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Sherwood-Davis & Geck Monoject® BlunTip™ I.V. Access Cannula with Vial Access Pin Device is designed to provide needleless drug access. The sterile access pin is used to pre-pierce the rubber drug vial closure, facilitating direct medication access with the BlunTip* cannula. Only one access pin penetration is required to enable repeated BlunTip* cannula access. Once drawn , the medicaton can be delivered through any pre-pierced I.V. port compatible with the BlunTip* cannula.

The Monoject® BlunTip™ I.V. Access Cannula with Vial Access Pin products combine a new access pin with the currently marketed BlunTip I.V. Access cannula. The access pin and cannula, in combination, perform the same function as a hollow-bore needle when used for accessing the contents of a drug vial. The Vial Access device has been designed to improve I.V. drug administration safety for both the clinician and the patient. This product has been extensively tested to ensure product safety and efficacy. The primary design goal of the Vial Access products is to eliminate the hazards associated with a sharp, hollow-bore hypodermic needle in I.V. drug administration. The brightly colored, sterile access pin enables users to prepierce the drug vial closure for subsequent access using a BlunTip cannula.

This submission (K980062) for the Monoject® BlunTip™ I.V. Access Cannula with Vial Access Pin does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

This document is a 510(k) premarket notification for a medical device. The core purpose of a 510(k) is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against specific acceptance criteria in the manner you've described for an AI/algorithm-based device.

Here's a breakdown of why the requested information is absent and what the document does provide:

1. A table of acceptance criteria and the reported device performance: This is not present. The document states, "Although there are no performance standards associated with this device, the testing and design features have shown that there are no new issues with safety and effectiveness." This indicates that formal, objective performance metrics with acceptance criteria, common for AI/algorithm-based devices (e.g., sensitivity, specificity, AUC), were not established or reported in this submission for this type of mechanical device.

2. Sample size used for the test set and the data provenance: Not applicable. There is no mention of a "test set" in the context of an algorithm or diagnostic performance. The testing mentioned would have been primarily engineering and usability testing for a physical device, not data for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic algorithms is not relevant here.

4. Adjudication method for the test set: Not applicable.

5. 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 physical device, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

What this 510(k) submission does discuss (related to performance and safety):

• Design Goal: To eliminate hazards associated with sharp, hollow-bore hypodermic needles in I.V. drug administration.
• Function: The access pin and cannula, in combination, perform the same function as a hollow-bore needle for accessing drug vial contents.
• Testing: "This product has been extensively tested to ensure product safety and efficacy." (However, specifics of the tests and their results are not detailed in this public summary).
• Substantial Equivalence: The primary argument for clearance is its substantial equivalence to:
  • The Becton Dickinson 18 gauge Hypodermic needle.
  • Monoject® gauge hypodermic needles manufactured by Sherwood Davis and Geck.
  • Other products like Becton Dickenson Interlink Multi-Dose Access Cannula and Baxter/Becton Dickinson Interlink® Multi-Dose Vial Access System.
  • The Monoject® BlunTip™ I.V. Access Cannula (marketed under K960982) is included with this product.

In summary, the provided document is for a mechanical medical device (a cannula and vial access pin system) seeking 510(k) clearance by demonstrating substantial equivalence, not an AI or algorithmic device subject to the performance metrics you've outlined. Therefore, the specific information requested in your prompt is not available in this filing.

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