(266 days)
Maxcon Reusable Sharps Container is intended to be used for the collection and transportation of used medical sharps. The container is intended to be used in hospitals and clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.
Maxcon Reusable Sharps Container is of injection molded high density polyethylene plastic, and designed for a multiple-use of 250 cycles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. No part of the container is intended to come in contact with patients. The containers are designed to be non-sterile, puncture resistant, leak resistant on the sides and bottom, impact resistant, closable and stable. The recommended fill level is engraved onto the plastic and corresponds to the product identification label's level line. The container body is in the color of red, while the container lid is in the color of black. The products are supplied to waste management companies that are responsible for transporting, decanting, decontaminating, and destroying the containers. The black lid is used to slide across the container top. When in use, move the lid to show an opening with a size depending on the sharps waste to be dropped, and drop sharps waste into the container safely and effectively by gravitational force, allows easy disposal of sharps. After the sharps is deposited, slide the lid closed along the groove to recover the container body for temporary closure. When the content reaching to the fill line, use a 6" cable tie to lock together the lid and container body for final closure. The container is not for use in area with unsupervised patient access.
The provided text is a 510(k) Premarket Notification for a medical device: Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421. This document describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices. It is crucial to understand that this is not an AI/ML-based medical device. Therefore, the questions related to AI/ML model performance, such as MRMC studies, training/test sets, ground truth establishment by experts, and adjudication methods, are not applicable to this submission.
The document focuses on the physical and functional performance of the reusable sharps container.
Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The non-clinical tests are summarized in a table on pages 12-14.
| Test Conducted | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Tumbling with sharps simulation | ISO 23907-2:2019 Sharps injury protection - Requirements and test methods, Part 2:Reusable sharps containers | No rupture, leakage, or deterioration that could adversely affect its safe use or functionality. | Passed |
| Transport Simulations | ISO 23907-2:2019 Sharps injury protection - Requirements and test methods, Part 2:Reusable sharps containers | No rupture, leakage, or deterioration that could adversely affect its safe use or functionality. | Passed |
| Process simulations, including opening, decanting, decontamination, and closing processes of 250 cycles | ISO 23907-2:2019 Sharps injury protection - Requirements and test methods, Part 2:Reusable sharps containers | No rupture, leakage, or deterioration that could adversely affect its safe use or functionality. | Passed |
| Container Stability | ISO 23907-2:2019 Sharps injury protection - Requirements and test methods, Part 2:Reusable sharps containers | Container shall not topple over | Passed |
| Strength of Handles | ISO 23907-2:2019 Sharps injury protection - Requirements and test methods, Part 2:Reusable sharps containers | Handle/carrying feature shall not break or detach | Passed |
| Resistance to penetration | ISO 23907-2:2019 Sharps injury protection - Requirements and test methods, Part 2:Reusable sharps containers | Force needed to penetrate test specimens shall be a minimum of 20 N or greater. | Passed |
| Resistance to damage and leakage after dropping | ISO 23907-2:2019 Sharps injury protection - Requirements and test methods, Part 2:Reusable sharps containers | No evidence of leakage and no breach of the sharps containment area. | Passed |
| Label Integrity Test | ISO 23907-2:2019 Sharps injury protection - Requirements and test methods, Part 2:Reusable sharps containers | Labels are intact and legible after decontamination processing. | Passed |
| Resistance to spillage by toppling | ISO 23907-2:2019 Sharps injury protection - Requirements and test methods, Part 2:Reusable sharps containers | No evidence of breach of the sharps containment area | Passed |
| Microbiological validation | ISO 23907-2:2019 Sharps injury protection - Requirements and test methods, Part 2:Reusable sharps containers | No organisms are recovered from areas where a 10^4/ml challenge-suspension of representative pathogens in whole blood has been applied and dried. | Passed |
| Stacking Test | 49CFR 178.606 | No leakage, deterioration, buckling that might affect transportation safety or damage to contents | Passed |
| Vibration Test | 49CFR 178.608 | No rupture or leakage | Passed |
| Usable Capacity Test | ---- | The real using capacity should be ± 3% different from designed capacity. | Passed |
| Leak Proof on the sides and bottom | ---- | The side and bottom should be of no water leakage after soaking with water for 24 hours. | Passed |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the "sample size" in terms of number of units tested for each non-clinical test. Instead, it indicates that the container was subject to various process simulations over its intended life cycle, specifically "250 cycles" for process simulations (filling, closing, decanting, decontaminating). This implies a single or very small number of physical samples would undergo these cyclical tests.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" in the context of device testing. The tests are "non-clinical" and likely conducted in a laboratory setting. The applicant is Ningbo Maxcon Medical Technology Co., Ltd. in China, so the testing would presumably be done in China or by a contracted lab that adheres to the stated ISO and CFR standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This question is not applicable. This is a physical medical device (sharps container), not a diagnostic device relying on expert interpretation of data or images. Ground truth is established by objective physical measurements and functional performance against defined standards (e.g., "no rupture, leakage," "force needed to penetrate").
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This question is not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The testing results are objective pass/fail criteria based on physical and mechanical properties.
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:
This question is not applicable. This is not an AI/ML-based device, and therefore, no MRMC studies involving human readers and AI assistance were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by international and national standards (e.g., ISO 23907-2:2019, 49 CFR 178.606, 49 CFR 178.608) that define acceptable physical and functional performance for sharps containers. This includes objective measurements such as:
- Absence of rupture or leakage.
- Resistance to penetration (minimum force in Newtons).
- Container stability (not toppling).
- Handle integrity (not breaking or detaching).
- Legibility of labels after processing.
- Microbiological validation (no organism recovery).
- Usable capacity within a percentage deviation.
- Leak-proof property after soaking.
8. The sample size for the training set:
This question is not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
This question is not applicable. There is no training set as it's not an AI/ML model.
§ 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).