(65 days)
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:
| Parameter | Acceptance Criteria (Implicit from ISO 11608-2:2012) | Reported Device Performance (for NovoFine® 32G (0.23/0.25 mm) x 6mm) |
|---|---|---|
| Assembly Torque | Specified torque values | No rejections occurred |
| Dose Accuracy | (Standard-defined accuracy) | No rejections occurred |
| Removal Torque | Specified torque values | No rejections occurred |
| Biocompatibility | Adherence to ISO 10993 series | Followed ISO 10993-11:1993, ISO 10993-10:2002, ISO 10993-05, ISO 10993-04 |
| Sterilization | ISO 11135-1:2014, SAL 10-6, ISO 10993-7 (residuals) | Sterilization validated annually, LAL limit ≤ 20 EU/device |
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.
§ 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).