(97 days)
The container is intended for use by healthcare providers, such as hospitals, laboratories, medical clinics, veterinary clinics and other facilities where needles are generated. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps.
The Enviro Sharp Solutions 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, Sci-Med Waste employees will empty and sanitize the unit and return it to the facility to use for the next switch out. The durable high-density polyethylene construction of the Enviro Sharp Solutions 3 makes it leakproof, 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 an analysis of the provided text regarding the acceptance criteria and study for the Enviro Sharp Solutions 3 device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Performance Metric | Reported Performance | Outcome |
|---|---|---|---|
| Puncture Resistance | Needle penetration force | "Pass" (referencing Health Devices 22 standard) | Meets Criteria |
| Leak Resistance | 24 hours filled with water | "Pass" (referencing Health Devices 22 standard) | Meets Criteria |
| Vibration | 1 hour repetition bounce | "Pass" (referencing 49 CFR 178.608 standard) | Meets Criteria |
| Free Fall Drop | 5 drops 3.9 feet | "Pass" (referencing 49 CFR 178.603 standard) | Meets Criteria |
| Stacking | 24 hours under 65 lbs | "Pass" (referencing 49 CFR 178.606 standard) | Meets Criteria |
| Simulated Life-Use | No visible signs of failure after cleaning, filling, depositing waste, and sanitizing. | "no visible signs of failure" | Meets Criteria |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a precise numerical sample size for the "random sampling" of containers subjected to simulated life-use or for the individual performance tests (Puncture, Leak, Vibration, Free Fall Drop, Stacking). It refers to "all components of a random sampling" for the simulated life-use.
- Data Provenance: The data is retrospective, generated from testing performed on the device components. The country of origin is not explicitly stated but is implied to be within the US given the FDA submission and US regulatory standards cited (e.g., OSHA, CFR). The testing occurred over "a two-day period from November 5, 2008 to November 7, 2008."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document does not describe the use of human experts to establish ground truth for the performance tests. The "ground truth" for these tests is based on objective measurements and observations against established engineering and regulatory standards (Health Devices 22, 49 CFR).
- The final assessment for the performance tests is reported by "Container Testing Laboratory, Inc.," indicating an accredited testing facility, but individual expert qualifications are not detailed.
4. Adjudication Method for the Test Set
- No human adjudication method (like 2+1 or 3+1) is mentioned or implied for the performance tests. The tests involve objective measurements against pass/fail criteria from regulatory standards.
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 disposal container and not an AI-assisted diagnostic or decision support tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. The device is a physical product, not an algorithm or software. The performance tests are by definition "standalone" in the sense that they evaluate the physical product's characteristics against objective criteria.
7. The Type of Ground Truth Used
- The ground truth used for the performance tests is derived from established engineering and regulatory standards. For example, the "Pass" for Puncture, Leak, Vibration, Free Fall Drop, and Stacking implies that the device performance met the quantitative or qualitative criteria specified within Health Devices 22 and various sections of 49 CFR. For the simulated life-use, the ground truth was the absence of visible signs of failure.
8. The Sample Size for the Training Set
- This question is not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable, as there is no training set for this device.
§ 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).