(84 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is a waste management system designed to collect surgical fluid waste and smoke, which are functions related to cleanliness and safety in a surgical environment, not direct treatment or diagnosis of a medical condition.
No
The device is a fluid and smoke collection system, designed to manage waste during surgical procedures. It does not provide information for diagnosing a condition or disease.
No
The description clearly states the device is a "Waste management system" intended to "collect surgical fluid waste as well as collect smoke generated by electrosurgical or laser devices." This functionality inherently requires physical hardware components for collection and management, not just software.
Based on the provided information, the Neptune Waste Management System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to collect surgical fluid waste and smoke generated during surgical procedures. This is a physical process of waste management within a clinical setting.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This is the core function of an IVD.
- Device Description (Not Found): While the description is missing, the intended use clearly points away from diagnostic testing.
- No Mention of Biological Samples: The device collects surgical fluid waste and smoke, which are byproducts of a procedure, not samples intended for diagnostic analysis.
Therefore, the Neptune Waste Management System falls under the category of a surgical waste management device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 collect smoke plume created by electrosurgery or laser devices.
Product codes
FYD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating Room, Surgical Centers and Doctor's Offices
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 (301) 594-4618. Additionally, for questions on the promotion and Office of Comphance at (301) as contact the Office of Compliance at (301) 594-4639. 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 (301) 443-6597 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
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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