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The Neptune Waste Management System is intended to be used in the Operating Room, Pathology, Surgical Centers and Doctor's Offices to collect and sterilize surgical fluid waste as well as evacuate smoke generated from electro-cautery or laser devices.

The Neptune Waste Management System (hereafter referred to as the Neptune System) collects and evacuates surgical fluid waste as well as smoke generated from lasers and electro-cautery devices. The Neptune System also provides its own independent suction capability, in lieu of wall suction, and can electronically measure fluid volume output. The Neptune System is a closed system. It replaces vacuum canisters and reduces the solid waste that is generated by the use of suction canisters.

The Neptune System includes two pieces of equipment; a Rover unit and the Docking Station. The Rover has an accessory, the Infrared Transmitter, to actuate the Rover's smoke evacuation capability.

The Rover incorporates a 20 liter basin for the collection of fluid waste and can evacuate smoke generated from electro-cautery and laser devices through a variety of disposable tubing kits. The Rover's basin features volume markings and a built-in electronic volume meter. The Rover's manifold can handle up to four suction lines. The Rover features a vacuum blower motor that is used to evacuate smoke. The vacuum blower motor can also be used as an independent source of suction.

The Docking Station's control panel incorporates three switches that allow for simple user interaction and control of the process. A series of voice alarms provides user instructions for ease of use.

The Infrared Transmitter attaches onto the power cord of a laser or an electrocautery device. When a laser or electro-cautery device is turned on, an infrared signal is sent that activates the Rover's smoke evacuation capability.

The provided text describes the Neptune Waste Management System, but it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI/ML performance.

Instead, the document focuses on:

• Device Description: What the Neptune System is, its components (Rover, Docking Station, Infrared Transmitter), and its functions (collects fluid, evacuates smoke, independent suction, electronic volume measurement).
• Intended Use: Where and how the device is meant to be used (Operating Room, Pathology, Surgical Centers, Doctor's Offices for fluid waste collection/sterilization and smoke evacuation).
• Substantial Equivalence: Listing predicate devices to which the Neptune System is deemed substantially equivalent.
• Performance Testing (General): Mentioning that testing was conducted to verify its ability to sterilize fluid medical waste, prevent reflux, and verify battery backup/recharge.
• Software Testing: Stating that verification and validation testing was performed.
• Electrical Safety Testing: Compliance with IEC 601.1 and UL 2601.
• Regulatory Approval: The FDA's 510(k) clearance letter.

Therefore, I cannot provide the requested information in the table or answer the specific questions related to AI/ML device performance, as this document pertains to a traditional, non-AI medical device from 1999.

If you have a different document describing an AI/ML medical device and its performance study, please provide that.

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