(163 days)
The InMode System with the Morpheus8 90 Applicator is intended for use in dermatological procedures where coaqulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 90 Applicator is limited to Skin Types I-IV.
The InMode System with the Morpheus8 90 Applicator is a RF technology based device intended for dermatological applications which require coagulation/contraction of soft tissue or hemostasis. The device platform is identical to the one in FDA-Cleared InMode System with the Fractora3D 90 Applicator (K180189), inclusive of minor software modifications. The InMode System with the Morpheus8 90 Applicator employs fractional RF multi-electrode technology for procedures requiring electrocoaqulation and hemostasis. The Morpheus8 90 Applicator is deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Morpheus8 90 Applicator consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 90 Applicator is connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The Morpheus a handle and a detachable, sterilized, disposable, singleuse 24 pin tip head accessory.
The provided text is a 510(k) summary for the InMode System with the Morpheus8 90 Applicator. It describes a device that is substantially equivalent to a previously cleared device. Therefore, the information provided focuses on demonstrating this substantial equivalence rather than presenting an independent acceptance criteria study for a novel device or AI algorithm.
Here's a breakdown based on your request, filling in where possible from the provided text and noting when the information is not available due to the nature of a 510(k) submission for an already cleared device's modification:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a modification (clearing the Fractora 3D 90 for a treatment depth of up to 7mm via software change) and claiming substantial equivalence to predicate devices, explicit "acceptance criteria" and "reported device performance" in the sense of a new clinical study with specific metrics are not detailed for the subject device in the provided document. Instead, the document relies on previously established performance of predicate devices and comparative testing.
The "acceptance criteria" can be inferred as meeting the safety and performance characteristics of the predicate devices. The "reported device performance" is implicitly that the subject device performs equivalently.
| Acceptance Criteria (Inferred) | Reported Device Performance (Implied) |
|---|---|
| Safety and effectiveness equivalent to predicate devices (K180189, K200947). | Demonstrated through non-clinical testing, including: |
| Compliance with electrical and mechanical safety standards (IEC 60601-1). | Full compliance with IEC 60601-1 demonstrated (inherited from predicate and confirmed for modifications). |
| Compliance with electromagnetic compatibility standards (IEC 60601-1-2 and IEC 60601-2-2). | Full compliance with IEC 60601-1-2 and IEC 60601-2-2 demonstrated (inherited from predicate and confirmed for modifications). |
| Generation of fractional coagulation necrosis pattern in target tissues via thermal effect. | Ex-vivo tissue testing demonstrated equivalent fractional coagulation necrosis patterns to predicate devices, even at the expanded treatment depth of 7 mm. Bench testing confirms device specifications are met. This includes comparing the thermal effect of the subject device to the primary predicate up to a treatment depth of 7 mm. |
| Software functions correctly for the extended treatment depth. | Software validation testing performed (for minor software modifications to implement the 7mm depth). |
| Maintains patient contact material inertness and safety. | Patient contact materials are identical to the predicate device. |
| Device specifications (RF max output power, frequency, dimensions, weight, input voltage) are met. | Specifications are provided and implicitly met: RF Max Output Power: 65 Watt, RF Output Frequency: 1 MHz, Dimension: 46cm W x 46cm D x 100cm H, Weight: 30 Kg, Main Line Frequency: 50-60 Hz, Input Voltage (nominal): 100-240 VAC. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a numerical sample size for patients or clinical cases. The testing was primarily ex-vivo tissue testing and bench testing.
- Data Provenance: The testing for the current submission was conducted to compare the subject device to the predicate devices. The original predicate device (K180189) performance testing is referenced, and further ex-vivo testing was performed with the secondary predicate device (K200947). The exact location or nature (retrospective/prospective) of these non-clinical tests is not specified beyond "ex-vivo tissue testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. Given that the testing detailed is primarily ex-vivo and bench testing, rather than a clinical trial requiring human interpretation of results against a gold standard, this type of expert review is typically not part of these types of 510(k) submissions.
4. Adjudication Method for the Test Set
- This information is not provided. As above, for non-clinical, ex-vivo, and bench testing, a formal adjudication process using multiple experts is generally not applicable in the same way it would be for clinical image interpretation or diagnosis.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a MRMC comparative effectiveness study was not done. The document states, "No clinical data was submitted." The submission relies on non-clinical performance data and substantial equivalence to legally marketed predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- This device is not an AI algorithm. It is a physical medical device (radiofrequency technology for dermatological applications). Therefore, the concept of "standalone algorithm performance" is not applicable here. The "performance" refers to the device's physical and functional capabilities.
7. The Type of Ground Truth Used
- For the ex-vivo tissue testing, the "ground truth" would be the physical measurement and visual assessment of the fractional coagulation necrosis pattern in the tissue. This is a direct physical effect, not an expert consensus or pathology report in the traditional sense for diagnostic AI. For electrical, mechanical, and EMC testing, the "ground truth" would be the defined standards (e.g., IEC 60601 series).
8. The Sample Size for the Training Set
- Not applicable. This document describes a medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no training set for this device.
