(110 days)
Single use devices that are indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration. Additionally, the PLUS device is designed with a larger viewing window indicated where pharma company offering is a low fill volume and instructions request visualization. The PLUS device is designed with a robust plunger and built in extended finger flanges indicated where pharma customer offering is viscous.
The modification to the predicate device is the addition of the X100L PLUS device to the UltraSafe Passive Needle Guard X-Series family. The SSI UltraSafe PLUS Passive Needle Guard is an antineedlestick accessory for pre-filled ISO standard glass syringes. The device is composed of a guard, body, spring and plunger, is non-sterile and single use. The activation of the UltraSafe PLUS Passive Needle Guard device remains the same. Upon completion of the guard will slide forward, cover and lock over the needle of the syringe. It is a visual and/or audible recognition that the device safety feature has activated. The SSI devices are categorized as skin contact with a duration of category A- limited (
The provided 510(k) summary describes the UltraSafe PLUS Passive Needle Guard, an accessory for pre-filled ISO standard glass syringes designed to prevent accidental needlesticks. The submission focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (UltraSafe PLUS Passive Needle Guard) |
|---|---|
| Activation Functionality: The safety device activates as intended upon completion of injection, covering and locking over the needle. | "The safety device activated in all 500 devices with zero failures... All 500 devices activated with zero failures meaning the device activated at the appropriate time under expected conditions of use and provided protection against unintended sharps injury..." |
| Non-Impedance to Clinical Performance: The device does not impede or adversely affect the intended clinical performance (e.g., successful injection, emptying of syringe, administering medication). | "All injections were completed successfully; the safety device activated in all 500 devices with zero failures, consistent with the emptying of the syringe and administering all the medication, meaning the device did not impede the intended clinical performance." |
| Premature Activation Prevention: The device does not activate prematurely under expected conditions of use. | "All 500 devices activated with zero failures meaning the device activated at the appropriate time under expected conditions of use..." |
| Protection Against Unintended Sharps Injury: Provides protection against unintended sharps injury until disposal. | "All 500 devices activated with zero failures meaning the device activated at the appropriate time under expected conditions of use and provided protection against unintended sharps injury until disposal." |
| Failure Rate (Statistical Confidence): The true failure rate (for activation) is no higher than 0.7% with 97.5% confidence, and no higher than 1.1% with 99.5% confidence. (This is derived from the FDA Guidance cited and implied as the acceptance benchmark for the 0 failures observed). | "testing 500 devices with zero failures for activation for a '97.5% confident that the true failure rate was no higher than 0.7% and 99.5% confidence that it is no higher than 1.1%'" |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 500 devices.
- Data Provenance: The study was a "simulated use study" conducted internally by Safety Syringes, Inc. (as indicated by "Safety Syringes, Inc. maintains a Quality System... Test procedures, test protocols, and reports are maintained within the Quality System"). The country of origin is not explicitly stated, but the company is based in Carlsbad, CA, USA. The study design is prospective as it involves testing new devices to confirm performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a mechanical safety accessory, and its "ground truth" (i.e., whether it activated correctly or not, or impeded injection) is determined by direct observation during simulated use, not by expert interpretation of complex data. No expert review or consensus was required for establishing the outcome of the mechanical activation.
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Adjudication method for the test set:
- Not applicable. The "ground truth" was directly observed mechanical function (activation/non-activation, successful injection). There was no need for adjudication as there were zero failures observed which simplifies the outcome to a clear pass/fail for each device.
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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 is a medical device (a needle guard) and not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study is not relevant to its evaluation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. As noted above, this device is a mechanical safety accessory, not an algorithm. The study performed was a "simulated use study" that inherently involves human interaction with the device during the injection process. The performance reported is that of the device in this simulated use, which is its intended "standalone" operational mode.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was based on direct observation of mechanical function during simulated use, specifically:
- Successful completion of injections.
- Activation of the safety device (guard sliding forward, covering, and locking over the needle).
- Absence of premature activation.
- Protection against sharps injury.
- Essentially, it's a functional performance ground truth, directly observable and measurable during the test procedure.
- The ground truth was based on direct observation of mechanical function during simulated use, specifically:
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The sample size for the training set:
- Not applicable. This device is a mechanical one and does not involve machine learning or AI, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of 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).