(173 days)
ESG-410:
The electrosurgical generator, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in the following medical fields:
- Open surgery
- Laparoscopic surgery
- Endoscopic surgery
Only for use by a qualified physician in an adequate medical environment.
PK Cutting Forceps (CF-PK0533):
The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures.
ESG-410 Generator:
The subject device ESG-410 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. The front panel of the proposed ESG-410 features a touch screen GUI (graphical user interface) that displays 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 assess user-defined settings and procedures.
PK Cutting Forceps:
The PK Cutting Forceps are a bipolar electrosurgical device that may be utilized in laparoscopic and open general surgery to grasp, coagulate, transect, dissect and retract tissue. The PK Cutting Forceps were cleared via K142759. They are currently intended to be used only with the existing ESG-400 generator per the Indications for Use statement. This submission will demonstrate compatibility with the new ESG-410 generator, and the Indications for Use statement will remove a specific generator model and the compatible generators will be reflected in the labeling. Minor modifications, which did not affect safety and effectiveness, were assessed via internal documentation since the original clearance and will be identified within the submission.
The provided text describes a 510(k) premarket notification for an electrosurgical generator (ESG-410) and accessories, including PK Cutting Forceps. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or safety through large-scale clinical trials.
Therefore, the information you're asking for, particularly regarding acceptance criteria tied to device performance in terms of patient outcomes or diagnostic accuracy, and detailed MRMC studies with expert adjudication and effect sizes, is not typically found in a 510(k) submission for a device like an electrosurgical generator.
The "acceptance criteria" for this type of device are primarily related to meeting recognized electrical safety, electromagnetic compatibility (EMC), thermal safety, software validation, and functional performance standards. The "study that proves the device meets the acceptance criteria" refers to a series of bench and non-clinical/preclinical tests designed to show that the new device performs comparably to the predicate device and meets relevant performance standards.
Let's break down what is available in the document related to your questions, and where specific requested information is not applicable or provided.
Acceptance Criteria and Reported Device Performance
The core "acceptance criterion" for a 510(k) submission is substantial equivalence to a predicate device. This is demonstrated by showing similar technological characteristics, intended use, and comparable safety and effectiveness. "Performance" here largely refers to meeting technical specifications and demonstrating similar tissue effects to the predicate, not clinical outcomes in patients.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category | Specific Criteria (Inferred from document) | Reported Device Performance / Method of Proof |
|---|---|---|
| Substantial Equivalence (Overall) | Demonstrate equivalent technology, performance, dimensions, intended use, and materials to predicate devices, and no new concerns of safety or effectiveness. | Extensive comparison to predicate ESG-400 (K141225) and reference devices (Covidien Valleylab FT10 K151649, Erbe VIO 300D K060484). Detailed comparison of output modes (monopolar cut/coag, bipolar cut/coag). Bench testing confirms comparable tissue effects and electrical waveforms. |
| Electrical Safety | Compliance with AAMI/ANSI ES 60601-1:2005/(R)2012 and IEC 60601-2-2:2017 Ed.6. | Design complies with recognized standards. Specifically, "ACTIVE ACCESSORY HF Dielectric Strength" testing per IEC 60601-2-2:2017 Ed.6, Clause 201.8.8.3.103 was repeated for PK Cutting Forceps with ESG-410. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Ed. 4.0:2014. | Design complies with recognized standards. FDA guidance "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices" was followed. |
| Thermal Safety | Compliance with recognized standards (implied, likely IEC 60601-1). | Design complies with recognized standards. "Maximum Temperature During Normal Use" testing per IEC 60601-2-2:2017 Ed.6, Clause 201.11.1.1 was repeated for PK Cutting Forceps with ESG-410. |
| Software Validation | Compliance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) for a "Major Level of Concern". | Software validation activities performed in accordance with the FDA Guidance. |
| Functional Performance (Electrosurgical Generator) | Same range of waveform outputs and power levels as predicate. Comparable tissue effects and electrical waveforms to predicate/reference devices across various modes. Usability, user interface, and risk assessment are acceptable. | Verification and validation tests; bench studies including electrical, dimensional, functional, stability tests. Preclinical (simulated use) evaluation and testing of tissue effects and thermal safety on three clinically relevant tissue types. Comprehensive validation bench tests confirmed comparable tissue effects for applicable modes. |
| Functional Performance (PK Cutting Forceps Compatibility) | Confirm compatibility with the new ESG-410 generator. | Basic compatibility testing conducted. Specific tests (HF Dielectric Strength, Maximum Temperature) repeated with ESG-410. |
| Biocompatibility | Not directly in patient contact for ESG-410; PK Cutting Forceps established in prior 510(k). | ESG-410 and accessories do not have direct/indirect patient contact; biocompatibility not required. For PK Cutting Forceps, established in K142759 per ISO 10993-1, no changes affecting biocompatibility. |
| Risk Management | Compliance with ISO 14971:2007. Residual risk evaluated as acceptable. | Risk analysis carried out according to internal acceptance criteria based on ISO 14971:2007. Use-related hazardous situations assessed. |
Detailed Responses to Specific Questions:
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A table of acceptance criteria and the reported device performance:
- See table above. The "performance" for this type of device is predominantly technical and functional performance against standards and predicate devices, not clinical effectiveness in terms of patient outcomes.
