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NovoFine® 32 G Tip (0.23/0.25) X 6 mm ETW needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, semaglutide and somatropin.

NovoFine® 32 G Tip (0.23/0.25) 6 mm ETW needle is designed for single use. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Use the needles as described in the instructions for use that comes with the pen-injector device and as instructed by the healthcare professional. After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, a new disposable needle must be used.

The provided document is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a new, novel device might. The core of this submission is that "No physical change has been made from K062500 cleared on November 21, 2006 and K090111 cleared on February 1, 2010. The only change was to include an additional drug name in the indication for use statement."

Therefore, the "acceptance criteria" discussed are largely in reference to functional compatibility with the new drug (semaglutide) and adherence to existing standards, rather than new performance-based acceptance criteria for the needle itself.

Here's the breakdown of the information requested, based on the provided text:

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

The document doesn't explicitly state "acceptance criteria" in a separate table for the device performance as a whole. Instead, it compares the current device to predicates based on established specifications and reports that functional compatibility tests were performed against an ISO standard.

For the functional compatibility with the semaglutide pen-injector, the acceptance criteria are implicit in the ISO 11608-2:2012 standard and the specific parameters tested:

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 for Functional Compatibility (Semaglutide): 120 pen needles for each pen-injector variant tested. This means 120 pen needles were tested with Variant 1 and 120 with Variant 3.
  • (60 pen needles subsequent to low dose and 60 pen needles subsequent to high dose for each variant).
• Data Provenance: Not explicitly stated, but implies prospective testing conducted by Novo Nordisk (or a contracted lab) as part of the design verification for the 510(k) submission. No country of origin for data is specified, but the manufacturing sites are Nipro Medical Industries Ltd, Japan and Nipro Corporation Ltd, Thailand, which may imply where some testing could have occurred.

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 information is not applicable to this type of device and study. The testing involves objective physical measurements and adherence to international standards (ISO), not expert consensus on medical images or diagnoses.

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

• This information is not applicable. The testing involves objective physical measurements and adherence to international standards (ISO), not subjective interpretations requiring adjudication.

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

• This information is not applicable as the device is a hypodermic needle, not an AI-powered diagnostic or assistive tool.

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

• This information is not applicable as the device is a hypodermic needle, not an algorithm.

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

• The "ground truth" for the device's substantial equivalence and performance revolves around objective physical measurements compared against international standards (ISO 11608-2:2012 for pen-needles, ISO 10993 series for biocompatibility, ISO 11135-1:2014 for sterilization) and established internal specifications of the predicate device.

8. The sample size for the training set

• This information is not applicable. The device is a physical medical device (hypodermic needle), not a machine learning algorithm requiring a 'training set'. The "training" data refers to the historical data and performance of the predicate device.

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

• This information is not applicable for the reasons stated above. The "ground truth" for the predicate device would have been established through its own rigorous testing and adherence to standards at the time of its initial clearance (K062500 and K090111). The current submission relies on the fact that the physical design is identical to these previously cleared devices.

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For use in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products.

The NovoFine® 32G Tip needle is designed for single use in conjunction with insulin injection delivery devices. Prior to giving an injection, the protective tab is removed from the plastic needle cap of the single-use disposable needle. With the disposable needle remaining in the needle cap, it is then carefully screwed onto the delivery injection device until tight and then the needle outer and inner caps are removed. Prepare for injection by following the procedure described in the instruction leaflet provided with the pen injection device and instructions from your health care professional. After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent injection, another disposable needle must be used. Delivery device function checks can be performed with the NovoFine® 32G Tip by using the needle cap as described in the instruction leaflet provided with the pen injection device.

The provided 510(k) Premarket Notification for the NovoFine® 32G Tip Disposable Needle does not contain detailed acceptance criteria or a study that specifically "proves the device meets the acceptance criteria" in terms of performance metrics based on detailed statistical analysis. Instead, it relies on substantial equivalence to a predicate device and non-clinical testing.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding device performance results in a quantitative manner (e.g., minimum tensile strength: X, device measurement: Y).

Instead, the submission states:

• Claimed Performance: "NovoFine® 32G Tip needles meet all applicable product and quality standards for hypodermic single lumen needle products."
• Study Type: "Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards."

Without the specific standards referenced and the detailed results of those tests, a precise table cannot be constructed. The "acceptance criteria" are implied to be compliance with these "existing domestic and international standards" for hypodermic needles.

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

The document does not specify the sample size used for the performance tests.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given it's a medical device, it's highly likely the testing was prospective, but this is not confirmed in the text.

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

This information is not applicable as the device is a sterile disposable hypodermic needle and the evaluation is based on engineering and biocompatibility standards, not on interpretations by medical experts for diagnostic accuracy. Ground truth, in this context, would be established by validated test methods and reference materials, not expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used for expert review in clinical studies, typically for diagnostic devices or algorithms.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI systems where human readers interpret data, and the device aims to assist or replace that interpretation. This device is a physical sterile needle.

6. If a Standalone Study Was Done

Yes, in essence. The submission indicates "Biocompatibility and performance tests have been performed." These tests would be conducted on the NovoFine® 32G Tip needles themselves, in a "standalone" fashion, to confirm they meet relevant physical, chemical, and biological safety standards specified for hypodermic needles. The performance is assessed against these established standards, which serve as the implicit acceptance criteria.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be established by:

• Validated test methods: e.g., sterility tests, needle strength tests, material composition analysis.
• Reference standards: Established specifications for materials, dimensions, and performance of hypodermic needles as outlined in "existing domestic and international standards" (e.g., ISO, ASTM standards relevant to medical devices and needles).
• Biocompatibility guidelines: Meeting established criteria for biological safety as per international standards (e.g., ISO 10993 series).

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical device, not an AI algorithm, so there is no "training set" in the context of machine learning.

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

This information is not applicable for the reasons stated above.

Summary of what is known from the document regarding compliance:

The primary method used to demonstrate safety and effectiveness for the NovoFine® 32G Tip Disposable Needle is substantial equivalence to a previously cleared predicate device (NovoFine® 31G x 6 mm needle, K002403) and compliance with relevant non-clinical performance and biocompatibility standards. The document states: "Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards." This statement serves as the general proof that the device meets the implicit acceptance criteria defined by those standards. However, the specific details of these tests (e.g., sample sizes, specific criteria, detailed results) are not provided in this 510(k) summary.

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