(129 days)
No
The summary describes a computerized RF device for electrocoagulation and hemostasis, but there is no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
Yes
The device is described as "intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis," which are medical procedures for therapeutic purposes.
No
The device is described as an RF technology-based device intended for dermatological and general surgical procedures for electrocoagulation and hemostasis, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly details hardware components such as an AC/DC power supply unit, RF generator, controller, user interface with LCD touch screen, applicators, cable, foot switch, and disposable electrode pins. This indicates it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis." This describes a procedure performed directly on the patient's body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The device description details a system that delivers radiofrequency energy to the skin via electrodes. This is a therapeutic or surgical device, not a diagnostic device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, urine, or any other biological sample. The device's function is to apply energy to the skin for therapeutic/surgical 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.
N/A
Intended Use / Indications for Use
The InMode System with the Fractora3D/3D-90 Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis.
At higher energy levels greater than 62 m./pin, use of the FRF applicator is limited to Skin Types I-IV.
Product codes
GEI
Device Description
The InMode System with the Fractora3D/3D-90 Applicators is a computerized, programmed, RF technology based device intended for dermatological applications which requires skin electrocoagulation and hemostasis.
The device platform is basically constituted on the same system platform as FDA cleared for InMode FRF Applicator (K151273). The InMode System with the Fractora3D/3D-90 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Fractora3D/3D-90 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multielectrode pins. The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters.
The InMode System with the Fractora3D/3D-90 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Fractora3D/3D-90 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises a disposable, single use, 24 electrode pins tip.
Following are the InMode System with the Fractora3D/3D-90 Applicators specifications:
RF Max Output Power: 65 Watt RF Output Frequency: 1[MHz] ± 2% Dimension: 46cm W x 46cm D x 100cm H (18.2'' W x 18.2'' D x 40'' H) Weight: 30 Kg (66 lbs.) Main Line Frequency (nominal): 50-60 Hz Input Voltage (nominal): 100-240 VAC
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dermatological and General Surgical procedures. Prescription Use.
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 bench tests were performed to measure the accuracy and consistency of the RF output parameters of the InMode System and compare them to the specific design requirements and to the RF output parameters of the predicate device. The results of the bench tests demonstrate that the InMode System complies with the design requirements and consists of similar RF output specifications as the predicate device and therefore, is substantially equivalent to the predicate device.
The thermal effects of the InMode System with the Fractora3D/3D-90 Applicators and tissue healing process were evaluated in a preclinical study. The study was conducted on porcine model and included a single RF treatment followed by histology analysis performed immediately, 7, 14 and 21 days post treatment. The animal study results show that the InMode System with the Fractora3D/3D-90 Applicators are safe for use and effective in achieving the specified indications of dermatological and general electrocoagulation and hemostasis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K102461, K082451, K142438, K151019, K081365
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 1, 2018
InMode MD Ltd. % Amit Goren Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 44425 Israel
Re: K180189
Trade/Device Name: InMode System with Fractora3D/3D-90 Applicators Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: May 1, 2018 Received: May 4, 2018
Dear Amit Goren:
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. 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.
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); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K180189
Device Name
InMode System with the Fractora3D/3D-90 Applicators
Indications for Use (Describe)
The InMode System with the Fractora3D/3D-90 Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis.
