(71 days)
NovoFine® Autocover™ 30G x 8 mm needles are used in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products. Additionally, after withdrawal of the needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.
The NovoFine® Autocover™ 30G x 8mm 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 cap is 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. While pushing the needle into the skin, the shield and lock will be pushed into the house enabling the needle to penetrate the skin barrier and into the subcutaneous tissue.
After the injection, the needle is removed from the skin. The NovoFine® Autocover™ needle stick safety mechanism will activate automatically when the needle is withdrawn from the skin. Once NovoFine® Autocover™ is in the locked position, it can no longer be used. The needle is not exposed protecting against an unintentional needlestick. The red indicator windows tells the user that the safety lock has been activated. 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 Autocover by using the needle cap as described in the instruction leaflet
This retrieved document is a 510(k) Premarket Notification for the NovoFine® Autocover™ 30G Disposable Safety Needle. It details the device's description, intended use, and claims substantial equivalence to predicate devices. It does not contain a quantitative study that establishes acceptance criteria and then proves the device meets those criteria with specific performance metrics and statistical analyses.
Instead, the document highlights:
- Substantial Equivalence: The primary assertion is that the NovoFine® Autocover™ 30G needle is substantially equivalent to existing predicate devices (NovoFine® 31G x 6 mm needle (K002403) and BD SafetyGlide™ 25G x 16mm needle (K951254)) in terms of intended use, technology/principle of operation, materials, and performance. This is the basis for FDA clearance in this document.
- Non-Clinical Tests: States that "Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards." However, it does not provide the specific acceptance criteria, test methodologies, or results of these tests.
- Clinical Tests (Handling Tests): States that "Handling tests were conducted to investigate the efficacy and safety of the NovoFine® Autocover™ 30G disposable safety needles by diabetes nurse educators, diabetes patients and staff nurses." Again, it does not provide specific acceptance criteria, detailed methodology, sample sizes, or quantitative results from these tests. It only concludes that "Differences between the devices tested do not raise any significant issues of safety and effectiveness."
Therefore, based solely on the provided text, I cannot complete the requested tables and information blocks with specific quantitative data on acceptance criteria and device performance from a formal study.
However, I can extract the information that is present and explain what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with existing domestic and international standards for biocompatibility and performance. | Results "in compliance" with standards. (Specific standards, criteria, and performance results not provided) |
| Efficacy and safety as determined by handling tests. | "Differences between the devices tested do not raise any significant issues of safety and effectiveness." (Specific endpoints, criteria, and results not provided) |
| Substantial equivalence to predicate devices (NovoFine® 31G x 6 mm and BD SafetyGlide™ 25G x 16mm) in intended use, technology/principle of operation, materials, and performance. | Document asserts substantial equivalence. (No quantitative comparison metrics provided) |
2. Sample Size and Data Provenance for Test Set
- Sample Size for Test Set: Not specified. The document mentions "handling tests" conducted by "diabetes nurse educators, diabetes patients and staff nurses" but does not quantify the number of participants or the number of tests performed.
- Data Provenance: Not explicitly stated, but the submission is from Novo Nordisk Inc. in Princeton, New Jersey, USA. The "handling tests" imply a prospective clinical use environment, likely within the US given the submission context.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not explicitly stated. The "handling tests" involved "diabetes nurse educators, diabetes patients and staff nurses." Their specific qualifications (e.g., years of experience) are not provided.
- Qualifications of Experts: "Diabetes nurse educators, diabetes patients and staff nurses."
4. Adjudication Method
- Adjudication Method: Not mentioned. The handling tests appear to be a qualitative assessment of ease of use and safety, not a formal adjudication process for establishing a "ground truth" in the typical sense of measuring diagnostic accuracy.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, this document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is a safety needle, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No, this document does not describe a standalone algorithm performance study. The device is a physical medical device (safety needle).
7. Type of Ground Truth Used
- Type of Ground Truth: The concept of "ground truth" in the context of diagnostic accuracy (e.g., pathology, outcomes data) is not applicable here. The "handling tests" evaluated user experience, efficacy of the safety mechanism, and overall safety. The "ground truth" for compliance with standards would be established by the results of those standard tests (e.g., tensile strength, biological reactivity), which are stated as being in compliance but not detailed.
8. Sample Size for Training Set
- Sample Size for Training Set: Not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
Summary of what the document implies about meeting acceptance criteria:
The document asserts that the device meets acceptance criteria primarily through:
- Substantial Equivalence: By demonstrating that the device is fundamentally similar in design, materials, and intended use to previously cleared predicate devices.
- Compliance with Standards: By stating that non-clinical performance and biocompatibility tests were conducted and found to be in compliance with existing domestic and international standards.
- Positive User Feedback/Handling Test Results: Indicating that handling tests by target users (nurse educators, patients, staff nurses) showed no significant issues regarding efficacy and safety.
Crucially, the document is a summary and does not include the detailed reports of these tests, which would contain the specific acceptance criteria and the raw or summarized performance data against those criteria. Its purpose is to demonstrate substantial equivalence for regulatory clearance, not to publish a detailed scientific study.
§ 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).