(20 days)
The ERBE ESU Model VIO 200 S is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.
The ERBE ESU Model VIO 200 S is an ESU that uses High Frequency (HF) electrical current waveforms to cut and/or coagulate tissue. It has a display as well as various cutting and coagulation modes with defined effect levels to provide the physician flexibility in interventional applications (i.e. its ability to generate the HF current). The system has automatic start and stop features. The equipment is programmable and various accessories (e.g. footswitches, hand instruments, etc.) as well as modes may be assigned to perform specific functions. When activated, the device has an audio as well as a visual erroring system (i.e. malfunctions or user errors are detected with medical personnel being alerted visually and/or by sound with, in some cases, no energy being delivered.). Also, the ESU can be used in association with an ERBE compatible Argon Plasma Coagulator (APC). The unit is supplied non-sterile and is reusable.
The provided text is a 510(k) summary for an electrosurgical unit (ESU). This type of device is an electrical instrument used in surgery for cutting and coagulating tissue. The review process for such devices, especially special 510(k)s, focuses on demonstrating substantial equivalence to a predicate device. This typically involves comparing technical specifications and performance data, often through bench testing and electrical safety/EMC testing, rather than clinical studies with human subjects or AI performance metrics.
Therefore, many of the requested categories for AI-based medical devices are not applicable to this submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Deliver HF electrical current for cutting/coagulation. | "The ERBE ESU Model VIO 200 S is intended to deliver high frequency electrical current for the cutting and/or coagulation of tissue." (Identical to predicate) |
| Protective Circuits: Same as predicate. | "The modified ESU... has the same... protective circuits." |
| Basic Accessories: Uses same basic accessories as predicate. | "The modified ESU... uses the same basic accessories." |
| Modes of Operation: Presence and functionality of specified modes. | Common modes (Auto Cut, Endo Cut Q, Endo Cut I, Soft Coag, Forced Coag, Bipolar Soft Coag with/without Auto Stop, APC modes) are present, but some have power limitations compared to the predicate. |
| User Interface: Functional display for mode/power selection. | Has a display with LEDs for effect/wattage settings. User-friendly interface, though no on-screen tutorial. |
| Programmability: Adequate programming capabilities. | 9 program possibilities (less than predicate's 99), deemed "adequate" and less confusing. |
| Error Monitoring: Audio and visual error system. | Has "audio and visual error monitoring." |
| Compatibility with APCs: Functions with ERBE compatible APCs. | "Can be used in association with an ERBE compatible Argon Plasma Coagulator (APC)." |
| Max Wattage: Adequate for intended use. | Maximum 200 watts (less than predicate's 300 watts), deemed "more than adequate." |
| Power Delivery: Delivers only necessary power in Cut/Coag modes. | "Still only delivers the amount of power needed" in Cut and Coag Modes. |
| Safety and Efficacy: No adverse effect from modifications. | "The changes did not raise safety or efficacy concerns nor adversely affect safety or effectiveness." |
| Effectiveness: Efficient unit. | "The modified ESU is an efficient unit." |
Study Proving Acceptance Criteria:
The document describes a "Special 510(k)" submission. This type of submission relies heavily on demonstrating substantial equivalence to a legally marketed predicate device (ERBE VIO ESU Model VIO 300 D, K060484). The "study" proving the device meets acceptance criteria is primarily a comparative analysis of technical specifications and performance data against the predicate device, supported by verification and validation activities.
The statement "all the changes were verified or validated" implies that internal testing was conducted to ensure the modified device performs as expected and meets its design specifications, consistent with established quality system procedures for medical device manufacturing. This would include testing related to electrical safety, electromagnetic compatibility (EMC), general performance (e.g., power output accuracy, current waveform characteristics), and the functionality of various modes.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of human data. For bench testing and engineering verification, the "sample size" would relate to the number of units tested, the number of test runs, or the range of parameters evaluated. This information is not detailed in the 510(k) summary.
- Data Provenance: The device is manufactured by ERBE Elektromedizin GmbH in Germany. The verification and validation activities would likely have been conducted internally by the manufacturer. This is an engineering/bench testing assessment, not a clinical study involving patients or human data in the traditional sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. For a device like an electrosurgical unit, "ground truth" is typically defined by engineering specifications, safety standards (e.g., IEC 60601 series for medical electrical equipment), and established performance metrics for HF energy delivery. Experts involved would be engineers, electrical safety specialists, and possibly medical professionals advising on clinical requirements, but not establishing a "ground truth" for diagnostic accuracy.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes where discrepancies need resolution. This submission focuses on technical equivalence and safety/performance characteristics verified through engineering testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is used to assess the diagnostic accuracy or effectiveness of a system (often an imaging system or AI algorithm) by comparing independent interpretations from multiple readers across multiple cases. This is not relevant for an electrosurgical unit.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
- Not applicable. The ERBE ESU Model VIO 200 S is an electromechanical device, not an AI algorithm. Its performance is inherent in its hardware and software design for delivering HF current, not derived from an AI model.
7. The Type of Ground Truth Used
- The "ground truth" for this medical device's performance is based on engineering specifications, international safety standards (e.g., IEC), and the documented performance of the predicate device. Verification and validation activities would confirm that the device meets these pre-defined technical criteria (e.g., output power within tolerance, impedance recognition, safety features functioning).
8. The Sample Size for the Training Set
- Not applicable. This device does not employ an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no AI algorithm or training set, this question is irrelevant to the device described.
§ 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.