NEPTUNE WASTE MANAGEMENT STSTEM

K012991 · Stryker Instruments · FYD · Nov 29, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012991
• Device Name: NEPTUNE WASTE MANAGEMENT STSTEM
• Applicant: Stryker Instruments
• Product Code: FYD · General, Plastic Surgery
• Decision Date: Nov 29, 2001
• 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, Surgical Centers and Doctor's Offices to collect surgical fluid waste as well as smoke generated by electrocautory or laser devices.

Device Story

Neptune Waste Management System collects surgical fluid waste and smoke generated during electrocautery or laser procedures. Used in operating rooms, surgical centers, and doctor's offices by clinical staff. Device functions as a vacuum-based collection system for fluids and smoke, mitigating exposure to surgical waste. Benefits include improved environmental safety and waste management efficiency in clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Surgical exhaust apparatus; vacuum-based fluid and smoke collection system. Class II device (21 CFR 878.4400).

Indications for Use

Indicated for collection of surgical fluid waste and smoke generated by electrocautory or laser devices in operating rooms, surgical centers, and doctor's offices.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2001

Ms. Suzanne Velazquez Sr. Regulatory Representative Stryker Instruments Instruments Division 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K012991

Trade/Device Name: Neptune Waste Management System Regulation Number: 878.4400 Regulation Name: Apparatus, Surgical, Exhaust Regulatory Class: II Product Code: FYD Dated: August 21, 2001 Received: September 6, 2001

Dear Ms. Velazquez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 vir 1) vice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

{1}------------------------------------------------

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal states and regaraters, including, but not limited to: registration You must compry with an all not 100 s reg (21 CFR Part 801); good manufacturing practice. allu listing (21 CFR Pat 807), laceling (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 110(k) premarket notification. The FDA finding of substantial equivalence of your device to 310(k) premarket nouriewed.
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 regulation (21 CFR Part 801 IT you desire specific ad not 2017 - 10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and Office of Comphance at (301) as contact the Office of Compliance at [phone]. advertising or your the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under nother (210) It is it it it it is 6011).
the Act may be obtained from the Division of Small Manufacturers, International and the Act may be obtained from the DPHs. 63.000 638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timoth A. Uluturk

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

Page __ 1_ of ________________________________________________________________________________________________________________________________________________________________

## Indications for Use Statement

K 012991

510(k) Number

Device Names

Neptune Waste Management System

Indications

The Neptune Waste management system is intended to be used in The Neptune Waste Mailagent Centers and Doctor's Offices to the Operating Room, Burgical fluid waste as well as collect smoke concer and cropedectrocautory or laser devices.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use_

Clins. lin

(Division Sign-Off) (Division Sign-Uni)
Division of Dental, Infection Control,
Division of Dental, Infection Devices Division of General Hospital Dey 510(k) Number