NEPTUNE WASTE MANAGEMENT SYSTEM

K990037 · American Immuno Tech · FYD · Aug 24, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990037
• Device Name: NEPTUNE WASTE MANAGEMENT SYSTEM
• Applicant: American Immuno Tech
• Product Code: FYD · General, Plastic Surgery
• Decision Date: Aug 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5070
• Device Class: Class 2

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.

Device Story

Neptune Waste Management System collects/sterilizes surgical fluid waste and evacuates surgical smoke. System comprises Rover unit and Docking Station. Rover features 20L basin, volume markings, electronic volume meter, and vacuum blower motor for suction/smoke evacuation. Infrared Transmitter attaches to laser/electro-cautery power cords; triggers smoke evacuation automatically upon device activation. Manifold supports up to four suction lines. Docking Station provides control interface and voice alarms. Used in OR, pathology, surgical centers, and doctor's offices by clinical staff. Closed system design replaces traditional vacuum canisters, reducing solid waste. Provides independent suction capability. Healthcare providers use volume data for fluid monitoring; system automates waste management process, improving OR safety and efficiency.

Clinical Evidence

No clinical data. Performance testing conducted to verify sterilization of fluid medical waste, manifold inlet port valve efficacy in preventing reflux, and battery back-up/recharge functionality. Software verification and validation testing performed.

Technological Characteristics

Closed system; 20L basin; vacuum blower motor; infrared transmitter for remote actuation; electronic volume meter; voice alarm system. Electrical safety compliant with IEC 601.1 and UL 2601. Sterilization capability for fluid waste.

Indications for Use

Indicated for use in operating rooms, pathology labs, surgical centers, and doctor's offices for the collection and sterilization of surgical fluid waste and the evacuation of smoke generated by electro-cautery or laser devices.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Stackhouse Biovac Laser Fume Evacuation System (K874512)

Reference Devices

• Steris SafeCycle 40
• Niche Medical SmartVac
• Dornoch Red>Away

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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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)