At higher energy levels greater than 62 m./pin, use of the FRF applicator is limited to Skin Types I-IV.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY INMODE SYSTEM WITH THE FRACTORA3D/3D-90 APPLICATORS
510(k) Number K180189
Applicant Name:
| Company Name: | InMode MD Ltd. |
|---|---|
| Address: | Tabor Building, Shaar Yokneam |
| Yokneam 20692 | |
| Israel | |
| Tel: +972-4-9097470 | |
| Fax: +972-4-9097471 | |
| E-mail: amit@asteinrac.com |
Contact Person:
Official Correspondent: Amit Goren
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
|---|---|
| Address: | 20 Hata'as Str., Suite 102 |
| Kfar Saba 44425 | |
| Israel | |
| Tel: | +972-9-7670002 |
| Fax: | +972-9-7668534 |
| E-mail: | amit@asteinrac.com |
| Date Prepared: | April 29, 2018 |
| Trade Name: | InMode System with the Fractora3D/3D-90 Applicators |
| Classification Name: | CFR Classification section 878.4400; (Product code GEI) |
| Classification: | Class II Medical Device |
Predicate Device:
The InMode System with the Fractora3D/3D-90 Applicators is substantially equivalent to the following predicate device;
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| EndyMed Medical Ltd. | Intensif Applicator | K130501 |
| InMode MD Ltd. | InMode FRF Applicator | K151273 |
4
Fractora3D/3D-90 Applicators 510(k) file Section 5 - 510(k) Summary
Page 2 of 5
Device Description:
The InMode System with the Fractora3D/3D-90 Applicators is a computerized, programmed, RF technology based device intended for dermatological applications which requires skin electrocoagulation and hemostasis.
The device platform is basically constituted on the same system platform as FDA cleared for InMode FRF Applicator (K151273). The InMode System with the Fractora3D/3D-90 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Fractora3D/3D-90 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multielectrode pins. The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters.
The InMode System with the Fractora3D/3D-90 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Fractora3D/3D-90 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises a disposable, single use, 24 electrode pins tip.
Following are the InMode System with the Fractora3D/3D-90 Applicators specifications:
RF Max Output Power: 65 Watt RF Output Frequency: 1[MHz] ± 2% Dimension: 46cm W x 46cm D x 100cm H (18.2'' W x 18.2'' D x 40'' H) Weight: 30 Kg (66 lbs.) Main Line Frequency (nominal): 50-60 Hz Input Voltage (nominal): 100-240 VAC
Intended Use/Indication for Use:
The InMode System with the Fractora3D/3D-90 Applicators is intended for use in Dermatologic and General Surgical procedures for Electrocoagulation and Hemostasis. At higher energy levels greater than 62 m]/pin, use of the FRF applicator is limited to Skin Types I-IV. Performance Standards:
The InMode System with the Fractora3D/3D-90 Applicators has been tested and complies with the following voluntary recognized standards:
- AAMI/ANSI 60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R)2012 And ● A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, Mod).
- IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment Part 1-2: ● General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
5
Fractora3D/3D-90 Applicators 510(k) file Section 5 - 510(k) Summary
- IEC 60601-2-2 Edition 5.0 2009-02, Medical Electrical Equipment Part 2-2: ● Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories.
Non-Clinical (Bench) Performance Data:
Performance bench tests were performed to measure the accuracy and consistency of the RF output parameters of the InMode System and compare them to the specific design requirements and to the RF output parameters of the predicate device. The results of the bench tests demonstrate that the InMode System complies with the design requirements and consists of similar RF output specifications as the predicate device and therefore, is substantially equivalent to the predicate device.
Animal Performance Data / Histology Data:
The thermal effects of the InMode System with the Fractora3D/3D-90 Applicators and tissue healing process were evaluated in a preclinical study. The study was conducted on porcine model and included a single RF treatment followed by histology analysis performed immediately, 7, 14 and 21 days post treatment. The animal study results show that the InMode System with the Fractora3D/3D-90 Applicators are safe for use and effective in achieving the specified indications of dermatological and general electrocoagulation and hemostasis.
Clinical Performance Data:
Not Applicable
Biocompatibility
All device materials which come in direct contact with the patient skin are biocompatible. The following 510(k)s were mentioned as reference devices for Biocompatibility determination: K102461, K082451, K142438, K151019 and K081365.
Substantial Equivalence:
A comparison table is provided below comparing the intended use and basic technological characteristics of the InMode System with the Fractora3D/3D-90 Applicators to the intended use and basic technological characteristics of the predicate devices.
6
| Fractora3D/3D-90 Applicators 510(k) file |
|---|
| Section 5 - 510(k) Summary |
| Technological
Characteristic | InMode System
with the
Fractora3D/3D-
90 Applicators
InMode MD Ltd.
