(270 days)
Tiger Reusable Sharps Containers and accessories are intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal, storage and transportation of hazardous sharps.
Tiger Reusable Sharps Containers are of injection-molded polypropylene plastic, designed for reusable 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.
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 product identification label's level line.
The device in question is the Tiger Reusable Sharps Container.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Standard | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps | ASTM F 2132 -01 (Reapproved 2008)e1 | The force needed to penetrate test specimens shall be a minimum of 20 N or greater. | Pass |
| DOT Drop Test | 49 CFR 178.603 | There is no damage to the outer packaging likely to adversely affect safety during transport, there is no leakage of the filling substance from the inner packaging. | Pass |
| DOT Stacking Test | 49 CFR 178.606 | No test sample may show any deterioration or distortion, which could adversely affect safety or container strength during transport causing instability in stacks of packages. | Pass |
| DOT Vibration standard | 49 CFR 178.608 | A packaging passes the vibration test if there is no rupture or leakage from any of the packages. No test sample should show any deterioration which could adversely affect transportation safety or any distortion liable to reduce packaging strength. | Pass |
| Container stability | ISO 23907, ISO 23907-2 | The container shall not topple over when tested. | Pass |
| Aperture and closure | ISO 23907, ISO 23907-2 | It shall be possible to place sharps into the sharps container without using a second hand to manipulate the aperture. The aperture of containers intended to be placed in public access areas should be designed to restrict hand entry and removal of contents from the container. The aperture should be designed to prevent the risk of overfilling. | Pass |
| Resistance to penetration | ISO 23907, ISO 23907-2, ASTM F2132-01 | The force needed to penetrate test specimens shall be a minimum of 20 N or greater. | Pass |
| Resistance to damage or leakage after dropping | ISO 23907, ISO 23907-2 | There shall be no evidence of leakage and no breach of the sharps containment area. Minimum five minutes after every topple: - There shall be no evidence that the performance or function of the container has been compromised. - The container's temporary closure shall remain intact. | Pass |
| Resistance to spillage by toppling | ISO 23907, ISO 23907-2 | There shall be no evidence of leakage and no breach of the sharps containment area. Minimum five minutes after every topple: - There shall be no evidence that the performance or function of the container has been compromised. - The container's temporary closure shall remain intact. | Pass |
| Accessory strength test | ISO 23907, ISO 23907-2 | The strength of Wall Enclosures and Metal Wall brackets shall be tested by filling their associated sharps container with water. The filled container shall be placed into one of each of the respective wall-mounted accessories. After 48 hours, the containers shall be removed, and the accessories shall be inspected for any loss of integrity. There shall be no evidence of sagging, breakage, liquid leakage, or changes in performance for the locking mechanisms. | Pass |
| Fill line | ISO 23907, ISO 23907-2 | The fill line indicator shall be determined by the design of the container, considering the risk of sharps extending above the fill line. It shall be at a level no greater than 85 % of the total capacity of the container. | Pass |
| Lifespan simulation testing | ISO 23907 First edition 2012-09-01, ASTM F2132-01 (reapproved 2008), ISO 23907-2 First edition 2019-11 | To verify the performance of the devices conforms to the applicable performance standards requirement after Lifespan Simulation Testing. | Pass |
| Cytotoxicity Tests | ISO10993-5 | 8.6 Evaluation Criteria (Details not provided in the document, but implies a pass/fail determination based on standard cytotoxicity evaluation). | Based on the conditions of the test, the device was found to be non-cytotoxic. |
| Skin Sensitization Test | ISO10993-10 | 9.4 Evaluation of results (Details not provided in the document, but implies a pass/fail determination based on standard skin sensitization evaluation). | Based on the conditions of the test, the device was found to be non-sensitizing. |
| Skin Irritation Test | ISO10993-10 | 9.4 Evaluation of results (Details not provided in the document, but implies a pass/fail determination based on standard skin irritation evaluation). | Based on the conditions of the test, the device was found to be non-irritating. |
| Chemical Residues Test | ISO/DIS 15883-5 | 5.3 Quantitative Study of Extracts (Details not provided in the document, but implies evaluation of chemical residues). | Pass |
| Cleaning Validation | FDA Guidance, AAMI TIR 30, ISO/DIS 15883-5 | 1 Evaluation pass/fail criteria for the residual protein and hemoglobin (blood) by Spectrophotometric method (Method 1) | |
| 2 Evaluation pass/fail criteria for residual TOC by total organic carbon analyzer (Method 2) | Pass | ||
| Disinfection Validation | FDA Guidance, AAMI TIR 30, ISO/DIS 15883-5 | The disinfection process should be deemed effective if all three of the following are met: | |
| The concentration of the challenge suspension meets 1.1.2 c) requirements. | |||
| The positive control 1.2.2 e) shows microbial growth of each challenge organism. | |||
| After processing, no challenge organism was recovered at any site. | Pass |
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 explicitly state the specific sample sizes used for each individual test or the data provenance (country of origin, retrospective/prospective). It generally refers to "test specimens" or "test samples" for each performance test. The performance testing was done to demonstrate compliance with recognized international and national standards.
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 tests performed are physical, chemical, and biological performance tests for a medical device (sharps container), not diagnostic image analysis or clinical studies requiring expert ground truth establishment. The "ground truth" for these tests is defined by the technical specifications and acceptance criteria of the referenced standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the type of performance testing conducted. Adjudication methods are typically used in clinical trials or studies involving human assessment or interpretation, not for objective engineering or laboratory tests.
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 and not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for these performance tests is based on objective measurements and predefined thresholds established by the relevant national and international standards (e.g., ISO, ASTM, DOT CFR). For biological tests, the ground truth is based on the absence of cytotoxicity, sensitization, irritation, or successful disinfection/cleaning as per the specified methods and criteria. No expert consensus, pathology, or outcomes data were used to establish the ground truth for these device performance tests.
8. The sample size for the training set
This information is not applicable. The device is not an AI/machine learning model and therefore does not have a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above; there is no training set for this type of device.
§ 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).