(15 days)
The UltraSafe Passive™, X-Series, Needle Guard is intended for use as a safety mechanism designed to reduce the occurrence of accidental needlesticks to healthcare professionals during disposal of a used syringe and needle assembly. The UltraSafe Passive, X-Series, Needle Guard is snapped onto the barrel of an ISO Standard pre-filled glass syringe, in a retracted position. Upon completing the injection, the UltraSafe Passive, X-Series, Needle Guard passively activates and covers the exposed needle. When the Passive Needle Guard is activated, it provides protection from an accidental needlestick. The healthcare professional disposes the used syringe and needle assembly in a sharps container.
UltraSafe Passive™, X-Series, Needle Guards are single use devices that are indicated for use as an accessory with ISO Standard pre-filled glass syringes to protect healthcare professionals from accidental needle sticks.
The UltraSafe Passive™, X-Series, Needle Guard is an accessory for ISO Standard pre-filled glass syringes. ISO Standard pre-filled glass syringes are supplied in multiple sizes. They fit with ISO Standard pre-filled glass syringes ranging from 0.5 mL to 5.0 mL of fill volume.
The guards are designed to meet the requirements specified in ISO 11040-4 Prefilled syringes - Part 4 Glass barrels for injectables (March 1995).
The provided text describes a 510(k) submission for the UltraSafe Passive™, X-Series, Needle Guard. The submission focuses on demonstrating substantial equivalence to a predicate device, the UltraSafe® Injection System Needle Guard - B-Series, rather than establishing de novo acceptance criteria associated with a specific diagnostic performance outcome.
Instead of traditional diagnostic acceptance criteria (e.g., sensitivity, specificity, accuracy), the study evaluates the safety, performance, and usability of the new passive device compared to the manually activated predicate device through a controlled simulated clinical use test.
Here's an analysis of the "acceptance criteria" and the study based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Device Performance (UltraSafe Passive™, X-Series) |
|---|---|
| Needle Stick Safety | Rated equal to, or better than, the B-Series. |
| Overall Performance | Rated equal to, or better than, the B-Series. |
| Usability | Rated equal to, or better than, the B-Series. |
| Clarity & Adequacy of Directions for Use | Rated equal to, or better than, the B-Series. |
| Response to Need for In-Service Training | Rated equal to, or better than, the B-Series. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated beyond "nurses involved in this study" and "study participants." The exact number of nurses is not provided.
- Data Provenance: The study was a "controlled simulated clinical use test." It is prospective in nature, as it involved active participation of users with the device. The country of origin is not specified but given the company information (Carlsbad, CA, USA) and the FDA submission, it can be inferred that the study was likely conducted in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable in the context of this device. The "ground truth" here is subjective user feedback and comparative assessment by "nurses" on safety, performance, and usability, rather than an objective diagnostic or clinical outcome requiring expert consensus for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no "ground truth" to adjudicate in the traditional sense of diagnostic accuracy. The study involved user ratings and comparisons.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a mechanical safety accessory, not an AI or imaging device that would involve human "readers" interpreting cases. The study was a comparative user evaluation of a medical device's safety features and usability.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical accessory where "human-in-the-loop performance" (i.e., use by healthcare professionals) is its primary mode of operation and evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" was established through user evaluation and comparative ratings by nurses during a simulated clinical use test. It's based on subjective feedback and direct comparison of the new device (X-Series) against the predicate device (B-Series) on parameters of safety, performance, and usability. There is no objective medical ground truth (like pathology or clinical outcomes) being assessed for this type of device.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of mechanical device evaluation. The "iterative user evaluations" conducted by Safety Syringes, Inc. prior to the controlled simulated clinical use test might be considered analogous to developmental testing, but not a formal "training set" in the context of AI/machine learning.
9. How the ground truth for the training set was established
Not applicable as there was no formal "training set" with ground truth in the traditional sense for this device.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).