(230 days)
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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AUG 24 1391
American Immuno Tech
Neptune Waste Management System 510(k)
K990037
SECTION 5. 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Name, Address, Phone and Fax number of the Applicant: American Immuno Tech 320 Kalmus Drive Costa Mesa, CA 92626 Phone: 714-241-8431 Fax: 714-241-8435
Contact Person: Alan Davidner
Date Prepared: January 5, 1999
Device Name: Neptune Waste Management System
Device Description: 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.
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American Immuno Tech
Neptune Waste Management System 510(k)
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.
Intended Use: 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.
Substantial Equivalence: The Neptune Waste Management System is substantially equivalent in materials, design and intended use to a combination of the following 510(k) devices and 510(k) exempt devices: The Steris® SafeCycle 40, a fluid waste management system; the Niche Medical SmartVac™, a smoke evacuation system; the Dornoch Red>Away, an infectious fluid collection and disposal system; and the Stackhouse Biovac Laser Fume Evacuation System (K874512).
Performance testing: Testing was conducted on the Neptune Waste Management System to verify the ability of the Neptune Waste Management System to sterilize fluid medical waste, to verify the ability of the manifold inlet port valves to prevent reflux and to verify battery back-up and recharge.
Software Testing: Verification and validation testing was performed on the device software.
Electrical Safety Testing: The device design will be compliant with IEC 601.1 and UL 2601.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 1999
Ms. Esther Saltz American Immuno Tech 320 Kalmus Drive Costa Mesa, California 92626
K990037 Re : Neptune Waste Management System Trade Name: Requlatory Class: II Product Code: FYD Dated: May 24, 1999 May 26, 1999 Received:
Dear Ms. Saltz
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Ms. Saltz
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Direc tor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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American Immuno Tech
K990037 510(k) Number (if known):
Neptune Waste Management System Device Name:
The Neptune Waste Management System is intended to be Indications For Use: The Noptane wating Room, Pathology, Surgical Centers and Doctor's Offices to collect and sterilize surgical fluid waste as well as collect smoke generated from electrocautery or laser devices.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tarald C.kn
ion Sign-Off Division of Dental. Infection Control, and General Hospital Infection
and General Hospital Devices
510(k) Number _K 990037
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.