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The Demis Two Gallon Sharps Containers are designed for use in areas with controlled access such as labs and pharmacies. They contain features for both temporary and final closure. The Bemis Two Gallon Sharps Containers have a volume of 6 qt. and weigh 1 lb. 2 oz. with dimensions of 8.5"II x 11.5"W x 7.6"D. Two Gallon Sharps Containers are injection molded of polypropylene plastic and are available in translucent red and beige. These containers are NOT reusable. Bemis Two Gallon Sharps Containers are puncture resistant with integral sidewalls and bottom and have a typical wall thickness of .070". The containers are leakproof on the sides and bottom. The Two Gallon Sharps Containers are labeled with the Biohazard warning symbol that is 1½" in height. The label color is orange-red, with lettering and symbol in contrasting color in accordance with OSIIA regulations. The labels are attached directly to the conor in accordance will of a promanent adhesive. The labels boldly indicate fill level of shree-quarter capacity. Bemis Two Gallon Sharps Containers are translucent with clear lids, therefore, allowing visibility at all levels. The Demis Two Gallon Sharps Container is designed for use in areas with controlled access. There is no limitation to hand access for this container as the opening is designed to accept other objects such as butterfly needles, test tubes and vials. Following final closure, the container remains closed during normal handling. There are no features to bend, break, or shear the needle. The lid also incorporates a "needle key" which can be used to unscrew needles from blood collection tube holders. Two Gallon Sharps Containers lock on wall mounted brackets. A key that is unique to this bracket is used to unlock containers from the bracket. The containers are shipped in two pieces and require assembly by the user. Instructions are included in every case.
Here's a breakdown of the requested information based on the provided 510K Summary for the Bemis Two Gallon Sharps Container:
This document describes a physical medical device (sharps disposal container) rather than a software-based AI/ML device. Therefore, many of the requested fields related to AI/ML studies, ground truth, and expert evaluation are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Source) | Reported Device Performance |
|---|---|---|
| Puncture Resistance | "...the average puncture force for the sharps contact areas of each region of nominal uniform thickness of the container shall not be less than 3.4 lb./ft. with no one value less than 2.8 lb./ft." (ASTM proposed standard, according to ECRI Puncture Resistance criteria). Additionally, Bemis internally set a critical wall thickness of .055" (rejecting parts below this) to ensure compliance, though .050" would pass the test. | Testing was done on the Bemis Two Gallon Sharps Containers using this standard. All wall thicknesses of .050" will pass the puncture tests, however, Bemis will reject any parts with wall thicknesses less than .055". (This implies the device meets the 3.4 lb./ft. average and 2.8 lb./ft. minimum requirement.) |
| Leak Resistance | "...there shall be no leakage of the contents over a 24 hour period when filled with water and positioned in an upright position." (ECRI Health Devices Leak Resistance criteria) | The Bemis Two Gallon Sharps Containers passed this requirement when tested using this method. |
| Overfill Warning | Contents should be viewed to determine fill level. (ECRI Overfill Warning criteria) (Note: No specific standard exists.) | Bemis Two Gallon Sharps Containers are translucent with clear lids, therefore, allowing visibility at all levels. Labels boldly indicate fill level of three-quarter capacity. |
| Inlet/Closure (One-handed Operation) | The inlet should accept sharps safely and easily with one-handed operation. (ECRI Inlet and Closure Characteristics criteria) | There is no limitation to hand access for this container as the opening is designed to accept other objects such as butterfly needles, test tubes and vials. Following final closure, the container remains closed during normal handling. (Implies safe and easy acceptance, though one-handed operation is not explicitly stated as 'tested' only 'designed for'.) |
| Freestanding Capability (Stability) | The container should be stable in its upright position when tipped to 20 degrees, and when in the temporary closed position, contents should not spill out when toppled. (ECRI Freestanding Capability criteria) | Testing done on the Bemis Two Gallon Sharps Container at a topple angle of greater than 20 degrees, showed the container retaining its solid contents. (Exceeds the 20-degree stability requirement and confirms no spillage of solid contents.) |
| Impact Resistance | Containers, when in the final closure position and dropped from a distance of 24 inches, remain intact (lid remains on container) and sharps do not escape. (Proposed Canadian Standard CAN/CSA - Z316.6) (Note: No specific standard existed at the time of submission.) | Bemis Two Gallon Sharps Containers passed this test. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test. For physical device testing, it is common to test a representative number of units from a production batch or engineering samples. The provenance of the data is internal testing by Bemis Manufacturing Company, likely conducted retrospectively for the purpose of demonstrating compliance. The country of origin of the data would be the USA (Wisconsin, where Bemis is located).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. For physical device performance tests like puncture resistance, leak resistance, and impact resistance, the "ground truth" is established by the physical properties of the material and design, measured against objective, quantifiable criteria using laboratory equipment and established test methods (e.g., force gauges for puncture, visual inspection for leakage). No human experts are used to "establish ground truth" in the way they would for medical image interpretation.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in AI/ML performance studies. For physical device testing, the results are objective measurements or pass/fail outcomes based on predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. MRMC studies are relevant for evaluating the impact of AI/ML systems on human readers (e.g., radiologists, pathologists). This document is for a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No. This is not an AI/ML device. The "standalone" performance here refers to the device's inherent physical properties and functionalities without human interpretation. The reported tests are essentially standalone performance evaluations of the physical container.
7. The Type of Ground Truth Used
The ground truth used for these tests is objective physical measurement and adherence to predefined performance standards (or proposed standards). This includes:
- Force measurements (for puncture resistance)
- Observation of leakage (for leak resistance)
- Observation of stability and contents retention (for freestanding capability)
- Observation of integrity after impact (for impact resistance)
- Visibility of contents (for overfill warning)
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no training set for an AI/ML model, there's no ground truth to establish for it.
§ 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).