(52 days)
The Bemis One Quart Phlebotomy Container is a sharps disposal container. It is intended for the safe disposal of needles and syringes in areas with or without controlled access. They are typically used in patient rooms, nurse's stations, doctors' and dentists' offices and on med carts.
The One Quart Phlebotomy Container has a volume of 1.0 gt. and weigh .0.2 1b (3.2oz.) with dimensions of 8 "H x 4.3"W x 4.3"D. One Quart Phlebotomy Containers are injection molded with polypropylene plastic in translucent red. These products are typically a .. 970" wall thickness. The One Quart Phlebotomy containers are NOT reusable.
The One Quart Phlebotomy Containers are puncture-resistant, injection-molded containers with integral sidewalls and bottom. They are leakproof on the sides and bottom.
They are labeled with the Biohazard warning symbol. The label color is orange-red, 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 One Quart Phlebotomy Container is secured to a tray or table top in an adhesive-backed injection molded plastic base.
There are no features to bend, break, or shear the needle.
The lid incorporates a "needle key" which can be used to unscrew needles from blood collection tube holders. After blood collection, the needle is inserted into the slotted opening and slid forward until firmly seated, and turned to unscrew the needle from the tube holder.
The lid has two openings: one intended to accommodate blood tube needles only and the other, larger opening to accept larger sharps such as butterfly needles. Both openings have covers that may be temporarily closed during transportation. Each cover also has a tab that is inserted in slots for final locking closure for disposal.
This document describes a physical medical device (sharps disposal container), not a software or AI/ML-based device. Therefore, many of the requested categories related to AI/ML studies, data sets, and ground truth establishment are not applicable.
Here's the information that is applicable based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical or definitive pass/fail thresholds for each test. Instead, it presents a comparison to a predicate device, showing that the new device passed the same tests. The "acceptance criteria" are implied by the "PASS" outcome for each test.
| Acceptance Criteria (Implied) | Reported Device Performance (Bemis One Quart Phlebotomy Container) |
|---|---|
| Impact Resistance | PASS |
| Puncture Resistance | PASS |
| Overfill Detection | PASS |
| Leak Resistance | PASS |
| Sharps Access and Closure | PASS |
| Stability in Upright Position | PASS |
| Handling | PASS |
| Capacity: 1 qt. | 1 qt. |
| Feature to Minimize Aerosolization | Two lids with temporary snap closure |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the tests conducted (e.g., how many containers were drop-tested for impact resistance). It also does not provide data provenance (e.g., country of origin, retrospective/prospective) for these physical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device subject to engineering and mechanical testing, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not applicable. Physical device testing generally involves objective measurements or observations against predefined standards, not expert adjudication.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for the physical tests would be the established engineering standards or test methods for evaluating medical sharps disposal containers (e.g., ASTM standards for puncture resistance, leak resistance, etc.), against which the device's performance was measured. However, the specific standards are not cited in the summary.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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).