(90 days)
The 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.
The Sharps Container is a piece of equipment used in hospitals, physicians' offices, dental offices, laboratories, home health areas, patient rooms and other locations of medical waste. The sharps container is designed to safely contain used needles or syringes and prevent accidental needle sticks from used syringes or needles.
The device is made of injected molded polypropylene material. The material . is made of molded plastic into a specific shape. The actual shape is designed to sit on the floor or a desk.
On the outer casing of all the sharps containers is the Biohazard Warning label in Orange, noticeably displayed.
The molded plastic container is designed and manufactured such that there . will be no leakage during storage, handling or transport.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Sharps Container, Model Lns-T1
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Impact Resistance | Passed (according to testing against BS7230:1990, ASTM F2132:2008, and OSHA 29CFR1910) |
| Puncture Resistance | Passed (according to testing against BS7230:1990, ASTM F2132:2008, and OSHA 29CFR1910) |
| Leak Resistance (leak-proof on sides/bottom) | Passed (according to testing against BS7230:1990, ASTM F2132:2008, and OSHA 29CFR1910) |
| Mechanical Safety | Passed (according to testing against BS7230:1990, ASTM F2132:2008, and OSHA 29CFR1910) |
| Environmental Safety | Passed (according to testing against BS7230:1990, ASTM F2132:2008, and OSHA 29CFR1910) |
| Performance | Passed (according to testing against BS7230:1990, ASTM F2132:2008, and OSHA 29CFR1910) |
| Material (Polypropylene) | Meets, device is made of injected molded polypropylene material. |
| Sharps closure (flaps closed and locked) | Meets, designed for flaps to be closed and locked in place for removal. |
| Single Use | Meets, device is indicated as single-use. |
The acceptance criteria are implied by the comparison to the predicate device and the standards used for performance testing (BS7230:1990, ASTM F2132:2008, OSHA 29CFR1910). The reported device performance is that the "product passed all tests."
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size for the test set or the exact data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Mechanical, environmental safety and performance testing have been accomplished according to BS7230:1990, ASTM F2132:2008 and OSHA 29CFR1910." and that the "product passed all tests." This suggests that the testing was conducted in a laboratory setting to meet these specific standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and is not provided in the document. The device is a physical sharps container, and its performance (e.g., impact, puncture, leak resistance) is evaluated through standardized mechanical and environmental testing against established engineering standards, not through human expert interpretation of data.
4. Adjudication Method for the Test Set
This information is not applicable and is not provided in the document. As mentioned above, the evaluation is based on objective measurements against engineering standards, not expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human interpretation is involved. This device is a physical container, and its effectiveness is determined by its physical properties.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable to a physical device like a sharps container. "Standalone" performance usually refers to an algorithm's ability to perform a task without human intervention, which doesn't fit the context of this product. The device's performance is inherently "standalone" in that it performs its function (containing sharps) without human "in-the-loop" interaction for its core function evaluation beyond its initial use.
7. The Type of Ground Truth Used
The ground truth for the performance testing was established by recognized industry and safety standards: BS7230:1990, ASTM F2132:2008, and OSHA 29CFR1910. These standards define the parameters and methodologies for evaluating the safety and effectiveness of sharps containers (e.g., impact, puncture, and leak resistance).
8. The Sample Size for the Training Set
This information is not applicable and is not provided. The development and testing of a physical product like a sharps container do not typically involve "training sets" in the context of algorithms or machine learning. The design implicitly relies on engineering principles and material science, which are validated through physical testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" in the context of this device. The design principles and manufacturing processes are likely informed by engineering best practices, prior product development, and regulatory requirements (e.g., those found in the referenced standards).
§ 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).