(163 days)
NovoFine® Plus needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin.
NovoFine® Plus needles are single use, sterile need in conjunction with pen injector 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. 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, another disposable needle must be used.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NovoFine® Plus 32G x 4 mm Disposable Needle:
This document is a 510(k) summary for a medical device cleared via substantial equivalence. As such, it does not detail a study to "prove the device meets acceptance criteria" in the way one might expect for a novel device undergoing clinical trials to establish efficacy. Instead, it demonstrates that the device is as safe and effective as a legally marketed predicate device through non-clinical testing and comparison of technological characteristics. Therefore, many of the typical acceptance criteria and study details for an AI/algorithm-based device outlined in your prompt are not applicable here.
However, I will extract the relevant information where possible, and explicitly state when a particular detail is not available or not applicable based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from relevant standards or comparison) | Reported Device Performance (as demonstrated in testing or comparison) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2009 | Tests performed, results in compliance. |
| Performance | Compliance with ISO 11608-2:2012 (Pen injectors for medical use - Part 2: Needles - Requirements and test methods) | Tests performed, results in compliance. |
| Manufacturing Quality | Compliance with cGMP for Medical Devices (ISO 13485:2012) | Manufactured, sterilized, packaged, and labeled on validated equipment and QA-released in accordance with cGMP. |
| Packaging & Sterility | Compliance with ISO 11607-1:2006 (Packaging for terminally sterilized medical devices) & ASTM F1980-07 (Accelerated Aging for Shelf Life) | Final design verification test supports meeting specified requirements; Shelf life testing performed according to standard. |
| Safety & Effectiveness | Substantial equivalence to predicate devices (NovoFine® 32G Tip x 6 mm (K090111), NovoTwist® 32G Tip x 5 mm (K093109), BD Pen Needle 32G x 4 mm (K123300)) | Demonstrated through design equivalency and functional testing, concluding differences do not raise significant safety/effectiveness issues. |
| Intended Use | For use with pen injector devices for subcutaneous injection of drugs. | Device is intended for this use, consistent with predicate devices. |
| Technological Characteristics | Matching or not raising new safety/effectiveness concerns compared to predicate devices (e.g., materials, principles of operation). | Considered substantially equivalent in intended use, technology, principles of operation, and materials. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "The needle samples tested are manufactured..." and "The NovoFine® Plus 32G 4 mm needles are subjected to a final design verification test." This implies a sample was tested for engineering and performance characteristics, but the size is not specified.
- Data Provenance: The device was developed and tested by Novo Nordisk R&D. The testing was non-clinical, involving laboratory and engineering tests against international standards. The origin of "data" in the sense of patient data is not applicable, as this is a device and not an AI or diagnostic algorithm which would use patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. "Ground truth" in the context of expert consensus on medical images or diagnoses is not relevant for a hypodermic needle. The "ground truth" here is compliance with established engineering and biocompatibility standards, and functional performance, which is determined through laboratory testing by specialized personnel (e.g., engineers, quality control staff).
4. Adjudication Method for the Test Set
Not applicable. This is not an observational or diagnostic study requiring expert adjudication of results. Compliance is determined by objective measurement against standard specifications.
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 device is a hypodermic needle, not an AI or diagnostic tool, and therefore MRMC studies are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device does not have an algorithm and is not a standalone diagnostic or AI tool. Performance is inherently "standalone" in the sense that the needle's physical characteristics and function are tested without a human "reading" or "interpreting" its output beyond using it for its intended purpose.
7. The Type of Ground Truth Used
The "ground truth" for the device's acceptance is its compliance with international and domestic consensus standards (e.g., ISO 11608-2, ISO 10993-1, ISO 11607-1, ASTM F1980) and its demonstrated functional performance in non-clinical laboratory tests. Additionally, the concept of substantial equivalence to existing, legally marketed predicate devices forms a key part of the "ground truth" for its regulatory clearance.
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" in the AI sense.
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).