(18 days)
The SteriSharp™ 2.5 Gallon RSDC reusable containers are intended to be used by healthcare providers (hospitals, laboratories, medical clinics, veterinary clinics, and other such areas and facilities where needles, sharps waste and other infectious waste is generated). The containers are designed to safely contain sharps waste prior to removal from generating facility and ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse according to 49 CFR Sections 178.603, 173.4465(d), 173.465(e) and 178.608.
REUSABLE PLASTIC SHARPS DISPOSAL CONTAINER; two components of the device include (a) a plastic mail-drop, torturous path tumbler lid (where needles and sharps waste is inserted) and (b) a rotationally molded plastic bottom (the container), leak-proof on four sides and bottom, where needles are dropped and stored until container unit is emptied and cleaned.
The provided text describes the acceptance criteria and the results of a study for the "SteriSharp™ 2.5-Gallon RSDC" reusable sharps disposal container.
Here's the breakdown of the information requested:
1. Table of acceptance criteria and the reported device performance
| Test | Reference | Acceptance Criteria / Description | Reported Device Performance |
|---|---|---|---|
| Puncture | Health Devices 22 | Needle penetration force | Pass |
| Vibration | 49 CFR 178.608 | 1 hour repetitive bounce | Pass |
| Free Fall Drop | 49 CFR 178.603 | -18° C 5 drops 1.2 meter | Pass |
| Stacking | 49 CFR 178.606 | 24 hrs. under 30 kg | Pass |
| Penetration | 49 CFR 178.609(h)(1) | 7 kg steel rod - 1 meter | Pass |
| Overall Containment | N/A (implied by individual tests) | Preventing the loss or dispersal of contents during transport | Pass ("visually appears to satisfy the test criteria and be capable of preventing the loss or dispersal of the contents for conditions normal to transport.") |
2. Sample size used for the test set and the data provenance
The document does not specify a numerical sample size for the test set. For instance, for "Free Fall Drop," it states "5 drops," implying a small sample for that specific test, but a general sample size for the overall device testing isn't provided.
The data provenance is not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given the context of a 510(k) submission to the FDA, it is highly likely the testing was conducted in a U.S.-based lab and was a prospective evaluation of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The tests are engineering and performance-based, governed by specific regulations and standards (e.g., 49 CFR), rather than relying on human expert interpretation of results that would require "ground truth" establishment in the typical sense (e.g., for medical imaging). The 'ground truth' for these tests is defined by the passing criteria of the regulations themselves.
4. Adjudication method for the test set
This information is not applicable and not provided. The tests are objective, pass/fail evaluations based on defined physical criteria and regulations, not subjective assessments requiring adjudication among multiple observers.
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
This section is not applicable. The device is a physical sharps disposal container, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related comparative effectiveness was performed.
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 product, not an algorithm.
7. The type of ground truth used
The ground truth for this device is based on regulatory standards and established test criteria. For example:
- Puncture: Defined by a specific needle penetration force.
- Vibration: Defined by "1 hour repetitive bounce" as per 49 CFR 178.608.
- Free Fall Drop: Defined by surviving "5 drops 1.2 meter" at "-18° C" as per 49 CFR 178.603.
- Stacking: Defined by withstanding "24 hrs. under 30 kg" as per 49 CFR 178.606.
- Penetration: Defined by resistance to a "7 kg steel rod - 1 meter" as per 49 CFR 178.609(h)(1).
The overall ground truth is that the container must visibly prevent loss or dispersal of contents under these tested conditions.
8. The sample size for the training set
This section is not applicable. This is a physical device, and the concept of a "training set" is typically associated with machine learning algorithms.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons 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).