(132 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:
- HP101306A (optional sterile/non-sterile)
- HP172206A (optional sterile/non-sterile ●
- HP172246A (non-sterile) ●
The provided text describes the 510(k) premarket notification for the InMode RF System, which is a device for electrocoagulation and hemostasis in dermatological and general surgical procedures. The notification focuses on demonstrating substantial equivalence to a previously cleared predicate device (InMode RF System, K160193), particularly with the addition of a modified hand piece, HP172246A.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable format with corresponding "reported device performance" in a table for each criterion. Instead, it describes performance through compliance with standards and comparative testing for substantial equivalence.
However, based on the context, we can infer some implied "acceptance criteria" related to functionality, safety, and equivalence, and align them with the reported test results.
| Implied Acceptance Criterion | Reported Device Performance |
|---|---|
| Functionality/Performance Equivalence: Device (with new HP172246A) operates similarly to the predicate device in terms of RF energy output, waveform, amplitude, frequency, duty cycle, load, and crest factor. | Non-Clinical (Bench) Performance Data: "The results of the bench tests demonstrate that the InMode RF System with the HP172246A hand piece operates within the predefined system performance requirements, exerting similar output power density as to the predicate device (K160193)." Specifically, side-by-side comparison tests were performed to evaluate output measurements. |
| Safety and Effectiveness (Thermal Effects): The device (with new HP172246A) effectively achieves electrocoagulation and hemostasis in target tissue without posing new safety concerns. | Animal Performance Data / Histology Data: "The ex-vivo study results show that the InMode RF System with the HP172246A hand piece is safe for use and effective in achieving the specified indications of dermatological and general electrocoagulation and hemostasis." This was evaluated through a single RF treatment followed by TTC staining analysis on porcine tissue models. |
| Compliance with Recognized Standards: The device meets general and specific electrical safety, EMC, and sterilization standards. | Performance Standards: InMode RF System complies with a list of FDA recognized consensus standards including: AAMI/ANSI 60601-1, IEC 60601-1-2, IEC 60601-2-2, AAMI/ANSI/ISO 11137-1, AAMI/ANSI/ISO 11137-2, AAMI/ANSI/ISO 11737-1, AAMI/ANSI/ISO 11737-2, AAMI/ANSI/ISO 11607-1, and ASTM F1980-07. |
| Device Specifications: The device (with new HP172246A) operates within specified electrical and physical parameters. | Device Specifications: A table of specifications is provided, including Main Line Frequency (50-60 Hz), Input Voltage (100-240 VAC), Electrosurgical Unit dimensions (14.2"W x 18.2"D x 40"H), Platform weight (33 lb.), RF Max Output Power (40 Watt), and RF Output Frequency (1 ± 2% MHz). (The bench tests confirmed operation within "predefined system performance requirements".) |
2. Sample Size Used for the Test Set and Data Provenance
-
Non-Clinical (Bench) Performance Data:
- Sample Size: Not explicitly stated as a number. The text mentions "a side by side comparison tests were performed utilizing the HP172246A and the HP172206A hand pieces." This implies at least one of each handpiece was used, but the number of tests or repetitions is not specified.
- Data Provenance: This is bench testing, not human or animal data from a specific country. It's presumably conducted by the manufacturer, InMode MD Ltd., at their facilities. It's retrospective in the sense that it's testing a completed device design, but it's not retrospective patient data.
-
Animal Performance Data / Histology Data:
- Sample Size: The study was conducted on "three different porcine tissue models (muscle, liver & fat)." It does not specify the number of samples within each tissue type or the number of animals used.
- Data Provenance: Not explicitly stated, but it's an ex-vivo study using porcine tissue. The location of the study (e.g., country) is not mentioned. This can be considered prospective data gathered for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Non-Clinical (Bench) Performance Data: No external experts are mentioned for establishing ground truth for bench tests. The "ground truth" here is the physical measurement of electrical parameters against engineering specifications and comparison to the predicate device's measured output.
- Animal Performance Data / Histology Data:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The "ground truth" was established by "TTC staining analysis," which is a standard histological technique, implying interpretation by trained personnel, likely a pathologist or equivalent, but specific expert qualifications are not provided.
4. Adjudication Method for the Test Set
- Non-Clinical (Bench) Performance Data: No adjudication method is mentioned. Bench tests typically involve objective measurements against predefined specifications.
- Animal Performance Data / Histology Data: No adjudication method is mentioned. The "TTC staining analysis" would be interpreted by a single or multiple histologists/pathologists, but a formal adjudication process (e.g., 2+1, 3+1) is not described.
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 study was done. This device is a surgical energy-based device, not an AI-powered diagnostic or assistive tool for human readers. Clinical performance data was "Not Applicable" for this 510(k) submission, meaning no human clinical trials were performed for this specific modification to demonstrate substantial equivalence.
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, not an algorithm. Therefore, a standalone algorithm performance study is irrelevant.
7. The Type of Ground Truth Used
- Non-Clinical (Bench) Performance Data: The ground truth for these tests was the engineering specifications of the device and the measured output of the predicate device.
- Animal Performance Data / Histology Data: The ground truth was based on histological staining (TTC staining analysis) to evaluate thermal effects on tissue.
8. The Sample Size for the Training Set
- Not applicable. As this is a medical device for energy delivery rather than an AI/ML algorithm, there is no "training set" in the machine learning sense. The device's operation is based on predefined electrical and physical principles, not on learned patterns from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8).
§ 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.