Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.

Therapeutic

No.
The device is indicated for aesthetic treatments such as improving lines, wrinkles, skin laxity, and cellulite, and for muscle toning, rather than for the treatment of diseases or medical conditions.

Diagnostic

No

Explanation: The SofWave System is described as a non-invasive dermatological aesthetic treatment device for improving facial lines, wrinkles, lifting tissue, and improving the appearance of cellulite. It also has a module for improving muscle tone and firmness. Its primary purpose is aesthetic treatment, not diagnosis of a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components including a console, applicator with ultrasonic transducers, and an Electrical Muscle Stimulation (EMS) Module. While software is mentioned for control and user interface, it is integral to the function of these physical components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for non-invasive dermatological aesthetic treatments (improving lines/wrinkles, lifting tissue, improving cellulite, improving muscle tone). This is a direct treatment applied to the body, not a test performed on a sample taken from the body.
Device Description: The device uses ultrasound and electrical muscle stimulation (EMS) to directly interact with the patient's tissues. It does not analyze biological samples.
Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is to deliver energy to the body for therapeutic/aesthetic purposes.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

NGX, OHV

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

facial, submental (beneath the chin), neck, abdominal, arms, thighs, buttocks

Indicated Patient Age Range

22 and older.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K240687, K233926

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K192264

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

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"

1

(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

2

Enclosure

3

Indications for Use

Submission Number (if known)

K241685

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.

5

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 for
use as a non-invasive dermatological
aesthetic treatment to improve facial	The SofWave System is indicated for
use as a non-invasive dermatological
aesthetic treatment to improve facial

Table 1: Substantial Equivalence Chart - SofWave Module

6

	Subject Device	Predicate Device K240687
Product	SofWave (SofWave Module)	SofWave (SofWave Module)
	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 regions for
subjects aged 22 and older. The
SofWave System is also intended for
short-term improvement in the
appearance of cellulite.	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 regions for
subjects aged 22 and older. The
SofWave System is also intended for
short-term improvement in the
appearance of cellulite.
Device Technology	High Intensity non-focused
Ultrasound	High Intensity non-focused
Ultrasound
System Components	Console that includes the power
sources, electrical components
and user interface (touchscreen) Handpiece	Console that includes the power
sources, electrical components
and user interface (touchscreen) Handpiece
Energy Delivered per
PZT	3-5 Joule per PZT (Lift and Precise
applicators)

2.6-7 Joule per PZT (Smooth
applicator) | 3-5 Joule per PZT (Lift and Precise
applicators)

Table 2: Substantial Equivalence Chart – Pure Impact Module

| | Subject Device | Predicate Device
(K240687) | Predicate Device
(K233926) |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | SofWave (Pure Impact
Module) | SofWave (Pure Impact
Module) | accufit |
| Regulation Number | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 |
| Classification Name | Powered muscle
stimulator | Powered muscle
stimulator | Powered muscle
stimulator |
| Product Code | NGX | NGX | NGX |
| Indication for Use | indicated to be used
for:
• Improvement of
abdominal tone, for
strengthening of the
abdominal muscles,
for development of
firmer abdomen. | indicated to be used
for:
• Improvement of
abdominal tone, for
strengthening of the
abdominal muscles,
for development of
firmer abdomen. | • Relaxation of
muscle spasms
• Prevention or
retardation of
disuse atrophy
• Increase local blood
circulation. |
| | Subject Device | Predicate Device
(K240687) | Predicate Device
(K233926) |
| Product | SofWave (Pure Impact
Module) | SofWave (Pure Impact
Module) | accufit |
| | Improvement of
muscle tone and
firmness, for
strengthening
muscles in arms,
thighs and buttocks
areas. | Strengthening,
toning and firming
of buttocks and
thighs. | Muscle re-
education Maintaining or
increasing range of
motion Immediate
postsurgical
stimulation of calf
muscles to prevent
venous thrombosis 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 |
| Power Source | Console Power source:
100-240AC, 50/60Hz

Rechargeable Lithium
Ion Polymer Battery
Pack 3.7 V
Nominal Voltage: 3.7V
Nominal Capacity:
600mA | Console Power source:
100-240AC, 50/60Hz

7

8

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.

