(15 days)
The Sage Sharps Disposal Containers with Screw Top Caps is intended for single use disposal of used or contaminated medical sharps, including, but not limited to, hypodermic needles, syringes, lancets, and Blood Needles. The containers can be used in variety of healthcare settings. The containers are suitable for physician offices, dental offices, laboratories, home health and other generators of medical waste. The containers are also appropriate for patient room applications.
The Sage Products, Inc. Sharps Containers with Screw Top Caps are molded, single use, non-sterile, disposable, sharps disposal containers. The containers are designed to hold used sharps such as angio-caths, blood needles, lancets and various sized syringes. Various sizes of the container will be offered to meet customer disposal needs. The shape of the container will either be rectangular or circular depending upon its size. The only access to the container is through the screw top closure. Products will be available with or without a neck insert at the opening to limit the ability of the sharps to exit the container after disposal.
The provided text describes a Pre-Market Notification (510K) for Sharps Containers with Screw Top Caps and does not contain information about the acceptance criteria or a study that proves the device meets specific performance metrics in the way typically associated with AI/ML medical devices. The document focuses on regulatory compliance, design features, and substantial equivalence to predicate devices.
However, I can extract the "Design Features" and their "Safety and Effectiveness Basis" which can be interpreted as the functional requirements or "acceptance criteria" that the device is intended to meet. The "study" in this context refers to the rationale and regulatory references provided for each design feature, rather than a formal clinical or technical performance study with quantitative results.
Here's the information extracted from the document, framed to best answer your request:
Acceptance Criteria and Documented Device "Performance"
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Design Feature) | Safety and Effectiveness Basis (Reported "Performance" / Rationale) |
|---|---|
| Impact Resistance | The impact resistance test will provide information about the container's ability to retain solid contents, following lid closure and locking, in the event it is dropped during handling/transport. |
| Puncture Resistance | Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are puncture resistant. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, ii |
| Overfill Detection | During use, containers for contaminated sharps shall be replaced routinely and not be allowed to overfill. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 2, iii |
| Leak Resistance | Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are Leak Proof on sides and bottom. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, iii. |
| Sharps Access and Closure | Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are closable. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, i |
| Stability | During use, containers for contaminated sharps shall be maintained upright throughout use. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 2, ii |
| Mounting Accessories | During use, containers for contaminated sharps shall be easily accessible to personnel and located as close as is feasible to the immediate area where sharps are used or can be reasonably anticipated to be found. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 2, i |
| Handling | Sharps containers should be safe and easy to handle in transport. |
| Capacity | This value gives the user an estimate or comparison of volume. |
| Mailability | Per the Domestic Mail Manual, Section 2.2, "No item may be packaged so that its contents could harm employees, equipment, or other mail." |
Additional Information Not Present in the Document:
The provided text is a summary for a traditional medical device (sharps containers) and does not involve AI/ML. Therefore, the following points are not applicable or cannot be answered from the provided text:
- Sample sized used for the test set and the data provenance: Not applicable. The document discusses design features and regulatory compliance for physical sharps containers. It does not refer to a "test set" in the context of data for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not relevant for this device.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI algorithm.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for these containers is their physical adherence to safety standards and regulations (e.g., puncture resistance, leak-proof).
- The sample size for the training set: Not applicable. There is no training set for a physical sharps container.
- How the ground truth for the training set was established: Not applicable.
Summary of the "Study" and "Proof" within this context:
The "study" that proves the device meets the "acceptance criteria" (design features) is implicitly the Pre-Market Notification (510K) submission process itself. This process requires the manufacturer to demonstrate that their device is "substantially equivalent" to predicate devices already on the market. The provided "Safety and Effectiveness Basis" for each design feature serves as the manufacturer's justification and commitment that the device meets these functional requirements, usually through adherence to established standards (like OSHA regulations) or through internal testing (e.g., "impact resistance test will provide information...").
The FDA's letter (K980490) confirms that, based on the information provided in the 510(k) submission, the device is considered substantially equivalent and can be marketed, implying that the detailed justification for each design feature (which would have included test reports or validated design specifications) was satisfactory.
§ 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).