(251 days)
Maxcon Sharps containers (1 QT Sharps Container, MA1112; 5.4 QT Sharp Container MA1212 ; 5.4 QT Sharps Container MA1213; 7 Liter Sharps Container MA1324) are single-use, disposable, non-sterile containers, intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, and blood needles by qualified personnel in health care facilities in which medical sharps may be used. All device models are not in contact with or available to the patient in normal use, and all device models are not for use in areas with unsupervised patient access.
Maxcon Sharps Containers are 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. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant, leak resistant on the sides and bottom, impact resistant, closable and stable. Large access openings allow for disposal of sharps with one hand use. The plastic used for the sharps containers are of polypropylene , the same as that of the comparable predicate devices. Labels are printed in black text and a black bio-hazard symbol. Labels are adhered to the containers at the time of the manufacture with a fill line warning not to fill above this line. The cover base and the lid (closure) come pre-assembled with the body 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 cover to the body. There is no feature to bend, break, or shear needle ,includes blunting and melting of needle in the containers.
Acceptance Criteria and Device Performance Study for Maxcon Sharps Containers
This document outlines the acceptance criteria for Maxcon Sharps Containers and summarizes the non-clinical test study demonstrating the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Container Stability | The container shall not topple over when tested. | Passed |
| Strength of Handles | The handle/carrying feature shall not break or detach during testing. | Passed |
| Resistance to Penetration | The force needed to penetrate test specimens of the container shall be a minimum of 16N and an average of 18N or greater. | Passed |
| Resistance to Damage and Leakage after Dropping | There shall be no evidence of leakage and no breach of the sharps containment area after tested. | Passed |
| Resistance to Spillage by Toppling | There shall be no evidence of leakage and no breach of the sharps containment area after tested. | Passed |
| Stacking Test | No test sample may leak. No test sample may show any deterioration which could adversely affect transportation safety or any distortion likely to reduce its strength, cause instability in stacks of packages, or cause damage to inner packagings likely to reduce safety in transportation. | Passed |
| Vibration Test | There is no rupture or leakage from any of the packages. No test sample should show any deterioration which could adversely affect transportation safety or any distortion liable to reduce packaging strength. | Passed |
| Sharps Access and Closure for Repeated Openings and Closings | After the simulated time of Sharps access and closure for repeated openings and closings of the Sharps containers, all locking mechanism of the samples should be of no malfunction, and should lock sharps container permanently and securely. | Passed |
| Label Integrity Test | Any marking or labelling on the container that is essential for safe use shall be visible and easily legible. And the required information are included in labels. | Passed |
| Usable Capacity Test | The difference between the measured capacity volume and designed capacity should be ±3%. | Passed |
| Leak Proof on the Sides and Bottom | leak proof on the sides and bottom. | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of units (sample size) for each test set. However, for "Resistance to Penetration," it mentions cutting the external surface of "the container" into 24 approximately equal sized areas, implying at least one container was used per test. For "Stacking Test" and "Vibration Test," it mentions using "Three sample packagings" selected at random.
The data provenance is not specified in terms of country of origin. The study appears to be a retrospective non-clinical test conducted by the manufacturer, Ningbo Maxcon Medical Technology Co., Ltd.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the tests performed are non-clinical (physical and mechanical tests) and do not involve human interpretation or subjective assessment by experts to establish ground truth. The results are based on objective measurement and observation against predefined criteria in relevant standards.
4. Adjudication Method for the Test Set
This information is not applicable as there is no human interpretation or subjective assessment that would require adjudication. The tests involve quantifiable measurements and observations of physical performance.
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
There was no MRMC comparative effectiveness study conducted. The device is a physical sharps container and does not involve AI or human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical sharps container and does not involve any algorithm or AI.
7. The type of ground truth used
The ground truth for these non-clinical tests is established by fulfilling the objective, quantifiable criteria defined by recognized international and national standards, specifically:
- ISO 23907-1:2019 (Sharps injury protection — Part 1: Requirements and test methods for sharps containers)
- 49CFR 178.606 (US Department of Transportation hazardous materials regulations for drumming and packaging – specifically related to stacking tests)
- 49CFR 178.608 (US Department of Transportation hazardous materials regulations for drumming and packaging – specifically related to vibration tests)
- OSHA Regulations (Standards - 29 CFR) Bloodborne Pathogens. 1910.1030, (d)(2)(viii)(C) (for leak proof testing)
These standards define the methodologies and acceptable performance limits.
8. The sample size for the training set
This is not applicable as the device is a physical product and does not involve any machine learning models that require a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical product and does not involve any machine learning models or training sets.
§ 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).