9

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 | Symmetrical
Biphasic | Symmetrical
Biphasic | Symmetrical
Biphasic | Symmetrical
Biphasic | Symmetrical
Biphasic | Symmetrical
Biphasic | Symmetrical
Biphasic | Symmetrical
Biphasic | Not publicly
available. | Symmetrical
biphasic |
| Shape | Square wave | Square wave | Square wave | Square wave | Square wave | Square wave | Square wave | Square wave | Not publicly
available. | 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 publicly
available. | 52-58.4 Vpp @
500Ω; |
| Maximum
Output
Voltage | 204 Vpp @ 2
kΩ (± 10%) | 204 Vpp @ 2
kΩ (± 10%) | 204 Vpp @ 2
kΩ (± 10%) | 204 Vpp @ 2
kΩ (± 10%) | 204 Vpp @ 2
kΩ (± 10%) | 204 Vpp @ 2
kΩ (± 10%) | 204 Vpp @ 2
kΩ (± 10%) | 204 Vpp @ 2
kΩ (± 10%) | Not publicly
available | 102-106
Vpp @ 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 publicly
available. | 150-154
Vpp @ 10kΩ |
| Maximum
Output
Current | 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 publicly
available. | 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 publicly
available | 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 publicly
available. | 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 publicly
available. | 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 publicly
available. | 2-25 Hz |
| For
multiphasic
Waveform
Symmetrical
Phases? | Yes,
Symmetrical
Biphasic | Yes,
Symmetrical
Biphasic | Yes,
Symmetrical
Biphasic | Yes,
Symmetrical
Biphasic | Yes,
Symmetrical
Biphasic | Yes,
Symmetrical
Biphasic | Yes,
Symmetrical
Biphasic | Yes,
Symmetrical
Biphasic | Not publicly
available. | Not publicly
available. |
| Phase
duration | 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 publicly
available. | N/A |
| Net charge | 0 uC @500Ω
(Being
Biphasic in | 0 uC @500Ω
(Being
Biphasic in | 0 uC @500Ω
(Being
Biphasic in | 0 uC @500Ω
(Being
Biphasic in | 0 uC @500Ω
(Being
Biphasic in | 0 uC @500Ω
(Being
Biphasic in | 0 uC @500Ω
(Being
Biphasic in | 0 uC @500Ω
(Being
Biphasic in | Not publicly
available. | 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 net
charge would
be Zero) | nature the net
charge would
be Zero) | nature the net
charge would
be Zero) | nature the net
charge would
be Zero) | nature the net
charge would
be Zero) | nature the net
charge would
be Zero) | nature the net
charge would
be Zero) | nature the net
charge would
be Zero) | | |
| Maximum
Phase 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 publicly
available. | 41.6-46.8 µC,
500 Ω |
| Maximum
Current
density | 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 publicly
available. | 1.057-1.672
mA/cm2, 500 Ω |
| | *measured
with 50 x
50mm
rectangular
electrodes | *measured
with 50 x
50mm
rectangular
electrodes | *measured
with 50 x
50mm
rectangular
electrodes | *measured
with 50 x
50mm
rectangular
electrodes | *measured
with 50 x
50mm
rectangular
electrodes | *measured
with 50 x
50mm
rectangular
electrodes | *measured
with 50 x
50mm
rectangular
electrodes | *measured
with 50 x
50mm
rectangular
electrodes | Not publicly
available. | N/A |
| Maximum
Power Density | 0.052
Watt/cm² @
500Ω Load | 0.052
Watt/cm² @
500Ω Load | 0.052
Watt/cm² @
500Ω Load | 0.052
Watt/cm² @
500Ω Load | 0.052
Watt/cm² @
500Ω Load | 0.052
Watt/cm² @
500Ω Load | 0.052
Watt/cm² @
500Ω Load | 0.052
Watt/cm² @
500Ω Load | Not publicly
available. | 0-0671-0.0869
Watt/cm², 500
Ω |
| | *measured
with 50 x
50mm
rectangular
electrodes | *measured
with 50 x
50mm
rectangular
electrodes | *measured
with 50 x
50mm
rectangular
electrodes | *measured
with 50 x
50mm
rectangular
electrodes | *measured
with 50 x
50mm
rectangular
electrodes | *measured
with 50 x
50mm
rectangular
electrodes | *measured
with 50 x
50mm
rectangular
electrodes | *measured
with 50 x
50mm
rectangular
electrodes | Not publicly
available. | N/A |
| Burst Mode | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | Not publicly
available. | Yes for one
configuration,
not for the other |
| ON Time | 6 seconds | 6 seconds | 6 seconds | 4 - 12 seconds | 6 seconds | 6 seconds | 6 seconds | 4 seconds | Not publicly
available. | N/A |
| OFF Time | 4 seconds | 4 seconds | 4 seconds | 2 - 6 seconds | 4 seconds | 4 seconds | 4 seconds | 2 seconds | Not publicly
available. | N/A |

10

11

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.