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510(k) Data Aggregation
(85 days)
InMode System with the Morhpeus8 Applicators
The InMode System with the Morpheus8 Applicators is intended for use in dermatological procedures for electrocoagulation and hemostasis.
At higher energy levels greater than 62 mJ/pin, use of the Morpheus8 (Fractora) Applicator is limited to Skin Types I-IV.
The InMode System with the Morpheus8 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 InMode System with the Morpheus8 Applicators (K192695). The InMode System with the Morpheus8 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Morpheus8 Applicators are designed to 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 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The Morpheus8 Applicator comprises handle and detachable, sterilized, disposable, single use 12, 24, 40 pin and T tip head accessory.
This document describes a 510(k) premarket notification for the InMode System with the Morpheus8 Applicators. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared device (K192695). As such, the "acceptance criteria" and "study" described are primarily focused on demonstrating this equivalence rather than a de-novo clinical trial for a new performance claim.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the substantial equivalence comparison to the predicate device (K192695). The reported device performance is largely a direct comparison of technological characteristics and safety standards adherence.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (InMode System with Morpheus8 Applicators, K200947) |
|---|---|
| Intended Use/Indications for Use: Substantially equivalent to predicate. | Indications for Use: The InMode System with the Morpheus8 Applicators is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use of these Applicators is limited to Skin Types I-IV. (Slight expansion to "general surgical procedures" compared to predicate's "dermatological procedures" but deemed substantially equivalent). |
| Product Code, Class: Identical to predicate. | Product Code, Class: GEI, Class II (Identical to predicate). |
| Anatomical Sites: Identical to predicate. | Anatomical Sites: Body parts requiring treatment as specified in the indication for use (Identical to predicate). |
| Target Population: Identical to predicate. | Target Population: Adults requiring treatment as specified in the indication for use (Identical to predicate). |
| Environment Used: Identical to predicate. | Environment Used: Hospital or Clinic setting (Identical to predicate). |
| Energy Used/Delivered: Identical to predicate. | Energy Used/Delivered: RF energy (Identical to predicate). |
| Design/Mechanism of Action: Substantially equivalent to predicate. | Design/Mechanism of Action: Fractional RF technology for localized dermis and sub-dermis coagulation triggering slow collagen regeneration and fibroblast cells' proliferation (Identical to predicate). |
| Components: Substantially equivalent to predicate. | Components: Console (power supply, RF generator, controller, touch screen), Applicator (cable, handle, 12, 24, 40 & T tip heads), Footswitch. (Similar to predicate). |
| System Dimensions: Identical to predicate. | System Dimensions: 46cm W x 46cm D x 100cm H (Identical to predicate). |
| Weight (Platform): Identical to predicate. | Weight (Platform): 30 Kg (70.4 lbs.) (Identical to predicate). |
| Applicator Weight: Similar, minor difference noted but not impacting equivalence. | Applicator Weight: Applicator - 0.4 Kg (0.88 lbs.), Tip - 0.02 Kg. (The predicate's applicator weight is not explicitly stated in the table but "idem" is used for other characteristics suggesting substantial similarity). |
| Number of pins: Identical to predicate. | Number of pins: 12, 24 and 40 pins (Identical to predicate). |
| Maximal Treatment depth: Similar, with increased depth for some tips in the subject device, justified by testing. | Maximal Treatment depth: 0.5mm (T tip head), 4.0mm (12 pin tip head), 7.0mm (24 and 40 pin tip heads). (Predicate had 4.0mm for 24 and 40 pin tips, subject device showed increased depth). |
| RF energy level: Similar, with increased range for some tips in the subject device, justified by testing. | RF energy level: 5-30 (24 tip head up to 1 mm), 5-30 (T tip head and 12 tip head), 5-60 (24 and 40 in the range of 2-7mm). (Predicate had 5-60 for 12, 24, and 40 in 2-4mm range, subject had increased range for some tips). |
| Cable Dimensions: Identical to predicate. | Cable Dimensions: 270 cm (Identical to predicate). |
| Performance (Frequency, Max Output Power, Max Pulse Duration): Identical to predicate. | Performance: Frequency: 1 MHz, Maximal RF output power: 65W, Maximal pulse duration: up to 74msec (Identical to predicate). |
| Standards Met: Compliant with recognized standards. | Standards Met: AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-2 (Identical to predicate and evaluated for compliance). |
| Biocompatibility: Identical to predicate. | Biocompatibility: All materials are biocompatible (Identical to predicate). |
| Compatibility with Environment and Other Devices: Compliant with EMC safety standard. | Compatibility with Environment and Other Devices: Compliant with IEC 60601-1-2 (EMC Safety) standard (Identical to predicate). |
| Sterility: Identical to predicate. | Sterility: 12, 24, 40 and T tip head are Gamma sterilized and for single use. Morpheus8 Applicator handle is for multiple use (Identical to predicate). |
| Mechanical Safety: Compliant with IEC 60601-1 standard. | Mechanical Safety: Compliant with IEC 60601-1 standard (Identical to predicate). |
| Thermal Safety: Compliant with IEC 60601-1 standard. | Thermal Safety: Compliant with IEC 60601-1 standard (Identical to predicate). |
| Radiation Safety: Compliant with EMC safety standard. | Radiation Safety: Compliant with IEC 60601-1-2 (EMC Safety) standard (Identical to predicate). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The primary test set mentioned is an ex-vivo tissue study on a porcine animal model. The sample size is not explicitly stated as a number of animals or tissue samples, but it indicates "a single treatment of two different harvested porcine tissues: muscle and fat."
- Sample size: Not explicitly quantified. Refers to "a single treatment of two different harvested porcine tissues."
- Provenance: Ex-vivo tissue study on a porcine animal model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The ex-vivo study describes TTC staining to visualize coagulation necrosis, which is typically evaluated by pathologists or scientists with expertise in tissue histology, but no specific number or qualifications are given for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. The ex-vivo study focused on an objective measurement of coagulation necrosis visualized by TTC staining, rather than a subjective interpretation that would typically require an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. This device is an electrocoagulation and hemostasis device, not an AI diagnostic or assistance tool. Therefore, the concept of "human readers improve with AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument (hardware-based) for dermatological procedures, not an algorithm, and it requires human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the ex-vivo tissue study, the type of "ground truth" used was visualization of tissue coagulation necrosis pattern immediately stained by TTC staining. This is a direct pathological/histological assessment marker for the intended effect of electrocoagulation.
8. The sample size for the training set
Not applicable. This device is hardware-based and does not involve AI or machine learning models that require a "training set."
9. How the ground truth for the training set was established
Not applicable. As stated above, there is no AI/ML training set.
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