(48 days)
The BIOTOP HookSafe™ LUER-LOCK Safety Syringe; models 3cc/mL, and 10cc/mL serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection. The safety mechanism may limit accidental needle stick injuries as well as help to prohibit syringe reuse.
The HookSafe™ LUER-LOCK series is the Safety Syringe with the following functional advantage: Single use, completely non-reusable, all parts and components can be safely inoperative and safely discarded. Fully meets anti-needlestick requirements and incorporates anti-reuse functionality as well. As with any normal syringe, after the injection process, the syringe plunger should be fully depressed to ensure complete injection of the serum. It is at this stage where the anti-reuse function of our syringe begins; a mechanism within our syringe engages the syringe needle and forms a lock. At this point, one simply needs to pull the syringe plunger back again and the needle will be completely retracted into the barrel of the syringe. Because the needle, when retracted, is in a stably-tilted position and forced against the inner shoulder of the syringe barrel. At this stage the syringe becomes completely harmless and fully meets its anti-reuse functionality.
The provided text does not contain detailed information about specific acceptance criteria and the results of a study designed to prove a device meets those criteria. Instead, it describes a 510(k) submission for the BIOTOP HookSafe™ LUER-LOCK Safety Syringe, focused on demonstrating substantial equivalence to a previously cleared predicate device.
The document highlights the following:
- No explicit acceptance criteria for "performance" beyond substantial equivalence: The core claim is that the new models are substantially equivalent to the predicate device despite a "small change in the needle change mechanism." The "discussion of non-clinical tests" simply states "Compliance to the applicable standards is completely identical to that of the device being modified." This suggests that the acceptance criteria for the new device are implicitly the same as those met by the predicate device, and the current submission relies on the predicate's established performance.
- "Verification and validation tests" are mentioned but not detailed: The text states, "Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate could maintain the same safety and effectiveness as that of cleared device." However, no specifics about these tests (e.g., protocols, sample sizes, failure rates, or specific performance metrics) are provided.
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.
Here's a breakdown of what can be inferred or determined from the text, and what critically cannot:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Not explicitly stated for this device) |
|---|---|
| Safety: | |
| Limit accidental needle stick injuries (functional) | Demonstrated to maintain safety equivalent to predicate device. |
| Prohibit syringe reuse (functional) | Demonstrated to maintain effectiveness equivalent to predicate device. |
| Effectiveness: | |
| Enable medication injection/fluid withdrawal (functional) | Demonstrated to maintain effectiveness equivalent to predicate device. |
| Compliance to applicable standards (not specified here) | "Compliance to the applicable standards is completely identical to that of the device being modified." (K041970) |
Missing Information for Table: Specific quantitative acceptance criteria (e.g., "Needle stick injury rate
§ 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).