(38 days)
The DeRoyal Industries Inc. TraceCart Sharps Collection Container is to be used by generators of medical waste in any health care setting where the safe collection and disposal of contaminated waste and medical sharps is required, such as in hospitals, doctors' offices, and other health care settings.
The DeRoyal Industries, Inc. TraceCart Sharps Collection Container is an accessory to a single lumen hypodermic needle. The proposed device functions in the same manner as predicate devices to provide the safe collection and containment of various types of contaminated waste and sharps such as syringes, needles, and laparoscopic devices.
Device Design/Materials UsedPhysical Progetties: The proposed device is comprised of high-density polyethylene (HDPE). The lid is comprised of opaque polypropylenc. The DeRoyal TraceCart Sharps Collection Container passed the following test methods: impact resistance, puncture resistance, overfill detection, leak resistance, stack test, stability, volume capacity, and wall material thickness.
Here's an analysis of the provided text regarding the DeRoyal Industries, Inc. TRACECART SHARPS COLLECTION CONTAINER, focusing on acceptance criteria and supporting studies:
This document is a 510(k) summary for a medical device. 510(k)s evaluate substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness through clinical trials with strict acceptance criteria and ground truth. Therefore, many of the requested data points (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance) are not typically applicable or provided in a 510(k) submission like this. Instead, the emphasis is on demonstrating that the new device performs as safely and effectively as existing, legally marketed devices.
However, we can extract the acceptance criteria and the type of study conducted to show that these criteria were met, which are primarily engineering and performance tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Method) | Reported Device Performance |
|---|---|
| Impact resistance | Passed |
| Puncture resistance | Passed |
| Overfill detection | Passed |
| Leak resistance | Passed |
| Stack test | Passed |
| Stability | Passed |
| Volume capacity | Passed |
| Wall material thickness | Passed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size used for each test. It simply states that the "DeRoyal TraceCart Sharps Collection Container passed the following test methods." For engineering tests like these, sample sizes are typically determined by relevant ISO standards or internal quality procedures, but are not usually detailed in a 510(k) summary.
- Data Provenance: Not explicitly stated, but these types of tests are typically conducted prospectively by the manufacturer (DeRoyal Industries, Inc.) in their own testing facilities or by accredited laboratories, following specified test protocols. The country of origin of the data would likely be the USA, where DeRoyal Industries is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable / Not specified. For engineering performance tests of a sharps container (e.g., measuring puncture resistance, leak resistance), "experts" in the sense of medical professionals establishing a ground truth are not relevant. The ground truth is established by objective physical measurements and adherence to engineering specifications for materials and design. The "experts" would be the engineers or technicians performing the tests, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- Not applicable / Not specified. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple expert readers in interpreting complex data (e.g., medical images). For objective engineering tests, the outcome is typically a pass/fail based on predetermined thresholds, so no human adjudication is needed to establish "ground truth."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is typically performed for diagnostic or AI-assisted devices to assess the impact of the device on human reader performance. A sharps collection container is a physical containment device, not a diagnostic tool, so an MRMC study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This concept pertains to artificial intelligence algorithms operating independently. The DeRoyal TraceCart Sharps Collection Container is a physical medical device; thus, standalone algorithm performance is not relevant. The device's standalone performance is effectively demonstrated by the engineering tests described.
7. The Type of Ground Truth Used
- The ground truth for these tests is based on objective engineering standards and physical properties. For example:
- Puncture resistance: Ground truth is the material's ability to resist penetration by a defined force from a sharp object (e.g., a needle), as measured against industry standards.
- Leak resistance: Ground truth is the container's ability to hold liquids without leakage under specified conditions.
- Wall material thickness: Ground truth is a direct physical measurement.
8. The Sample Size for the Training Set
- Not applicable. "Training set" refers to data used to train an artificial intelligence or machine learning model. This device is a physical container, not an AI system. Its design and material selection would be based on engineering principles and material science, not a "training set" of data in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As established in point 8, there is no "training set" for this device in the context of AI/ML. The "ground truth" for its design and manufacturing would be established through material specifications, engineering drawings, and quality control 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).