening of theabdominal muscles,for development offirmer abdomen. | • Relaxation ofmuscle spasms• Prevention orretardation ofdisuse atrophy• Increase local bloodcirculation. |
| Subject Device | Predicate Device(K240687) | Predicate Device(K233926) | |
| Product | SofWave (Pure ImpactModule) | SofWave (Pure ImpactModule) | accufit |
| Improvement ofmuscle tone andfirmness, forstrengtheningmuscles in arms,thighs and buttocksareas. | Strengthening,toning and firmingof buttocks andthighs. | Muscle re-education Maintaining orincreasing range ofmotion Immediatepostsurgicalstimulation of calfmuscles to preventvenous thrombosis Improvement ofabdominal tone, forstrengthening of theabdominal muscles,for development offirmer abdomen. Improvement ofmuscle tone andfirmness, forstrengtheningmuscles in arms,thighs and buttocksareas | |
| Power Source | Console Power source:100-240AC, 50/60HzRechargeable LithiumIon Polymer BatteryPack 3.7 VNominal Voltage: 3.7VNominal Capacity:600mA | Console Power source:100-240AC, 50/60HzRechargeable LithiumIon Polymer BatteryPack 3.7 VNominal Voltage: 3.7VNominal Capacity:600mA | 100-240VAC ,50/60Hz, 1.0A (Fuse:250V / 6.3A) |
| Patient LeakageCurrent - NormalCondition | Normal condition = lessthan 100μA | Normal condition = lessthan 100μA | Less than 100μA |
| Display | Touch screen LCD | Touch screen LCD | Touch screen LCD |
| Number of OutputChannels | Maximum of 4 channelsper treatment (up to 2on arms) | Maximum of 4 channelsper treatment | 2 |
| Method of ChannelIsolation | Separate units for pulsegeneration (wirelessunits). Line power is NA | Separate units for pulsegeneration (wirelessunits). Line power is NA | Double insulated wirenon- conductiveenclosure |
| Regulated Current orRegulated Voltage | Regulated current | Regulated current (allchannels) | Regulated current |
| Subject Device | Predicate Device(K240687) | Predicate Device(K233926) | |
| Product | SofWave (Pure ImpactModule) | SofWave (Pure ImpactModule) | accufit |
| Software / Firmware /MicroprocessorsControls? | Yes | Yes | Yes |
| Automatic OverloadTrip? | Yes | Yes | Yes |
| Automatic No-Load Trip | Yes | Yes | Yes |
| Automatic Shut off? | Yes | Yes | Yes |
| Patient OverrideControl? | Yes | Yes | Yes |
| Indicator Display:On/Off Status? | Yes | Yes | Yes |
| Low Battery? | Yes | Yes | Yes |
| Voltage/Current Level? | Yes (Energy level) | Yes (Energy level) | Yes |
| Timer Range (minutes) | Up to 60 minutes | Up to 60 minutes | 13, 30, 45 minutes |
| Compliance withVoluntary Standards | IEC 60601-1, IEC60601-1-2, IEC 60601-2-10, ISO 14971 | IEC 60601-1, IEC60601-1-2, IEC 60601-2-10, ISO 14971 | IEC 60601-1, IEC60601-1-2, IEC 60601-2-10, ISO 14971, UL60601, CSA C22.2 No606.1 |
| Compliance With 21CFR 898 | Yes, the electrodecable can never beplugged in the ACsocket, not evenaccidentally | Yes, the electrodecable can never beplugged in the ACsocket, not evenaccidentally | Yes |
| Housing Material andConstruction | PCABS510 for consolecovers & end pointshells | PCABS510 for consolecovers & end pointshells | ABS plastic |
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Notably, the subject Pure Impact module has very similar output waveform specifications as the accufit predicate device and the HIVOX reference device. As shown in the detailed comparison below, all parameters are similar between the devices. Differences are minor and not clinically relevant.
