(372 days)
Rehrig Healthcare Systems reusable 17 gallon sharps container is intended to be used for the collection and transportation of used medical sharps. The container is intended to be used in hospitals and clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.
Sharps Tank Reusable Sharps Container, Device Part Number: MW009. Empty Weight: 9.4 lbs, Color: Red with contrasting Biohazard Symbol, Dimensions: 20.00"L x 12.50"W x 25.8"H. Opening Dimensions: Main lid opening (approximate) - 18.00" x 10.7", Sub-lid opening (approximate) - 8.0" x 6.0". Both the main lid and sub-lid have temporary and final closures. Temporary closures are intended to allow opening and closing of the container by the user and to protect against spillage if toppled. The final closure is designed to secure the container during transport.
The provided text is a 510(k) cleared letter from the FDA for a reusable sharps container. It does not contain any information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.
The document is a regulatory approval letter, confirming that the "Sharps Tank Reusable Sharps Container" is substantially equivalent to a legally marketed predicate device. It specifies the intended use, physical characteristics of the device, and regulatory information.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device meets acceptance criteria based on the provided input.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Mr. David Olmstead Principal/Founder Rehrig Pacific Company 614 Hunters Lane Brentwood, Tennessee 37027
APR 2 5 2012
Re: K111085
Trade/Device Name: Sharps Tank Reusable Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Sharps Container Regulatory Class: II Product Code: MMK Dated: April 24, 2012 Received: April 25, 2012
Dear Mr. Olmstead:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device 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.
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Page 2- Mr. Olmstead
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem /default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, P.S.
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: K111085
Device Name: Sharps Tank Reusable Sharps Container
Device Part Number: MW009
Indications for Use Statement:
Rehrig Healthcare Systems reusable 17 gallon sharps container is intended to be used for the collection and transportation of used medical sharps. The container is intended to be used in hospitals and clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.
Empty Weight: 9.4 lbs
Color: Red with contrasting Biohazard Symbol
Dimensions: 20.00"L x 12.50"W x 25.8"H
Opening Dimensions:
Main lid opening (approximate) - 18.00" x 10.7"
Sub-lid opening (approximate) - 8.0" x 6.0"
Both the main lid and sub-lid have temporary and final closures. Temporary closures are intended to allow opening and closing of the container by the user and to protect against spillage if toppled. The final closure is designed to secure the container during transport.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth P. Clavie-Willie
Division Sign-Off) ivision of Anesthesiology, General Hospital fection Control, Dental Devices
KILI 085 510(k) Number:
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).