(30 days)
The InMode RF System is indicated for use in dermatological and general surgical procedures for electro-coagulation and hemostasis
The InMode RF System (InMode MD Ltd.) is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.
The InMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece is comprised of a disposable, single use; internal and external electrodes.
The InMode RF System is compatible with the following hand pieces:
- . HP060909A (Non-sterilized)
- HP101306A (Non-sterilized/Sterilized) ●
- HP172206A (Non-sterilized/Sterilized) .
- . HP172246A (Non-sterilized/Sterilized)
- HP172248A (Sterilized )
This document is a 510(k) summary for the InMode RF System, seeking substantial equivalence to a previously cleared InMode RF System (K171593). It describes the device, its intended use, and the studies conducted to demonstrate its safety and effectiveness.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a numeric or specific performance metric table format as one might expect for a clinical trial endpoint. Instead, the acceptance criteria are implicitly tied to demonstrating the device's ability to perform "electrocoagulation and hemostasis" safely and effectively, and showing substantial equivalence to the predicate device.
The reported device performance is described through various tests rather than numerical outcomes against pre-defined thresholds.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| I. Safety and Basic Performance (Electrical, Mechanical, EMC, Usability) | The InMode RF System complies with the following FDA recognized consensus standards: |
- AAMI/ANSI 60601-1 (2012) (General Requirements For Basic Safety And Essential Performance)
- IEC 60601-1-2 (Edition 3.0, 2007) (Electromagnetic Compatibility)
- IEC 60601-2-2 Edition 5.0 2009-02 (High-Frequency Surgical Equipment)
- IEC 60601-1-6:2013-10 (Usability)
- IEC 62366-1:2015 (Usability Engineering)
Non-Clinical (Bench) Performance Data: The modified InMode RF System was evaluated for its system performance specifications. "The results of the bench tests demonstrate that the modified InMode RF System performed as expected and in a similar fashion to the predicate device." The modified device software/firmware was retested to verify system configuration and integration with all ancillary hand pieces. |
| II. Effectiveness in Electrocoagulation and Hemostasis (Tissue Interaction) | Animal Performance Data / Histology Data (Ex-vivo study): The thermal effects of the modified InMode RF System on target tissue were evaluated. "The ex-vivo study results show that the modified InMode RF System is safe for use and effective in achieving the specified indications of dermatological and general electrocoagulation and hemostasis." |
| III. Substantial Equivalence to Predicate Device | "Based on the comparison to the predicate device and on the performance testing, the modified InMode RF System is substantially equivalent to the predicate InMode RF System for the mentioned indication for use."
The subject device is composed of the same main device components as the predicate (K171593), except for the addition of two new hand piece versions. It uses the same underlying technology for the same intended use (delivery of monopolar RF energy, monitored and controlled by the ESU). It introduces similar safety features and complies with the same relevant consensus standards as the predicate. Performance bench, ex-vivo, and software validation test results show the modified system produced and delivered desired RF energy according to design requirements, comparable to the predicate. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Bench Performance Data: Not explicitly stated, but it involved system performance specifications and retesting of software/firmware with all ancillary hand pieces. No specific "test set" in terms of biological samples or patients is mentioned. This is likely an engineering validation with a variety of operational scenarios.
- Animal Performance Data / Histology Data: "The study was conducted on three different porcine tissue models (muscle, liver & fat)." This is an ex-vivo study (meaning performed on tissue outside a living organism).
- Data Provenance: Porcine tissue models (ex-vivo). Specific country of origin is not mentioned. Retrospective/prospective doesn't apply to ex-vivo models in the same way as human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Animal Performance Data / Histology Data: The document mentions "TTC staining analysis" was used to evaluate thermal effects. It does not specify the number of experts, their qualifications, or if any experts were used to establish a "ground truth" for this specific analysis. It's implied that standard histological analysis protocols were followed.
4. Adjudication Method for the Test Set:
- Not applicable as no human-read test set requiring adjudication (e.g., image interpretation) is described for the primary performance evaluations for substantial equivalence.
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:
- Not applicable. This device is an electrosurgical system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed or is relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm, but a physical medical device (RF system). Its performance is inherently "standalone" in its function of generating RF energy.
7. The Type of Ground Truth Used:
- Bench Performance Data: Engineering specifications, design requirements, and comparisons to the performance of the predicate device (K171593) served as the "ground truth" or reference for expected performance.
- Animal Performance Data / Histology Data: The "ground truth" for effectiveness in achieving thermal effects for electrocoagulation and hemostasis was established through TTC staining analysis on the porcine tissue models. This is a direct biological measure of tissue viability/damage.
8. The Sample Size for the Training Set:
- Not applicable. This is a medical device, not an AI/machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this type of device.
§ 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.