(28 days)
The Valleylab FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium.
The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.
The Valleylab™ FT10 Energy Platform (VLFT10) provides radio frequency (RF) energy for monopolar and bipolar surgical applications, and tissue-fusion and vessel-sealing applications (LigaSure/vesselsealing function). It is a combination of a full-featured general-surgery electrosurgical unit and a bipolar vessel sealing system. The monopolar and bipolar sections, including the LigaSure section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery. The LigaSure/vessel-sealing section of the system provides power for vessel sealing.
The VLFT10 is used in hospitals and other health care facilities where surgical procedures are carried out.
The VLFT10 can be used with a variety of legally marketed accessories including monopolar and bipolar instruments and a newly introduced bipolar adapter, footswitches, and return electrode pads. The VLFT10 connects to electrical mains and operates at an input line frequency of 47-63 Hz.
This document is a 510(k) premarket notification for the Valleylab FT10 Electrosurgical Platform, which is an electrosurgical generator. It describes modifications made to the device, primarily software updates, and the testing conducted to demonstrate that these changes do not affect the device's safety or performance.
However, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets criteria, in the context of an AI/ML-driven medical device. The document is for an electrosurgical platform, not an AI/ML device. Therefore, it does not include details about:
- A table of acceptance criteria and reported device performance (for AI/ML metrics like sensitivity, specificity, etc.)
- Sample sizes for test sets (in the context of image data)
- Data provenance (country of origin, retrospective/prospective)
- Number of experts and their qualifications for ground truth establishment
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth (pathology, outcomes, expert consensus for AI)
- Sample size for training sets
- How ground truth for training sets was established
Instead, the document focuses on engineering and performance characteristics of an electrosurgical device, such as:
- Safety and essential performance (IEC 60601-1, IEC 60601-2-2)
- Electromagnetic compatibility (IEC 60601-1-2)
- Ex vivo testing (using porcine tissue for thermal effects)
- System verification (non-IEC electrical, instrument compatibility, basic functionality)
- Software verification and validation (FDA guidance for software in medical devices)
- Usability testing (IEC 62366)
The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This further confirms that the type of study and data requested (which is typical for AI/ML device submissions) was not performed or required for this particular submission.
Therefore, I cannot extract the requested information from the provided text.
§ 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.