(241 days)
Sharps Safes are designed to be used by Paramedics or Home Care Providers who need a small, portable and rugged sharps container which can be used in remote locations to dispose of contaminated needles.
The device is comprised of a 1.5 inch diameter plastic tube (model 1.5), or a 2.0 diameter plastic tube (model 2.0). Securely attached to each end is a plastic cap. Secured inside the cap attached to the bottom end is a hard plastic disc designed to prevent needle penetration. The cap on the top end has a ¼ inch hole in the center. Radiating from the hole are slits cut in the plastic which form flaps through which a sharps can be inserted. A vinyl cover is provided for the top to provide a moisture tight seal.
This document is a 510(k) summary for the DURA-VAC Sharps Safe 1.5 and Sharps Safe 2.0. It describes the device, its intended use, and non-clinical tests. Clinical tests were explicitly stated as "Not required."
Here's the breakdown of the acceptance criteria and the "study" (non-clinical tests) that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Non-Clinical Tests) |
|---|---|
| No needle ejection upon impact / Impact Resistance | No needle ejection when dropped from eight (8) feet onto concrete. No damage to container. |
| Puncture Resistance (Sides - 1.5") | 5.12 lb. average for sides. |
| Puncture Resistance (Bottom - 1.5") | 6.56 lb. average for bottom. |
| Puncture Resistance (Sides - 2.0") | 5.80 lb average for sides. |
| Puncture Resistance (Bottom - 2.0") | 6.99 lb. average for bottom. |
| Wall Thickness (Sides - 1.5") | .072 inches average for sides. |
| Wall Thickness (Bottom - 1.5") | .1174 inches average for bottom. |
| Wall Thickness (Sides - 2.0") | .078 inches average for sides. |
| Wall Thickness (Bottom - 2.0") | .1125 inches average for bottom. |
| Sharps Closure Pull Test | 45 lb. for 24 hours. |
| Capacity (1.5") | 15.8 cu. in./6.75 oz. |
| Capacity (2.0") | 28.2 cu. in./12.30 oz. |
| Leakproof (Bottom) | The bottom is leakproof. |
| Leakproof (Top with cover) | The top is also leakproof when the vinyl cover is in place. |
| Disposal (Heavy metals) | Sharps Safes contain no heavy metals and can be incinerated. |
| Attachment Strap Strength | A Sharps Safe will support 45 pounds when secured to a surface by the attachment straps. |
2. Sample sized used for the test set and the data provenance
The document does not explicitly state the sample sizes for each non-clinical test performed (e.g., how many units were dropped for impact resistance, or how many tests were done for puncture resistance). It reports average values, implying multiple measurements were taken, but the exact number is missing.
The data provenance is from DURA-VAC, a US-based company (Ventura, CA). The tests are internal non-clinical tests performed by the manufacturer, not external data. The document does not specify if the tests were performed retrospectively or prospectively, but given they are part of a 510(k) submission, they would have been performed prospectively to support the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as there was no "ground truth" in the typical sense of expert review for image/data interpretation. The tests were physical and mechanical objective measurements.
However, it is mentioned that "The combined talents of sixty (60) fire department Paramedics were used to develop Sharps Safes." While not establishing "ground truth" for a test set, these paramedics presumably provided input on the practical needs and shortcomings of existing devices, influencing the design and implicit acceptance criteria. Their qualifications are stated as "fire department Paramedics."
4. Adjudication method for the test set
This is not applicable. The non-clinical tests involved objective physical measurements (e.g., weight, distance, force) rather than subjective assessments requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Tests: Not required." The study focused on the physical and mechanical performance of the device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical sharps container, not an algorithm or software. It does not have "standalone" (algorithm-only) performance in the conventional sense of AI/software.
7. The type of ground truth used
For the non-clinical tests described, the "ground truth" was established by objective physical measurements and engineering standards. For example, impact resistance was measured by observation of needle ejection and damage after dropping from a specified height. Puncture resistance was measured by applying force until penetration.
8. The sample size for the training set
This is not applicable. The device is a physical product, not a machine learning model. Therefore, there is no "training set" in the context of data for an algorithm.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for a physical 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).