(114 days)
PureWay Compliance 1.4 Quart Sharps Collector Container is single-use, disposable, non-sterile and intended to be used for healthcare purposes for safe containment and disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target user is for healthcare professionals.
The PureWay Sharps Collector is injection molded with High Density Polyethylene plastic (HDPE). Designed for single use, the container is puncture resistant, leak resistant on the sides and bottom, closable and stable. The container is labeled with a fill line and instructions for snapping the container lid closed. "Do Not Overfill" to prevent overfill. The label is white and blue with white text and a black biohazard symbol is printed on a red background. The container is made of two parts, (Base and Lid) that form a single unit. The red colored base is conical shaped, and the lid is a clamshell design snapped in place for a tight seal when the container is full. The device is a non-sterile, single use, disposable infectious waste container and is designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container is conical which allows for one hand disposal of sharps and a clamshell lid for means of closure.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Test Method/Applicable Standard(s) | Acceptance Criteria | Reported Device Performance (PureWay 1.4 Quart) |
|---|---|---|---|
| Container stability | ISO 23907-1:2019 Section 5.1 | The container shall not topple over when tested. | Pass |
| Resistance to penetration | ISO 23907-1:2019 Section 5.3 | When tested, the force needed to penetrate test specimens shall be a minimum of 16 N and an average of 18 N or greater. | Pass |
| Resistance to damage or leakage after dropping | ISO 23907-1:2019 Section 5.4 | When tested there shall be no evidence of leakage and no breach of the sharp's containment area. Minimum five minutes after each topple, the following points shall be visually checked: |
- No evidence that the performance or function of the container has been compromised.
- Container's temporary closure shall remain intact. | Pass |
| Resistance to damage or leakage after toppling | ISO 23907-1:2019 Section 5.5 | There shall be no evidence of breach of the sharps containment area. Minimum five minutes after each topple, the following points shall be visually checked: - There shall be no evidence that the performance or function of the container has been compromised.
- The container's temporary closure shall remain intact. | Pass |
| Fill line indicator | ISO 23907-1:2019 Section 4.2.7 | 1. Fill line shall be determined by the design of the container, taking into account the risk of sharps extending above the fill line, and shall be at a level no greater than 85% of the total volume of the container. - Fill line feature helps prevent overfilling and is a critical safety feature of a sharps container.
- It shall be possible to ensure the sharps are not above the fill line. This can be achieved either visually or mechanically. | Pass |
| Strength of Handles | ISO 23907-1:2019 4.2.2 and 5.2 | 1. All sharps containers shall be provided with one or several handles. - The handle/carrying feature shall not break or detach during testing.
- The position of the handles(s), finger recesses, protrusions or flanges shall not interfere with the normal use of the container.
- Fill the container with a mass equivalent to 150% of manufacturer's maximum allowable gross mass. Suspend the container by its handles(s) at the intended carrying points(s) from a rigid support for 1 h at a temperature of (23+/- 5) degrees Celsius. Remove the container from the support and inspect the handles for integrity and for any evidence of detachment of the handles(s) from the container. | Pass, no evidence of detachment of the handles(s) from the container. (Note: Predicate Device listed as N/A - No Handles) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of sharps containers) used for the non-clinical tests. It refers to the tests performed "when tested," implying a defined test protocol, but the specific number of units tested for each criterion is not provided.
The data provenance is from non-clinical bench testing performed by PureWay Compliance Inc., as indicated by the "Summary of Non-Clinical Performance Data" section and the overall context of a 510(k) submission for a medical device. The tests were performed to ISO 23907-1:2019 standards, which are international standards. The country of origin for the testing itself is not explicitly stated, but the company headquarters is in Carson, CA, USA. The data is prospective in the sense that these tests were conducted specifically to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the "study" described is entirely non-clinical (bench testing) of a physical product (sharps collector). There is no "ground truth" to be established by human experts in the context of diagnostic or interpretive performance.
4. Adjudication Method for the Test Set
This section is not applicable as the "study" is non-clinical bench testing and does not involve human interpretation or adjudication for establishing ground truth. The results are based on objective physical measurements and observations against pre-defined engineering standards.
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
An MRMC comparative effectiveness study was not done. This device is a physical sharps collector and does not involve AI or human readers for diagnostic or interpretive purposes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical sharps collector and does not involve any algorithms or software for standalone performance evaluation.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of this device is defined by the acceptance criteria specified in the international standard ISO 23907-1:2019 for "Sharps containers – Part 1: Requirements for sharps containers for single-use." These are objective, measurable physical properties and functional requirements for the sharps collector.
8. The Sample Size for the Training Set
This section is not applicable. This is a physical medical device, not a machine learning or AI model. Therefore, there is no "training set" in the context of data-driven model development.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 8.
§ 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).