(143 days)
K210877 Inmode's Evolve System with T3 Applicator
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on RF and EMS-TENS technology controlled by user preprogramming and treatment settings.
Yes
The device is described as treating multiple medical conditions, including pain relief, muscle relaxation, muscle re-education, and increasing blood circulation, which are all therapeutic purposes.
No
The device is intended for therapeutic purposes, such as pain relief, muscle treatment, and fat reduction, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components including an LCD display, power supply, real-time controller, RF generators, and fans. While software controls the system, it is an integral part of a larger hardware system that delivers RF and EMS-TENS energy.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Evolve System with the Transform Applicator uses RF and EMS-TENS technology applied externally to the body for therapeutic purposes (pain relief, muscle stimulation, fat reduction). It does not analyze samples taken from the body.
- Intended Use: The stated intended uses are all related to external physical treatments and not diagnostic testing of biological samples.
Therefore, the device described is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Evolve System with the Transform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions.
The Transform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The Transform Applicator in EMS mode is intended for:
- . Relaxation of muscle spasms
- . Prevention or retardation of disuse atrophy
- . Increasing local blood circulation
- . Muscle re-education
- . Maintaining or increasing range of motion
- . Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
The Transform Applicator in TENS mode is intended for:
- . Symptomatic relief and management of chronic, intractable pain
- . Post-surgical acute pain
- . Post-trauma acute pain
Additionally the Transform Applicator in sequential RF/EMS mode is intended for:
- . Non-invasive lipolysis (breakdown of fat) of the abdomen.
- Reduction in circumference of the abdomen
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Evolve System with the Transform Applicator is designed to deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The Evolve System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings. The subject device platform system is identical to the FDA-cleared Evolve System platform (K210877).
The Evolve System includes the following components:
- LCD display touch screen,
- Audio loudspeaker,
- 48V AC/DC power supply,
- Real time controller, distributor card and 2 RF generators, .
- . Fans
The System operates while connected to the Transform Applicator.
The purpose of this submission is to add non-invasive lipolysis (breakdown of fat) of the abdomen and reduction in circumference of the abdomen to the indications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen, calf muscles
Indicated Patient Age Range
Not Found
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)
A prospective, multi-site, single arm clinical study of 44 subjects was completed to demonstrate safety and efficacy of the Evolve System with Transform Applicators in circumference reduction. - Treatments of sequential bi-polar RF energy and EMS were performed in 3 sessions, two weeks apart from each other. Patients were evaluated at baseline (pre-treatment) and at follow-up visits at 1 and 3 months post-treatment.
Three distinct measurements were used to evaluate fat reduction: circumference measurement by measurement tape (primary endpoint), fat thickness caliper measurement, and fat layer ultrasound measurement. Each of these measures independently demonstrated reduction in fat, and findings were consistent and strongly correlated with each other.
Before and after 3 months photographs were assessed by three blinded evaluators. The success criteria for the percentage of subjects were met, with the correct identification rate exceeding 70%. Subjects rated comfort during treatment using the Therapy Comfort Questionnaire immediately after each of their three treatments. The average comfort scores for each timepoint were rated as between comfortable and indifferent during treatment. Comfort scores statistically significantly improved when comparing the initial and later treatments, suggesting that subjects either acclimated to the treatment over time or that subsequent treatments are less uncomfortable. The majority of subjects were satisfied with the results.
No serious adverse events were observed.
Overall, the findings of this study provide strong evidence for the safety and effectiveness of the system.
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.
K202199 BTL-899ST, K163415 Syneron Medical's SlimShape System
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.
K210877 Inmode's Evolve System with T3 Applicator
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 13, 2023
InMode Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K231495
Trade/Device Name: The Evolve System with the Transform Applicator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 12, 2023 Received: September 12, 2023
Dear Janice Hogan:
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
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.
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.10.13
15:16:56-04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known)
Device Name
The Evolve System with the Transform Applicator
Indications for Use (Describe)
The Evolve System with the Transform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions.
The Transform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The Transform Applicator in EMS mode is intended for:
- . Relaxation of muscle spasms
- . Prevention or retardation of disuse atrophy
- . Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion ●
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis ●
The Transform Applicator in TENS mode is intended for:
- Symptomatic relief and management of chronic, intractable pain
- . Post-surgical acute pain
- . Post-trauma acute pain
Additionally the Transform Applicator in sequential RF/EMS mode is intended for:
- . Non-invasive lipolysis (breakdown of fat) of the abdomen.
