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510(k) Data Aggregation
(179 days)
STERICYCLE, INC.
The Stericycle Sharps Management Service Reusable Sharps Container is intended for use in health care facilities for the storage and transport for disposal of syringes and other medical sharps waste.
The Stericycle Sharps Management Service Reusable Sharps Container is a single piece, reusable, sharps container that is intended to be used in health care facilities where medical sharps waste is generated. The container is injection molded of polypropylene copolymer with a uniform nominal thickness of 0.125". The container is available in 2 and 4 gallon sizes and in red or yellow color. The lid of the container is constructed so that the sharps waste is disposed safely and effectively by gravitational force when the waste is placed in the inner tray. The Stericycle Sharps Containers utilize a counterbalanced lid design that acts as a protective barrier to keep sharps objects within the container from coming back up through the lid and anyone from reaching into the container to retrieve sharps waste.
The Stericycle Sharps Management Service Reusable Sharps Container is intended for use in healthcare facilities for the storage and transport for disposal of syringes and other medical sharps waste.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The device passed all performance tests, indicating it meets the defined acceptance criteria.
| Acceptance Criteria (Test Standard / Description) | Reported Device Performance |
|---|---|
| Life-cycle testing (Subsequent to conditioning of units representative of reprocessing and transport of the 2- and 4-gallon Reusable Sharps Containers, the units were tested and evaluated for the following parameters): | |
| • Vibration Resistance (ISTA 3E) | Pass |
| • Impact Resistance (The filled container maintains its integrity when dropped 4 ft. to a concrete surface and retains its solid contents.) | Pass |
| • Leak Resistance (The container loses no liquid over a 24-hour period.) | Pass |
| • Needle Puncture Resistance (ASTM F2132-01:2008) | Pass |
| DOT Standards: | |
| • DOT Vibration Resistance (49 CFR 178.608) | Pass |
| • DOT Impact Resistance (49 CFR 178.603) | Pass |
| • DOT Stacking Resistance (49 CFR 178.606) | Pass |
| Other: | |
| • Topple Resistance (AS/NZS 4261:1994, Appendix D) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that each test was performed on "both 2- and 4-gallon Container sizes." It does not specify the number of containers for each size that were tested, meaning the exact sample size is not explicitly provided beyond indicating that both types were included in the evaluation.
- Data Provenance: The tests are nonclinical performance tests conducted in a laboratory setting based on established standards. There is no information regarding country of origin or whether the data is retrospective or prospective, as these are not relevant to nonclinical bench testing.
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 evaluation involved nonclinical performance testing against established standards, not interpretation by human experts. The "ground truth" is defined by the objective pass/fail criteria of the specified test standards.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation involved nonclinical performance testing against established standards, not human judgment or adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, often with AI assistance. The Stericycle Sharps Management Service Reusable Sharps Container is a physical medical device, and its performance is evaluated through bench testing against engineering standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an AI algorithm. Its performance is inherent to its physical properties and design, tested directly through nonclinical methods.
7. The Type of Ground Truth Used
The ground truth used for the performance evaluation is based on established industry and regulatory standards for sharps containers and transportation, such as:
- ISTA 3E (Vibration Resistance)
- ASTM F2132-01:2008 (Needle Puncture Resistance)
- 49 CFR 178.608, 178.603, 178.606 (DOT standards for Vibration, Impact, and Stacking Resistance)
- AS/NZS 4261:1994, Appendix D (Topple Resistance)
- Internal specifications for impact and leak resistance (e.g., "Retains its solid contents when dropped 4 ft. to a concrete surface," "loses no liquid over a 24-hour period").
These standards define objective and measurable criteria for acceptable performance.
8. The Sample Size for the Training Set
This information is not applicable. The Stericycle Sharps Management Service Reusable Sharps Container is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the device is not an AI/ML algorithm and therefore does not have a training set or associated ground truth for training.
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