(48 days)
The Valleylab Laparoscopic Handsets (models E2750, E2750T, E2751 and E2751T) and the Electrodes (models E2770 series, E2780 series, E2780R series and E2780R-ASP) are intended for use in those laparoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable.
The device is not intended to be used in endoscopic surgical procedures.
The Valleylab Laparoscopic Handsets referenced above are sterile, disposable devices, capable of delivering either electrosurgical cutting or coagulation currents, as well as irrigation and suction. They are for single use only, and are not to be resterilized.
The Valleylab Laparoscopic Electrodes referenced above are sterile, disposable electrodes. The Electrodes are offered in two lengths, 28 cm and 36 cm., and are designed for use with a 5 mm trocar cannula, or larger trocar cannulas with appropriate 5 mm adapters. The Electrodes are for single use only, and are not to be resterilized.
The provided text does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML medical device. Instead, it describes a traditional medical device (Valleylab Laparoscopic Handsets and Electrodes) and details its intended use, product description, and safety/performance characteristics related to biocompatibility and electrical testing.
Therefore, I cannot extract the requested information (such as reported device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies) as it is not present in the given text.
The text focuses on:
- Intended Use: Laparoscopic surgical procedures where electrosurgical current, irrigation, and suction are desired from a single handset.
- Product Description: Sterile, disposable handsets and electrodes for single use, capable of delivering electrosurgical cutting/coagulation, irrigation, and suction. Electrodes come in different lengths and are for use with 5mm (or larger) trocar cannulas.
- Safety and Performance (general statement): "Published studies indicate that laparoscopic and thoracoscopic electrosurgery is safe and effective in a variety of surgical procedures." (This is a general statement, not specific to a study on this particular device's performance against defined acceptance criteria).
- Biocompatibility Testing: Materials selected demonstrated appropriate biocompatibility, and patient contact components were tested according to USP Class V or ISO Standard 10993-1.
- Electrical Testing:
- High voltage breakdown: Handsets and electrodes passed testing at a minimum of 5200 volts RMS (60 Hz) for 60 seconds, exceeding AAMI HF18-1986 requirement of 3000 volts RMS.
- High Frequency Leakage Current: Electrodes confirmed to be well below the acceptable limit of 150mA (IEC Standard 601-2-2).
- High Frequency Breakdown: Designed to meet IEC Standard 601-2-2 and confirmed during product qualification.
None of this information pertains to an AI/ML device or its performance against specific clinical or analytical acceptance criteria.
§ 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.