(597 days)
No
The description focuses on electrical pulse generation and delivery controlled by proprietary embedded software with parameters selected by the operator. There is no mention of AI, ML, or any learning or adaptive capabilities.
No.
The intended use explicitly states, "Legend Pro DMA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind."
No
The device is described for muscle conditioning to stimulate healthy muscles, not for diagnosis. Its intended use explicitly states it is "not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind," which further indicates it is not a diagnostic device.
No
The device description clearly outlines hardware components including a system console, applicators with electrodes, and mentions hardware implementation of pulse generation. While it includes embedded software, it is not solely software.
Based on the provided information, the Legend Pro DMA is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "muscle conditioning to stimulate healthy muscles." This is a physical intervention applied directly to the body, not a test performed on samples taken from the body.
- Device Description: The device generates electrical pulses delivered to the skin overlaying muscles. This is a physical stimulation method.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Legend Pro DMA's function is to directly stimulate muscles for conditioning, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
Legend Pro DMA is intended for muscle conditioning to stimulate healthy muscles.
Legend Pro DMA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
Legend Pro DMA is intended to be operated by a trained professional who is present to monitor treatment.
Product codes
NGX
Device Description
The Legend Pro DMA generates a sequence of electrical pulses which are delivered to the skin overlaying the muscles intended to be stimulated. The Legend Pro DMA consists of a floor-mounted, rolling System Console that generates voltage output delivered though metal electrodes in the three different DMA Applicators. The System Console generates electrical pulses, and delivers modulated low frequency rectangular biphasic waveforms via electrodes incorporated in different Applicators connected to the System Console:
- LP DMA Applicator No. 1 for large Areas (includes 6 stainless-steel equidistant electrodes)
- LP DMA Applicator No. 2 for Medium areas (includes 3 stainless-steel equidistant electrodes)
- LP DMA Applicator No. 3 for Small Areas (includes 3 stainless-steel equidistant ● electrodes)
The Legend Pro DMA is controlled by a proprietary embedded SW. The system SW provides the treatment parameters. The hardware (HW) then implements the actual pulse generation according to the parameters provided by the software. Via the GUI in the System Console, the physician selects the Applicator according to the size of the area being treated and the treatment parameters (Frequency, % Height/Amplitude, pulse width and Treatment Duration). During the treatment session, the operator moves the Applicator across the skin that is lubricated with glycerine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professional who is present to monitor treatment.
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)
The Legend Pro DMA has been tested to establish its safety and performance. The following design verification and validation processes were performed according to the FDA Guidance Document for Powered Muscle Stimulator 510(k)s Document issued on: June 9, 1999 and based on the Predicate device, the Body System, K182440:
- Risk analysis per ISO 14971 ●
- Electrical, electromagnetic compatibility safety testing according to IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10.
- Software verification and validation according to IEC 62304 and FDA Guidance ● "Principles of Software Validation Guidance for Industry and FDA Staff, January 2002".
- Performance testing (e.g., energy measurements, including Output Waveforms).
- Reprocessing evaluation according to FDA's guidance "Reprocessing Medical ● Devices in Health Care Settings: Validation Methods and Labeling FDA Guidance (2015, Updated June 9, 2017)".
- Biocompatibility evaluation according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing with a Risk Management Process, September 2020 and "Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin DRAFT", October 2020
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Body System (K182440)
Reference Device(s)
AK Body Toning Device (K152420)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 21, 2021
Pollogen, Ltd % Amaya De Levie RA Director Benjamin L. England and Associates 810 Landmark Dr. Suite 126 Glen Burnie, Maryland 21061
Re: K200545
Trade/Device Name: Legend Pro DMA Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: September 14, 2021 Received: September 22, 2021
Dear Amaya De Levie:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200545
Device Name Legend Pro DMA
Indications for Use (Describe)
Legend Pro DMA is intended for muscle conditioning to stimulate healthy muscles.
