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510(k) Data Aggregation
(266 days)
Med-Tainer Single Deposit Containers (SDC) are intended for the safe collection and transport of medical sharps. The reusable 10 gallon and 17 gallon containers are to be used in supervised areas of healthcare institutions such as hospitals, clinics, veterinary offices and laboratories.
Med-Tainer Single Deposit Container (SDC) is used to collect medical sharps in supervised areas of healthcare facilities. The containers are rotationally molded and made of low density polyethylene. They are available in 17 gallon and 10 gallon sizes and in five colors: red, teal, yellow, blue and green. Med-Tainer SDC is a reusable container intended to be reprocessed up to 780 times. The products are supplied to waste management companies that are responsible for transporting, decanting, decontaminating, and destroying the containers. The accompanying lids vary by purpose. The black transport lid is used during transport of the filled container. The combination of black large lab lid, with an opening to discard sharps, and the black small lab lid, used to slide across the large lab lid when not in use, allows easy disposal of sharps. The color coordinating restrictive lid with a mail box type opening is intended to prevent hand or finger access.
This document describes the Med-Tainer Single Deposit Container (SDC), a device for the safe collection and transport of medical sharps. The bulk of the provided text details various performance tests conducted on the device to prove it meets certain acceptance criteria.
Here's the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Name | Reported Device Performance |
|---|---|
| Life Span Processing Simulation (per CAN/CSA Z316.6-14 BA.8.3.1) - 780 processing cycles without damage | All containers successfully completed 780 processing simulation cycles without damage. |
| Life Span Transport Simulation (per CAN/CSA Z316.6-14 BA.8.3.2) - 780 transport cycles without damage | All containers completed transportation without damage. |
| Leak Resistance Test (per Health Devices, August - September 1993, ECRI, Vol. 22 Nos. 8-9 pgs. 383-384) - No loss of fluid after 24 hours | Passed (containers processed 780 times were filled with water and checked after 24 hours for loss of fluid). |
| Container Stability Test (per ISO 23907) - Does not topple over on a 15° incline | Passed (containers processed 780 times were filled with material of density 0.20 ± 0.01kg/l and placed on an incline with a minimum angle of 15°, repeated for each side). |
| Strength of Handles (per ISO 23907) - No breakage or detachment when suspended for an hour with 150% maximum gross mass | Passed (containers processed 780 times were filled with a mass equivalent to 150% of the manufacturer's maximum gross mass, closed, suspended by handles for an hour at 23 ± 5℃, and examined). |
| Resistance to Damage and Leakage after Dropping (per ISO 23907) - No leakage or loss of integrity after 1-meter drop | Passed (containers processed 780 times, filled with liquid and sharps, closed, and dropped 1 meter on bottom, side wall, and adjacent side wall; inspected for leakage and/or loss of integrity). |
| Resistance to Damage and Leakage after Dropping (modified) (per ISO 23907) - No leakage or loss of integrity after 1-meter drop with heavier fill | Passed (containers filled with liquid, sharps, glass, and stainless steel (40.1 lbs), closed, and dropped 1 meter on bottom, side wall, and adjacent side wall; inspected for leakage and/or loss of integrity). |
| Puncture Resistance (per ASTM F2132-01) - Average ≥ 3.4 lbf (15 N), no value < 2.8 lbf (12.5 N) | Passed (12 thinnest areas of each side tested with a 21 gauge hypodermic needle). |
| Puncture Resistance (processed) (per ASTM F2132-01) - Average ≥ 3.4 lbf (15 N), no value < 2.8 lbf (12.5 N) after 780 cycles | Passed (12 thinnest areas of each side of containers processed 780 times tested with a 21 gauge hypodermic needle). |
| Drop Test (per 49 CFR 178.603) - No loss of contents after 1.2-meter drop | Passed (containers filled, closed, conditioned, and dropped 1.2 meters on top, bottom, end, side, and top corner; examined for loss of contents). |
| Stack Test (per 49 CFR 178.606) - No deformation or release of contents after 28 days at 104°F with 130 lbs stacked | Passed (containers subjected to 104°F for 28 days with 130 pounds stacked on top; examined for deformation or release of contents). |
| Vibration Testing (per 49 CFR 178.608) - No deterioration or loss of contents after 60 minutes of vibration | Passed (containers placed on a vertical linear vibration table at 1-inch amplitude and 4.25 Hz for 60 minutes; inspected for deterioration or loss of contents). |
| Cleaning Validation (per FDA Guidance) - Met or surpassed performance criteria | All containers successfully met or surpassed performance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for each test (e.g., how many individual containers were subjected to each test). However, it consistently refers to "containers" in plural, implying more than one.
The data provenance is from prospective testing conducted by the manufacturer, Snyder Industries, Inc., to demonstrate the device's performance against established industry standards (CAN/CSA, ECRI, ISO, ASTM, 49 CFR, FDA Guidance). No country of origin for the data is explicitly mentioned beyond the US-based company and FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For the Med-Tainer SDC, the "ground truth" is not established by human expert consensus on diagnostic images or similar. Instead, the ground truth is defined by the objective pass/fail criteria of the various engineering and performance tests based on the referenced standards. No human experts were used to establish the ground truth in the traditional sense of medical image interpretation. The "experts" in this context are the engineers and technicians who conducted the tests and interpreted the results against the predefined quantitative criteria in the standards.
4. Adjudication Method for the Test Set
Not applicable. The tests are either objective measurements (e.g., force to penetrate, fluid loss, toppling) or visual inspections against defined criteria by the testing personnel. There is no mention of a formal adjudication process (like 2+1 or 3+1 consensus) as typically seen in clinical studies involving interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a physical sharps container, not an AI-powered diagnostic tool that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) study was done
No, this question is not applicable. The device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is objective engineering and performance test criteria defined by various national and international standards (CAN/CSA Z316.6-14, Health Devices by ECRI, ISO 23907, ASTM F2132-01, 49 CFR 178.603, 49 CFR 178.606, 49 CFR 178.608) and FDA Guidance. This includes quantitative measurements (e.g., average penetration force, presence/absence of leakage, toppling) and visual inspection against specified conditions.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product and does not involve a training set as would be used for a machine learning algorithm.
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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