(129 days)
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.
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.
Based on the provided text, the device in question is the "InMode System with Fractora3D/3D-90 Applicators," which is an electrosurgical cutting and coagulation device. The document is a 510(k) summary, which aims to demonstrate substantial equivalence to a predicate device rather than proving efficacy through clinical trials with specific acceptance criteria as one might see for novel AI/software devices. Therefore, much of the requested information regarding "acceptance criteria" for performance, "ground truth establishment," "expert adjudication," and "multi-reader multi-case studies" is not applicable or explicitly stated in the context of this traditional medical device submission.
Here's a breakdown of the information that is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Compliance with Regulatory Standards (Electrical Safety, EMC) | The device was tested and complies with: - 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 60601-1-2 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. - 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. |
| Accuracy and Consistency of RF Output Parameters (Bench Test) | Performance bench tests were performed to measure the accuracy and consistency of the RF output parameters. Results demonstrated that the InMode System complies with design requirements and consists of similar RF output specifications as the predicate device. |
| Safety and Efficacy for Indicated Use (Animal Study) | A preclinical study on a porcine model evaluated thermal effects and tissue healing. "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." |
| Biocompatibility of Patient Contact Materials | All device materials which come in direct contact with the patient skin are biocompatible. Reference made to predicate devices: K102461, K082451, K142438, K151019 and K081365 for biocompatibility determination. |
| Substantial Equivalence to Predicate Device (Performance Specs) | 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 predicate EndyMed Intensif Applicator (K130501). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- Bench Test: Not explicitly stated how many tests were run, but it refers to "performance bench tests."
- Animal Study: The study was conducted on a "porcine model." The exact number of animals is not specified, but it refers to a "single RF treatment" per animal at various follow-up times (immediately, 7, 14, and 21 days post-treatment).
- Clinical Data: "Not Applicable" for this 510(k) submission.
- Data Provenance: The device manufacturer (InMode MD Ltd.) is located in Israel. The studies are described as pre-clinical (animal model) and bench tests. The location where these specific tests were performed is not detailed. The data is retrospective in the sense that it's reported for a 510(k) submission, but the tests themselves would have been performed prospectively as part of validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This concept of "ground truth established by experts" is not explicitly applicable or discussed in the context of this traditional device submission for electrocoagulation and hemostasis. The "ground truth" for the animal study would be the histological findings and clinical observations of tissue effect and healing. The expert interpreting these would likely be a veterinary pathologist, but their number and qualifications are not specified in this summary.
4. Adjudication method for the test set
- Not applicable/mentioned. This is typically relevant for diagnostic AI studies where multiple readers might review cases.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study was not done. The document states "Clinical Performance Data: Not Applicable."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not an AI/algorithm-driven device. It is a physical electrosurgical device. Therefore, the concept of "standalone performance" of an algorithm is not applicable. The device's performance stands alone in its ability to deliver RF energy as specified.
7. The type of ground truth used
- For the non-clinical studies:
- Bench Tests: The ground truth is the designed specifications and physical measurements of RF output parameters.
- Animal Study: The ground truth is histological analysis (tissue changes and healing process) and observation of the gross thermal effects in the porcine model.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As this is not an AI/machine learning device, there is no "training set" or ground truth establishment method for one.
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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
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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
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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) |
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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 YokneamYokneam 20692Israel |
| 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 44425Israel |
| 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 |
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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.
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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.
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| Fractora3D/3D-90 Applicators 510(k) file |
|---|
| Section 5 - 510(k) Summary |
| TechnologicalCharacteristic | InMode Systemwith theFractora3D/3D-90 ApplicatorsInMode MD Ltd.(Subject Device) | IntensifApplicatorEndyMedMedical Ltd.K130501(Main Predicate) | InMode FRFApplicatorInMode MD Ltd.K151273(ReferencePredicate) |
|---|---|---|---|
| Dimensions | 46cm W x 46cm Dx 100cm H | 30cm W x 19cm Dx 115cm H | 46cm W x 46cm Dx 100cm H |
| [18.2" W x 18.2"D x 40" H] | [12" W x 8" D x45" H] | [18.2" W x 18.2"D x 40" H] | |
| WeightPlatform weightApplicator weight | 30 Kg (70.4 lbs.)0.4 Kg (0.88 lbs.)Tip weight - 0.02Kg | 33 Kg (72.6 lbs.)0.28 Kg (0.62 lbs.) | 30 Kg (70.4 lbs.)0.22 Kg (0.5 lbs.)Tip weight - 0.02Kg |
| ApplicatorDimensions: | ApplicatorFootprint Area:1.6cm x 1.2cm | ApplicatorFootprint Area:1.1cm x 1.1cm | ApplicatorFootprint Area:1.6cm x 1.2cm |
| Applicator needlesfield area:0.95cm X 1.1 cm | Applicator needlesfield area:0.9cm X 1.2 cm | ||
| Maximum volumeof treatment :16mm x 12mm x4.0mm | Maximum volumeof treatment :11mm x 11mm x3.5mm | Maximum volumeof treatment:16mm x 12mm x2.5mm | |
| Number of pins | 24 pins | 25 pins | 24 pins |
| Maximal Treatmentdepth | 4.0mm | 3.5mm | 2.5mm |
| Cable Dimensions: | 250 cm | idem | idem |
| Performance | Frequency: 1 MHzMaximal RFoutput power:65WMaximal pulseduration: up to74msec | Frequency: 1 MHzMaximal RFoutput power: 25WMaximal pulseduration: up to200msec | Frequency: 1 MHzMaximal RFoutput power: 65WMaximal pulseduration: up to74msec |
| Standards Met | IEC 60601-1IEC 60601-1-2 | idem | idem |
| TechnologicalCharacteristic | InMode Systemwith theFractora3D/3D-90 ApplicatorsInMode MD Ltd.(Subject Device) | IntensifApplicatorEndyMedMedical Ltd.K130501(Main Predicate) | InMode FRFApplicatorInMode MD Ltd.K151273(ReferencePredicate) |
| ANSI AAMI60601-2-2 forsafety of highfrequency surgicalequipment |
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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.
§ 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.