(70 days)
The Arrow SharpsAway II™ Locking Disposal Cup is intended as a single use needle protection device, which covers the end of needles after use to minimize the risk of needle sticks. This device is designed for use with 15 Ga. to 30 Ga. needles for various clinical procedures.
The proposed SharpsAway II™ Locking Disposal Cup was created to help prevent needle sticks by providing a means of moving used sharps from procedure to sharps container.
The SharpsAway II™ Locking Disposal Cup is a device designed to prevent needle sticks by covering used sharps. The provided text outlines the performance tests conducted to demonstrate its substantial equivalence to a legally marketed predicate device (Devon Industries - Point-Lok® Needle Protection Device, K946289).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the performance tests were designed to demonstrate substantial equivalence to the predicate device. Therefore, the "reported device performance" is that the device met the requirements such that it was deemed substantially equivalent.
| Acceptance Criteria (Implied) | Reported Device Performance Statement |
|---|---|
| Prevention of needle sticks (General functionality) | "The results of the performance tests demonstrate that the device is substantially equivalent to the legally marketed predicate device." |
| Effective locking mechanism (Simulated Use Study) | Passed (implied by overall substantial equivalence conclusion) |
| Resistance to punctures (Puncture Resistance Test) | Passed (implied by overall substantial equivalence conclusion) |
| Reliable gripping (Gripping Mechanism Functionality Test) | Passed (implied by overall substantial equivalence conclusion) |
| Containment of fluids (Water Leak Test) | Passed (implied by overall substantial equivalence conclusion) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample sizes used for any of the performance tests (Simulated Use Study, Puncture Resistance, Gripping Mechanism Functionality Test, Water Leak). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not contain any information about experts used to establish a ground truth for the test set. The tests appear to be physical or mechanical performance tests rather than clinical studies requiring expert interpretation.
4. Adjudication Method for the Test Set
The provided text does not mention any adjudication method. Given the nature of the performance tests (e.g., puncture resistance, water leak), it is unlikely that a human adjudication method like 2+1 or 3+1 would be applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This device, the SharpsAway II™ Locking Disposal Cup, is a medical device for sharps disposal, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study comparing AI assistance with human readers was not done, and there is no mention of AI in the provided documentation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
As stated above, this device is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm-only performance study was not done.
7. The Type of Ground Truth Used
For a physical device like the SharpsAway II™ Locking Disposal Cup, "ground truth" would typically be established by:
- Engineering specifications and standards: For tests like Puncture Resistance, there would be predefined standards or internal specifications for resistance levels.
- Functional requirements: For tests like Simulated Use and Gripping Mechanism, the "ground truth" is whether the device successfully performs its intended function (e.g., locks a needle, grips effectively) under simulated use conditions.
- Physical properties: For the Water Leak test, the ground truth is simply the absence of a leak.
The document implicitly suggests that these tests were performed against such established criteria to determine if the device functioned as intended and was substantially equivalent to the predicate.
8. The Sample Size for the Training Set
This device is not an AI/ML product, so there is no concept of a training set in this context.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of medical device, this question is not applicable.
§ 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).