Legend Pro DMA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
Legend Pro DMA is intended to be operated by a trained professional who is present to monitor treatment
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 201 Subpart D) |
| Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
K200545
| Applicant Name: | Udi Russo
Pollogen Ltd.
6 Kaufman Street
Tel Aviv, Tel-Aviv, ISRAEL 6801298
Phone: +972 3 5104110
Fax: +972 3 5104112 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amaya De Levie
Lumenis Ltd.
6 Hakidma Street PO Box 240,
Yokneam Industrial Park
Yokneam 2069204
Israel
Phone: +972-549599073
E-mail: Amaya.delevie@gmail.com |
| Date Prepared: | October 20, 2021 |
| Trade Name: | Legend Pro DMA |
| Classification Name: | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Product Code: | NGX |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 890.5850 |
| Panel: | Physical Medicine |
| Predicate Device: | Body System (K182440) |
| Reference Device | AK Body Toning Device (K152420) |
Intended Use/ Indications for Use:
Legend Pro DMA is intended for muscle conditioning to stimulate healthy muscles.
Legend Pro DMA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
Legend Pro DMA is intended to be operated by a trained professional who is present to monitor treatment.
4
Device Description:
The Legend Pro DMA generates a sequence of electrical pulses which are delivered to the skin overlaying the muscles intended to be stimulated. The Legend Pro DMA consists of a floormounted, rolling System Console that generates voltage output delivered though metal electrodes in the three different DMA Applicators. The System Console generates electrical pulses, and delivers modulated low frequency rectangular biphasic waveforms via electrodes incorporated in different Applicators connected to the System Console:
- . LP DMA Applicator No. 1 for large Areas (includes 6 stainless-steel equidistant electrodes)
- . LP DMA Applicator No. 2 for Medium areas (includes 3 stainless-steel equidistant electrodes)
- LP DMA Applicator No. 3 for Small Areas (includes 3 stainless-steel equidistant ● electrodes)
The Legend Pro DMA is controlled by a proprietary embedded SW. The system SW provides the treatment parameters. The hardware (HW) then implements the actual pulse generation according to the parameters provided by the software. Via the GUI in the System Console, the physician selects the Applicator according to the size of the area being treated and the treatment parameters (Frequency, % Height/Amplitude, pulse width and Treatment Duration). During the treatment session, the operator moves the Applicator across the skin that is lubricated with glycerine.
| Parameter | Legend Pro DMA | Principal
Predicate Device | Reference Device | Same/
Similar/Different |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K200545 | K182440 | K152420 | N/A |
| Device Name
and Model | Legend Pro DMA | Body System | AK Body Toning
Device | N/A |
| Manufacturer | Pollogen | A-1 Engineering | AK Beauty Enterprises,
LLC | |
| Product Code | NGX | NGX | NGX | Same |
| Type of Use | Prescription Use
(Part 21 CFR 801
Subpart D) | Prescription Use
(Part 21 CFR 801
Subpart D) | Over-The-Counter Use
(21 CFR 801 Subpart
C) | Same |
| Intended Use | Legend Pro DMA is
intended for
muscle
conditioning to
stimulate healthy
muscles. | The Body System
is intended for
muscle
conditioning to
stimulate healthy
muscles. | The AK Body Toning
Device is intended for
use by healthy persons
to apply
transcutaneous
electrical muscle
stimulation
(EMS) through skin-
contact electrodes in
order to improve or
facilitate muscle
performance. | Same Intended use as
the Predicate. Similar
to the Reference |
| | Legend Pro DMA is
not intended to be
used in conjunction
with therapy or | The Body System
is not intended to
