(54 days)
The AUTOCON III 400 is intended for use by qualified surgeons to provide a high frequency electrical current for monopolar and bipolar cutting and coagulation of tissue structures during surgical operations.
The AUTOCON III 400 is an electrosurgical unit (ESU) that generates High Frequency (HF) electrical current to cut and/or coagulate tissue. AUTOCON III 400 offers a total of 37 different modes that can be divided into 4 main categories: Monopolar cutting (13 modes), monopolar coagulation (11 modes), bipolar cutting (4 modes), and bipolar coagulation (9 modes). The various modes in each category represent different settings that provide controlled cutting and coagulation. Each mode can be defined by the waveform type, power, crest factor, and duty cycle which correspond to different tissue effects. AUTOCON III 400 consists of a generator, a foot switch, and a power cord. A touchscreen user interface displays the connection status of accessories and peripherals and allows the user to select modes, power settings, effect, and various other settings. AUTOCON III 400 has a bipolar socket, a monopolar socket, and neutral electrode socket for the instruments and accessories with which the generator is compatible. Contact quality indicators are displayed to indicate if the neutral electrodes are correctly connected or not.
The KARL STORZ Endoscopy-America, Inc. AUTOCON III 400 is an electrosurgical generator designed for monopolar and bipolar cutting and coagulation of tissue during surgical operations. The submission focuses on non-clinical performance data to demonstrate substantial equivalence to its predicate devices.
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a tabulated format for direct comparison of numerical thresholds. Instead, it details the type of non-clinical tests performed and concludes that the device performed comparably to its predicate devices. The study aimed to demonstrate substantial equivalence, meaning the AUTOCON III 400 performs as safely and effectively as the predicate devices. The reported performance is an affirmation of compliance with recognized standards and comparable results in bench testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | In compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. |
| Electromagnetic Compatibility (EMC) | In compliance with IEC 60601-1-2. |
| Performance Testing (Bench Top) | Comparative verification testing performed per FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued on August 15, 2016." |
| ESU Technical Specifications | Output Waveform at the rated load was tested. |
| ESU Power Output | Power Output at maximum and half-of-maximum intensity over the range of expected loads was tested. |
| Miscellaneous Components/Accessories | Functional testing of accessories was conducted. |
| System Testing | Thermal Effects on Tissue (liver, kidney, muscle) were observed. Contact Quality Monitoring (CQM) was tested. Testing confirmed that comparable tissue effects and electrical waveforms could be achieved for all modes of operation. |
| Conclusion of Equivalence | The non-clinical tests demonstrated that the subject device is as safe as and as effective as the predicate devices. Differences between the subject and predicate devices do not raise new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench-top testing and does not specify a numerical sample size for the "test set" in terms of patient data or clinical cases. The testing was focused on the device itself and its interaction with proxy materials (e.g., tissue samples like liver, kidney, muscle).
- Data Provenance: The data is based on non-clinical, bench-top testing performed by the manufacturer, KARL STORZ Endoscopy-America, Inc. The document does not specify the country of origin of the data beyond the manufacturer's location in El Segundo, CA, USA, and the regulatory body (FDA) in the USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This was a non-clinical, bench-top study evaluating the technical performance and safety of an electrosurgical unit against regulatory standards and predicate devices, not a study requiring expert clinical ground truth on patient outcomes or diagnoses.
4. Adjudication Method for the Test Set:
Not applicable. Since there was no clinical data or assessment by human readers/experts for a diagnostic or treatment outcome, no adjudication method was used. The evaluation was based on objective measurements and comparison to recognized standards and predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The AUTOCON III 400 is an electrosurgical generator, and its evaluation focused on electrical safety, electromagnetic compatibility, and bench-top performance, not on interpretation by human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone study was performed in the sense that the device's performance was evaluated based on its technical specifications and physical effects, without direct human intervention in the "performance" during the tests outside of operating the device for the bench tests. The tests assessed the device's output, waveform, power, and thermal effects on tissue, which are intrinsic properties of the algorithm/hardware. This was a "device-only" performance assessment in a controlled bench setting.
7. Type of Ground Truth Used:
The "ground truth" for this study was established through:
- Compliance with recognized electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
- Comparison to the performance of legally marketed predicate devices (AUTOCON II 400 and ERBE VIO 300D) as defined by the FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery."
- Objective measurements of technical specifications (e.g., output waveform, power output, thermal effects on tissue) to demonstrate "comparable tissue effects and electrical waveforms" to the predicate devices.
8. Sample Size for the Training Set:
Not applicable. This device is an electrosurgical generator, not an AI/ML-based device that typically requires a training set of data. The "design" and "settings" of the device are based on engineering principles and intended surgical effects, not on learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set was used for this type of medical 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.