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June 13, 2024
InMode Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street. Floor 23 Philadelphia, Pennsylvania 19103
Re: K240017
Trade/Device Name: InMode System with the Morpheus8 90 Applicator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: NA Received: May 16, 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/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (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 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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
Long H. Chen -- S Date: 2024.06.13 07:46:52 -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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
InMode System with the Morpheus8 90 Applicator
Indications for Use (Describe)
The InMode System with the Morpheus8 90 Applicator is intended for use in dermatological procedures where coaqulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 90 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) #: | K240017 | 510(k) Summary | Prepared on: 2024-06-11 |
|---|---|---|---|
| ----------- | --------- | ---------------- | ------------------------- |
Contact Details
| 21 CFR 807.92(a)(1) | |
|---|---|
| Applicant Name | InMode Ltd. |
| Applicant Address | Tabor Building, Shaar Yokneam POB 44 Yokneam Illit 2069200 Israel |
| Applicant Contact Telephone | +972-4-9097470 |
| Applicant Contact | Mrs. Suhair Francis |
| Applicant Contact Email | Suhair.Francis-Najjar@inmodemd.com |
Device Name
| 21 CFR 807.92(a)(2) | |
|---|---|
| Device Trade Name | InMode System with the Morpheus8 90 Applicator |
| Common Name | Electrosurgical cutting and coagulation device and accessories |
| Classification Name | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation Number | 878.4400 |
| Product Code | GEI |
Legally Marketed Predicate Devices
| 21 CFR 807.92(a)(3) | ||
|---|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K180189 | InMode System with Fractora3D/3D-90 Applicators | GEI |
| K200947 | InMode System with the Morpheus8 Applicators | GEI |
Device Description Summary
| 21 CFR 807.92(a)(4) | |
|---|---|
| -- | --------------------- |
The InMode System with the Morpheus8 90 Applicator is a RF technology based device intended for dermatological applications which require coagulation/contraction of soft tissue or hemostasis.
The device platform is identical to the one in FDA-Cleared InMode System with the Fractora3D 90 Applicator (K180189), inclusive of minor software modifications. The InMode System with the Morpheus8 90 Applicator employs fractional RF multi-electrode technology for procedures requiring electrocoaqulation and hemostasis. The Morpheus8 90 Applicator is deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The device provides enhanced safety while minimizing possible side effects by monitoring RF parameters.
The InMode System with the Morpheus8 90 Applicator consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 90 Applicator is connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The Morpheus a handle and a detachable, sterilized, disposable, singleuse 24 pin tip head accessory.
Following are the InMode System with the Morpheus8 90 Applicator specifications:
| RF Max Output Power: | 65 Watt |
|---|---|
| RF Output Frequency: | 1 MHz |
| Dimension: | 46cm W x 46cm D x 100cm H |
| (18.2" W x 18.2" D x 40" H) |
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Weight: 30 Kg (70.4 Ibs.)
Main Line Frequency: 50-60 Hz
Input Voltage (nominal): 100-240 VAC
Intended Use/Indications for Use
The InMode System with the Morpheus8 90 Applicator is in dermatological procedures where coagulation/contraction of soft tissue or hemostasis is needed.
At higher energy levels greater than 62 ml/pin, the use of the Morpheus8 90 Applicator is limited to Skin Types I-V.
Indications for Use Comparison
The device has similar indications for use as the predicate. Specifically, An additional change for this 510(k) submission consists of modified indications for use; the mention of "coagulation of soft tissue" is added to the indications. This change in the wording of the indications does not refer to a different intended use nor a different performance claim.
Technological Comparison
The design and components in the InMode System, including the console (with power supply, RF generator, controller and display panel) and the Applicator (with cable, connole, handle and tip) are identical to the design and components found in the primary predicate device (K180189) except for minor design changes to the handle to improve ergonomics and manufacturing process. The safety features and compliance with safety standards in the Morpheus8 90 Applicator are identical to the safety features and compliance with safety standards found in the primary predicate device. (K180189). Patient contact materials are also identical.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The current system is a modification to InMode's system with the Fractora 3D 90 Applicator cleared for ocedures for electrocoagulation and hemostasis (K180189).
The subject of the current 510(k) is to clear the Fractora 3D 90 for a treatment depth of up to 7mm. This change is implemented via software only.
No clinical data was submitted.
Performance testing which supported the primary predicate device (K180189), remains applicable, including software validation testing, electrical and mechanical safety testing to EC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2 and IEC 60601-2-2, bench testing, and ex-vivo tissue testing to evaluate the fractional coagulation necrosis pattern of target tissues formed by thermal effect. These performance tests demonstrated that the device's performance and specifications meet system requirements.
Further, ex-vivo testing was performed with the secondary predicate device K200947 up to a treatment depth of 7 mm. This testing is equally relevant to the current submission. Additional testing was provided in this submission comparing the thermal effect of the subject device to the primary predicate up to a treatment depth of 7 mm. Thus, the data and information provided demonstrates the subject device is substantially equivalent to and is as safe and as effective as the predicate device.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
§ 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.