be used in
conjunction with | | |
| Parameter | Legend Pro DMA | Principal
Predicate Device | Reference Device | Same/
Similar/Different |
| 510(k) Number | K200545 | K182440 | K152420 | |
| Device Name
and Model | Legend Pro DMA | Body System | AK Body Toning
Device | N/A |
| | treatment of
medical diseases
or medical
conditions. Legend
Pro DMA is
intended to be
operated by a
trained
professional who is
present to monitor
treatment. | therapy or
treatment of
medical diseases
or medical
conditions of any
kind. The Body
System is
intended to be
operated by a
trained
professional who
is present to
monitor treatment. | | |
| Mode of
Operation | Application of
transcutaneous
electrical muscle
stimulation
(EMS) through skin-
contact electrodes | Application of
transcutaneous
electrical muscle
stimulation
(EMS) through
skin-contact
electrodes | Application of
transcutaneous
electrical muscle
stimulation
(EMS) through skin-
contact electrodes | Same mode of
operation as the
Predicate and
Reference |
| Mode of
application | Metal (Stainless
steel) electrodes in
the System
Applicator emit
electric energy to the
skin while the system
applicator is rolled
across the treatment
area | Fixed self-
adhesive, gelled
pad applicators
attached to the skin
for muscle
conditioning. | Metal electrodes in the
device emit electric
energy to the skin
while the device is
rolled across the
treatment area | Different from the
predicate (moving
electrodes vs. fixed
electrodes) but similar
to the Reference
device. See Section
12.4. |
| Body
Application
Areas | Body | Body | Not publicly available | |
| Power Source(s) | 110-240 V
50-60 Hz | 110-240 vac (AC
wall plug-in)
50 - 60 Hz | Battery
3 x 1.5 V
AAA batteries | Same as the
Predicate. Different
from the Reference
device |
| Method of Line
Current Isolation | Medical Power
Supply, Transformer
in output stage | Power Supply
isolation | N/A - Internal Power
Type BF | Similar to the
Predicate |
| Patient Leakage
Current | | | | |
| - Normal
Condition
(μΑ) | 1.5 μΑ | .05 μΑ | N/A (battery operated
device) | Similar to the Predicate |
| - Single Fault
Condition
(μΑ) | 40 μΑ | 5 μΑ | N/A (battery operated
device) | Similar to the Predicate
and below 500
μΑ
value in guidance. |
| Number of
Output Modes | 1 | 5 | 1 | Different. Modes are
comparable. No issues
of safety or
effectiveness |
| Number of
Output
Channels: | 1 | 16 | 1 | Different. Each session
will use one of three
Applicators. No
difference in safety or
effectiveness. |
| Parameter | Legend Pro DMA | Principal
Predicate Device | Reference Device | Same/
Similar/Different |
| 510(k) Number | K200545 | K182440 | K152420 | |
| Device Name
and Model | Legend Pro DMA | Body System | AK Body Toning
Device | N/A |
| | | | | Applicator is moved to
cover entire treatment
area. |
| Synchronous or
Alternating? | N/A Single output
channel. | Synchronous | N/A Single channel. | Different. Not required
for one output channel |
| Method of
Channel
Isolation | N/A Single output
channel. | Power Supply
isolation | N/A Single channel. | Different. Single
channel does not
require channel
isolation. |
| Regulated
Current or
Regulated
Voltage? | Voltage | Current and Voltage | Voltage | Similar to the
Predicate. Different
form the Reference
device |
| Software/Firmwa
re/Microprocess
or Control? | Yes | No | No | Different. The software
is validated. The
output from each is
comparable. Does not
directly affect safety
and effectiveness. |
| Automatic
Overload Trip? | No | Yes | No | Same as the
Reference. Different
from the predicate
device |
| Automatic No-
Load Trip? | No | Yes | No | Same as the
Reference. Different
from the predicate
device |
| Automatic Shut
Off? | No | Not publicly
available | Yes | Different. |
| Patient Override
Control? | Yes | Not publicly
available | Yes | Similar to the
Reference device.
