(204 days)
The syringe as supplied is a device with a small barrel, plunger and fixed needle, calibrated in units of insulin (U-100), to be used to administer (infuse) insulin subcutaneously. It incorporates features that include reuse prevention and sharps injury prevention.
The 1mL Unitract® Insulin Syringe is a sterile, fixed needle, single use, insulin (U-100) syringe, consisting of a barrel and plunger assembly. The syringe is supplied in two needle sizes, being 27G x ½" and 29G x ½".
The devices function in a manner similar to standard syringes for filling and mixing insulin and subcutaneous injection, but also incorporates a sharps injury prevention (automatic needle retraction) and reuse prevention (auto disable) feature.
The sharps injury prevention feature allows for automatic and full retraction of the needle into the syringe barrel immediately after the full dose has been expelled; where the rate of retraction may be controlled by the user. The reuse prevention feature also engages immediately after retraction, which prevents further movement of the plunger in either direction.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically associated with medical device performance (e.g., sensitivity, specificity, accuracy for diagnostic devices, or specific numerical performance targets for other devices).
The document is an abbreviated 510(k) summary for the Unilife 1mL Unitract® Insulin Syringe. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against predefined acceptance criteria for the device's primary function in terms of a clinically measured outcome or a specific performance metric.
Here's an breakdown of the types of information that are present, and what is missing for your request:
What is present in the document:
- Non-Clinical Performance Data: It mentions that mechanical performance tests were conducted to verify the device meets design specifications based on FDA Consensus Standard ISO 8537:1991 and AS 1077:1992.
- Specific Tests Conducted: It lists "Additional performance testing was conducted on the safety features relating to peak activation forces of the retraction mechanism, spring reaction forces and forces to override the auto disable feature." It also mentions chemical testing (Reducing Matter, Extractable Trace Metals, Non-Volatile Residue, pH and chemical residues) and biocompatibility testing (Cytotoxicity and Pyrogens).
- Sterilization Validation: Sterilization processes are validated to DIN EN 550:1994 to a sterility assurance level (SAL) of 10^-6.
- Manufacturing Process Control: States that functional, chemical, and biological tests are performed on each production lot number.
- Conclusion: The device is deemed "substantially equivalent" based on performance testing, intended use, and design principles, and "any differences cited do not raise any new questions of safety and effectiveness."
What is missing from the document (and therefore I cannot provide in the requested format):
- A table of acceptance criteria and the reported device performance: While standards are mentioned (ISO 8537, AS 1077, DIN EN 550), the specific numerical acceptance criteria from these standards and the actual numerical results of the device's performance against those criteria are not detailed. For example, it doesn't say "peak activation force must be X-Y Newtons; our device measured Z Newtons."
- Sample size used for the test set and the data provenance: Not mentioned for any of the performance tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a physical device, not an AI/diagnostic software.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For physical testing, the ground truth would be the objective measurement against the specified standard/design requirement, but the specifics aren't provided.
- The sample size for the training set: Not applicable as it's not an AI/algorithm.
- How the ground truth for the training set was established: Not applicable.
In essence, this document provides a high-level summary of the types of tests done to support a 510(k) submission, confirming adherence to relevant standards and design specifications, but it does not delve into the detailed quantitative results required to fulfill your request for specific acceptance criteria and reported performance metrics.
§ 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).