(10 days)
The DGSS™ is intended to be used for the scavenging of waste anesthetic gases from anesthesia machines used during the provision of general anesthesia to adults and children.
The DGSSTM is a single unit, designed to replace a traditional anesthetic gas scavenging (interface) assembly, located between the exhaust outlet of an anesthesia machine and the waste anesthetic gas disposal (WAGD) suction line in an operating room. Like prior technology, it provides a safe interface between anesthesia delivery systems and hospital-provided WAGD suction lines, The DGSS™ is intended to be used for the scavenging of waste anesthetic gases from anesthesia machines used during the provision of general anesthesia to adults and children. The DGSS™ incorporates the same safety systems as predicate devices, providing relief of excess positive pressure and excess negative pressure to the patient through the use of "pop-off" relief valves, in compliance with ASTM 1343-02 - Anesthetic Equipment - Scavenging Systems for Anesthetic Gases. Although the indications and intended use are identical with predicate devices, the DGSS™ replaces the manually-adjusted needle valve with an automatic mechanism regulating the flow in the WAGD suction line. This valve is controlled by a pressuresensing switch which closes the valve when negative pressure is sensed in the manifold. This serves to reduce the needless entrainment of room air into the WAGD system of the healthcare facility. This sensor-valve arrangement operates within the inlet pressure range of -0.5 to 3.5 cm H2O, as specified by ASTM 1343-02 The valve-sensor mechanism is electrically powered with low-voltage direct current to prevent any hazard of electrical or fire injury in compliance with IEC 60601-1. The valve is normally open, so that a failure of electrical power results in the unit reverting to function identically to the predicate device. Other failure modes operate identically with the predicate device. Although the electrical portion of the device section presents no hazard of spark or fire, additional protection is provided by physically separating the electrical system from the waste gas pathway. This isolates the electrical subsystem from exposure to any oxygen-enriched waste anesthetic gas. Although technologically more advanced and efficient than the predicate device, the DGSS™ presents no additional issues of safety or efficacy due to its design. Any failure of the new design feature converts the device to one identical to predicate technology. Due to this design, the DGSS™ is substantially equivalent to the predicate device.
The provided text is a 510(k) summary for a medical device called the Dynamic Gas Scavenging System (DGSSTM). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The text focuses on demonstrating that the DGSSTM is substantially equivalent to a previously cleared predicate device (Ohio Waste Gas Scavenging Reservoir, K842003) by highlighting its similar indications for use and safety systems, while noting an improvement in efficiency through an automatic flow regulation mechanism. The key argument for substantial equivalence is that any failure of the new design feature causes the device to revert to the exact function of the predicate device.
Therefore, I cannot provide the requested table and study details based on this input. The information provided is primarily for regulatory clearance based on substantial equivalence, not a performance study against specific acceptance criteria.
§ 868.5430 Gas-scavenging apparatus.
(a)
Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.(b)
Classification. Class II (performance standards).