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Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not specify "sample sizes" in the typical clinical study sense for test sets of patients or cases. Instead, it refers to "bench studies" and "preclinical (simulated use) evaluation and testing of tissue effects." For tissue effects, it mentions "three clinically relevant tissue types were evaluated in all applicable modes." This implies material samples or ex-vivo tissue, not a patient cohort.
- Data Provenance: The tests are described as bench and preclinical (simulated use), conducted by the manufacturer (Olympus Winter & Ibe GmbH) and contract manufacturer (STEUTE TECHNOLOGIES GMBH & CO. KG), both located in Germany. There is no mention of country of origin of patient data as no clinical studies were deemed necessary. The studies were non-clinical/preclinical.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this submission. Ground truth, in the context of diagnostic AI or similar devices, is established by expert review (e.g., radiologists) for specific patient cases. This device is an electrosurgical generator. Its "ground truth" is its ability to adhere to technical specifications, produce specific electrical waveforms, and achieve desired tissue effects in a controlled, non-clinical environment, which is assessed through engineering and physical measurements. No human expert "ground truth" for a test set of medical images/cases is mentioned or relevant here.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in clinical studies where multiple readers interpret cases and their consensus/disagreement needs to be resolved to establish ground truth or compare diagnostic performance. This is a technical performance and safety submission for an electrosurgical device, not a diagnostic one.
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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, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices to assess how AI assistance impacts human reader performance. The ESG-410 is an electrosurgical generator, a surgical tool, and does not involve human "readers" interpreting images with or without AI assistance. Clinical and animal studies were explicitly stated as "not necessary."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The ESG-410 contains "software," and "software validation activities were performed." This implies standalone testing of the software's functionality, but not in the context of an "algorithm only" performance for things like diagnostic accuracy (e.g., a standalone AI imaging algorithm). For this device, standalone performance refers to its ability to generate the correct electrical outputs and control the surgical modes as programmed. This was part of the "non-clinical (electrical, dimensional, functional, stability)" testing.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on engineering specifications, physical measurements of electrical output waveforms, and qualitative/quantitative assessment of tissue effects in simulated environments (preclinical/bench testing). This is not a "ground truth" derived from human experts, pathology, or patient outcomes data, as no clinical studies were performed.
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The sample size for the training set:
- Not applicable/Not mentioned. This is not an AI/machine learning device that requires a training set of data for an algorithm to learn from in the typical sense (e.g., imaging data for a diagnostic algorithm). The software validation refers to standard software development life cycle processes, not machine learning model training.
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How the ground truth for the training set was established:
- Not applicable. As explained above, there's no "training set" in the context of machine learning for this device. Its software and functional parameters are designed and validated based on established engineering principles and performance standards for electrosurgical devices, rather than learned from a data set with pre-established ground truth labels.
In summary, the provided FDA 510(k) document details a substantial equivalence claim for an electrosurgical generator and its accessories. The "acceptance criteria" and "proof" provided are consistent with a regulatory pathway for electrical surgical devices, focusing on meeting established technical performance standards and demonstrating comparability to predicate devices through bench and preclinical testing, rather than extensive clinical studies or AI algorithm performance validation metrics typical for imaging diagnostics.
§ 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.