(58 days)
The SnapEvac and PenAdapt is an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed. This device is considered an accessory to an electrosurgical unit (ESU). SnapEvac and PenAdapt removes surgical smoke during surgical procedures that use ESU for cutting and cauterizing. This device is used in conjunction with a suction (vacuum) source.
Contraindications: This device should not be used for microsurgery.
The PlumePen® Elite, PlumePen® Ultra, and PlumePen® Pro is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Indicated for use to remove smoke plume from the surgical site and to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect.
The smoke evacuation devices that are the subject of this 510(k) are PlumePen Surgical Smoke Evacuation Pencils (Elite, Pro and Ultra), PenAdapt Electrosurgical Pencil Adapters and Electrosurgical Pencil Adapters. By interfacing with an effective smoke evacuation unit, these devices function as part of the system to remove smoke particles from the point of surgical activity during procedures that use an electrosurgical unit (ESU) for cutting and cauterizing.
PlumePen Smoke Evacuation Pencils: The PlumePen® Elite, Pro, and Ultra family of devices are sterile, single use electrosurgical hand pieces featuring an integrated smoke evacuation channel. The devices, when connected to an electrosurgical generator and smoke evacuation system are designed to remove smoke plume generated during the use of the pencil for electrosurgical procedures.
PenAdapt and SnapEvac Electrosurgical Pencil Adapters: PenAdapt and SnapEvac are sterile, single use pencil adapters which fit over standard electrosurgical pencils while keeping the blade exposed. They enable the capture and removal of smoke generated during the use of the pencil, in procedures that require cutting and cauterization, when connected to an effective smoke evacuation system.
The provided text describes the 510(k) premarket notification for electrosurgical accessories (PlumePen Surgical Smoke Evacuation Pencils, PenAdapt, and SnapEvac Electrosurgical Pencil Adapters). The purpose of this notification is to demonstrate substantial equivalence to legally marketed predicate devices.
However, the request asks for specific details related to acceptance criteria and a study proving a device meets acceptance criteria, specifically in the context of an AI/ML-driven medical device. The provided document details the testing for electrosurgical tools to demonstrate functional equivalence and safety, not the performance of an AI/ML diagnostic or assistive device.
Therefore, the information required to answer the prompt (acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert roles, adjudication methods, MRMC study details, standalone performance, ground truth types, etc.) is not present in the provided text. The document refers to standard medical device testing such as functionality verification (e.g., 90% smoke capture), electrical safety, biocompatibility, sterilization validation, and packaging validation, which are applicable to physical electrosurgical devices, not AI/ML algorithms.
My response will acknowledge that the requested information is not available in the provided document, as it pertains to a different type of medical device evaluation (AI/ML vs. physical electrosurgical tools).
§ 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.