(16 days)
The 1 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSS™) is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
The 1 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSSTM) is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe provided with permanently attached needle. The Safety Tray Safety Allergy Syringe Tray consists of 25 Bak'Snap syringes within a single sterile barrier.
The provided text is a 510(k) summary for the Bak'Snap DuoPro™ Safety Syringe. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about the acceptance criteria or the specific study details that would prove the device meets such criteria.
The "TESTING" section (under point 7) states:
"Verification and validation testing presented in this premarket notification includes testing to demonstrate conformance to standards, testing according to FDA guidance, biocompatibility per ISO 10993, and sterilization re-validation."
This statement confirms that testing was done, but it does not provide any specifics regarding:
- A table of acceptance criteria and the reported device performance: There is no table or detailed description of performance metrics (e.g., retraction force, failure rate of safety mechanism, needle occlusion rate) or their corresponding pass/fail criteria.
- Sample size used for the test set and the data provenance: No sample sizes are mentioned for any of the tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant for a physical medical device like a syringe. Ground truth would typically refer to a diagnostic or algorithmic outcome validation.
- Adjudication method for the test set: Irrelevant, as ground truth establishment is not applicable in this context.
- 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: Irrelevant, as this device is a physical syringe, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Irrelevant, as this device is a physical syringe, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a physical device's performance testing (e.g., for biocompatibility, sterility, or safety mechanism function). Instead, performance is measured against engineering specifications and relevant standards.
- The sample size for the training set: Irrelevant, as this device does not involve a "training set" in the machine learning sense.
- How the ground truth for the training set was established: Irrelevant, as this device does not involve a "training set."
In summary, the provided 510(k) summary confirms that testing was conducted to demonstrate conformance to standards, FDA guidance, biocompatibility, and sterilization. However, it does not elaborate on the specific acceptance criteria or the detailed results of these tests necessary to fulfill the request. This level of detail is typically found in the full submission to the FDA, not necessarily in the publicly available 510(k) summary.
§ 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).