Search Results

The Clickfine Pen Needle is intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

The Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needles are used by peeling back the peel tab and snapping or screwing the hub onto the threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the pen-injector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the insulin is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the fluid through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.

This submission (K131125) is an administrative change to revise the Indications for Use for the Clickfine Pen Needle to align with predicate devices, allowing for Over-the-Counter (OTC) marketing for all compatible injection pens. As such, no new performance data was required or submitted to demonstrate safety and effectiveness. The FDA concluded substantial equivalence based on the administrative nature of the change and the existing clearance of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this was an administrative submission and no new performance and safety data were required or submitted, there are no specific acceptance criteria or reported device performance metrics in this document. The device did not undergo a new study to establish performance against new criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No new performance studies were conducted.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. No new performance studies were conducted.

4. Adjudication Method for the Test Set:

Not applicable. No new performance studies were conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This was an administrative change, not a comparative effectiveness study.

6. If a Standalone Performance Study Was Done:

No. This submission did not involve a standalone performance study. The substantial equivalence was based on existing predicate devices.

7. The Type of Ground Truth Used:

Not applicable. No new performance studies were conducted. The "ground truth" for this submission was the existing clearances and intended uses of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. No new studies involving training sets were conducted.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No new studies involving training sets were conducted.

Ask a specific question about this device