- Reduction in circumference of the abdomen ●
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
InMode's Evolve System with the Transform Applicator
Submitter
InMode Ltd. Address: Tabor Building, Shaar Yokneam Yokneam 2069200 lsrael Tel: +972-4-9097470 Fax: +972-4-9097471 Contact Person: Suhair Francis-Najjar Date Prepared: May 14, 2023
Name of Device: The Evolve System with the Transform Applicator
Common or Usual Name: Electrosurgical, Cutting & Coagulation Device & Accessories
Classification Name: 21 CFR 878.4400 Electrosurgical, Cutting & Coagulation Device & Accessories
Regulatory Class: Class II
Product Code: GEI
Predicate Devices
K202199 BTL-899ST K163415 Syneron Medical's SlimShape System
Reference Devices
K210877 Inmode's Evolve System with T3 Applicator
Device Description
The Evolve System with the Transform Applicator is designed to deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The Evolve System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings. The subject device platform system is identical to the FDA-cleared Evolve System platform (K210877).
The Evolve System includes the following components:
- LCD display touch screen, ●
- Audio loudspeaker,
- 48V AC/DC power supply, ●
- Real time controller, distributor card and 2 RF generators, .
- . Fans
5
The System operates while connected to the Transform Applicator.
The purpose of this submission is to add non-invasive lipolysis (breakdown of fat) of the abdomen and reduction in circumference of the abdomen to the indications.
Intended Use / Indications for Use
The Evolve System with the Transform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions.
The Transform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The Transform Applicator in EMS mode is intended for:
- . Relaxation of muscle spasms
- . Prevention or retardation of disuse atrophy
- . Increasing local blood circulation
- . Muscle re-education
- . Maintaining or increasing range of motion
- . Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
The Transform Applicator in TENS mode is intended for:
- . Symptomatic relief and management of chronic, intractable pain
- . Post-surgical acute pain
- . Post-trauma acute pain
Additionally the Transform Applicator in sequential RF/EMS mode is intended for:
- . Non-invasive lipolysis (breakdown of fat) of the abdomen.
- Reduction in circumference of the abdomen
Summary of Technological Characteristics
The subject of this 510(k) submission is the expansion of indications for use for the Evolve System with the Transform Applicator to include non-invasive lipolysis (breakdown of fat) of the abdomen. There are no physical changes to the device since its clearance in K210877 which includes both bipolar radiofrequency (RF) / Electrical Muscle Stimulation (EMS) treatment modes. There have been minor software changes to allow the delivery of a sequential RF/EMS for non-invasive lipolysis treatment. Importantly, the parameters of the
6
delivered RF or EMS pulse are unchanged, the only change is that the treatments are automatically delivered sequentially.
With respect to the proposed additional indication (non-invasive lipolysis of the abdomen; reduction in circumference of the abdomen), the Evolve System with the Transform Applicator is substantially equivalent to the primary predicate device BTL-899ST (K202199) by BTL and the additional predicate device, SlimShape System (K163415) by Syneron Medical. BTL-899ST is selected as primary predicate, as it similarly supplies RF/EMS to achieve noninvasive lipolysis. SlimShape (K163415) is selected as an additional predicate as its RF treatment parameters closely resemble those used by the subject device. The system is also physically identical to the reference device, Evolve System with T3 Applicator cleared in K210877 (aside from minor software changes). A substantial equivalence chart comparing the similarities and differences between the Transform System and its predicate devices is provided below. None of the minor differences in technological features from the predicates raise any new safety or effectiveness questions, and clinical data confirms that these differences do not adversely impact safety or effectiveness.
Performance Data
Updated software documentation was supplied to support the minimal changes to software.
A prospective, multi-site, single arm clinical study of 44 subjects was completed to demonstrate safety and efficacy of the Evolve System with Transform Applicators in circumference reduction. - Treatments of sequential bi-polar RF energy and EMS were performed in 3 sessions, two weeks apart from each other. Patients were evaluated at baseline (pre-treatment) and at follow-up visits at 1 and 3 months post-treatment.
Three distinct measurements were used to evaluate fat reduction: circumference measurement by measurement tape (primary endpoint), fat thickness caliper measurement, and fat layer ultrasound measurement. Each of these measures independently demonstrated reduction in fat, and findings were consistent and strongly correlated with each other.
