(156 days)
The Isolyser SDS is a sharps container intended for use in non-clinical settings for the disposal of contaminated sharps.
The Isolyser Syringe Disposal System (SDS) has the same uses as other sharps containers in commercial distribution: to provide safe and effective disposal of medical sharps. The major difference between the Isolyser SMS 1000 and the SDS relate to the setting in which the device will be used. The SDS is intended for use in non-clinical settings while the Isolyser SMS 1000 is used in clinical settings. As is true for the Isolyser SMS 1000, the SDS is closable, puncture resistant and leakproof on the sides and the bottom. The fluorescent orange BIOHAZARD warning labels are clearly visible with lettering in contrasting color and are affixed by adhesive to the SDS containers. Like the SMS 1000, the SDS container maintains a stable and upright position. There is no feature to bend, break, or shear the needle off the hub of the syringe. When the SDS is full, the user adds water to the SDS to activate the "Gel-loc" system. After replacing the cap on the SDS, the user shakes the container well. The user then places the SDS into the carton provided and seals it with tape. The user then disposes of the sealed carton according to local, state and federal laws. The disposal methods for the SMS 1000 and the SDS are quite similar. As is true for SMS 1000, the SDS containers are designed so that no user is required to reach by hand into the container to retrieve the contaminated reusable sharps. As indicated on all labels for SDS containers, safe and effective disposal of the waste is easily accomplished.
The provided text is a 510(k) summary for the Isolyser SDS container, focusing on its substantial equivalence to a legally marketed predicate device (Isolyser SMS 1000). It is not a study that provides performance data against specific acceptance criteria.
Therefore, most of the requested information cannot be extracted directly from the provided text because this type of regulatory submission establishes equivalence based on similar design and intended use, rather than presenting detailed experimental results against a new set of performance criteria for the new device.
Here's what can be gathered, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. The document establishes substantial equivalence by stating the new device (Isolyser SDS) has "essentially the same technical characteristics" as the predicate device (Isolyser SMS 1000) and that "The data demonstrate that the performance of the Isolyser SDS is substantially equivalent to other legally marketed sharps containers." No specific acceptance criteria or quantitative performance data are reported for the SDS container itself.
2. Sample size used for the test set and the data provenance:
Not applicable. No "test set" in the context of performance evaluation (e.g., measuring puncture resistance or leak-proof properties against a standard) is described. The document relies on the established safety and effectiveness of the predicate device (Isolyser SMS 1000) and the similarity in design and function.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a study involving expert review or ground truth establishment in a diagnostic or clinical sense.
4. Adjudication method for the test set:
Not applicable. No test set requiring adjudication is described.
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 a medical device for sharps disposal, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used:
Not applicable. In the context of substantial equivalence for a sharps container, the "ground truth" is typically an existing set of regulatory standards and the demonstrated performance of the predicate device. The claim is that the new device meets these implicit standards through its similarity to the predicate.
8. The sample size for the training set:
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what can be inferred from the document:
- Acceptance Criteria (Implied): The implied acceptance criteria are the safety and effectiveness standards already met by legally marketed sharps containers, specifically the predicate device, Isolyser Sharps Management System ("SMS") 1000 (K943626).
- Study Proving Device Meets Criteria: The "study" (or rather, the basis for the 510(k) submission) is a comparison to a predicate device (Isolyser SMS 1000). The document argues that the Isolyser SDS "has essentially the same technical characteristics as the Isolyser SMS 1000" and that "The materials and method of manufacturing the SDS container itself is nearly identical to the methods used to manufacture the SMS 1000." The only difference noted is the disposal method ("Gel-Loc System" for SDS vs. "catalyst" for SMS 1000), which the submitter claims "does not materially affect the safety or effectiveness of the device."
- Conclusion: The submission concludes that "The data demonstrate that the performance of the Isolyser SDS is substantially equivalent to other legally marketed sharps containers." The FDA's letter concurs with this finding of substantial equivalence.
§ 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).