(84 days)
The InMode RF Multi-System with the Non-invasive Applicators employs RF energy for various applications:
•Forma (Plus). Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
•WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids.
•BodyFX™ (WMBody)/MimiFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.
The InMode RF Multi-System with the Fractional Applicators employs RF energy for various applications:
•Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin.
•Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV
•Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV
The InMode RF Multi-System supports multiple radiofrequency (RF) applications and accessories. The InMode RF Multi-System is compatible with the Fractional RF Applicators and the Non-Invasive RF Applicators, and employs RF energy for various applications.
The InMode RF Multi-System consists of platform console with an AC/DC power supply unit, two applicator connectors, RF generator, RF measuring circuit, controller, footswitch and user interface including a touch screen. The RF Applicator is connected to the console via a cable and a footswitch activates the energy delivery to the applicator. The applicators are comprised of a handle and electrodes, and some of them are used with a single-use tip.
This 510(k)-file submission includes all the FDA-Cleared applicators under one submission with the RF-supporting console, as cleared in K182325, compatible with all applicators.
The below list comprises the set of applicators to be registered under the subject device:
- . Non-Invasive RF Applicators:
- Forma (Plus) O
- Plus (Plus Plus) O
- Plus90 O
- WMface O
- BodyFXTM (WMBody) O
- MiniFX™ O
- Fractora O
- 24 pins tip (FRF) -
- -60 pins tip
- Morpheus8™M O
- 12 pins tip (Prime Tip) ।
- 24 pins tip (Fractora 3D) -
- 40 pins tip (Body Tip) -
- -T tip
This document describes a 510(k) premarket notification for the InMode RF Multi-System. It aims to demonstrate substantial equivalence to previously cleared predicate devices. The information provided heavily focuses on bench performance data (electrical safety, EMC, software V&V) and comparison to predicate devices, rather than clinical performance data with specific acceptance criteria directly tied to efficacy on patients.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set information is not detailed in this document in the typical format one would expect for a clinical performance study demonstrating direct efficacy on patients for specific indications.
The document states "Clinical Performance Data: Non-Applicable" and "Animal Performance Data / Histology Data: Non-Applicable". This indicates that the substantial equivalence determination for this device largely relies on similarities in design, materials, and compliance with general electrical and safety standards, rather than new clinical trials demonstrating performance against specific clinical efficacy metrics.
However, based on the provided text, I can infer the acceptance criteria and how the device proves it meets those criteria in the context of a 510(k) submission, which focuses on substantial equivalence to existing devices.
Here's an interpretation based on the provided document:
Acceptance Criteria and Device Performance (in the context of Substantial Equivalence)
The primary acceptance criterion for a 510(k) submission, especially when clinical data is "Non-Applicable," is demonstrating substantial equivalence to existing legally marketed predicate devices. This means that the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance (as demonstrated by the study) |
|---|---|
| I. Functional and Technical Equivalence | |
| 1. Intended Use / Indications for Use Equivalence | The InMode RF Multi-System has substantially equivalent indications for use as the predicate devices. The non-invasive applicators are for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, non-invasive treatment of mild to moderate facial wrinkles and rhytids, and temporary reduction in the appearance of cellulite. The fractional applicators are for dermatological procedures requiring ablation and resurfacing of the skin, and for dermatological and general surgical procedures for electrocoagulation and hemostasis (with specific energy level limitations for skin types I-IV). These mirror the predicate devices' claims. |
| 2. Technological Characteristics Equivalence | The device employs RF energy, similar to predicates. Key specifications like RF Output Frequency (1 MHz), Input Voltage, Main Line Frequency, Dimensions, and Weight are identical or comparable to the main predicate (K182325). The maximum RF output power for the multi-system (65W) is higher than the main predicate (40W), but the individual applicators maintain similar or identical max RF energy levels to their specific reference predicates (e.g., Fractional applicator max energy levels are similar to K102461, K151273, K192695, K200947; Non-invasive applicator max output powers are similar to K131362, K140926, K160329, K172302). Minor design modifications were made to support all applicators, mainly in software. |
| II. Safety and Performance Compliance | |
| 1. Electrical Safety | The device complies with IEC 60601-1 and IEC 60601-2-2 standards. Test certificates and reports were provided. |
| 2. Electromagnetic Compatibility (EMC) | The device complies with IEC 60601-1-2 standard. Test certificates and reports were provided. |
| 3. Usability | The device complies with IEC 60601-1-6 (Usability) standard. |
| 4. Software Verification and Validation (V&V) | Software V&V testing was conducted as per FDA guidance. The software was deemed a "major" level of concern, and documentation was provided to demonstrate its safety. User interface was slightly changed to support all applicators. |
| 5. Biocompatibility | All patient-contacting materials are stated to be biocompatible, similar to predicate devices. |
| 6. Sterility | All fractional tips are Gamma-sterilized. (Non-invasive applicators are "NA" for sterility). |
| 7. Reprocessing | Handles are to be reprocessed in accordance with user manual instructions; fractional tips are single-use. This aligns with predicate devices. |
| III. No New Questions of Safety/Effectiveness | The performance testing and comparison to predicate and reference devices demonstrate that minor differences do not raise new safety or effectiveness concerns. The device maintains device performance and safety due to the exact functionality and mechanism of operation. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set for efficacy. The "testing" here refers to bench testing for electrical safety, EMC, software V&V, and comparison of technical specifications. There are no explicit "test set" patient sample sizes mentioned for clinical performance, as the document states "Clinical Performance Data: Non-Applicable."