Before and after 3 months photographs were assessed by three blinded evaluators. The success criteria for the percentage of subjects were met, with the correct identification rate exceeding 70%. Subjects rated comfort during treatment using the Therapy Comfort Questionnaire immediately after each of their three treatments. The average comfort scores for each timepoint were rated as between comfortable and indifferent during treatment. Comfort scores statistically significantly improved when comparing the initial and later treatments, suggesting that subjects either acclimated to the treatment over time or that subsequent treatments are less uncomfortable. The majority of subjects were satisfied with the results.
No serious adverse events were observed.
Overall, the findings of this study provide strong evidence for the safety and effectiveness of the system.
7
Conclusions
The Evolve System with the Transform Applicator is as safe and effective as the predicate devices. The Evolve System with the Transform Applicator has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Evolve System with the Transform Applicator and its predicate devices raise no new issues of safety or effectiveness. Clinical data demonstrate that the Evolve System with the Transform Applicator is as safe and effective as the predicates. Thus, the Evolve System with the Transform Applicator is substantially equivalent.
| Full name and
510(k) number | The Evolve System
with the Transform
Applicator | The SlimShape
System | BTL-899ST | Comparison |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K163415 | K202199 | |
| Device Class | II | II | II | Same |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| Product Code | GEI | GEI | GEI | Same |
| Intended Use/
Indications for Use | The Transform Applicator
in sequential RF/EMS
mode is intended for:
for non-invasive
lipolysis (breakdown
of fat) of the
abdomen. for reduction in
circumference of the
abdomen. | The SlimShape System
is indicated for non-
invasive lipolysis
(breakdown of fat) of
the abdomen. The
device is
indicated for reduction
in circumference of the
abdomen. | BTL-899ST is
indicated to be used
for:
Non-invasive lipolysis
(breakdown of fat) of
the abdomen. Reduction in
circumference of the
abdomen. Non-invasive lipolysis
(breakdown of fat) of
the thighs. Reduction in
circumference of the
thighs. | Same intended use.
Same indications as
SlimShape.
Same indications as a subset
of the indications of the BTL. |
| User Population (Skin
Type) | No restrictions in skin
type | No restrictions in skin
type | BTL-899ST is intended
for use with Skin Type
I, II and III. | BTL is not indicated for use in
Skin Types darker than III.
This limitation of the predicate
is due to technological
factors, and any risks are
mitigated in the subject
device. |
| Full name and
510(k) number | The Evolve System
with the Transform | The SlimShape
System | BTL-899ST | Comparison |
| | Applicator | K163415 | K202199 | |
| System Components | Energy generators,
Applicators,
Computer for
controlling the System console
(touch screen) | Energy generators,
Applicators,
Computer for
controlling the system's output
System console
(touch screen) | Energy
generators,
Applicators,
Computer for
controlling the system's output
System console
(touch screen) | Same |
| Applicator Design | Hand-free applicators
fixed by a fixation belt | Hand-free applicators
fixed by a fixation belt | Hand-free applicators
fixed by a fixation belt | Same |
| Selection of
Parameters (Intensity,
Time) by the User | Yes | Yes | Yes | Same |
| Principles of Operation | User applies desired
variable amounts of
energy to the patient until
the tissue is heated,
while monitoring the
degree of heating and
any adverse reaction on
the patient's skin. | User applies desired
variable amounts of
energy to the patient
until the tissue is
heated, while
monitoring the degree
of heating and any
adverse reaction on the
patient's skin. | User applies desired
variable amounts of
energy to the patient
until the tissue is
heated, while
monitoring the degree
of heating and any
adverse reaction on
the patient's skin. | Same |
| Skin Temperature
Monitoring | Yes | Yes | Yes | Same |
| STOP Button for
Patient | Yes | Yes | Yes | Same |
| Basic Technology | The system combines
bipolar radiofrequency
with electric muscle
stimulation | The system combines
bipolar radiofrequency
with mechanical
suction. | The system combines
bipolar radiofrequency
with electric muscle
stimulation | All systems are based on
bipolar RF energy
delivery.
The additional energy
applied is different in
SlimShape (vacuum; the
absence of this feature in
the subject device does
not raise any new risks).
The application of EMS
in the subject device is
similar to BTL. In
addition, safety is
supported by clinical
studies. |
| Sterility | Not Sterile | Not Sterile | Not Sterile | Similar |
| Single/Multiple Use | Multiple use | Multiple use | Multiple use | Similar |
InMode's Transform System Substantial Equivalence Chart
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