(7 days)
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.
§ 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).