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The CareFine™ Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin.

CareFine™ Pen Needles are single use, sterile medical devices designed to be used in conjunction with pen injectors and pen cartridges for the subcutaneous injection of insulin. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and lengths (4mm, 5mm, 6mm, and 12.7mm). CareFine™ Pen Needles are sterile by EtO terminal sterilization, and they are non-toxic and non-pyrogenic.

The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient-end and the cartridgeend of the cannula are lubricated using a silicone based lubricant for ease of injection and rubber septum penetration.

An injection-molded inner shield is assembled over the patient-end of the cannula to protect the point from damage and accidental needle-sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away label to provide a sterile barrier and tamper evident seal. The peel-away label is pre-printed with information, which includes the lot number, needle gauge and needle length.

The individual needle assemblies are packaged in cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to a SAL of 10° by EtO terminal sterilization.

The purpose of this Special 510(k) is to request modification to our CareFine™ Pen Needles to include colored inner needle shields to distinguish the needle length.

It is also Facet's intent to notify the Agency of non-significant changes to the cannula point bevel geometry. There are two additional needle point geometries being offered: a 5 bevel configuration corresponding to the QuintaPoint™ marketed name, and a second needle tip geometry identified as the SuperPoint™.

The intended use for the modified device remains the same as the predicate device.

This document describes a 510(k) submission for an insulin pen needle, which is a medical device, not an AI/ML powered medical device. Therefore, the information typically requested for AI/ML device studies, such as specific acceptance criteria for algorithm performance (e.g., sensitivity, specificity, AUC), sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, is not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on material, design, manufacturing, and intended use. The "acceptance criteria" in this context refer to the successful completion of non-clinical performance tests to ensure the device's safety and effectiveness.

Here's a breakdown of the available information based on your request, highlighting where the AI/ML specific criteria do not apply:

1. A table of acceptance criteria and the reported device performance:

Note: The document states that "All verification and validation activities identified by the risk analysis were performed to demonstrate continued conformance with applicable conformance standards. The principle device demonstrated equivalent performance to the predicate device during testing." Specific numerical results or detailed performance metrics for each test are not provided in this summary, only that they were performed and met the criteria for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Not Applicable: This is a physical medical device. The "test set" in this context refers to the samples of the device used for the non-clinical performance tests listed above (e.g., biocompatibility testing of materials, mechanical strength testing). The document does not specify the number of individual devices or material samples used for each test. Data provenance in the sense of patient data is not relevant here.

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 AI/ML devices typically refers to expert-labeled data. For this physical device, "ground truth" is established by adherence to recognized international standards (e.g., ISO, ASTM) for biocompatibility and mechanical testing, performed by qualified testing personnel in accredited laboratories. The document does not specify the number or qualifications of these testing personnel, as it's assumed to be part of standard quality system practices for medical device manufacturing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable: Adjudication methods are relevant for subjective expert review of data (e.g., imaging in AI/ML studies). For objective non-clinical tests, the results are typically interpreted against pre-defined criteria in the test standard, rather than through an adjudication process.

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 medical device. MRMC studies and the concept of human reader improvement with AI assistance are specific to AI/ML powered devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable: This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable (in the AI/ML sense): For this device, "ground truth" is established by the results of standardized non-clinical tests (e.g., cytotoxicity assays, sensitization tests, strength tests) as interpreted against the specified criteria within relevant ISO and ASTM standards. The ultimate "ground truth" for regulatory clearance is that the device is substantially equivalent to a legally marketed predicate device, demonstrating equivalent safety and effectiveness based on these tests and design comparisons.

8. The sample size for the training set:

• Not Applicable: This is a physical medical device. There is no concept of a "training set" for an algorithm.

9. How the ground truth for the training set was established:

• Not Applicable: This is a physical medical device. There is no training set or associated ground truth establishment.

Summary of the Study:

The central "study" presented here is a Special 510(k) submission designed to demonstrate substantial equivalence of a modified insulin pen needle (CareFine™ Pen Needle with colored inner needle shields and new bevel geometries: QuintaPoint™ and SuperPoint™) to its predicate device (CareFine™ Pen Needle, K133100). The changes are described as "non-significant" and primarily relate to aesthetic features (colored shields for length distinction) and minor modifications to the cannula point bevel geometry.

The primary evidence presented to meet acceptance criteria is:

• Design Equivalency: Explicitly stating that the modified device has the same indication for use, does not alter fundamental scientific technology, incorporates the same basic design, uses the same operating principles, is manufactured from the same materials, is sterilized identically, and uses the same packaging.
• Non-Clinical Performance Data: A list of biocompatibility and mechanical tests performed (e.g., Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Toxicity, Hemocompatibility, Needle Shield Assembly Strength) in accordance with relevant ISO and ASTM standards. The document states these tests were "performed" and "demonstrated equivalent performance to the predicate device during testing." This implies the results met the acceptance criteria defined by these standards.
• Clinical Data: The submission explicitly states "Clinical data is not required," further emphasizing the non-AI/ML nature of the review and reliance on substantial equivalence through non-clinical means.

In essence, the study is a regulatory submission that leverages existing predicate device data and specified non-clinical testing to affirm that minor modifications do not compromise the device's safety or effectiveness, thereby meeting the "acceptance criteria" for 510(k) clearance by demonstrating substantial equivalence.

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