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The BOVIE Model X40 Electrosurgical Generator is Indicated for Use in laparoscopic surgical procedures for the cutting and coagulation of human tissue.

The BOVIE Model X40 can be used in conjunction with the appropriate accessories and instruments for applications in:

General Surgery
Gynecology
Urology
Gastroenterology

For more than 50 years, high-frequency (HF) surgery has been used to cut and/or coagulate biological tissue using the intrinsic thermal effect of electric current. Berchtold has produced a state-of-the-art electrosurgical generator for international distribution. The BOVIE Model X40 represents one of the latest of these instruments. It is based upon Berchtold's long standing commitment to the provision of high quality surgical equipment and is produced in accordance with established international standards for such instruments.

In order to protect the patient and user from inadvertent injury from the use of this instrument it is provided with several safety features. These include:

Self checking software which performs an automatic safety check each time the instrument is turned on.

Real time, continuous monitoring of the patient contact with the neutral electrode.

Automatic detection of the use of split or single plate neutral electrode.

Automatic monitoring of HF leakage current and non-programed output.

Automatic detection and display of malfunction.

State-of-the-art control panel with audio (spoken) verification of unit function and confinmation of foot or finger switch activation.

Automatic cut-off to prevent excess tissue over-heating and electrode sticking.

Automatically adjusted output to ensure the cutting power is maintained at the minimum level required to effect the cut as tissue characteristics or electrode geometry change.

The provided text is a 510(k) premarket notification for an electrosurgical generator (BOVIE Model X40), not an AI/ML medical device. Therefore, it does not contain the specific information requested about acceptance criteria and studies related to AI/ML performance.

The document primarily focuses on:

• Device Description: High-frequency electrosurgical generator for cutting and coagulating tissue.
• Safety Features: Self-checking software, continuous patient contact monitoring, automatic detection of neutral electrode type, HF leakage monitoring, malfunction detection, audio verification, automatic cut-off for overheating, and automatically adjusted output.
• Intended Use: Laparoscopic surgical procedures (cutting and coagulation) in General Surgery, Gynecology, Urology, and Gastroenterology.
• Regulatory Information: Substantial equivalence determination by the FDA to a predicate device marketed before May 28, 1976.

Since the device is an electrosurgical generator and not an AI/ML diagnostic or prognostic tool, the concepts of "acceptance criteria for AI performance," "sample sizes for test/training sets," "ground truth establishment by experts," "adjudication methods," or "MRMC studies to compare human readers with/without AI" are not relevant to this submission.

The "safety features" listed in the summary statement act as the implicit "acceptance criteria" for this device, which are validated through general electrical safety and performance testing typically required for such devices (e.g., IEC 60601 series standards), though these specific tests are not detailed in the provided excerpt beyond a general statement that "test results obtained and included in this 510(k) Notification demonstrate that the BOVIE Model X40 is safe and effective."

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