Patient-Controlled
Manual Switch used as
a patient control in the
case of discomfort that
stop power
transmission
immediately after the
patient presses the
button |
| - Indicator
Display: | | | | |
| - On/Off Status | Yes | Yes | Yes | Similar to Predicate
and Reference |
| - Low Battery | N/A | N/A | No | N/A |
| - Voltage/Curr
ent Level | Voltage | Yes | Proportional Voltage
level indicator | Similar to the
Predicate and
Reference
Controlled/displayed
via GUI |
| - Timer Range
(minutes) | 1-99 min | None | 5 min | Similar to Predicate
and Reference |
| Parameter | Legend Pro DMA | Principal
Predicate Device | Reference Device | Same/
Similar/Different |
| 510(k) Number | K200545 | K182440 | K152420 | |
| Device Name
and Model | Legend Pro DMA | Body System | AK Body Toning
Device | N/A |
| Compliance with
Voluntary
Standards? | Yes
IEC60601-1
IEC60601-1-2
IEC60601-2-10
IEC62304
ISO 10993 | Yes
Electrical Safety:
Comply with IEC
60601-1 and IEC
60601-2-10
EMC: Comply with
IEC 60601-1-2
Biocompatibility:
ISO10993-5 and
ISO10993-10 | Yes
IEC 60601-1
IEC 60601-1-2
UL 60601-1 (2003)
CSA C22.2 No. 601.1
IEC 60601-2-10 | Similar to Predicate
and Reference. |
| Compliance with
21 CFR 898 | Yes | Yes | N/A (electrodes are
integral with the device,
there are no separate
leads) | Compliant with 60601-
1 |
| Weight (lbs., oz.) | ~30 Kg; 66 lbs | Not publicly
available | 800 g | N/A |
| Dimensions (in.)
[W x H x D] | 45 x 110 x 45 cm
17.7 x 43.3 x 17.7 in | Not publicly
available | 3.12 x 3.51x 7.0 (IN) | N/A |
| Housing
Materials and
Construction | Metal, Plastics | Aluminium | ABS | N/A |
Summary of Technological Characteristics
5
6
7
OUTPUT SPECIFICATIONS
| Parameter | Legend Pro DMA | Principal
Predicate Device | Reference Device | Similar/Different |
|-----------------------------------------------------------------|--------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K200545 | K182440 | K152420 | |
| Device Name and
Model | Legend Pro DMA™ | Body System | AK Body Toning
Device | N/A |
| Waveform (e.g.,
pulsed
monophasic,
biphasic) | Biphasic | Biphasic | Monophasic | Similar to Predicate
and different from
Reference |
| Shape (e.g.,
rectangular,
spike, rectified
sinusoidal) | Rectangular | Rectangular | Rectangular | Similar to Predicate
and Reference |
| Maximum Output
Voltage (volts) (+/-
10%) | 60V@500Ω
3.95VRMS@500Ω | 58V@500 Ω
VRMS not publicly available
but not higher than 10VRMS
to meet 60601-2-10 | 10.4V@500Ω
VRMS not publicly available
but not higher than 10VRMS
to meet 60601-2-10 | Similar to Predicate |
| | 200V@2000Ω
12.3VRMS@2000Ω | 88V@2000Ω
VRMS not publicly
available | 35.6V@2000Ω
VRMS not publicly
available | Different from
predicate but not
higher than 10VRMS
@500 Ω
to meet 60601-2-10 |
| | 360V@10000Ω
17.6VRMS@10000Ω | Not publicly available | 88.0V@10000Ω
VRMS not
publicly
available | Predicate information
not publicly
available. Different
from reference but
not higher than
10VRMS @500 Ω
to meet 60601-2-10 |
8
| Parameter | Legend Pro DMA | Principal
Predicate Device | Reference Device | Similar/Different |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------|-------------------------------------------------------------------------------------------|
| 510(k) Number | K200545 | K182440 | K152420 | |
| Device Name and
Model | Legend Pro DMA™ | Body System | AK Body Toning
Device | N/A |
| Maximum Output
Current (mA@ Ω)
(+/- 10%) | 120mA@500Ω | 108mA@500 Ω | 22 mA@500Ω | Similar to the
predicate |
| | 100mA@2000Ω | Not publicly available | 18 mA@2000Ω | Predicate information
not publicly available |
| | 36mA@10000Ω | Not publicly available | 9mA@10000Ω | Predicate information
not publicly available |
| Pulse Width
(µsec) | 20 to 400 µsec | 500 to 2500 µsec | 1000 µsec | Different from
predicate but does
not raise issues of
safety or
effectiveness |
| Phase duration | 10 to 200 µsec | Not publicly available | Not publicly available | N/A |
