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510(k) Data Aggregation
(85 days)
REHRIG PACIFIC COMPANY
Rehrig Healthcare Systems SharpsTank™ reusable sharps containers are intended to be used for the collection and transportation of contaminated sharps.
Rehrig Healthcare's reusable 4.9 gallon sharps containers are intended to be used for the collection and transportation of used medical sharps. The containers are intended to be used by healthcare workers in hospitals, clinics, physician offices, dental offices, laboratories, veterinarian offices, and other areas where sharps disposal is needed.
A 4.9 gallon reusable sharps container consisting of the container body, an integrated hinged lid, a torturous path mail chute and flusher insert.
Sharps are deposited into the container by placing the used sharps in the horizontal torturous path mail chute which allows the sharps to drop into the container while keeping fingers and hands away from direct access to the contents in the container. During use the containers can be placed in the optional counter top holder or in the optional wall brackets.
When the contents reach the fill line the flusher and lid are engaged into the final secured position.
The SharpsTank™ Reusable Sharps Container underwent performance testing to demonstrate its safety and effectiveness.
Here's an overview of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Criteria | Test Standard | Acceptance Criteria Met (Results) |
|---|---|---|
| Life-cycle testing | CSA Z316.6-07, Clause 6.2 | Passed |
| Vibration testing | 49 CFR 178.608 | Passed |
| Puncture resistance | ASTM F 2132-01 | Passed |
| Leak resistance | Health Devices, Aug-Sept 1993, ECRI, Vol. 22 Nos. 8-9 | Passed |
| Final closure | 49 CFR 178.608, 49 CFR 178.603, 49 CFR 178.606 | Passed |
| Stability testing | AS/NZS 4261:1994 Appendix D | Passed |
| Handle strength | AS/NZS 4261:1994 Appendix A | Passed |
| Fill Capacity | CSA Z316.6-07, Clause 6.2.3 and Rehrig Design Verification | Passed |
| Drop Test (Impact Resistance) | 49 CFR 178.603 | Passed |
| Stack testing | 49 CFR 178.606 | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" in terms of patient data or clinical samples. The testing described is for the physical and functional aspects of the container itself, following established engineering and safety standards. Therefore, the "sample size" would refer to the number of containers or components tested for each specific criterion. The document does not explicitly state the number of units tested for each standard.
The data provenance is not applicable in the context of typical clinical studies (e.g., country of origin, retrospective/prospective clinical data) as this pertains to the engineering and regulatory compliance testing of a medical device (sharps container). The standards cited are international (CSA, ASTM, AS/NZS) and US federal regulations (CFR).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided because the "ground truth" for this type of device (a sharps container) is defined by its ability to meet objective, quantifiable engineering and safety standards. Expert consensus, as typically understood in medical imaging or diagnostics, is not relevant for determining if a container is puncture-resistant or leak-proof. The ground truth is established by the specified criteria in each test standard.
4. Adjudication Method for the Test Set:
Not applicable. The performance is determined by passing or failing the objective criteria outlined in each specified test standard, not through an adjudication process involving human reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or screening devices where human readers interpret medical data (e.g., images) with and without AI assistance. The SharpsTank™ is a physical medical device (reusable sharps container), not a diagnostic or AI-powered interpretative system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical container, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for this device's performance testing is adherence to established national and international engineering and safety standards. This includes:
- Engineering Standards: CSA Z316.6-07, ASTM F 2132-01, AS/NZS 4261:1994.
- Federal Regulations: 49 CFR 178.608, 49 CFR 178.603, 49 CFR 178.606.
- Industry Guidance: Health Devices, ECRI.
These standards define the objective performance levels required for attributes like puncture resistance, leak resistance, stability, and impact resistance.
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" in the context of this device. The SharpsTank™ is a physical product, not an AI or machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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(372 days)
REHRIG PACIFIC COMPANY
Rehrig Healthcare Systems reusable 17 gallon 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.
Sharps Tank Reusable Sharps Container, Device Part Number: MW009. Empty Weight: 9.4 lbs, Color: Red with contrasting Biohazard Symbol, Dimensions: 20.00"L x 12.50"W x 25.8"H. Opening Dimensions: Main lid opening (approximate) - 18.00" x 10.7", Sub-lid opening (approximate) - 8.0" x 6.0". Both the main lid and sub-lid have temporary and final closures. Temporary closures are intended to allow opening and closing of the container by the user and to protect against spillage if toppled. The final closure is designed to secure the container during transport.
The provided text is a 510(k) cleared letter from the FDA for a reusable sharps container. It does not contain any information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.
The document is a regulatory approval letter, confirming that the "Sharps Tank Reusable Sharps Container" is substantially equivalent to a legally marketed predicate device. It specifies the intended use, physical characteristics of the device, and regulatory information.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device meets acceptance criteria based on the provided input.
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