(107 days)
The Reverse Vaccuum (RevVac) Safety Syringe, is a sterile, single use, disposable, autoretracting safety piston syringe which is intended for injection of fluid into the body, while reducing the risk of sharps injury and the potential for syringe reuse. The device is intended for use for subcutaneous and intramuscular use.
The ReVac (Reverse Vacuum) Safety Syringe is a piston type hypodermic syringe with an automated needle retraction system. The device works like a typical syringe in that after removal of the cap, the user pulls back the syringe to feed liquid back into the barrel. Once the plunger is fully depressed, and the fluid inside is fully dispensed, a vacuum is created that is sufficient to force the retraction of the needle into the hollow chamber of the syringe. The needle is not visible and is fully inaccessible. The needle cannot be removed from the syringe without completely destroying the syringe.
The ReVac (Reverse Vacuum) Safety Syringe is a piston type hypodermic syringe with an automated needle retraction system. It is sterile, non-toxic, non-pyrogenic, retractable syringe designed to provide a safe reliable method for intramuscular and subcutaneous injection of drugs and or fluids while helping to provide protection from accidental needle sticks.
The provided text describes a 510(k) premarket notification for the ReVac Safety Syringe, focusing on its substantial equivalence to a predicate device rather than a comprehensive study to establish specific performance acceptance criteria for a novel device. Therefore, much of the requested information regarding detailed study design, sample sizes, expert involvement, and ground truth establishment is not present in this submission.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (Futura Safety Syringe K000860) based on similarities in intended use, design, and system performance, as well as conformity to internationally recognized standards.
| Acceptance Criterion (Inferred from standards and claims) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Injection of fluid into the body, reducing sharps injury risk, preventing syringe reuse. | "Both devices are indicated for injecting fluids into the body with a permanently fixed, single lumen hypodermic needle, while helping to reduce the risk of needle sticks." |
| Design Equivalence (Piston Syringe): Sterile, single-use, disposable, permanently fixed needle. | "Both products are piston syringes, provided sterile, single-use and disposable." |
| System Performance Equivalence (Needle Retraction): Retracts contaminated needle safely inside syringe immediately after injection. | "Lastly both syringes retract the contaminated hypodermic needle safely inside syringe immediately after the completion of the patient injection." |
| Biocompatibility: Meets safety standards for biological interaction (ISO 10993-1:1997). | "The testing provided in the premarket notification includes biocompatibility..." |
| Sterility: Meets standards for sterile hypodermic syringes (ISO 7886-1:1993, ISO 7864:1993). | "The ReVac (Reverse Vacuum) Safety Syringe... is sterile, non-toxic, non-pyrogenic..." |
| Functionality (e.g., auto-disable, fixed dose for immunization): (ISO 7886-3:2005 - Note: This standard applies to auto-disable syringes for fixed dose immunization. While listed, the document doesn't explicitly state the ReVac is a fixed-dose syringe, so its specific applicability needs further context.) | "The ReVac (Reverse Vacuum) Safety Syringe is a piston type hypodermic syringe with an automated needle retraction system." |
Study Details
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Sample size used for the test set and the data provenance:
- The document mentions "Side by Side equivalence information with the Futura Safety Syringe is provided to show that the two products are equivalent in performance." However, it does not specify the sample size used for this comparative testing.
- The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The testing described appears to be primarily laboratory-based physical/mechanical testing against standards and direct comparison rather than relying on expert clinical assessment for "ground truth" in the way a diagnostic device might.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of the device (a safety syringe) and the type of testing described (biocompatibility, standard conformity, side-by-side performance), it's unlikely a clinical adjudication method like 2+1 or 3+1 would be applicable.
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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:
- A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable to a safety syringe device. This type of study is typically used for diagnostic imaging or AI-assisted diagnostic tools.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable to a medical device like a safety syringe. The device itself is the "standalone" component in its intended use. There is no AI algorithm being evaluated.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance comparison, the "ground truth" would likely be the established performance and safety profile of the predicate device, as determined by its own regulatory clearance and adherence to relevant standards. For the ReVac syringe, conformity to the listed ISO standards and functional performance mimicking the predicate device served as the basis for equivalence.
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The sample size for the training set:
- This is not applicable. This device does not use machine learning or AI models, so there is no training set.
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How the ground truth for the training set was established:
- This is not applicable as there is no training set 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).