- Data Provenance: The data provenance is primarily from bench testing conducted by the manufacturer (InMode Ltd.) and external labs for standard compliance. The country of origin for the applicant is Israel. This is a premarket notification, indicating retrospective evaluation against regulatory standards and existing predicate devices, rather than prospective clinical data collection for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. Since the study is primarily focused on demonstrating substantial equivalence through bench testing, rather than establishing clinical ground truth for diagnostic or therapeutic accuracy, there is no mention of external experts or their qualifications for establishing ground truth in this context. The "ground truth" here is compliance with recognized safety and performance standards (e.g., IEC standards), which is assessed through defined test procedures.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data or images. This is not a human-reader study or a clinical trial requiring such adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improvement:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical Performance Data: Non-Applicable." This type of study is specifically designed to assess human reader performance, usually in diagnostics, often with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical RF energy system used by a human operator, not an AI algorithm. Its "performance" is its ability to deliver RF energy safely and effectively as designed, and to perform its indicated functions.
7. The Type of Ground Truth Used:
- The "ground truth" for this 510(k) submission is based on:
- Regulatory Standards: Compliance with recognized international standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-2).
- Bench Test Results: Data from electrical safety, EMC, and software verification and validation testing, which confirmed the device's technical specifications and adherence to design requirements.
- Comparison to Predicate Devices: The established safety and effectiveness of the legally marketed predicate devices serve as the "ground truth" for substantial equivalence. The new device is compared against the known characteristics and performance of these predicates.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a "training set" of data in the sense of machine learning. The device's functionality is based on established RF technology and engineering principles.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" in the machine learning sense. The device's design and operational parameters are based on scientific and engineering knowledge, informed by the specifications of previously cleared predicate devices.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the words "FDA U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the second line.
July 22, 2020
InMode Ltd. % Amit Goren Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 Israel
Re: K201150
Trade/Device Name: InMode RF Multi-System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, PBX, ISA, NUV Dated: April 22, 2020 Received: April 29, 2020
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. 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.
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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.
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 Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name InMode RF Multi-System
Indications for Use (Describe)
The InMode RF Multi-System with the Non-invasive Applicators employs RF energy for various applications:
•Forma (Plus). Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
•WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids.
•BodyFX™ (WMBody)/MimiFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.
The InMode RF Multi-System with the Fractional Applicators employs RF energy for various applications:
•Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin.
•Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
At higher energy levels greater than 62m!/pin, use of the applicator is limited to skin types I-IV
•Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62m.//pin, use of the 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)
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510(K) SUMMARY INMODE RF MULTI-SYSTEM
510(k) Number K201150
Applicant Name:
Company Name: Address:
InMode Ltd. 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 102Kfar Saba 4442500Israel |
| Tel: +972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-mail: amit@asteinrac.com | |
| Date Prepared: | July 21, 2020 |
| Trade Name: | InMode RF Multi-System |
Classification Regulation:
| Classification Name | Regulation No. | Product Code |
|---|---|---|
| Electrosurgical cutting andcoagulation device and accessories. | 878.4400 | GEI, PBX |
| Therapeutic massager. | 890.5660 | ISA |
| Laser surgical instrument for use ingeneral and plastic surgery and indermatology. | 878.4810 | NUV |
Classification: Class II Medical Device
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| Manufacturer | Device | 510(k) No. |
|---|---|---|
| Main Predicate | ||
| InMode Ltd. | InMode RF System | K182325 |
| Reference Predicates | ||
| InMode Ltd. | InMode System MiniFX Applicator | K160329 |
| InMode Ltd. | InMode WMBody Device | K131362 |
| InMode Ltd. | InMode PLUS System | K172302 |
| InMode Ltd. | WMFACE Applicator | K140926 |
| InMode Ltd. | FRACTORA 60 pin | K102461 |
| InMode Ltd. | InMode System with Fractora3D/3D-90 Applicators | K180189 |
| InMode Ltd. | InMode FRF 24 pin Applicator | K151273 |
| InMode Ltd. | InMode System with the Morpheus8 12, 24, 40 & T Applicators | K192695 |
| InMode Ltd. | InMode System with the Morpheus8 Applicators | K200947 |
Predicate Device: The InMode RF Multi-System is substantially equivalent to the previously cleared predicate devices;
Device Description:
The InMode RF Multi-System supports multiple radiofrequency (RF) applications and accessories. The InMode RF Multi-System is compatible with the Fractional RF Applicators and the Non-Invasive RF Applicators, and employs RF energy for various applications.
The InMode RF Multi-System consists of platform console with an AC/DC power supply unit, two applicator connectors, RF generator, RF measuring circuit, controller, footswitch and user interface including a touch screen. The RF Applicator is connected to the console via a cable and a footswitch activates the energy delivery to the applicator. The applicators are comprised of a handle and electrodes, and some of them are used with a single-use tip.
This 510(k)-file submission includes all the FDA-Cleared applicators under one submission with the RF-supporting console, as cleared in K182325, compatible with all applicators.
The below list comprises the set of applicators to be registered under the subject device:
- . Non-Invasive RF Applicators:
- Forma (Plus) O
- Plus (Plus Plus) O
- Plus90 O
- WMface O
- BodyFXTM (WMBody) O
- MiniFX™ O
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- Fractora O
- 24 pins tip (FRF) -
- -60 pins tip
- Morpheus8™M O
- 12 pins tip (Prime Tip) ।
- 24 pins tip (Fractora 3D) -
- 40 pins tip (Body Tip) -
- -T tip
Following are the InMode RF Multi-System device specifications:
| RF Max Output Power | 65 Watt |
|---|---|
| RF Output Frequency | 1[MHz] ± 2% |
| Dimensions | 46cm W x 46cm D x 100cm H[18.2" W x 18.2" D x 40" H] |
| Console Weight | 32.0Kg [70.548lb] |
| Main Line Frequency (nominal) | 50-60 Hz |
| Input Voltage (nominal) | 100-240 VAC |
Intended Use/Indication for Use:
The InMode RF Multi-System with the Non-invasive RF Applicators employs RF energy for various applications:
- Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
- WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids.
- · BodyFX™ (WMBody)/MiniFX™ for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.
The InMode RF Multi-System with the Fractional Applicators employs RF energy for various applications:
- · Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin.
- · Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV
- · Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis.
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At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV
Performance Standards:
The InMode RF Multi-System complies with the following recognized consensus standards:
- [Rec. Number 19-4] ANSI AAMI ES 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
- · [Rec. Number 5-89] IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- · [Rec. Number 19-8] IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- · [Rec. Number 6-389] IEC 60601-2-2 Edition 6.0 2017-03 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 ●
The test certificates and test reports documents conclude that the InMode RF Multi-System complies with the requirements of all the above-mentioned standards. The test certificates and reports for the InMode RF Multi System are provided in section 17 of this 510(k) submission.
Non-Clinical (Bench) Performance Data:
The following performance data were provided in support of the substantial equivalence determination:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the InMode RF Multi-system. The system complies with the IEC 60601-1, IEC 60601-2-2 standards for safety and the IEC 60601-1-2 standard for EMC.
