(381 days)
FlexPen® needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, and somatropin.
FlexPen® needle is designed for single use in conjunction with Novo Nordisk injection delivery devices. 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. Prepare for injection by following the procedure described in the user manual 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 national/local regulations. For each subsequent injection, another disposable needle must be used. Delivery device function checks can be performed with the FlexPen® needle by using the needle cap as described in the user manuals provided with the Novo Nordisk pen injection devices.
FlexPen® needle is used in exactly the same manner as the NovoFine® needles. The instructions for use are described in the user manuals for Novo Nordisk delivery devices for injection and are the same for all NovoFine® needles and FlexPen® needle.
The provided document details a 510(k) summary for the FlexPen® needle. This is a medical device, and the submission focuses on demonstrating substantial equivalence to already marketed devices, rather than a novel AI or software-driven diagnostic tool. Therefore, many of the requested criteria (such as acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for AI models) do not apply directly to this type of submission.
Here's a breakdown of the relevant information provided and how it addresses the spirit of your request within the context of a medical device submission:
Acceptance Criteria and Study for FlexPen® Needle (K090111)
The FlexPen® needle is a sterile disposable hypodermic needle intended for use with pen injector devices for subcutaneous injection of insulin, liraglutide, and somatropin. The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices, meaning it performs as safely and effectively as these devices.
The study that proves the device meets the acceptance criteria is a non-clinical performance and biocompatibility study, along with a comparison of technological characteristics to predicate devices.
1. A table of acceptance criteria and the reported device performance
| Criteria Category / Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (FlexPen® needle) |
|---|---|---|
| Intended Use | For use with pen injector devices for subcutaneous injection of insulin, liraglutide, and somatropin (matching predicate devices). | Confirmed: FlexPen® needle is intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, and somatropin. This matches the intended use of predicate devices (K062500, K053470, K050106, K051899). |
| Technological Characteristics | Similar principle of operation, materials, and overall performance/design to predicate devices (K062500, NovoFine® 32G Tip x 6 mm; NovoFine® Autocover® 30G x 8 mm; Becton Dickinson BD Pen Needle (29G, 30G, 31G) x (5 mm, 8 mm, 12.7 mm)). Differences should not raise significant safety/effectiveness concerns. | FlexPen® needle is considered substantially equivalent in technology/principle of operation, materials, and performance to the listed predicate devices. The document explicitly states: "Differences between the devices do not raise any significant issues of safety and effectiveness." It also states, "FlexPen® needle is used in exactly the same manner as the NovoFine® needles." |
| Biocompatibility | In compliance with existing domestic and international standards for patient contact. | Biocompatibility tests have been performed, and the results are in compliance with existing domestic and international standards. |
| Performance (Functional) | Device functions as intended without compromise to safety or efficacy (e.g., proper fit with pen injector, needle integrity, smooth injection, sterility). | Performance tests have been performed, and the results are in compliance with existing domestic and international standards. The submission highlights "functional testing" to support design equivalency and substantial equivalence. The device is designed for single use, and proper disposal is outlined, implying expected single-use functionality. Delivery device function checks can be performed using the needle cap as described in user manuals, indicating compatibility and proper function. |
| Manufacturing Standards | Manufactured in accordance with current Good Manufacturing Practices (GMP) for Medical Devices. | FlexPen® needle will be manufactured in accordance with current Good Manufacturing Practices for Medical Devices. Confirmed through the overall submission process and regulatory oversight. |
| Sterility | Sterile disposable device. | The device is described as "Sterile disposable hypodermic needle." Performance tests (likely including sterility assurance) confirmed compliance. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a distinct "test set" sample size in the way an AI/software study would. The data provenance is based on non-clinical performance and biocompatibility testing conducted by Novo Nordisk Inc. The submission is silent on the specific number of needles tested for these non-clinical evaluations.
- Data Provenance: The studies were conducted by the manufacturer, Novo Nordisk Inc., based in Princeton, New Jersey, USA. The nature of the studies implies prospective testing of the new FlexPen® needle design against established standards and comparative analysis with predicate device specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept does not apply to this device submission. There is no "ground truth" established by experts for a test set in the context of an ordinary medical device like a hypodermic needle, unlike an AI diagnostic system. The "truth" is based on objective physical/chemical properties, functional performance, and biocompatibility standards.
4. Adjudication method for the test set
This concept does not apply. There was no need for expert adjudication as the assessment was based on objective non-clinical tests compared to established standards and the characteristics of predicate devices.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human interpretation plays a significant role, often in conjunction with AI. The FlexPen® needle is a physical medical device, not a diagnostic or AI-powered system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This is not an AI or software device.
7. The type of ground truth used
The "ground truth" for this device is based on:
- Existing domestic and international standards for biocompatibility, sterility, and performance of hypodermic needles.
- Functional testing demonstrating the device meets its intended mechanical and physical requirements.
- Comparison to legally marketed predicate devices to establish substantial equivalence in design, materials, and intended use. The "truth" is that the new device behaves similarly to the established safe and effective devices.
8. The sample size for the training set
This concept does not apply. There is no "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
This concept does not apply. There is no ground truth for a training set in this context.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).