(67 days)
The Noble Sharps container is a disposable over the counter sharps container that is intended for the safe disposal of used medical sharps. It is intended for use in offices, exam and patient rooms of small quantity healthcare providers such as medical doctors, dentists, and veterinarians. The size of the Sharps Container is 6 7/16" in height x 4 15/16" in width x 2 7/16" in depth. It is designed with 4- individual single use chambers with each holding 1-sharp, with a maximum sharp length of 6 1/8″.
The Noble Sharps Container are intended to be used at healthcare facilities, including nursing stations, medication carts, laboratories, emergency rooms, treatment rooms, and other small quantity waste generators for the safe disposal of hazardous sharps.
The Nobles Sharps Container is a single use device designed for the safe disposal of hazardous sharps. It is designed with 4-chambers, each chamber will hold one sharps. After each chamber is filled with a sharp, a locking lid is closed by pressing downward, thus permanently sealing the sharps inside the container. All materials including the bottom, sides, and locking lid are manufactured using PP7726 (polypropylene) the same material used in the predicate device, the GongDong disposable sharps container cleared under K082042. The size of the Noble Sharps Container is 6 7/16" in height, 4 15/16" in width and 2 7/16" in depth.
The Noble Sharps Container is a medical device designed for the safe disposal of hazardous sharps. The submission refers to performance testing under recognized standards to demonstrate substantial equivalence to its predicate device.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Puncture Resistance (ASTM F 2132) | Testing performed and deemed substantially equivalent to currently marketed sharps containers. |
| Topple Resistance (CSA Z316.6-07) | Testing performed and deemed substantially equivalent to currently marketed sharps containers. |
| Leakage Tests (BS 7320:1990) | Testing performed and deemed substantially equivalent to currently marketed sharps containers. |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample sizes for the performance tests (ASTM F 2132, CSA Z316.6-07, BS 7320:1990). Given that these are standard tests for physical properties, the sample sizes would typically be defined by the respective standards. The data provenance is not specified beyond the fact that the tests were conducted for the Noble Sharps Container. It's implied to be prospective testing specific to this device.
3. Number of Experts and Qualifications:
Not applicable. This is a medical device focused on physical performance rather than diagnostic accuracy that would require expert human review. The evaluation relies on standardized engineering tests.
4. Adjudication Method:
Not applicable. The performance is assessed through objective physical and mechanical testing as per established standards, not through human interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. The device is a sharps container, not an imaging or diagnostic device that would involve human readers or AI assistance in interpretation.
6. Standalone Performance Study:
Yes, a standalone performance study was done in the sense that the Noble Sharps Container was subjected to specific performance tests (puncture resistance, topple resistance, leakage) independent of human interaction for its intended function.
7. Type of Ground Truth Used:
The ground truth for the performance testing is implicitly defined by the pass/fail criteria and methodologies outlined in the referenced standards: ASTM F 2132, CSA Z316.6-07, and BS 7320:1990. These standards establish objective criteria for puncture resistance, topple resistance, and leakage, respectively.
8. Sample Size for Training Set:
Not applicable. This device is a physical medical device and not an AI/machine learning model, so there is no training set in the conventional sense.
9. How Ground Truth for Training Set was Established:
Not applicable, as 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).