(83 days)
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No
The device description focuses on the physical characteristics, materials, and mechanical testing of a reusable sharps container. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a container for collecting contaminated sharps waste, not for treating or diagnosing medical conditions.
No
This device is a container for collecting contaminated disposable sharps, not a device used to diagnose medical conditions.
No
The device description clearly indicates it is a physical container made of linear low-density polyethylene, designed for the collection and disposal of sharps waste. It undergoes physical testing and has physical components like a lid and a needle unwinder.
Based on the provided information, the Sharps Plus 5 Gallon Reusable Container is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the collection of contaminated disposable sharps within healthcare settings. This is a physical containment and disposal function, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description focuses on the physical characteristics, safety features, and handling of the container for waste management. It does not describe any components or processes related to analyzing biological specimens for diagnostic purposes.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood, tissue, or any other biological sample to provide information about a patient's health or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases, monitor health, or screen for conditions. The Sharps Plus container serves a crucial role in healthcare safety and waste management, but it does not fit the definition of an IVD.
N/A
Intended Use / Indications for Use
The Sharps Plus 5 Gallon Reusable Container is used within healthcare settings for the collection of contaminated disposable sharps.
Sharps Plus 5 Gallon Reusable Containers are generally supplied to hospitals by medical waste transporters or medical treatment facilities.
Sharps Plus 5 Gallon Reusable Containers are used by healthcare providers at the point of disposal where potentially infectious sharps waste is generated.
Product codes
FMI
Device Description
The Sharps Plus 5 Gallon Reusable Container has a wall thickness of . 125", approximately twice the thickness of most single use primary sharps containers ( 07" to .05"). The testing data illustrates the highly resilies of linear low-density polyethylene. The container is molded rotationally by building up layers of plastic. Each container is equipped with a needleunwinder. Containers remain locked within the Wall Safe when in use within the healthcare facility. Keys are kept with housekeeping and unit nursing station.
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
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare settings, medical waste transporters and regional treatment facilities, healthcare providers
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
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Summary of Performance Studies
The Sharps Plus 5 Gallon Reusable Container meets and exceed the primary design characteristics needed to comply with the OSHA Bloodborne Pathogens Standard as well as the American Society for Testing & Maserials. Data for the following tests have been provided; Free Fall Drop (ASTM DS276-944), Stacking (49 CFR 173.465(d), Penetration (49 CFR 173.465(e), Vibration (49 CFR 173.608, Puncture (Health Devices 22). In each of these tests, the Sharps Plus container passed the test criteria.
Key Metrics
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Predicate Device(s)
BioSystem The Sharps I result sharps container.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Food and Drug Administration Center for Devices and Radiological Health Document Mail Center, HFZ-401 1390 Piccard Drive Rockville, MD 20850
Kg80179
APR 1 3 1998
Re: Sharps Plus 5 Gallon Reusable Container Rotonios Manufacturing Bensenville, IL
510(k) Summary
The Sharps Plus 5 Gallon Reusable Container is substantially equivalent to the BioSystem The Sharps I result sharps container. The Sharps Plus 5 Gallon Reusable Container meets and exceed the primary design characteristics needed to comply with the OSHA Bloodborne Pathogens Standard as well as the American Society for Testing & Maserials. Data for the following tests have been provided; Free Fall Drop (ASTM DS276-944), Stacking (49 CFR 173.465(d), Penetration (49 CFR 173.465(e), Vibration (49 CFR 173.608, Puncture (Health Devices 22). In each of these tests, the Sharps Plus container passed the test criteria.
The Sharps Plus 5 Gallon Reusable Container has a wall thickness of . 125", approximately twice the thickness of most single use primary sharps containers ( 07" to .05"). The testing data illustrates the highly resilies of linear low-density polyethylene. The container is molded rotationally by building up layers of plastic. Each container is equipped with a needleunwinder. Containers remain locked within the Wall Safe when in use within the healthcare facility. Keys are kept with housekeeping and unit nursing station.
The Sharps Plus 5 Gallon Rousable Container is marketed to medical waste transporters and regional treatment facilities, handling the destruction of infectious waste. The Sharps Plus 5 Gallon Reusable Container is used solely as a primary container when being shipped over the road. It is common for these facilities to have a unique waste dumping/loading configuration. The Sharps Plus 5 Gallon Reusable Contamer is designed to be opened, emptied and cleaned mechanically, as per the OSHA Bloodborne Pathogens Standard. As with the prodicate device the lid is designed to slide on and off the container via a tongue and groove track. A mechanical arm is used to slide the lid off of the container. Regional treatment facilities handling reusable medical waste are required to use automated container washers. Containers are washed to remove gross contamination and disinfected with a low-level disinfectant. A "Reuse Tracking Label" is used to track the number of cycles and the length of time, containers are used in the field. The Tracking Label is marked after each wash out cycle. After 12 months of use the containers are discarded.
The use of a "horizontal drop" lid opening reduces exposure to needles improperly discarded. Needles are less likely to be onented with the needle face up towards the opening. Other products on the market, such as Devon Industries, Sage Products and Becon Dickinson, all feature a horizontal drop lid opening. The containers are manufactured with natural linear lowdensity polyethylene and are semi-translucent. This makes viewing the waste level through the cabinet window easier.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 1998
Mr. Ed Krausse Divisional Vice President Rotonics Manufacturing, Incorporated 736 Birginal Drive Bensenville, Illinois 60106
Re : K980179 Sharps Plus Reusable 5 Gallon Sharps Trade Name: Container Requlatory Class: II Product Code: FMI Dated: January 8, 1998 Received: January 20, 1998
Dear Mr. Krausse:
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts_800 to 895. _ A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Krausse
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA assoirson in postantial 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 general 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
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for use:
510(k) Number: 980179
Device Name: Sharps Plus 5 Gallon Reusable Container
The Sharps Plus 5 Gallon Reusable Container is used within healthcare settings for the collection of contaminated disposable sharps.
Sharps Plus 5 Gallon Reusable Containers are generally supplied to hospitals by medical waste transporters or medical treatment facilities.
Sharps Plus 5 Gallon Reusable Containers are used by healthcare providers at the point of disposal where potentially infectious sharps waste is generated.
Qian S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number
DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrance of CDRH, Office of Device Evaluation (ODE)
Prescription Use Or Over the Counter Use