(265 days)
Maxcon Two Gallon Chemotherapy Container (Model, MC1321) is intended for safe collection and containment of trace chemotherapy waste including needles, syringes, and empty vials. The container is non-sterile, to be single-used in areas with controlled access, such as nurse's stations, pharmacies and chemo treatment rooms, and the target population is for trained health-care professionals.
Maxcon Two Gallon Chemotherapy Container (Model: MC1321) is of 2 gallon capability, weight about 470gram, size of 275.6mm (length) ×181.5mm (width)× 275mm (height), and the maximum allowable gross mass of the container defined by the company is 2 Kg.There is no feature to bend, break, or shear needle (includes blunting and melting of needle)in the containers.
The container is made of base+gasketed cap+screw-on cap. The plastic components are made of injection-moulded of Poly-propylene (PP). The pad and gasket are made of Ethylene Vinyl Acetate (EVA) foam.
The closure system is designed, comprising of 4 components: Gasketed lid, Lid gasket pad, Screw-on cap, Cap gasket.
The provided text describes the 510(k) premarket notification for the Maxcon Two Gallon Chemotherapy Container (Model, MC1321). This document focuses on demonstrating substantial equivalence to a predicate device (Bemis Two Gallon Chemotherapy Container, K964858) through non-clinical performance data.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a table format with pass/fail results for each criterion. Instead, it lists the tests performed and indicates that the device "Passed" each of them. The regulatory standards referenced effectively serve as the acceptance criteria.
| Test/Characteristic | Standard/Criterion | Reported Device Performance |
|---|---|---|
| Puncture Resistance | ASTM F 2132-01 (2008) | Passed |
| Container Stability | ISO 23907:2012 | Passed |
| Drop/Impact Test | ISO 23907:2012 | Passed |
| Handle Strength | ISO 23907:2012 | Passed |
| Stacking Test | 49CFR 178.606 | Passed |
| Vibration Test | 49CFR 178.606 | Passed |
| Suitability for chemotherapy drugs | Not explicitly stated as a standard, but a specific test was performed. | Passed |
| Chemical Resistance (H2SO4, NaOH) | Not explicitly stated as a standard, but specific chemicals were used. | Passed |
| Shelf-life study | Real-time aging and accelerated-time aging to support a 3-year shelf life. | Passed |
2. Sample size used for the test set and the data provenance:
- Sample size: The document does not specify the sample size (number of containers) used for each test.
- Data provenance: The tests were conducted by Ningbo Maxcon Medical Technology Co., Ltd in China, as indicated by the submitter's identification. The data is non-clinical performance data gathered for regulatory submission. It is not specified if the tests were conducted prospectively or retrospectively, though typically such performance testing is done prospectively for new device submissions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a physical chemotherapy waste container and the "ground truth" for its performance is established through adherence to engineering and safety standards (e.g., puncture resistance, leak resistance, stability) rather than expert interpretation of medical images or patient outcomes. The evaluation is based on objective measurements against established test methods.
4. Adjudication method for the test set:
This information is not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish ground truth for subjective interpretations (e.g., medical image diagnosis). For physical device testing, the results are typically objective measurements against a defined standard.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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 Maxcon Two Gallon Chemotherapy Container is a physical medical waste container, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. As stated above, this device is a physical chemotherapy waste container, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's performance is established by objective measurements against recognized industry standards and regulatory requirements. This includes:
- ASTM F 2132-01 (2008) for puncture resistance.
- ISO 23907:2012 for container stability, drop/impact, and handle strength.
- 49CFR 178.606 for stacking and vibration tests.
- Internal testing for suitability with chemotherapy drugs and chemical resistance, and shelf-life studies.
8. The sample size for the training set:
This information is not applicable. This is a physical device and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
This information is not applicable. As mentioned 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).