(249 days)
Red2Green Reusable Sharps Containers and accessories 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 offices and other small quantity waste generators for the safe disposal, storage and transportation of hazardous sharps.
Red2Green Reusable Sharps Containers are reusable sharps containers designed for disposal of sharps. The containers are intended for over-the-counter use for the safe disposal of sharps, i.e. articles that can penetrate human skin. This definition includes, but is not limited to needles, scalpels, syringes with needles, disposable scissors, suture needles, stylets, trocars and broken test tubes.
The provided document is a 510(k) premarket notification for a medical device, specifically the Red2Green Reusable Sharps Container. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical safety and efficacy through human trials. Therefore, the information requested in your prompt related to clinical studies, human readers, ground truth established by experts, etc., is not typically found in this kind of document for a device like a sharps container.
However, the document does detail non-clinical performance testing and acceptance criteria. Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Puncture Resistance (ASTM F2132) | Average puncture force no less than 3.4 lbf with no one value from any region being less than 2.8 lbf. | All containers and lids were tested. Implicitly, the device met these criteria, as the conclusion states the device does not raise new issues of safety or efficacy and is substantially equivalent. |
| Impact with Leak (ISO 23907) | No loss of container integrity and no evidence of leakage. | All containers and lids were tested in each possible configuration. Implicitly, the device met these criteria. |
| Stability (ISO 23907) | Device did not topple. | One container was tested in both orientations (lid open). Implicitly, the device met these criteria. |
| Impact (49 CFR 178.603) | No damage to the outer packaging and no leakage of the filling substance. | Five containers were subjected to the test on base, top, side wall, adjacent side wall, and bottom corner. Implicitly, the device met these criteria. |
| Stacking (49 CFR 178.606) | The load was sustained for 24 hours at a temperature of 23° C and 50% relative humidity. No damage, leakage or deterioration that could adversely affect transportation safety was observed. | Five containers were subjected to a static load of 250 lbs for 24 hours. Implicitly, the device met these criteria. |
| Vibration (49 CFR 178.608) | No damage to the outer packaging and no leakage of the filling substance. | Three containers were subjected to vibration at 278 cpm for 1 hour. Implicitly, the device met these criteria. |
| Accessory Strength Test | No evidence of sagging, breakage, liquid leakage, or changes in performance for the locking mechanisms. | The strength of Wall Enclosures and Metal Wall Bracket was tested with associated sharps containers filled with water for 48 hours. Implicitly, the device met these criteria. |
| Repeated Opening Test | Device remained undamaged and there were no signs of malfunction of the lid. | Three samples of the Horizontal Drop Lid were manually opened and closed for 1000 repetitions. Implicitly, the device met these criteria. |
| Life Cycle Test | No evidence of discoloration, cracks, breaks or other deficiencies (such as deterioration to the label) that would prevent the containers from operating normally. After 400 cycles, the integrity of the device endured, and no changes to the performance or technical characteristics were visible after subsequent vibration, leak, and impact testing, and then puncture resistance testing on one container. | Five representative sharps containers were subjected to 400 cycles of filling, tipping, dumping, disinfecting, washing, drying, and processing, followed by vibration, leak, impact, and puncture resistance testing. Implicitly, the device met these criteria. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Puncture Resistance: "All containers and lids were tested." (Specific number of units not given, but implies comprehensive testing across product variations).
- Impact with Leak: "All containers and lids were tested in each possible configuration." (Specific number of units not given, but implies comprehensive testing across product variations and configurations).
- Stability: "One container."
- Impact: "Five containers."
- Stacking: "Five containers."
- Vibration: "Three containers."
- Accessory Strength: "One of each of the respective wall mounted accessories." (Number depends on accessories available).
- Repeated Opening: "Three samples of the Horizontal Drop Lid."
- Life Cycle: "Five representative sharps containers." (One of these was then used for puncture resistance).
Data Provenance: This document describes non-clinical laboratory testing performed by the manufacturer, Triumvirate Environmental, Inc. The location of the testing is not explicitly stated but is assumed to be internal to the company or through a contracted lab. This is retrospective data collected specifically for this 510(k) submission. There is no information regarding country of origin of data for clinical data as none was performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this document. The ground truth for this device's performance is based on meeting engineering and performance standards outlined by ASTM, ISO, and CFR, not on expert clinical consensus.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical data by multiple experts. For this device, performance is measured against objective laboratory criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance
This information is not applicable. This device is a physical sharps container and does not involve AI or human interpretation for its function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This device is a physical sharps container and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the Red2Green Reusable Sharps Container is established by adherence to recognized national and international performance standards (e.g., ASTM F2132, ISO 23907, 49 CFR 178.603, 178.606, 178.608) and predetermined acceptance criteria set forth by the manufacturer to demonstrate substantial equivalence to predicate devices. These standards define objective, measurable physical properties expected of sharps containers.
8. The Sample Size for the Training Set
This information is not applicable. "Training set" refers to data used to train AI algorithms, which is not relevant for this physical device. The non-clinical tests described are performance verification tests.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reason stated 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).