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The CareFine Pen Needle™ is intended for use with a pen injector device for the subculaneous 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 the blue needle shield will be offered in 8mm length. 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 Needle family to include blue colored inner needle shield to distinguish the 8mm needle length.

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

This document describes a Special 510(k) submission for a modification to an insulin pen needle, specifically the addition of a blue colored inner needle shield to distinguish an 8mm needle length. It is not a study that proves the device meets acceptance criteria in the typical sense of a clinical trial for efficacy or diagnostic performance. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device.

Here's an analysis based on your requested information:

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

For this specific submission (K141749), which is a Special 510(k) for a color change, the "acceptance criteria" are primarily related to proving that the modification does not raise new issues of safety or effectiveness and that the device remains substantially equivalent to the predicate. The performance data presented are for the original CareFine™ Pen Needle (K133100), not specifically for the blue shield modification.

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

• Sample Size: The document does not specify a separate "test set" sample size for the color change modification. The referenced non-clinical performance data (biocompatibility, needle shield strength) was performed for the original CareFine™ Pen Needle (K133100). The sample sizes for those specific tests are not provided in this summary.
• Data Provenance: Not explicitly stated for specific test cases, but the tests performed are standard biocompatibility and mechanical tests for medical devices, generally conducted in controlled laboratory environments. The manufacturer is Facet Technologies, LLC, located in Kennesaw, GA, USA, suggesting the data would likely originate domestically or from certified testing labs. The data is retrospective relative to this Special 510(k), as it refers to data submitted with the earlier Traditional 510(k) (K133100).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information (experts establishing ground truth for a test set) is typically relevant for studies involving subjective interpretation (e.g., image analysis, clinical diagnosis). For this device, which is a physical medical device (insulin pen needle) with a minor aesthetic modification, "ground truth" is established through objective engineering and biocompatibility testing against defined specifications and recognized international standards (e.g., ISO 10993, ASTM F756-8). Therefore, the concept of "experts establishing ground truth" in the way described for AI/diagnostic studies does not apply here. The "experts" would be the certified lab technicians and engineers performing these tests, and the regulatory bodies approving the test methods and results.

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

Not applicable for this type of device and submission. Adjudication methods are typically used in clinical trials or studies where subjective assessments or discrepancies in expert opinion need to be resolved. This document focuses on objective performance and equivalence to a predicate device.

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 (pen needle), not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies and the concept of "human readers improving with AI" are irrelevant.

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 or AI system.

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

The "ground truth" for demonstrating the safety and effectiveness of the original pen needle (K133100) was established through objective laboratory testing against recognized standards (ISO, ASTM) and internal test methods to demonstrate physical integrity, sterility, and biocompatibility. For this Special 510(k), the "ground truth" is the demonstrated substantial equivalence to previously cleared devices based on the technical characteristics and the determination that the color change does not impact safety or effectiveness.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

Not applicable. As above, no training set for an AI/ML model is involved.

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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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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, 8mm, and 12.7mm). CareFine™ Pen Needles are sterile (EtO terminal sterilization), 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 sterility barrier and tamper evidence seal. The peel-away label is pre-printed with information, which includes the lot number and needle gauge and 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 provided document is a 510(k) summary for the CareFine™ Pen Needles. It does not present a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/ML device would.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed devices, rather than establishing de novo safety and effectiveness through a dedicated study with defined acceptance criteria for novel performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not applicable to this type of submission.

However, I can extract the information that is present and explain why other points are not available in this context.

Acceptance Criteria and Device Performance (Not applicable - Substantial Equivalence Submission)

For a device like CareFine™ Pen Needles, the "acceptance criteria" are typically defined by recognized standards for medical devices of this type (e.g., ISO standards for sterile medical devices, specific performance tests for needles) and the performance characteristics of the predicate devices. The submission aims to show that the new device meets these standards and is comparable to the predicates, rather than proving a specific novel performance metric against pre-defined thresholds.

Study Details (Not applicable for this context of 510(k) 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 submission does not describe a "test set" in the context of an AI/ML device evaluation with a defined sample size for performance validation. The evaluation involved "predicate product comparative tests and performance tests" but specific sample sizes for these engineering/bench tests are not provided in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. "Ground truth" in the sense of expert consensus for medical image interpretation or similar complex diagnostic tasks is not relevant to this device. Bench testing and adherence to standards are the primary evaluation methods.

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

• Not applicable. No expert adjudication process for decision-making or truth establishment is described or implied for this type of device submission.

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 (pen needles), not an AI-assisted diagnostic tool.

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/Implicit. The "ground truth" for a pen needle's performance is established by engineering specifications, recognized industry standards (e.g., ISO, ASTM for needle strength, sterility), and comparison to the performance of predicate devices which have already proven safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

• Not applicable. As above, no training set exists for this device.

Summary of what the document does provide regarding device evaluation:

• Non-Clinical Performance Data: The CareFine™ Pen Needle was manufactured in accordance with Current Good Manufacturing Practices and underwent:
  • Appropriate biocompatibility tests
  • Sterility tests (to a SAL of 10-6)
  • Predicate product comparative tests (e.g., needle sharpness, length, gauge, shield dimensions, shield strength, hub/needle bond strength)
  • Performance tests
• Compliance: The test results are stated to be in compliance with existing domestic and international standards.
• Conclusion: Based on the design equivalency to predicate devices and the functional testing performed, Facet Technologies determined the CareFine™ Pen Needles are substantially equivalent and do not raise new issues of safety and effectiveness.
• Clinical Performance Data: Clinical data was not required for this 510(k) submission, indicating that the non-clinical and comparative performance data were deemed sufficient by the FDA for establishing substantial equivalence.

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