(69 days)
The Bemis Two Gallon Chemotherapy Container is a sharps disposal container. It is intended for the safe disposal of needles, syringes, and other chemotherapy waste in areas with controlled access. These areas, as defined by OSHA regulations 29 CFR 1910.1030 and 29 CFR 1910.1030, include nurse's stations, oncology, pharmacies, and chemotherapy treatment rooms.
The Bemis Two Gallon Chemotherapy Containers are designed for use in areas with controlled access, such as nurse's stations, oncology, pharmacies, and chemo treatment rooms. They feature a gasketed lid and screw-on plastic cap. The containers have a volume of 6 qt. and weigh 1 lb. The containers are injections of polypropylene plastic and are available in translucent white. These containers are NOT reusable. Bemis Two Gallon Chemotherapy Containers are puncture resistant with integral wall thickness of .070". The containers are leakproof on the sides and bottom. The lids are gasketed to guard against spills. The containers are labeled with the Biohazard warning symbol that is 1½" in height. The label color is orange-red and yellow, with lettering and symbol in contrasting color in accordance with OSHA regulations. The labels are attached directly to the surface of the container by a permanent adhesive. The labels boldly indicate fill level of three-quarter capacity. Bemis Two Gallon Chemotherapy Containers are translucent white, therefore, allowing visibility of fill level. The Bemis Two Gallon Chemotherapy Container is designed for use in areas with controlled access. The opening is designed to accept other objects related to hand access for this container as the opening is designed to accept other objects related to hand access for this container as the container remains closed during normal handling. The container should be stable in it's upright position when toppled to 20 degrees, and contents should not spill out when toppled. Containers, when in the final closure position and dropped from a distance of 24 inches, remain intact. There are no features to bend, break, or shear the needle. Two Gallon Chemotherapy Containers can be used freestanding or locked on wall mounted brackets. A key that is unique to this order is required to access and unlock containers from mounted brackets. The containers require assembly by the user. Instructions are included in every case.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Bemis Two Gallon Chemotherapy Container:
Device: Bemis Two Gallon Chemotherapy Container
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Acceptance Criteria | Reported Device Performance | Assessment |
|---|---|---|
| Material | Injections of polypropylene plastic. | Meets (Material specified) |
| Puncture Resistance | Average puncture force for sharps contact areas of each region of uniform thickness shall not be less than 2.8 lb./ft. (ASTM proposed standard) | "...Beminis Two Gallon Chemo Containers using Puncture tests... will reject any parts with wall thicknesses less than .055"." (Implied compliance, but no explicit "passed" statement based on 2.8 lb./ft.). |
| Leakproof (Sides & Bottom) | No leakage of contents over a 24-hour period when filled with water and positioned. (ECRI Leakproofness criteria) | "Section Sharps Containers passed this requirement when tested using this method." |
| Lid Design (Leakproof) | Gasketed to guard against spills. | Meets (Feature described) |
| Biohazard Warning Label | Orange-red and yellow, with 1½" height lettering and symbol in contrasting color, in accordance with OSHA regulations. Permanently attached. | Meets (Description matches criteria) |
| Overfill Warning/Visibility | Boldly indicate fill level of three-quarter capacity. (ECRI Overfill Warning Criteria) | "Bemis Two Gallon Chemotherapy Containers are translucent white, therefore, allowing visibility of fill level." (Meets visibility aspect, but no explicit mention of bold indication of fill level marker). |
| Closure Characteristics (One-handed operation) | No limitation of access for this container as the opening is designed to accept other objects related to hand access for this container as the opening is designed to accept other objects related to hand access for this container. Container remains closed during normal handling. (ECRI Closure Characteristics) | Meets (Description matches criteria – designed for one-handed operation without limiting access, remains closed during normal handling). |
| Freestanding Capability (Stability) | Stable in its upright position when topped to 20 degrees, and contents should not spill out when toppled. (ECRI Freestanding Capability criteria) | "Testing done on the Bemis Two Gallon Chemo Container showed the container retaining its solid contents." (Implies meeting the criteria, specifically for solid contents). |
| Impact Resistance | Containers, when in the final closure position and dropped from a height of 24 inches, remain intact. (Standard CAN/CSA - Z310.6 on Impact Resistance) | "Bemis Two Gallon Chemo Containers passed this test." |
| Needle Bending/Breaking/Shearing | No features to bend, break, or shear the needle. | Meets (Absence of features) |
| Wall Thickness Minimum | Test data indicated wall thickness of .070", and Bemis will reject parts less than .055". | Meets (Internal manufacturing control) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated for any of the tests. The text refers to "Testing done on the Bemis Two Gallon Chemo Containers" or "Section Sharps Containers passed this requirement," implying that at least one (but likely more) container was tested for each criterion.
- Data Provenance: Retrospective testing on manufactured containers. No country of origin is specified for the data collection, but the manufacturing company is US-based (Sheboygan Falls, WI).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This device is a physical sharps disposal container and does not involve subjective diagnostic interpretations. Therefore, there were no "experts" in the traditional sense (e.g., radiologists) used to establish ground truth for testing.
- The "ground truth" (acceptance criteria) was established by existing standards and criteria from organizations like ASTM, ECRI, OSHA, and CAN/CSA.
4. Adjudication Method for the Test Set
- Not applicable. The tests performed were objective physical/mechanical performance tests against established standards, not subjective assessments requiring adjudication among multiple human reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs. without AI assistance
- Not applicable. This device is a physical sharps container, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical container, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the performance tests was based on established industry standards and criteria from organizations such as:
- ASTM (American Society for Testing and Materials) proposed standard for puncture resistance.
- ECRI (Emergency Care Research Institute) criteria for Leakproofness, Overfill Warning, Closure Characteristics, and Freestanding Capability.
- OSHA (Occupational Safety and Health Administration) regulations for Biohazard warnings.
- CAN/CSA - Z310.6 on Impact Resistance (Canadian Standards Association/Canadian Standards Council).
8. The sample size for the training set
- Not applicable. This is a physical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
§ 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).