(125 days)
Not Found
No
The description focuses on automated feedback mechanisms based on temperature and impedance, which is a form of control system, not necessarily AI/ML. There is no mention of learning, training data, or complex pattern recognition typically associated with AI/ML in the provided text.
Yes.
The device description indicates its use in medical procedures for soft tissue coagulation, contraction, and hemostasis, which are therapeutic actions.
No
Explanation: The device description states its purpose is for "coagulation/contraction of soft tissue or hemostasis," which are therapeutic actions, not diagnostic. It generates RF energy and monitors tissue for treatment, not for identifying a condition or disease.
No
The device description explicitly states it consists of hardware components including an AC/DC power supply unit, RF generator, controller, user interface with touch screen, RF handpiece, cable, foot switch, and disposable handpieces with electrodes. This is not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed." This describes a procedure performed directly on a living patient's tissue, not on samples taken from the body.
- Device Description: The device generates RF energy and interacts directly with "target treatment tissue." This is consistent with an in-vivo (within a living organism) procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are designed to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the InMode RF System, as described, is a surgical device used for in-vivo procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The InMode RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.
Product codes
GEI
Device Description
The InMode RF System is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.
The InMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the handpiece. Multiple handpieces are available, all comprised of a disposable, single use plastic handle with active internal electrodes. A subset of handpieces have both internal (active) and external (return) electrodes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dermatological and general surgical procedures
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
The InMode RF System underwent performance testing, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2 and IEC 60601-2-2.
Comparative ex vivo tissue study results demonstrate the safety and efficacy of thermal effects of the new handpieces on three different tissue types, muscle, liver, and fat.
Bench testing shows that RF frequency and output of the new handpieces is as predicted with respect to RF specifications (waveform, amplitude, frequency, crest factor).
These performance tests demonstrated that the device's performance and specifications meet the system requirements.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
July 24, 2024
InMode Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103
Re: K240780
Trade/Device Name: InMode RF System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: March 21, 2024 Received: June 27, 2024
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 (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/cdrb/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" (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).
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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 820.70) 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,
Long H. Chen -S Digitally signed by Long H.Chen-S
Date: 2024.07.24 15:29:27 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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K240780
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
InMode RF System
Indications for Use (Describe)
The InMode RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY InMode Ltd.'s InMode RF System
Submitter's Name and Contact Information
InMode Ltd. Tabor Building, Shaar Yokneam POB 44 Yokneam Illit 2069200 Israel
Phone: +972-4-9097470 Email: Francis-Najjar@inmodemd.com Contact Person: Mrs. Suhair Francis
Date Prepared: March 21, 2024
Name of Device
InMode RF System
Name/Address of Sponsor
InMode Ltd. Tabor Building, Shaar Yokneam POB 44 Yokneam Illit 2069200 Israel
Classification Name: Electrosurqical cutting and coagulation device and accessories
Regulation Number: 878.4400
Product Code: GEI
Predicate Devices
K233642 - InMode RF System - Product Code: GEI
Intended Use / Indications for Use
The InMode RF System is indicated for use in dermatological and general surgical procedures where coaqulation/contraction of soft tissue or hemostasis is needed.
Technological Characteristics
The InMode RF System is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.
The InMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the handpiece. Multiple handpieces
4
are available, all comprised of a disposable, single use plastic handle with active internal electrodes. A subset of handpieces have both internal (active) and external (return) electrodes.
Substantial Equivalence
Indications for Use Comparison
The indications for use of the InMode RF System are identical to the indications for use of the FDA-Cleared InMode RF System (K233642).
Technological Comparison
The technological characteristics of the InMode RF System are substantially equivalent to the technological characteristics of the FDA-Cleared InMode RF System (K233642).
The design and components in the InMode System, including the console (with power supply, RF generator. controller and display panel) and the handpieces (with cable, connector to console, handle and RF energy delivering electrodes) are similar to the design and components found in the predicate. The safety features and compliance with safety standards in the modified InMode RF System are also similar to the safety features and compliance with safety standards found in the predicate device. Patient contact materials are also identical.
The cleared InMode RF System is compatible with the following handpieces: HP060909A; HP101306A; HP172206A; HP172246A; HP172248A; HP102206A, and HP253966A. The modified InMode RF System includes the addition of two new handpieces: HP1022B6A and HP2539B6A. No changes are made to the already cleared handpieces. The fundamental technology of the system is not altered. The new handpieces use the same technology and similar principles of operation and have the same power density as the already cleared device. The new handpieces are bipolar handpieces which have 2 active internal electrodes, and no external return electrodes. In addition the new handpieces allow the control of the thermal effect by selection of delivered amount of energy.
Any modifications in the technological characteristics do not raise new safety or effectiveness concerns.
Non-Clinical and/or Clinical Tests Summary & Conclusions
The InMode RF System underwent performance testing, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2 and IEC 60601-2-2.
Comparative ex vivo tissue study results demonstrate the safety and efficacy of thermal effects of the new handpieces on three different tissue types, muscle, liver, and fat.
Bench testing shows that RF frequency and output of the new handpieces is as predicted with respect to RF specifications (waveform, amplitude, frequency, crest factor).
These performance tests demonstrated that the device's performance and specifications meet the system requirements.
Consequently, it can be concluded that the InMode RF System is substantially equivalent to the predicate InMode RF System, FDA cleared in K233642, and may, therefore be legally marketed in the USA.