{7}------------------------------------------------
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. " The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Animal Performance Data / Histology Data:
Non-Applicable
Clinical Performance Data:
Non-Applicable
Substantial Equivalence:
The following tables provide a comparison information for the InMode RF Multisystem and its main predicate, the InMode RF System and for the subject device applicators and their compatible predicate reference devices:
| Subject DeviceInMode RF Multi-SystemK201150 | Main Predicate DeviceInMode RF SystemK182325 | |
|---|---|---|
| General | ||
| Product Code | GEI | GEI |
| Class | Class II | Class II |
| Manufacturer | InMode Ltd. | InMode Ltd. |
| RF platform | InMode RF Multi-System | InMode RF System |
| Prescription or OTC | Prescription use only | Idem |
| Target Population | Adults requiring treatment asspecified in the indication foruse | Idem |
| Anatomical sites | Body parts requiring treatmentas specified in the indicationfor use | Idem |
| Environment Used | Hospital or Clinic setting | Idem |
| Device description /Design | The InMode RF Multi-Systemis a line power, electrothermal, radio frequencysystem with integraltemperature and impedancefeedback. The system is | The InMode RF System is aline power, electro thermal,radio frequency system withintegral temperature andimpedance feedback. Thesystem is capable of |
| Subject DeviceInMode RF Multi-SystemK201150 | Main Predicate DeviceInMode RF SystemK182325 | |
| capable of delivering up to 65 watts of power. | delivering up to 40 watts of power. | |
| Device components | The InMode RF Multi-System consists of the same following components as the InMode RF System, with additional applicators as described in next table:• Electrosurgical Unit which includes the power supply, RF generator, controller and LCD touch screen control and display panel• RF measuring circuit• AC/DC power supply• Designated applicators• 2 Applicator connectors• Footswitch | The InMode RF System consists of the following components:• Electrosurgical Unit which includes the power supply, RF generator, controller and LCD touch screen control and display panel• RF measuring circuit• AC/DC power supply• Applicators• Applicators connector• Footswitch |
| Input Power | ||
| Main Line Frequency (nominal)Input Voltage (nominal)Input Current (rms) | 60 - 50Hz100-240VAC2A | idem |
| Dimensions | ||
| System | 46cm W x 46cm D x 100cm H[18.2" W x 18.2" D x 40" H] | idem |
| Weight | ||
| System | 32.0Kg [70.51b] | idem |
| RF Output Parameters | ||
| Maximum Output Power | 65[W] | 40[W] |
| Frequency | 1MHz | idem |
| Crest Factor (Rated Load) | $1.4\pm 2%$ | idem |
| Safety & adherence to consensus standards | ||
| Subject DeviceInMode RF Multi-SystemK201150 | Main Predicate DeviceInMode RF SystemK182325 | |
| Standards Met | System adheres to:• IEC 60601-1• IEC 60601-1-2• IEC 60601-2-2 | idem |
| Biocompatibility | Materials are biocompatible. | idem |
| Compatibility withEnvironment and OtherDevices | InMode RF System iscompliant with the IEC 60601-1-2 (EMC Safety) standard | idem |
| Electrical Safety | Power Requirements:100-240 VAC 50-60 HzThe InMode RF System iscompliant with the IEC 60601-1 standard. | idem |
| Mechanical Safety | The InMode RF System iscompliant with the IEC 60601-1 standard. | idem |
| Chemical Safety | Not Applicable | idem |
| Thermal Safety | The InMode RF System iscompliant with the IEC 60601-1 standard. | idem |
| Radiation Safety | The InMode RF System iscompliant with the IEC 60601-1-2 (EMC Safety) standard | idem |
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| TechnologicalCharacteristic | Subject DeviceInMode RF Multi-SystemK201150 | Reference PredicatesK102461 - FRACTORA 60pin ApplicatorK151273 - InMode FRF 24pin ApplicatorK192695 & K200947-Morpheus8 (Fractora 3D)Applicator with the 12, 24,40 & T tip heads |
|---|---|---|
| Product Code | GEI | idem |
| Class | Class II | idem |
| Manufacturer | InMode Ltd. | Idem |
| Device Technological Characteristics | ||
| Energy Used | Fractional RF | idem |
| Specifications | ||
| Max RF Energy output | 65W | idem |
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| TechnologicalCharacteristic | Subject DeviceInMode RF Multi-SystemK201150 | Reference PredicatesK102461 - FRACTORA 60pin ApplicatorK151273 - InMode FRF 24pin ApplicatorK192695 & K200947-Morpheus8 (Fractora 3D)Applicator with the 12, 24,40 & T tip heads |
