(157 days)
Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
The Containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used.
Sharps container are used to collect hazardous sharps such as needles, syringes, lancets and etc. The containers are single-use, disposable, non-sterile containers.
The Sharps Container constructed of polypropylene plastic. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant, leak resistant on the sides and bottom, impact resistant, closable, and stable.
The provided text describes the acceptance criteria and a study proving that Sharps Containers meet these criteria. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| NO. | Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 1 | Anti-penetrability | The puncture resistance of each section of the container greater than 15 N and the puncture resistance performance should met. | Pass |
| 2 | Resistance to damage and leakage after dropping | Containers remained upside down for 60 minutes while being observed for leakage. No leakage observed and there is also no liquid leakage. | Pass |
| 3 | Stack Test | The minimum height of the stack, including the test sample, is 3 meters. Upon completion of the stack test, containers observed for deformation. The containers should not be deteriorated. | Pass |
| 4 | Vibration Test | The containers should not be deteriorated. | Pass |
| 5 | Stability | The container should not slide or topple. | Pass |
| 6 | Strength of handles | The containers remained intact and handles should not rupture, tear, crack, or separate from the container. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each non-clinical test (e.g., how many sharps containers were subjected to each test).
The provenance of the data is not specified in terms of country of origin of the data or whether it was retrospective or prospective. These are lab tests conducted on the physical device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the described tests are non-clinical hardware performance tests, not studies requiring expert interpretation of results or ground truth establishment by medical professionals. The acceptance criteria are based on physical measurements and observations against established standards (ASTM F2132-01, ISO 23907, 49 CFR 178.606, 49 CFR 178.608).
4. Adjudication Method for the Test Set
This information is not applicable. The tests are objective measurements and observations against pre-defined acceptance criteria, not subjective assessments requiring adjudication by a panel of experts.
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 information is not applicable. The device is a Sharps Container, which is a physical medical device for waste disposal, not an AI or imaging diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical Sharps Container, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the Sharps Containers is based on:
- Established International Standards: ASTM F2132-01 (Reapproved 2008e1), ISO 23907, and 49 CFR 178.606, 49 CFR 178.608. These standards define the test methods and performance requirements (acceptance criteria) for sharps containers.
- Direct Physical Measurement and Observation: The tests involve physical manipulation (e.g., dropping, stacking, vibrating, puncturing) of the containers and subsequent observation and measurement of specific parameters (e.g., puncture resistance in Newtons, absence of leakage, absence of deterioration, stability, integrity of handles).
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device as it is a physical product and not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
§ 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).