SHARPS PLUS 5 GALLON SHARPS CONTAINER by ROTONICS MFG., INC.

Sharps Plus 5 Gallon Reusable Containers are used by healthcare providers at the point of disposal where potentially infectious sharps waste is generated.

Device Description

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 Contamer 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.

AI/ML Overview

The provided document is a 510(k) summary for the Sharps Plus 5 Gallon Reusable Container, which is a medical device for the collection of contaminated disposable sharps. The document focuses on establishing substantial equivalence to a predicate device and demonstrating compliance with relevant standards through testing.

Here's an analysis of the acceptance criteria and study information contained in the document, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria (Standard Reference)	Reported Device Performance
Free Fall Drop	ASTM D5276-94	Passed the test criteria
Stacking	49 CFR 173.465(d)	Passed the test criteria
Penetration	49 CFR 173.465(e)	Passed the test criteria
Vibration	49 CFR 173.465(f)	Passed the test criteria
Puncture	Health Devices 22 (?)	Passed the test criteria

Note: The document states that the Puncture test reference is "Health Devices 22". This is a less common standard reference than ASTM or CFR and its full title or specific criteria are not detailed in the provided text.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact number of containers tested for each individual test (Free Fall Drop, Stacking, Penetration, Vibration, Puncture). It only states that "Data for the following tests have been provided" and "In each of these tests, the Sharps Plus container passed the test criteria."
Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. Given it's a 510(k) submission to the FDA, it's highly likely the tests were conducted in the US (or according to US-recognized standards) and were prospective, specifically for this device's approval.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this document. The "ground truth" for the performance of a physical device like a sharps container is established by standardized engineering and material tests, not by expert consensus on clinical observations or images. The "experts" in this context would be the engineers and technicians performing the tests according to the specified ASTM or CFR standards. Their qualifications are assumed to be appropriate for conducting these technical tests.

4. Adjudication Method for the Test Set

This is not applicable to this type of device and testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving image interpretation or clinical outcomes where there might be disagreements among observers. For a physical device undergoing standardized performance tests, the outcome is typically a pass/fail based on objective measurements against predefined criteria, not an adjudication of human interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., radiology AI tools), to assess the impact of the device on human reader performance. It is not applicable to a physical sharps container.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a broad sense, standalone performance was assessed. The "device" in this context is the physical container, and its performance was evaluated in isolation through the listed engineering tests (Free Fall Drop, Stacking, Penetration, Vibration, Puncture). These tests measure the container's inherent physical properties and ability to meet safety standards without direct human intervention during the test itself (though humans operate the testing equipment). This is analogous to "algorithm only" performance in that it evaluates the device's intrinsic capabilities.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective measurements against established engineering and safety standards. These standards (ASTM D5276-94, 49 CFR 173.465(d), 49 CFR 173.465(e), 49 CFR 173.465(f), and "Health Devices 22") define the physical limits and conditions the container must withstand to be considered safe and effective for its intended use. The "pass" result indicates the device met these objective, pre-defined criteria.

8. The Sample Size for the Training Set

This is not applicable. The Sharps Plus 5 Gallon Reusable Container is a physical medical device, not an AI, machine learning, or software-based device that requires a "training set" of data. Its design and manufacturing are based on engineering principles and material science, not statistical models trained on data.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as #8. There is no training set for this type of device.

Summary

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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 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.

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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

Regulation Number and Section

§ 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).