(63 days)
The electrosurgical generator, in conjunction with compatible devices and electrosurgical accessories, is intended for cutting and coagulation of soft tissue and for ligation of vessels. The electrosurgical generator utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments.
The electrosurgical generator is intended to be used in the following medical fields:
- · Open surgery
- · Laparoscopic surgery, including single-site surgery
- · Endoscopic surgery
Only for use by a qualified physician in an adequate medical environment.
The subject device ESG-410 is a reusable, non-sterile electrosurgical generator that features different high frequency monopolar and bipolar cutting and coagulation modes with a maximum output power of 320 W, as well as capability to power the existing Olympus ultrasonic THUNDERBEAT and SONICBEAT devices via a redesigned HYBRID ULTRASONIC socket and four new modes using high frequency (RF bipolar output) energy and supporting ultrasonic energy. The maximum RF output power for the THUNDERBEAT mode is 110 W.
The electrosurgical generator, in conjunction with compatible devices and electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of soft tissue in open surgery, laparoscopic surgery (including single-site surgery), endoscopic surgery and for ligation of vessels. The electrosurgical generator utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments.
The front panel of the proposed ESG-410 features a touch screen GUI (graphical user interface) as well as the power switch (on/off), six output sockets and one neutral electrode socket.
The touch screen GUI displays the current settings of the chosen output mode, the connection status of accessories and peripherals connected to the electrosurgical generator. Soft keys are integrated into the GUI to switch between the output sockets, to enter the menu in order to edit settings/procedures (e.g. create/ edit user-defined settings/ procedures), to edit preferences (e.g. select language, touch tone control, output volume, or brightness) and to show service options (e.g. software version identifier, for service and maintenance purposes) or to access user-defined settings and procedures.
Here's a breakdown of the acceptance criteria and the study details for the ESG-410 (Models: WA91327U, WA91327W), based on the provided document:
This device is an electrosurgical generator, and the information provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel AI algorithm's performance against specific clinical endpoints. Therefore, many of the typical acceptance criteria and study details for AI/ML devices aiming to improve diagnostic accuracy are not applicable here. This submission relies heavily on demonstrating equivalent technical characteristics and safety performance to existing, cleared devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Output modes: The range of bipolar and monopolar output waveforms and power levels are identical to the primary predicate (K203277). | Confirmed: "The range of bipolar and monopolar output waveforms and the power levels are identical in comparison to the predicate ESG-410 electrosurgical generator, K203277." (Page 5) The ultrasonic and high-frequency output waveforms and power levels are equivalent to the secondary predicate (K211838). (Page 5) |
| Tissue Effects | Comparable tissue effects must be achieved for applicable modes of operation with applicable tissue types as predicate devices. | Confirmed: "For all modes the tests demonstrated comparable tissue effects and electrically comparable waveforms." (Page 8) "Testing confirmed that comparable tissue effects could be achieved for applicable modes of operation with applicable tissue types." (Page 9) |
| Thermal Safety | Thermal spread in vessels: Smaller than or not statistically significantly different from control groups (predicate devices or established norms). | Confirmed via non-clinical bench testing: "The thermal spread in vessels of test article (subject device) is smaller than or not statistically significantly different from those of control groups." (Page 8) Design complies with recognized standards (Section 2.8.3, Page 7). |
| Vessel Burst Pressure | Burst pressure in vessels (veins and arteries): Higher than or not statistically significantly different from control groups. | Confirmed via non-clinical bench testing: "The burst pressure in vessels (veins and arteries) of test article (subject device) is higher than or not statistically significantly different from those of control groups." (Page 7-8) |
| Electrical Safety & EMC | Compliance with recognized electrical safety and electromagnetic compatibility (EMC) standards. | Confirmed: Design "complies with recognized standards as listed in section 2.8.8." (Page 7) and FDA guidance followed. |
| Software Validation | Follow FDA guidances for software in medical devices, including "Major Level of Concern" and off-the-shelf software. Cybersecurity measures implemented. | Confirmed: Software validation activities performed in accordance with FDA Guidance (May 11, 2005) and "General Principles of Software Validation" (Jan 11, 2002). "Major Level of Concern". Off-the-shelf software guidance followed (Sept 27, 2019). Cybersecurity documented per AAMI TIR57 and FDA Guidance (Oct 02, 2014). (Page 8) |