|---|---|---|
| RF Frequency | 1 MHz | idem |
| Max RF Energy levels | FRACTORA 60 pin: 60WInMode FRF 24 pin: 60WMorpheus8 12, 24, 40: 60WMorpheus8 T: 30W | FRACTORA 60 pin: 62WInMode FRF 24 pin: 62WMorpheus8 12, 24 & 40: 60WMorpheus8 T: 30W |
| Tip needles penetrationdepth | FRACTORA 60 pin: 0.2mmInMode FRF 24 pin: 2.5mmMorpheus8 12, 24 pins:4.0mmMorpheus8 40 pin: 7.0mmMorpheus8 T: 0.5mm | idem |
| General Aspects | ||
| Biocompatibility | Materials are biocompatible. | idem |
| Sterility | All tips are Gamma-sterilized | idem |
| Reprocessing | Handle to be reprocessed inaccordance with user manualinstructions. Tips are forsingle-use | idem |
| TechnologicalCharacteristic | Subject DeviceInMode RF Multi-System | Reference PredicatesK131362- BodyFX(WMBody)K140926-WMFaceK160329- MiniFXK172302- Forma (Plus),Plus90 and Plus (Plus-Plus) |
|---|---|---|
| Product CodeClass | GEI, PBX, ISA/NUVClass II | idem |
| Manufacturer | InMode Ltd. | idem |
| Device Technological Characteristics | ||
| Energy Used | Bipolar RF | idem |
| Specifications | ||
| Maximal RF outputpower | BodyFX (WMBody): 50 [W]WMFace: 65 [W]MiniFX: 25 [W] | idem |
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| TechnologicalCharacteristic | Subject DeviceInMode RF Multi-System | Reference PredicatesK131362- BodyFX(WMBody)K140926-WMFaceK160329- MiniFXK172302- Forma (Plus),Plus90 and Plus (Plus-Plus) |
|---|---|---|
| Forma (Plus), Plus (Plus-Plus): 50 [W]Plus90: 50 [W] | ||
| RF Frequency | 1 MHz | idem |
| General Aspects | ||
| Biocompatibility | Materials are biocompatible. | idem |
| Sterility | NA | NA |
| Reprocessing | Applicators to be reprocessedin accordance with usermanual instructions. | idem |
The indications for use and technological characteristics of the InMode RF Multi-System are substantially equivalent to the indications for use and technological characteristics of the InMode RF System (predicate device, subject of K182325) and applicators (reference devices).
The design of and components included in the InMode RF Multi-System, including the main system platform, with power supply, RF generator, controller and display panel are similar to the design and components found in the main predicate device except for slight design modifications to support the utilization of all of the system applicators, mainly in software design. The subject device applicators possess similar technological principals to the predicate devices' applicators. Minor changes were done for some of the applicators, still the device performance and safety are maintained due to the exact functionality and mechanism of operation. Both the subject and predicate devices present similar performance specifications (for the specified indications for use) and similar monitoring features (where applicable) in order to maintain the desired performance specifications. The safety features and compliance with safety standards in the InMode RF Multi-System are similar to the safety features and compliance with safety standards found in the predicate device. Patient contacting materials are also similar. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the subject device underwent performance testing including software validation testing, electrical and mechanical safety testing according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2 and high frequency of surgical equipment testing according to IEC 60601-2-2. User interface was slightly changed in order to support all applicators, and labeling was updated to allow appropriate use.
Consequently, it can be concluded that the InMode RF Multi-System is substantially equivalent to the predicate InMode RF System, cleared under 510(k) K182325 and the
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InMode RF Multi-System 510(k) file Section 5 – 510(k) Summary
reference device cleared under 510(k) K1024615, K131362, K140926, K1512735, K160329, K172302, K180189, K192695 and K200947 and therefore, may be legally marketed in the USA.
Therefore, the InMode RF Multi-System may be legally marketed in the USA.
Conclusions:
Based on the performance testing and comparison to predicate device and reference devices, the InMode RF Multi-System is substantially equivalent to the InMode RF System (predicate device) and Applicators (reference devices).
§ 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.