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Table 3: Comparison of Waveform Specifications
| Subject Device | SofWave Pure Impact (K240687) | accufit(K233926) | HIVOX(K192264) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Basic | Focused | Enhanced | PlyoPulse | Basic | Focused | Enhanced | PlyoPulse | |||
| Waveform | SymmetricalBiphasic | SymmetricalBiphasic | SymmetricalBiphasic | SymmetricalBiphasic | SymmetricalBiphasic | SymmetricalBiphasic | SymmetricalBiphasic | SymmetricalBiphasic | Not publiclyavailable. | Symmetricalbiphasic |
| Shape | Square wave | Square wave | Square wave | Square wave | Square wave | Square wave | Square wave | Square wave | Not publiclyavailable. | Rectangular |
| 51 Vpp @500 Ω (±10%) | 51 Vpp @500 Ω (±10%) | 51 Vpp @500 Ω (±10%) | 51 Vpp @500 Ω (±10%) | 51 Vpp @500 Ω (±10%) | 51 Vpp @500 Ω (±10%) | 51 Vpp @500 Ω (±10%) | 51 Vpp @500 Ω (±10%) | Not publiclyavailable. | 52-58.4 Vpp @500Ω; | |
| MaximumOutputVoltage | 204 Vpp @ 2kΩ (± 10%) | 204 Vpp @ 2kΩ (± 10%) | 204 Vpp @ 2kΩ (± 10%) | 204 Vpp @ 2kΩ (± 10%) | 204 Vpp @ 2kΩ (± 10%) | 204 Vpp @ 2kΩ (± 10%) | 204 Vpp @ 2kΩ (± 10%) | 204 Vpp @ 2kΩ (± 10%) | Not publiclyavailable | 102-106Vpp @ 2kΩ |
| 228 Vpp @10 kΩ (±10%) | 228 Vpp @10 kΩ (±10%) | 228 Vpp @10 kΩ (±10%) | 228 Vpp @10 kΩ (±10%) | 228 Vpp @10 kΩ (±10%) | 228 Vpp @10 kΩ (±10%) | 228 Vpp @10 kΩ (±10%) | 228 Vpp @10 kΩ (±10%) | Not publiclyavailable. | 150-154Vpp @ 10kΩ | |
| MaximumOutputCurrent | 102 mA pp @500 Ω (± 10%) | 102 mA pp @500 Ω (± 10%) | 102 mA pp @500 Ω (± 10%) | 102 mA pp @500 Ω (± 10%) | 102 mA pp @500 Ω (± 10%) | 102 mA pp @500 Ω (± 10%) | 102 mA pp @500 Ω (± 10%) | 102 mA pp @500 Ω (± 10%) | Not publiclyavailable. | 104-117 mA pp@ 500Ω (±20%) |
| 102 mA pp @2 kΩ (± 10%) | 102 mA pp @2 kΩ (± 10%) | 102 mA pp @2 kΩ (± 10%) | 102 mA pp @2 kΩ (± 10%) | 102 mA pp @2 kΩ (± 10%) | 102 mA pp @2 kΩ (± 10%) | 102 mA pp @2 kΩ (± 10%) | 102 mA pp @2 kΩ (± 10%) | Not publiclyavailable | 51-53 mA pp @2kΩ (± 20%) | |
| 22 mA pp@10 kΩ (± 10%) | 22 mA pp@10 kΩ (± 10%) | 22 mA pp@10 kΩ (± 10%) | 22 mA pp@10 kΩ (± 10%) | 22 mA pp@10 kΩ (± 10%) | 22 mA pp@10 kΩ (± 10%) | 22 mA pp@10 kΩ (± 10%) | 22 mA pp@10 kΩ (± 10%) | Not publiclyavailable. | 15-15.4 mA pp@ 10kΩ-15.4 (±20%) | |
| Pulse Width | 250 to 350 µS(± 10%)@500Ω | 150 to 350 µS(± 10%)@500Ω | 150 to 350 µS(± 10%)@500Ω | 150 to 350 µS(± 10%)@500Ω | 250 to 350 µS(± 10%)@500Ω | 150 to 350 µS(± 10%)@500Ω | 150 to 350 µS(± 10%)@500Ω | 150 to 350 µS(± 10%)@500Ω | Not publiclyavailable. | 400 µSec |
| Frequency | 1-100Hz @500Ω | 1-100Hz @500Ω | 1-100Hz @500Ω | 1-100Hz @500Ω | 1-100Hz @500Ω | 1-100Hz @500Ω | 1-100Hz @500Ω | 1-100Hz @500Ω | Not publiclyavailable. | 2-25 Hz |
| FormultiphasicWaveformSymmetricalPhases? | Yes,SymmetricalBiphasic | Yes,SymmetricalBiphasic | Yes,SymmetricalBiphasic | Yes,SymmetricalBiphasic | Yes,SymmetricalBiphasic | Yes,SymmetricalBiphasic | Yes,SymmetricalBiphasic | Yes,SymmetricalBiphasic | Not publiclyavailable. | Not publiclyavailable. |
| Phaseduration | 250 to 350 µS(± 10%)@500Ω | 150 to 350 µS(± 10%)@500Ω | 150 to 350 µS(± 10%)@500Ω | 150 to 350 µS(± 10%)@500Ω | 250 to 350 µS(± 10%)@500Ω | 150 to 350 µS(± 10%)@500Ω | 150 to 350 µS(± 10%)@500Ω | 150 to 350 µS(± 10%)@500Ω | Not publiclyavailable. | N/A |
| Net charge | 0 uC @500Ω(BeingBiphasic in | 0 uC @500Ω(BeingBiphasic in | 0 uC @500Ω(BeingBiphasic in | 0 uC @500Ω(BeingBiphasic in | 0 uC @500Ω(BeingBiphasic in | 0 uC @500Ω(BeingBiphasic in | 0 uC @500Ω(BeingBiphasic in | 0 uC @500Ω(BeingBiphasic in | Not publiclyavailable. | 0.416-0.468 µC@500Ω |