| Usability | Assessment according to risk management plan; use-related hazardous situations assessed, risk mitigation defined, residual risk acceptable. | Confirmed: "Usability and user interface were also assessed according to the risk management plan. The assessment was based on Olympus predecessor product. Use-related hazardous situations were assessed and risk mitigation measures in terms of usability design for safety were defined. The residual risk was evaluated as acceptable." (Page 9) |
| Risk Management | Risk analysis carried out in accordance with established internal acceptance criteria based on ISO 14971:2019. | Confirmed: "Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971:2019." (Page 9) |
| Biocompatibility | Not required if no direct or indirect patient contact. | Confirmed: "The ESG-410 and foot switches do not come into direct or indirect patient contact. Therefore, biocompatibility evaluation and testing according to ISO 10993-1 is not required." (Page 7) |
| Reprocessing | Required cleaning, disinfecting, and drying procedures must be described in IFU. | Confirmed: "Required cleaning, disinfecting and drying procedures are described in the instructions for use." (Page 9) |
| Compliance with Standards | Compliance with specified FDA-recognized international standards (e.g., AAMI/ANSI/ES 60601 series, IEC 62304, ISO 14971, ASTM D4169-22, D4332-14). | Confirmed: "All standards applied are FDA recognized international standards." (Page 7) A detailed list of applied standards is provided in Section 2.8.8 (Pages 10-11). |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a distinct "test set" sample size in terms of number of cases or patients, as this is primarily a device safety and performance equivalence submission, not a diagnostic accuracy study.
- For Vessel Burst Pressure and Thermal Spread, studies were conducted on "vessels" which implies a quantity of biological samples (e.g., animal tissue, ex vivo human tissue) but the exact number is not provided. The comparison was to "control groups."
- For Performance Bench Testing (tissue effects, electrical waveforms, functional performance), the testing involved various "modes, instruments and test protocols/plans." The nature of these tests is laboratory bench testing using simulation and comparison.
- Data Provenance: The studies were non-clinical bench testing and preclinical (simulated use) evaluation.
- No information on country of origin of data or whether it was retrospective or prospective is relevant or provided, as these are not clinical studies on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable to this 510(k) submission. The ground truth for functional equivalence, tissue effects, thermal safety, etc., was established through objective engineering measurements, comparisons to predicate device measurements, and compliance with recognized standards, rather than expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. Adjudication methods like 2+1 are used in clinical diagnostic studies where expert reviewers resolve discrepancies in ground truth labeling. This submission relies on objective physical measurements and engineering evaluations.
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 is not an AI-assisted diagnostic device; it is an electrosurgical generator used for cutting and coagulation. Therefore, the concept of human readers improving with AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not an algorithm-only device. The device is hardware (an electrosurgical generator) with integrated software. Its performance is always "standalone" in the sense that the generator produces desired electrical outputs or ultrasonic vibrations based on its internal programming and user settings. The human operator is "in-the-loop" by controlling the device during a surgical procedure. The software validation tests mentioned (Section 2.8.5) assess the software's performance as part of the overall device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance claims in this submission is primarily based on:
- Objective engineering measurements: Verifying electrical waveform outputs, power levels, and adherence to specified performance parameters.
- Direct comparisons to predicate devices: Establishing that the new device's performance (e.g., tissue effects, thermal spread, burst pressure) is either identical, equivalent, or statistically non-inferior/superior to the legally marketed predicate devices.
- Compliance with recognized international standards: Demonstrating that the device meets established safety and performance benchmarks (e.g., AAMI/ANSI/IEC 60601 series for electrical safety, ISO 14971 for risk management).
8. The sample size for the training set
- This information is not applicable. This is not an AI/ML device that requires a training set in the typical sense for learning models. The software development and validation followed standard engineering practices, not machine learning model training.
9. How the ground truth for the training set was established
- This information is not applicable, as there is no training set for an AI/ML model.
§ 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.