(114 days)
Tiger 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 hypodermic needles, syringes, lancets and blood needles. The target population is for qualified personnel in health care facilities in which medical sharps may be used. All device models are not for use in areas with unsupervised patient access.
All device models only be used with appropriate mounting accessories.
Tiger Sharps Containers constructed of injection molded polypropylene plastic. They are designed for a single-use (disposable) by healthcare professionals. 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.
Lids and closures are uncolored translucent material allowing for a visual determination of fill level. The base is made from a high strength material to support the capacity of the container. The recommended fill level is engraved onto the plastic and corresponds to the level line on the product identification label.
The provided text describes the regulatory clearance of "Tiger Sharps Containers" and includes information about its performance testing. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Device Performance (Result) | Standard/Method |
|---|---|---|
| Puncture Resistance | Pass | ASTM F2132-01(2008)e1 |
| Resistance to Damage/Leaking after Drop | Pass | ISO 23907-2012 |
| Handle Strength | Pass | ISO 23907-2012 |
| Container Stability | Pass | ISO 23907-2012 |
| Stacking | Pass | 49 CFR 178.606 |
| Vibration | Pass | 49 CFR 178.608 |
| Drop test | Pass | 49 CFR 178.603 |
| Biocompatibility | Demonstrated compliance | Related international standards |
| Sterility | Not applicable (device is non-sterile) | N/A |
| Product Specifications (e.g., dimensions, capacity, materials) | Demonstrated compliance | Related international standards |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for each performance test. It only states that "Performance testing was provided in support of the substantial equivalence determination." The provenance of the data (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable as the device is a sharps container and the performance tests described are physical and mechanical tests, not clinical evaluations requiring expert interpretation of medical data. Therefore, there is no "ground truth" established by medical experts in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as #3. The performance tests are objective measurements against established standards.
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 physical sharps container, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a physical sharps container and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests appears to be defined by the consensus standards (e.g., ASTM F2132-01(2008)e1, ISO 23907-2012, 49 CFR) themselves. These standards specify the test methods and the acceptable criteria for "passing" a test, rather than relying on expert clinical consensus, pathology, or outcomes data in a medical sense.
8. The sample size for the training set
This information is not applicable. The device is a physical product that undergoes engineering performance testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for a machine learning model.
§ 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).