| Frequency (Hz) | 0.78, 1.56, 3.13, 6.25;
12.5 Hz | 200 to 1200 Hz | 75 Hz | Different from
Predicate, similar to
Reference |
| Net Charge
(microcoulombs
(µC) per pulse)
(If zero, state
method of
achieving zero net
charge.) | 0 @ 500Ω
biphasic waveform
Zero net charge is
achieved by
symmetrical
biphasic
waveforms | 0 @ 500 Ω
Zero net charge is
achieved by using
symmetrical
biphasic
waveforms | 22.5 µC @500Ω | Similar to Predicate |
| Maximum charge
per Phase, (µC) | 24µC @ 500Ω
@12.5Hz | 45 µC @ 500 Ω @
200 Hz | 22.5 µC @500Ω | Similar to Predicate
and Reference |
| Maximum Current
Density, (mA/cm²) | 1.1mA/cm² @ 500Ω | 5 mA / cm² | 4.17 mA/cm² @500Ω | Similar to Predicate
and Reference |
| Maximum Power
Density (W/cm²), | 0.0044 W/cm² @
500Ω | 0.012 W/cm² | 0.0089W/cm² @
500Ω | Similar to Predicate
and Reference |
| Burst Mode (i.e.,
pulse trains): | N/A no burst mode | Not publicly available | N/A, no burst mode | Similar to Reference |
9
Substantial Equivalence
The Legend Pro DMA shares with its principal predicate, the Body System (K182440), exactly the same intended use:
Legend Pro DMA is substantially equivalent to another legally marketed device, the Body System (K182440). The subject device, Legend Pro DMA, has the same general intended use and similar indications, technological characteristics, and principles of operation as the previously cleared predicate, the Body System (K182440). The Legend Pro DMA, similarly, to the Body System, is an electrical Muscle Stimulator for prescription use with a biphasic rectangular waveform, is voltage regulated and uses similar underlying technology and performance envelope. In addition, the Legend Pro DMA, meets the same safety standards, including biocompatibility and electrical safety. Provided as a reference, the AK Body Toning Device (K152420) was also included in the comparison tables in order to support the mode of the energy application to the target, as it uses non-stationary electrodes, similar to the electrodes and applicators used in the Legend Pro DMA. Overall, these three systems have the same principle of operation, applying transcutaneous electrical muscle stimulation (EMS) through skin-contact electrodes, and they all share the same intended use.
Performance Data
The Legend Pro DMA has been tested to establish its safety and performance. The following design verification and validation processes were performed according to the FDA Guidance Document for Powered Muscle Stimulator 510(k)s Document issued on: June 9, 1999 and based on the Predicate device, the Body System, K182440:
- Risk analysis per ISO 14971 ●
- . Electrical, electromagnetic compatibility safety testing according to IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10.
- Software verification and validation according to IEC 62304 and FDA Guidance ● "Principles of Software Validation Guidance for Industry and FDA Staff, January 2002".
- Performance testing (e.g., energy measurements, including Output Waveforms).
- Reprocessing evaluation according to FDA's guidance "Reprocessing Medical ● Devices in Health Care Settings: Validation Methods and Labeling FDA Guidance (2015, Updated June 9, 2017)".
- . Biocompatibility evaluation according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing with a Risk Management Process, September 2020 and "Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin DRAFT", October 2020
10
Clinical Testing
Not applicable.
Conclusion
Based on the intended use/Indications for use, design, materials, principle of operation, energy used and materials, the Legend Pro DMA is substantially equivalent to the legally marketed predicate device the Body System (K182440). The non-clinical performance data according to the FDA Guidance Document for Powered Muscle Stimulator 510(k)s Document issued on June 9, 1999, supports the substantial equivalence and includes an analysis of output waveforms.