(74 days)
The SteriSharp™ 3-Gallon RSDC reusable containers are intended for use by healthcare providers (hospitals, laboratories, medical clinics, veterinary clinics, and other such areas and facilities where needles, sharps waste and other infectious waste is generated). The containers are designed to safely contain sharps waste prior to removal from generating facility and until ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse.
The SteriSharp™ 3 is a reusable plastic sharps disposal container. It features a mail drop, torturous path tumbler lid for safe and easy disposal of sharps. Simply deposit syringes horizontally into the opening of the lid and they are deposited automatically into the container. When the container is full the tumbler will indicate that it is time to replace the unit. Just insert the locking tabs to secure the container in a closed position and replace it with a clean sanitized unit. Using our proprietary equipment, SteriLogic employees will empty and sanitize the unit and return it to your facility to use for the next switch out. The durable high-density polyethylene construction of the SteriSharp™ 3 makes it leak-proof, puncture resistant and stable. It meets or exceeds all OSHA recommendations for sharps containers, and because it is reusable, it is more environmentally friendly and less expensive than disposable alternatives.
Here's a breakdown of the acceptance criteria and study information for the SteriSharp™ 3-Gallon RSDC, based on the provided FDA 510(k) Notification:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Puncture Resistance | Health Devices 22 (Needle penetration force) | Pass |
| Leak Resistance | Health Devices 22 (24 hrs filled with water) | Pass |
| Vibration | 49 CFR 178.608 (1 hour repetitive bounce) | Pass |
| Free Fall Drop | 49 CFR 178.603 (5 drops 1.2 meter) | Pass |
| Stacking | 49 CFR 178.606 (24 hrs. under 30 kg) | Pass |
| Simulated Life-Use (Durability) | Withstand 100 cycles of use without visible signs of failure and subsequent performance testing. | Pass (no visible signs of failure, then performance tested and passed) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: A "random sampling" of the SteriSharp™ 3 container was used for the simulated life-use testing and subsequent performance tests. The exact number of units in this random sampling is not specified in the document.
- Data Provenance: The tests were conducted by the manufacturer or a contracted testing laboratory ("Container Testing Laboratory, Inc."). The document does not specify a country of origin for the data that would imply a geographical bias for the test set. All testing described is prospective, as it was performed specifically for this 510(k) submission to demonstrate the device's performance.
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 device is not an AI/diagnostic device that relies on expert interpretation for ground truth. The acceptance criteria are based on objective physical performance standards. The "ground truth" for these tests is the direct measurement of the device's physical properties against established safety and performance standards.
4. Adjudication Method for the Test Set:
- This is not applicable as there are no expert interpretations or subjective assessments requiring adjudication. The tests involve objective measurements and pass/fail criteria.
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 relevant for diagnostic devices where human readers interpret patient data (e.g., medical images) with and without AI assistance. The SteriSharp™ 3 is a physical sharps disposal container, so this type of study is not relevant to its evaluation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- This is not applicable. The SteriSharp™ 3 is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used:
- The ground truth used for these tests is based on objective performance standards and regulations (e.g., Health Devices 22, 49 CFR 178.603, 178.608, 178.606). These standards define the acceptable physical properties and performance characteristics (puncture resistance, leak resistance, vibration resistance, drop resistance, stacking strength) for disposable medical sharps containers. For the simulated life-use, the ground truth was the observable absence of failure and satisfactory functional performance after 100 cycles.
8. The Sample Size for the Training Set:
- This is not applicable. The SteriSharp™ 3 is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- This is not applicable for the same reasons as point 8.
§ 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).