(88 days)
FlexPen® needles are intended for use with pen injector devices for the subcutaneous injection of insulin 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 can 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.
This device is a hypodermic needle (FlexPen® needle) and the submission is a 510(k), which means it's seeking clearance based on substantial equivalence to predicate devices, rather than proving novel safety and effectiveness through clinical trials. Therefore, the information you've requested regarding acceptance criteria and studies to "prove the device meets acceptance criteria" is largely centered around non-clinical testing for equivalence and manufacturing standards, rather than clinical performance metrics.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance / Compliance |
|---|---|---|
| Manufacturing Standards | Current Good Manufacturing Practices (cGMP) for Medical Devices | "The FlexPen® needle will be manufactured in accordance with current Good Manufacturing Practices for Medical Devices." |
| Biocompatibility | Compliance with existing domestic and international standards. | "Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards." |
| Performance (Functional) | Demonstrated functional equivalence to predicate devices (NovoFine® 32G Tip x 6 mm, NovoFine® Autocover® 30G x 8 mm, and Becton Dickinson BD Pen Needle (29G, 30G, 31G)). This implies meeting mechanical, fluid flow, and usability characteristics implicitly required for a hypodermic needle. Specifically, "Differences between the devices do not raise any significant issues of safety and effectiveness." | "Performance tests have been performed and the results are in compliance with existing domestic and international standards." "Based on the design equivalency and the functional testing, Novo Nordisk had determined that the FlexPen® needle is substantially equivalent to a device currently marketed in the United States. Differences between the devices do not raise any significant issues of safety and effectiveness." |
| Intended Use | To be used with pen injector devices for the subcutaneous injection of insulin and somatropin. | The device's stated indications for use are "FlexPen® needles are intended for use with pen injector devices for the subcutaneous injection of insulin and somatropin." This is identical to the predicate devices. |
| Technological Characteristics | Substantial equivalence in technology/principle of operation and materials compared to predicate devices. | "The FlexPen® needle is considered substantially equivalent to the NovoFine® 32G Tip x 6 mm, NovoFine® Autocover® 30G x 8 mm, and to the Becton Dickinson BD Pen Needle (29G, 30G, 31G) in intended use... technology/principle of operation, materials and performance. Differences between the devices do not raise any significant issues of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the "performance tests" or "biocompatibility tests." It only states that these tests were performed. Given the nature of a 510(k) for a hypodermic needle, these tests would likely involve various standard engineering and materials testing methods (e.g., tensile strength, flow rate, corrosion resistance, sterility, cytotoxicity), which often use statistically valid but not necessarily large "sample sizes" in the clinical trial sense.
Data provenance is not explicitly stated (e.g., country of origin), but the tests are implied to be conducted by the manufacturer (Novo Nordisk). These are retrospective in the sense that they are routine tests performed for product development and regulatory submission, rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study that involves human interpretation or "ground truth" established by experts in the context of diagnostic performance. The "ground truth" for a hypodermic needle's performance is objective physical and chemical properties and functional characteristics, verified through standardized laboratory testing.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where different human readers interpret cases. The FlexPen® needle is a therapeutic medical device (for drug delivery), not a diagnostic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This concept is applicable to AI/ML software devices. The FlexPen® needle is a physical medical device.
7. Type of Ground Truth Used
The "ground truth" for the FlexPen® needle's performance is established by:
- Compliance with international and domestic standards for biocompatibility and performance (e.g., ISO standards for hypodermic needles).
- Demonstration of functional equivalence to legally marketed predicate devices through engineering and simulated use testing.
- Adherence to Current Good Manufacturing Practices (cGMP).
8. Sample Size for the Training Set
Not applicable. There is no AI/ML algorithm involved, so no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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).