(Subject Device) | Intensif
Applicator
EndyMed
Medical Ltd.
K130501
(Main Predicate) | InMode FRF
Applicator
InMode MD Ltd.
K151273
(Reference
Predicate) |
|------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Dimensions | 46cm W x 46cm D
x 100cm H | 30cm W x 19cm D
x 115cm H | 46cm W x 46cm D
x 100cm H |
| | [18.2" W x 18.2"
D x 40" H] | [12" W x 8" D x
45" H] | [18.2" W x 18.2"
D x 40" H] |
| Weight
Platform weight
Applicator weight | 30 Kg (70.4 lbs.)
0.4 Kg (0.88 lbs.)
Tip weight - 0.02
Kg | 33 Kg (72.6 lbs.)
0.28 Kg (0.62 lbs.) | 30 Kg (70.4 lbs.)
0.22 Kg (0.5 lbs.)
Tip weight - 0.02
Kg |
| Applicator
Dimensions: | Applicator
Footprint Area:
1.6cm x 1.2cm | Applicator
Footprint Area:
1.1cm x 1.1cm | Applicator
Footprint Area:
1.6cm x 1.2cm |
| | Applicator needles
field area:
0.95cm X 1.1 cm | | Applicator needles
field area:
0.9cm X 1.2 cm |
| | Maximum volume
of treatment :
16mm x 12mm x
4.0mm | Maximum volume
of treatment :
11mm x 11mm x
3.5mm | Maximum volume
of treatment:
16mm x 12mm x
2.5mm |
| Number of pins | 24 pins | 25 pins | 24 pins |
| Maximal Treatment
depth | 4.0mm | 3.5mm | 2.5mm |
| Cable Dimensions: | 250 cm | idem | idem |
| Performance | Frequency: 1 MHz
Maximal RF
output power:
65W
Maximal pulse
duration: up to
74msec | Frequency: 1 MHz
Maximal RF
output power: 25W
Maximal pulse
duration: up to
200msec | Frequency: 1 MHz
Maximal RF
output power: 65W
Maximal pulse
duration: up to
74msec |
| Standards Met | IEC 60601-1
IEC 60601-1-2 | idem | idem |
| Technological
Characteristic | InMode System
with the
Fractora3D/3D-
90 Applicators
InMode MD Ltd.
(Subject Device) | Intensif
Applicator
EndyMed
Medical Ltd.
K130501
(Main Predicate) | InMode FRF
Applicator
InMode MD Ltd.
K151273
(Reference
Predicate) |
| | ANSI AAMI
60601-2-2 for
safety of high
frequency surgical
equipment | | |
7
Fractora3D/3D-90 Applicators 510(k) file Section 5 - 510(k) Summary
Comparison Discussion:
The indications for use and technological characteristics of the InMode System with the Fractora3D/3D-90 Applicators are substantially equivalent to the indications for use and technological characteristics of the EndyMed Intensif Applicator.
The design and components in the InMode System, including the console (with power supply, RF generator, controller and display panel) and the hand piece Applicator (with cable, connector to console, handle and tip) are similar to the design and components found in the predicate Endymed Intensif System. The performance specifications (including RF frequency, pulse duration and RF energy per pin) of the InMode System were shown to be similar and yielded similar RF energy per pin values to those of the EndyMed Intensif Applicator. The safety features and compliance with safety standards in the InMode System with the Fractora3D/3D-90 Applicators are similar to the safety features and compliance with safety standards found in the predicate device. Patient contact materials are also similar. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the new InMode System with the Fractora3D/3D-90 Applicators 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 bench testing and animal preclinical testing to evaluate the thermal effect of the device and the tissue healing process. These performance tests demonstrated that the minor differences in the device design and specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Consequently, it can be concluded that the InMode System with the Fractora3D/3D-90 Applicators are substantially equivalent to the predicate EndyMed Intensif Applicator, FDA cleared in 510(k) K130501, and therefore, may be legally marketed in the USA.