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510(k) Data Aggregation
(70 days)
The M500-100 sharps container is designed to hold up to 30 syringes from 1 to 5 cc in size. This container is intended for use by trained medical personnel in a medical clinic setting for the safe disposal of hazardous sharps.
The M500-100 Sharps Container was compared to the below mentioned predicate containers in that it conforms to the same standards as its predicates. This container was made from polyethylene plastic with a polyethylene locking lid. This container was molded with no side or bottom seams. The predicate devices are also made of premotited polyethylene. The M500-100 has a lid, which locks when shut preventing any leakage or loss of its contents.
The M500-100 is designed to hold up to 30 used syringes of lec to 5cc in size. The syringes are placed into the container in a vertical position sharp side down. Other sharps may be disposed of by dropping them into the opening at the top.
The M500-100 sharps container has a flat bottom, which makes it stable when sitting on a table. This container can also be placed in a specially designed wall bracket.
There is a black line on this container to notify the user not to overfill .
The provided text describes a 510(k) submission for a medical device, specifically the M500-100 Sharps Container. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's effectiveness through a clinical study with detailed performance metrics like sensitivity/specificity or human reader improvement with AI.
Therefore, many of the typical acceptance criteria and study details requested (e.g., sample size for test sets, number of experts, MRMC studies, training set details) are not applicable to this type of device and submission. The "study" described is a series of tests to ensure the physical integrity and safety of the sharps container.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Derived from Description) | Reported Device Performance |
|---|---|
| No leakage when filled with water and allowed to stand | "showed no signs of leakage from the container." |
| Locked lid remains closed and prevents spillage/protrusion when dropped (3 feet) | "With the lid locked in place and the container filled with syringes the container was dropped from a suspended string 3 feet in the air onto a hard floor. The locked lid did not open up and there were no signs of the contents spilling out or protruding through the bottom." |
| Conformance to American Standards for Testing guidelines | "These test were conducted using the guidelines of the American Standards for Testing..." (Implies conformance) |
| Conformance to British Standards for Testing guidelines | "...and the British Standards of Testing." (Implies conformance) |
| Stability on a flat surface | "The M500-100 sharps container has a flat bottom, which makes it stable when sitting on a table." (Design feature, not a test with pass/fail) |
| Ability to hold 30 syringes (1cc to 5cc) | "The M500-100 is designed to hold up to 30 used syringes of 1cc to 5cc in size." (Design specification, not a test with pass/fail) |
| Notification of overfill | "There is a black line on this container to notify the user not to overfill." (Design feature, not a test with pass/fail) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. The text refers to "all tests" and "the M500-100 sharps container" implying that at least one unit of the device underwent each test. For a physical device like this, testing a small number (e.g., 1-5 units) to verify manufacturing quality and design integrity against standards is common practice.
- Data Provenance: The tests were conducted by Imagination Medical Inc. as part of their submission process. The text does not specify the country of origin of the data beyond the company's location in Jacksonville, Florida, USA. The tests appear to be prospective in nature, performed specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a physical device where "ground truth" for performance is established by objective physical tests (e.g., presence/absence of leakage, lid integrity after drop) against defined standards, not by expert consensus or interpretation.
4. Adjudication Method for the Test Set
- Not Applicable. As the tests are objective physical measurements, there is no need for adjudication by multiple experts. The outcome is directly observable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This type of study is relevant for diagnostic or screening devices where human interpretation is involved and needs to be compared with or augmented by AI. A sharps container is a physical container, not a diagnostic tool requiring human-in-the-loop performance evaluation.
6. If a Standalone Study Was Done
- Yes, in spirit. The described tests are a standalone evaluation of the device's physical properties. However, "standalone" in the context of AI usually refers to the algorithm's performance without human intervention. For a physical device, the tests conducted (leakage, drop test) represent its standalone physical performance.
7. The Type of Ground Truth Used
- Objective Physical Standards/Measurements. The "ground truth" for the tests was based on direct observation of physical integrity (no leakage, no spillage/protrusion) and adherence to guidelines from the American Standards for Testing and the British Standards for Testing.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of a physical medical device like a sharps container. This is not an AI/algorithm-driven device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
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