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510(k) Data Aggregation
(260 days)
NovoTwist® needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide and somatropin.
NovoTwist® needle is designed for single use in conjunction with Novo Nordisk injection delivery devices built with bayonet coupling. 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 pressed onto the injection delivery device with a bayonet coupling and twisted a quarter of a revolution until tightness and a confirmatory click is heard. Then the outer and inner caps of the needle are removed. Injection is performed 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. Function checks for the delivery device can be performed with the NovoTwist® needles by using the needle cap. The NovoTwist® needle is used in exactly the same manner as the NovoFine® and the BD Pen needle except it is built with an improved attachment mechanism. NovoTwist® needle is attached to the delivery device via a bayonet thread. This allows the user to press down and twist the needle a quarter of a revolution instead of tightening through several revolutions as with the NovoFine® needle, BD pen needle, and many other commercially marketed hypodermic needles that operate on the same principles. This improved mechanism is intended to reduce the attachment time. In addition, users can hear a confirmatory click when the NovoTwist® needle is attached correctly to the device. This user friendly feature is designed to ensure the needle is attached to the device correctly before beginning the injection.
NovoTwist® Needle Acceptance Criteria and Study Details
1. Acceptance Criteria and Reported Device Performance
The provided document describes a 510(k) summary for the NovoTwist® needle, claiming substantial equivalence to existing predicate devices. It references compliance with several ISO standards and outlines specific non-clinical tests. However, it does not explicitly state specific pass/fail acceptance criteria (e.g., "bubble leak rate must be less than X%") nor does it present quantitative results for how the device performed against these criteria. Instead, it generally states that the tests support the device meeting "specified requirements" and being "safely used."
Therefore, the table below reflects what is implied as acceptance for specific tests and the general statement of performance:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 11608-2:2000 (Pen-injectors for medical use - Part 2: Needles - Requirements and test methods) | "NovoTwist® 30G and 32G Tip needles have been subjected to many non-clinical tests throughout the development by Novo Nordisk R&D, and these tests comply with ISO 11608-2:2000..." |
| Performance and functionality evaluation (prototype tests) | "several prototype tests with NovoTwist® needles were conducted to evaluate the performance and functionality of the needles." (Implied successful evaluation) |
| Bubble leak test for sterility (per ISO 11607-1:2006) | Conducted as part of final design verification test. "...bubble leak test to ensure sterility..." (Implied successful compliance with standard) |
| Freedom from defects (per ISO 7864:1993) | Conducted as part of final design verification test for: defect needle point, patient needle point, silicone on patient-end needle, bond between hub and needle tube, visual control of quality of sealing. "...Freedom from defects in accordance with ISO 7864:1993..." (Implied successful compliance with standard) |
| Biocompatibility (per ISO 10993-1) | Reference made to prior successful biocompatibility tests for NovoFine needles (predicate device), as the cannula and silicone oil (components in contact with human tissue) are identical. "...we reference the biocompatibility tests to those previously conducted for the NovoFine needles in accordance with ISO 10993-1... which have been cleared by the Agency." (Implied successful compliance through substantial equivalence of materials) |
| Shelf life | "shelf life test has been performed on final released NovoTwist® 30G and 32G Tip needles in accordance with ISO 11607-1:2006..." (Implied successful determination of shelf life according to standard) |
| Handling test and Usability test | "handling test and usability test are performed..." (Implied successful performance indicating safe and effective use; specifics not detailed.) |
| Overall Design Verification | "The final design verification test consists of 34 mechanical and visual tests... In summary, the final design verification test supports that Novo Twist needles meet the specified requirements and that the needles can be safely used in various real-life situations of handling and use according to Instructions for Use." (Implied all 34 tests met their respective acceptance criteria.) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document states that the final design verification test involved "34 mechanical and visual tests" but does not specify the exact number of NovoTwist® needles tested for each of these tests. It only mentions that "The needle samples tested are manufactured, sterilized, packaged and labelled on validated equipment and QA-released in accordance with cGMP..."
- Data Provenance: The document implies the tests were conducted by "Novo Nordisk R&D" and that "The needle samples tested are manufactured...in accordance with cGMP for Medical Devices (ISO 13485:2003 Medical devices - Quality management systems Requirements for regulatory purposes)." This suggests the data is prospective and likely originated from internal company testing, presumably in facilities compliant with quality management systems. The country of origin for the data is not explicitly stated, but Novo Nordisk is a Danish multinational company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the described tests are non-clinical (mechanical, visual, sterility, biocompatibility, shelf-life, handling, and usability) and do not involve human assessment of medical images or patient outcomes that would require expert ground truth establishment in the traditional sense (e.g., by radiologists). The "ground truth" for these tests would be defined by the technical specifications and standards (e.g., ISO 11608-2) the device is being tested against.
4. Adjudication Method for the Test Set
This information is not applicable. The tests described are objective, physical, or chemical measurements/inspections against predefined specifications or standards. They do not involve subjective assessments requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests are required." The submission relies on non-clinical testing and substantial equivalence to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device, NovoTwist® needle, is a physical medical device (hypodermic needle), not a software algorithm or AI-powered system where a "standalone" algorithm-only performance would be relevant.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on established international standards and internal specifications. For example:
- ISO 11608-2:2000 (Pen-injectors for medical use - Part 2: Needles - Requirements and test methods)
- ISO 11607-1:2006 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems)
- ISO 7864:1993 (Sterile hypodermic needles for single use)
- ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system)
- Internal design specifications for mechanical, visual, and functional performance.
8. The Sample Size for the Training Set
This information is not applicable. As a physical medical device (hypodermic needle), there is no "training set" in the context of machine learning or artificial intelligence. The development process involves prototype testing and design verification, not algorithm training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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