(141 days)
Sharpsmart™ S2 disposable sharps container are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian office and other small quantity waste generators for the safe disposal of hazardous sharps. This device is intended for "Over-the-Counter" use.
The Sharpsmart™ S2 disposable sharps container is intended to be used in patient rooms, medication rooms, operating rooms, physicians' offices or any other patient care area requiring the use of a sharps container. It is a two-piece injection-molded container made from a polypropylene copolymer. The container is designed with a closure mechanism that allows multiple lid re-openings, while ensuring secure between uses. Both handle and lid can be secured out of the way for safe, unobstructed disposal of sharps. The S2 container is capable of standalone use. A Unique bracket design is offered as an additional measure to secure mounting on vertical or horizontal surfaces to prevent toppling. The bracket is not required for the use of the container. It only offers a secondary option for the user for ease of use.
The containers are closable, puncture resistant, leak proof on the sides and bottom and stable. The label, containing an overfill warning and an easily visible fill line, is adhered to the container at the factory. The containers are translucent and are red or yellow. The label is white and red with the biohazard warning.
Sharpsmart™ S2 disposable sharps containers are available in a 1 quart size. Each product has two parts, which assemble together to form a unit. Assembly is easily visualized. They can be nested together to reduce storage space.
The container is designed and certified to comply with penetration requirements, as represented though product testing for Test methods: AS/NZS 4031:1992 and Test Method: roprosence and the Transport of Dangerous Goods. 15th revised Ed. 6.1.5.3The Sharpsmart™ S2 disposable sharps containers meet or exceed OSHA recommendations for sharps containers.
The Daniels Sharpsmart S2 disposable sharps container is a device intended for the safe disposal of hazardous sharps in healthcare facilities. The 510(k) summary provides details about its acceptance criteria and the study that demonstrates its compliance.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Sharpsmart™ S2 disposable sharps container are based on various performance tests. The device's performance is reported as having "Passed" all these tests, indicating it meets the established criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Puncture Resistance | Passed |
| Handle Testing | Passed |
| Leak Resistance | Passed |
| Drop Test | Passed |
| Impact Testing | Passed |
| Stacking Test | Passed |
| Vibration | Passed |
These criteria align with recognized international standards for sharps containers, specifically:
- UN Recommendations on the Transport of Dangerous Goods. 15th revised Ed. 6.1.5.3
- AS/NZS 4031:1992
The summary also states that the device "meets or exceed OSHA recommendations for sharps containers."
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not explicitly state the sample size used for the performance tests (e.g., how many containers were tested for puncture resistance, drops, etc.). The data provenance is also not specified; however, given that the manufacturer is The Daniels Corporation PTY, LTD and the predicate device is from Solutions, Inc., it can be inferred that the testing likely occurred in a controlled lab environment and is part of a prospective study to demonstrate compliance with the referenced standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The product being reviewed is a physical sharps container, and its performance is evaluated through standardized engineering tests (e.g., puncture resistance, leak resistance, drop test). These tests do not rely on expert consensus for establishing ground truth in the same way clinical or imaging diagnostic devices might. Instead, the ground truth is defined by the Pass/Fail criteria of the specified test methodologies.
4. Adjudication Method for the Test Set
This information is not applicable. As stated above, the device performance is determined by meeting the objective Pass/Fail criteria of the engineering test methods, not through an adjudication process involving human reviewers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is typically conducted for diagnostic or imaging devices to assess human reader performance with and without AI assistance. The Sharpsmart S2 is a physical medical device (sharps container) for waste disposal, not a diagnostic tool requiring interpretation by human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone study in the context of an algorithm's performance was done. The device is a physical product, and its performance is measured directly through physical tests against defined standards, not through algorithmic output.
7. Type of Ground Truth Used
The ground truth used for these tests is the objective Pass/Fail criteria defined within the referenced international testing standards:
- UN Recommendations on the Transport of Dangerous Goods. 15th revised Ed. 6.1.5.3
- AS/NZS 4031:1992
These standards specify the conditions and measurements that constitute satisfactory performance for sharps containers (e.g., no penetration, no leakage, structural integrity after impact or drops).
8. Sample Size for the Training Set
No training set is applicable. This device is a physical product, and its evaluation does not involve machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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).