| Subject Device | SofWave Pure Impact (K240687) | accufit(K233926) | HIVOX(K192264) | |||||||
| Basic | Focused | Enhanced | PlyoPulse | Basic | Focused | Enhanced | PlyoPulse | |||
| nature the netcharge wouldbe Zero) | nature the netcharge wouldbe Zero) | nature the netcharge wouldbe Zero) | nature the netcharge wouldbe Zero) | nature the netcharge wouldbe Zero) | nature the netcharge wouldbe Zero) | nature the netcharge wouldbe Zero) | nature the netcharge wouldbe Zero) | |||
| MaximumPhase Charge | 17.85 µC @500Ω | 17.85 µC @500Ω | 17.85 µC @500Ω | 17.85 µC @500Ω | 17.85 µC @500Ω | 17.85 µC @500Ω | 17.85 µC @500Ω | 17.85 µC @500Ω | Not publiclyavailable. | 41.6-46.8 µC,500 Ω |
| MaximumCurrentdensity | 2.0 mA/cm² @500Ω | 2.0 mA/cm² @500Ω | 2.0 mA/cm² @500Ω | 2.0 mA/cm² @500Ω | 2.0 mA/cm² @500Ω | 2.0 mA/cm² @500Ω | 2.0 mA/cm² @500Ω | 2.0 mA/cm² @500Ω | Not publiclyavailable. | 1.057-1.672mA/cm2, 500 Ω |
| *measuredwith 50 x50mmrectangularelectrodes | *measuredwith 50 x50mmrectangularelectrodes | *measuredwith 50 x50mmrectangularelectrodes | *measuredwith 50 x50mmrectangularelectrodes | *measuredwith 50 x50mmrectangularelectrodes | *measuredwith 50 x50mmrectangularelectrodes | *measuredwith 50 x50mmrectangularelectrodes | *measuredwith 50 x50mmrectangularelectrodes | Not publiclyavailable. | N/A | |
| MaximumPower Density | 0.052Watt/cm² @500Ω Load | 0.052Watt/cm² @500Ω Load | 0.052Watt/cm² @500Ω Load | 0.052Watt/cm² @500Ω Load | 0.052Watt/cm² @500Ω Load | 0.052Watt/cm² @500Ω Load | 0.052Watt/cm² @500Ω Load | 0.052Watt/cm² @500Ω Load | Not publiclyavailable. | 0-0671-0.0869Watt/cm², 500Ω |
| *measuredwith 50 x50mmrectangularelectrodes | *measuredwith 50 x50mmrectangularelectrodes | *measuredwith 50 x50mmrectangularelectrodes | *measuredwith 50 x50mmrectangularelectrodes | *measuredwith 50 x50mmrectangularelectrodes | *measuredwith 50 x50mmrectangularelectrodes | *measuredwith 50 x50mmrectangularelectrodes | *measuredwith 50 x50mmrectangularelectrodes | Not publiclyavailable. | N/A | |
| Burst Mode | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | Not publiclyavailable. | Yes for oneconfiguration,not for the other |
| ON Time | 6 seconds | 6 seconds | 6 seconds | 4 - 12 seconds | 6 seconds | 6 seconds | 6 seconds | 4 seconds | Not publiclyavailable. | N/A |
| OFF Time | 4 seconds | 4 seconds | 4 seconds | 2 - 6 seconds | 4 seconds | 4 seconds | 4 seconds | 2 seconds | Not publiclyavailable. | N/A |
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Performance Data
Performance testing, including design verification testing and electrical safety testing, confirmed the minor changes in the SofWave module did not raise different questions. The software modifications were evaluated through software verification testing, which was completed successfully with no major issues found. In all instances, the subject SoftWave System performed as intended.
Clinical Summary
No clinical test data was used to support the decision of substantial equivalence.
Conclusion
SofWave has the same general intended use and similar indications for use and technological characteristics as the predicate device. The addition of arms to the Pure Impact indications for use and minor technological differences between the subject and the predicate devices do not raise different questions of safety or effectiveness. Performance testing has demonstrated that the device performs as intended. Thus, the SofWave System is substantially equivalent.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).