(448 days)
The ERBE ESU Model VIO dV with Accessories is intended to deliver High Frequency (HF) current for the cutting and/ or coagulation of tissue.
The ERBE ESU Model VIO dV with Accessories is an ElectroSurgical Unit that generates High Frequency (HF) electrical current to cut and/or coagulate tissue. The ESU has clearly defined Cutting and Coagulation Modes with different electrical waveforms and electrical parameters, which are programmed with defined Effect levels. The available Modes are Auto Cut, Dry Cut, Swift Coag, Forced Coag, and Bipolar Soft Coag with and without Auto Stop and BiClamp. Each Effect level corresponds to a specific voltage. The Modes provide the physician flexibility in interventional applications. Thus the Unit may be used for a broad array of surgical applications. The ESU user interface consists primarily of a touchscreen surrounded by a small number of physical controls, such as a power switch and connection points for the instruments and accessories with which the generator is compatible. Various hand instruments and neutral electrodes from ERBE and different manufacturers may be attached to and operated by the generator. The standard Accessories for the ESU consist of reusable Footswitches as well as Monopolar and Bipolar Cables. The VIO dV has a RCB (Remote Communication Bus) for remote control operation by the da da Vinci Xi Surgical System by Intuitive Surgical Inc.
The provided text describes a 510(k) premarket notification for the "ERBE ESU Model VIO dV with Accessories," an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance data.
Therefore, many of the requested sections below cannot be fully completed or are not applicable based on the provided text. The document states that "Animal or clinical performance testing was not considered necessary," which indicates that a detailed performance study as typically understood for AI/ML devices or novel medical devices with acceptance criteria was not performed.
Here's an attempt to extract and infer information where possible:
Acceptance Criteria and Device Performance Study Summary
The provided document, a 510(k) premarket notification, focuses on demonstrating substantial equivalence of the ERBE ESU Model VIO dV with Accessories (Software Version 3.1) to its predicate device (ERBE ESU Model VIO dV with Accessories, 510(k) Number K133180, and ERBE ESU Model 300 D with Accessories, 510(k) Number K083452). A formal, independent study with explicit acceptance criteria and corresponding reported performance metrics in the format typically seen for AI/ML or diagnostic devices is not detailed in this document.
Instead, compliance and equivalence are demonstrated through design control activities, verification and validation of software and hardware changes, and adherence to recognized consensus standards. The performance aspects discussed relate to the functional operation of the electrosurgical unit (ESU) in terms of its ability to deliver HF current for cutting and coagulation as specified, and the proper functioning of the BiClamp-Mode.
1. Table of Acceptance Criteria and Reported Device Performance
As a formal study with explicit acceptance criteria for a new AI/ML device was not conducted, this table cannot be populated as requested. The document indicates that tests were performed to show the ESU's BiClamp-Mode performs as specified and in accordance with the predicate device. The general "acceptance criteria" here implicitly refer to the device performing according to its design specifications and being substantially equivalent to the predicate.
| Criteria Category (Inferred) | Specific Acceptance Criteria (Inferred from Text) | Reported Device Performance (Inferred from Text) |
|---|---|---|
| Functional Equivalence | Device generates High Frequency (HF) electrical current for cutting and/or coagulating tissue, maintaining defined cutting and coagulation modes with specific electrical waveforms and parameters (Auto Cut, Dry Cut, Swift Coag, Forced Coag, Bipolar Soft Coag with and without AutoStop and BiClamp). | The device maintains the same intended use, basic technology, protective circuits, and uses the same basic accessories as the predicate. It has the same hardware design, energy source, user interface displays, and modes (Auto Cut, Dry Cut, Swift Coag, Forced Coag, Bipolar Soft Coag with and without AutoStop function). |
| Software Performance | Updated Software Version 3.1 for RCB remote control functions correctly with the da Vinci Xi Surgical System, activating HF and changing settings as intended. | Software validation for remote control functions has been carried out for VIO dV Software 3.1 as well as for the integrated system (VIO dV and da Vinci system). This implies successful verification that the software performs its intended remote control functions. |
| BiClamp-Mode Performance | The BiClamp-Mode performs as specified in the updated software 3.1 version and in accordance with the specifications of the predicate device ERBE ESU Model VIO 300 D. | Testing/measurement of the output parameters of the BiClamp-Mode was carried out. The statement "The BiClamp Mode performs as specified and in accordance with the specifications of the predicate device ERBE ESU Model VIO 300 D" indicates successful verification of this functionality. |
| Safety and Efficacy (General) | No new safety or efficacy issues compared to the predicate device. | Design control activities (planning, input, review, verification/validation, transfer, change control) were followed. The device complies with FDA's "Recognized Consensus Standards." The conclusion states, "There are no issues with the subject device that would raise additional safety or efficacy issues, when compared to the predicate devices." Implies that the device passed general safety and performance checks. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "testing/measurement of the output parameters of the BiClamp-Mode" and "software validation for remote control functions," implying internal testing. The specific number of test cases or samples for these internal verification and validation activities is not provided.
- Data Provenance: The testing appears to be internal verification and validation conducted by the manufacturer, ERBE Elektromedizin GmbH, in Germany. This would be considered prospective internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable to the type of testing described. The "ground truth" for an electrosurgical unit's performance typically refers to its physical output parameters matching design specifications, not expert interpretation of outputs or clinical outcomes from a diagnostic device.
4. Adjudication Method for the Test Set
- Not applicable as this was not an expert-based diagnostic study. The "adjudication" would involve comparing measured electrical output parameters against predefined engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not performed, nor was it considered necessary. The device is an electrosurgical unit, not an AI-assisted diagnostic or decision-making system where human reader improvement with AI would be relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This concept is not directly applicable in the context of an electrosurgical unit's performance evaluation as described. The software (version 3.1) enabling remote control was validated for its functionality (standalone as software, and integrated with the da Vinci system). The performance is inherent to the machine's operation, not an algorithm providing interpretations that a human might then use or act upon.
7. Type of Ground Truth Used
- The "ground truth" implicitly used for this device's performance validation is engineering specifications and verified electrical output parameters. For example, the BiClamp-Mode's output parameters were measured and compared against its specified performance and the performance of the predicate device (ERBE ESU Model VIO 300 D's specifications).
8. Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that "learns" from a training set. The software is deterministic and was developed and validated through traditional software engineering paradigms.
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.