(87 days)
Each UltraSafe® Injection System Needle Guard is attached to an ISO standard glass syringe that is pre-filled and equipped with a shield that covers the needle during disposal intending to reduce the occurrence of accidental needle sticks to users. This device is used for a wide range of patients from children to adults and parenteral methods of administration.
The UltraSafe® Needle Guerd is an accessory to the ISO 11040-4 standard glass syringe that is pre-filled. The device is totally disposable. It is a safety guard that can be mated with a pre-filled syringe of the same size. After use of the syringe, the guard is activated covering the needle and thus protecting the caregiver by eliminating the need to recap the needle and minimizing accidental needle stick injuries during disposal of the syringe/needle.
This document is a 510(k) Premarket Notification for the UltraSafe® Injection System Needle Guard, which is a safety accessory for pre-filled syringes. The submission primarily focuses on establishing substantial equivalence to a predicate device.
Acceptance criteria and device performance are not explicitly detailed in a quantitative table with specific metrics and thresholds. Instead, the document provides a qualitative comparison to the predicate device, emphasizing safety features and material equivalence.
Here's an analysis of the provided information regarding acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance:
Specific quantitative acceptance criteria (e.g., "force to activate guard > X N", "puncture resistance > Y psi") are not provided nor is quantitative performance data. The document relies on a descriptive comparison to the predicate device.
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Acceptance Criteria (Implicit/Qualitative):
- Needle Guard requires two-handed action to cover the needle.
- Needle Guards possess "considerably greater strength than the predicate device."
- Easy assembly and use with a pre-filled syringe.
- Provides the same usable needle length as an unguarded needle in the "ready-to-use" position.
- Allows typical hypodermic procedures equivalently to standard, unguarded needles.
- Biocompatible materials (same as predicate).
- Provides a shield that covers the needle during disposal to reduce accidental needle sticks.
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Reported Device Performance (Qualitative):
- "The Needle Guard requires a two-handed action in order to cover the needle point after use."
- "The Needle Guards have been tested and found to have considerably greater strength than the predicate device."
- "The Guard is easy to assemble and use with a prefilled syringe."
- "With the Needle Guards in the "ready-to-use" position, they provide the same useable needle length as an unguarded needle."
- "The user can perform typical hypodermic procedures equivalently to standard, unguarded needles."
- "The material has passed biocompatibility tests." (Implicitly, the UltraSafe® material has passed, as it is the same as the predicate).
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 for Test Set: Not specified. The document mentions "The Needle Guards have been tested," but does not provide details on the number of units tested or the methodology.
- Data Provenance: Not specified. There is no mention of the country of origin or whether testing was retrospective or prospective.
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):
- Not applicable. The submission relies on engineering and material testing, not expert interpretation of outputs like in AI/imaging devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of adjudication, as the assessment is based on physical performance and material properties rather than subjective interpretation requiring consensus.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, which is not the nature of this needle guard.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical safety accessory, not an algorithm. Its performance is inherent to its design and material properties, not an AI or software component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device would be established through engineering performance testing (e.g., strength, ease of use, ability to cover the needle) and biocompatibility testing to confirm material safety. This isn't a "ground truth" in the conventional sense of clinical diagnoses.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, this question is not relevant.
§ 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).