(265 days)
Maxcon Sharps containers(2.2QTSharpsContainer,MA1122;2GSharps Container MA1321;2GSharp Container MA1221; 8GSharps Container MA1352) are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal ofhazardous sharps such as hypodermic needles, syringes, lancets and blood needles.The target population is for qualified personnel in health care facilities in which medical sharps may be used. All the containers are intended to be used in areas where is no unsupervised patient access.
Maxcon Sharps Containers are made of injection molded polypropylene plastic, and designed for a single-use by qualified personnel in health care facilities and other facilities in which medical sharps may be used, the same as that of the comparable predicate devices.
Maxcon Sharps Containers are composed of 3 parts (base+lid+closure).No part of the container is intended to come in contact with patients and the sharps objects that will be placed within the containers. The lid and the closure come pre-assembled with the base not attached. Components are nested together to reduce room occupation in storage and shipping. The final on-site assembly is performed in health care facility by snapping the lid to the base.
Labels are on a red background with printed in black text and a black bio-hazard symbol. Labels are adhered to the containers at the time of the manufacture with the fill line warning matching the engraved fill line on the container.
There is no feature to bend, break, or shear needle ,includes blunting and melting of needle in the containers.
The provided document details the 510(k) submission for the Maxcon Sharps Container. Since this is for a medical device (sharps container) and not an AI/ML-driven diagnostic or therapeutic device, the concepts of "acceptance criteria," "device performance," "sample sizes," "ground truth," "experts," and "MRMC studies" are applied differently than described in the prompt, which is more suited for AI/ML outputs.
Instead, the acceptance criteria are based on established performance standards for sharps containers, and the "study" is a series of non-clinical tests demonstrating the device's adherence to these standards.
Here's the information adapted to the context of a sharps container:
1. Table of Acceptance Criteria and the Reported Device Performance
| Test | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Puncture Resistance | ASTM F2132-01 (Reapproved 2008) - "Standard Specification for Puncture Resistance of Material Used in Containers for Discarded Medical Needles and Other Sharps". The device must resist puncture. | Passed |
| Container Stability | ISO 23907:2012 - "Sharps injury protection - Requirements and test methods - Sharps containers". The container must maintain a stable and upright position. | Passed |
| Drop/Impact Test | ISO 23907:2012 - "Sharps injury protection - Requirements and test methods - Sharps containers". The device must resist damage and leakage after dropping. | Passed |
| Handle Strength | ISO 23907:2012 - "Sharps injury protection - Requirements and test methods - Sharps containers". The handle must demonstrate adequate strength. | Passed |
| Stacking Test | 49 CFR 178.606 - Performance test for packaging. The containers must withstand stacking without damage. | Passed |
| Vibration Test | 49 CFR 178.606 - Performance test for packaging. The containers must withstand vibration without damage. | Passed |
| Sharps access and closure for repeated openings and closings | Implied functional requirement for safe disposal and containment during use. | Passed |
| Label Integrity Test | ISO 23907:2012. Labels must remain legible and affixed after testing. | Passed |
| Usable Capacity Test | Implied functional requirement that the container meets its stated usable capacity. | Passed |
| Minimum Sharps Container wall Thickness Evaluation | Implied structural requirement that the container walls meet minimum thickness specifications for safety and durability. | Passed |
| Shelf-life study | Real-time aging and accelerated-time aging studies to support a shelf life of 3 years. The device must maintain its functionality and integrity over this period. | Passed (3 years supported) |
| Simulated life cycle test | Implied functional requirement that the container performs throughout its intended use cycle. | Passed |
| Leak Proof on the sides and bottom | Implied functional requirement to prevent leakage of contents. | Passed |
| Clarity | Each container must have one translucent component, allowing visibility to check whether the wasted sharp reaches the fill line. | Yes (as per device description) |
| Capable of maintaining a stable and upright position | Yes | Yes (as per device description) |
| Performance, effectiveness and safety | Must pass all tests listed above (Puncture, Stability, Drop, Handle, etc.). | Passed (all listed tests) |
| End-color change | No color change. | No color change (as per comparison to predicate) |
| Claimed sterilization cycles | Device must be non-sterile, as stated. | Non-sterile (as per comparison to predicate) |
| Operation way | Drop the wasted sharps into container by one hand. | Same as predicate (as per comparison) |
| Single use or not | Single used and disposable ones. | Single used and disposable ones (as per comparison) |
| Labeling | Biohazard labels visible on device. | Biohazard labels visible on device (as per comparison) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It only states that the tests were successfully passed ("Passed"). The data provenance is through the manufacturer's internal testing as part of their 510(k) submission, confirming compliance with international and US standards. This is prospective testing performed on the final device design. The country of origin of the device and testing is implied to be China (Ningbo Maxcon Medical Technology Co., Ltd. is based in China), under the guidance of US FDA recognized consensus standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not directly applicable to the evaluation of a sharps container. The "ground truth" for a sharps container's performance is defined by established engineering and safety standards (e.g., ASTM, ISO, CFR). The "experts" in this context would be the engineers and technicians performing the tests according to the specified methodologies and the regulatory bodies (like FDA) that define and enforce these standards. There is no mention of external clinical experts retrospectively reviewing test results for "ground truth" establishment in the way it applies to diagnostic algorithms.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 (common in clinical trials or AI performance evaluations involving human readers) are not applicable here. The assessment of whether a sharp container "passed" a test is based on objective measurements and predefined pass/fail criteria outlined in the standardized test protocols (e.g., did the container resist puncture up to a certain force, did it leak after a drop, etc.).
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
An MRMC study is not applicable to a sharps container. This type of study is designed to evaluate the performance of diagnostic imaging devices or AI algorithms by having multiple human readers interpret cases, often comparing performance with and without AI assistance. The Maxcon Sharps Container is a physical medical device for waste disposal, not an imaging or diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This concept is not applicable. The Maxcon Sharps Container is a physical product, not an algorithm. Its performance is inherent in its physical design and materials, and it functions independently, although it is used by humans.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for evaluating the Maxcon Sharps Container is defined by adherence to established international and national performance standards (e.g., ASTM F2132-01, ISO 23907:2012, 49 CFR 178.606, OSHA 29 CFR 1910.1030). These standards themselves represent a consensus of expert engineering and safety knowledge that defines what constitutes a safe and effective sharps container. There is no "pathology" or "outcomes data" in the sense of clinical disease diagnosis.
8. The sample size for the training set
This concept is not applicable. Sharps containers are physical devices manufactured through injection molding. They do not involve "training sets" in the context of machine learning. The design and manufacturing processes are refined through engineering principles, material science, and iterative prototype testing, not data-driven algorithm training.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for an algorithm. The "ground truth" for the design and manufacturing of the sharps container is the adherence to the performance requirements stipulated by the aforementioned safety and engineering standards. Manufacturing processes are validated to consistently produce devices that meet these specifications.
§ 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).