(27 days)
MultAchoice Scissor Instrument: The MultAchoice Scissor may be used in a variety of endoscopic procedures. This device is designed for cutting or transecting tissue. It is fully autoclavable. The insulated shaft of this device has a 5mm OD and a 31cm working length. This shaft may be rotated 360° independent of the instrument handle, thereby permitting increased visibility and access to desired structures. The MultAchoice Scissor has been fitted with a standard banana plug to accept a monopolar connecting cable (not included) for electrosurgery.
MultAchoice Grasper Instrument: The MultAchoice Grasper may be used in a variety of endoscopic procedures. This device is designed for grasping and manipulating tissue. It is fully autoclavable. The insulated shaft of this device has a 5mm OD and a 31cm working length. This shaft may be rotated 360° independent of the instrument handle, thereby permitting increased visibility and access to desired structures. The MultAchoice Grasper has been fitted with a standard banana plug to accept a monopolar connecting cable (not included) for electrosurgery.
MultAchoice Dissector Instrument: The MultAchoice Dissector may be used in a variety of endoscopic procedures. This device is designed for blunt dissection, temporary grasping, and manipulation of tissue. It is fully autoclavable. The insulated shaft of this device has a 5mm OD and a 31cm working length. This shaft may be rotated 360° independent of the instrument handle, thereby permitting increased visibility and access to desired structures. The MultAchoice Dissector has been fitted with a standard banana plug to accept a monopolar connecting cable (not included) for electrosurgery.
The MultAchoice™ Instruments are a set of reusable and configurable instruments consisting of a Handle, Insulated Shaft, and Instrument Insert that comprise a Laparoscopic Scissor, Grasper, and Dissector.
The provided text does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.
The document is a 510(k) summary for the MultAchoice™ Instruments, which are laparoscopic scissors, graspers, and dissectors. It describes the device, its intended use, and its substantial equivalence to a predicate device. The key difference highlighted is the additional capability of the MultAchoice™ Instruments being reusable, as opposed to the predicate device which was likely single-use.
The FDA's response letter confirms the substantial equivalence determination.
Therefore, none of the requested information regarding acceptance criteria, study design, or performance metrics can be extracted from this text. This particular submission appears to be focused on demonstrating equivalence based on design and intended use, rather than a clinical performance study with specific metrics.
§ 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.