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510(k) Data Aggregation
(30 days)
The DropSafe™ Sicura™ are sterile, single-use passive safety injection needles to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection.
DropSafe™ Sicura™ are Sterile, single-use passive safety injection needles to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection. DropSafe™ Sicura™ are single patient and used by HCP (Healthcare professionals: nurses, pharmacist and physician). DropSafe™ Sicura™ passive safety injection needles, are hypodermic needles intended for subcutaneous and intramuscular injection of fluids using syringes with male luer slip or luer lock fitting. Passive safety injection needles are equipped with passive sharps prevention feature. They are sterilized with ETO. Non-toxic single use, single patient devices. The device is designed to minimize the risk from accidental needle sticks with an already used needle by application of a sharps injury prevention feature. Following use, the slider of the needle is automatically locked out preventing reuse. The needle is protected by an external cover, the cover must be in place during the connection between the needle and the syringe. After removing the external cover the needle is still protected by a transparent slider, the slider will protect the needle and the user during the injection activity (sharp prevention feature). The slider is transparent for allowing the user to have a clear view of the cannula during the injection. During the injection the slider progressively uncovers the cannula; this action is possible thanks to the presence of two components (spring and sleeve) which let the slider moves up and down. Once the injection is done and the needle removed from the slider automatically covers the cannula and remain blocked, guaranteeing the sharp prevention feature. The confirmation about the blocking is done thanks to the appearing of red marks visible through the housing. DropSafe™ Sicura™ is not intended to be used for the drawing up of drugs from vials and/or ampule, for which it's indicated to use blunt needles. Each DropSafe™ Sicura™ is individually packaged in a sealed container. The DropSafe™ Sicura™ is used by opening the blister and applying the needle on a syringe filled with drug. While inserting the needle into the skin at a 90° or 45° angle (with or without skin fold), the slider glides into the housing. While the slider glides into the housing, the safety feature is activated. Following injection, the slider glides back into its initial position, completely covering the needle where it remains locked. The red safety lock indicator tells the user that the safety lock has been activated. Once the DropSafe™ Sicura™ is in the locked mode, it cannot be reused. The DropSafe™ Sicura™ is detached from the syringe and disposed of into a sharps container according to local requirements. The DropSafe™ Sicura™ assembly consists of a cannula that is assembled into an injection molded hub using an UV glue. The hub has been designed in order to guarantee a proper connection with luer lock and luer slip nozzle of syringes. The cannula is lubricated using a silicone-based lubricant for ease of injection and thus reduce friction during the injection. The other components that are assembled onto hub/cannula components are stainless steel spring, injection molded housing, sleeve with red coloured stripes and slider. The coupling of spring, sleeve and slider let have the safety prevention feature of the device, avoiding accidental needle-sticks. This needle assembly is inserted into a protective injection molded cover and blistered with a peel away medical grade paper which provides a sterility barrier.
Here is the requested information regarding the acceptance criteria and study proving the device meets those criteria, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Test parameter | Acceptance Criteria (Requirement) | Reported Device Performance (Result) |
|---|---|---|
| Cannula Materials | The needle shall be made of tubing materials specified in ISO 9626:2016 and ISO 15510:2014. | Meets standard |
| Dimensions | The needles diameters are in compliance with clause 4.10.1 of ISO 7864:2016 and requirements of ISO 9626:2016. Tolerances on lengths shall be in accordance to ISO 7864:2016 (clause 4.10.2). | Meets standard |
| Bond between hub and needle tube | The union of the hub and needle tube shall not break when tested in accordance to ISO 7864 (Clause 4.12). | Meets standard |
| Freedom from defects | The needle tube shall fulfill the requirements of ISO 7864 (clause 4.10.3). | Meets standard |
| Lubrication | The needle tube should be lubricated. The lubricant shall not, under normal or corrected-to-normal vision, be visible as droplets of fluid on the outer or inner surfaces of the needle tube. The quantity of lubricant used should not exceed 0.25 mg/cm² of the lubricated surface area of the needle tube. | Meets standard |
| Cleanliness | When inspected by normal or corrected-to-normal vision without magnification under an illuminance of 300 lx to 700 lx, the surface of the hypodermic needle tube shall appear free from particles and extraneous matter. When examined under 2.5× magnification, the hub socket (fluid path surface) shall appear free from particles and extraneous matter. | Meets standard |
| Limits for Acidity or Alkalinity | When determined with a laboratory pH meter and using a general purpose electrode, the pH value of an extract prepared in accordance with Annex A shall be within one unit of pH of that of the control fluid. | Meets standard |
| Limits for extractable metals | When tested by a recognized microanalytical method, for example by an atomic absorption method, an extract prepared in accordance with Annex A shall, when corrected for the metals content of the control fluid, contain not greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0.1 mg/l. | Meets standard |
| Color of hub | The hub shall be made either of pigmented or of unpigmented material. If pigmented, the color shall be in accordance with ISO 6009. | Meets standard |
| Needle point | When examined under 2.5× magnification the needle point shall appear sharp and free from feather edges, burrs and hooks. The needle point should be designed so as to minimize coring and fragmentation when penetrating vial closures. Penetration testing can provide an indication of the needle point sharpness and lubrication. | Meets standard |
| Patency of lumen | The flow rate of water through the needle shall not be less than 80% of an unprocessed needle tube of equivalent outer diameter and length having a minimum inner diameter in accordance with ISO 9626 when tested under the same pressure. | Meets standard |
| Sharp injury protection | The needle shall meet the requirements of ISO 23908, the conformity to this standard has been verified also through usability and Sharps injury prevention studies. | Meets standard |
| Hub conical fitting | The conical socket of the hypodermic needle hub shall meet the requirements of ISO 80369-7. | Meets standard |
| Sterility and Biocompatibility | The needle in its unit packaging shall have been subjected to a validated sterilization process resulting in a Sterility Assurance Level of at least 10^-6 in accordance with recognized ISO standards. The needle shall be free from biological hazard in accordance with the requirements of ISO 10993-1. | Meets standard |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample size for the test set used in the non-clinical performance data.
- Data Provenance: The tests were conducted according to international standards (ISO 7864:2016, ISO 9626:2016, ISO 23908:2011, and ISO 80369-7:2021). The information does not specify the country of origin of the data, but it is implied to be from a conformity assessment by the manufacturer (Pikdare S.p.A, Italy). The studies appear to be prospective as they are verification/validation tests performed to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document for the non-clinical performance tests. The tests are based on established ISO standards, which define the ground truth through their methodologies and established limits.
- For the "Simulated Use Study" for sharps injury prevention, it states "the participation of clinical users," but the number and qualifications of these users are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided for any of the tests mentioned. The non-clinical tests are standard measurements against ISO requirements, which typically don't involve complex adjudication among experts. For the simulated use study, the adjudication method is not described.
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:
- No MRMC comparative effectiveness study was done as the device is a hypodermic needle and not an AI/imaging device that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A standalone performance assessment was done for the device through the "Non-Clinical Performance Data" by testing various physical and material properties against ISO standards. This demonstrates the device's inherent design and manufacturing qualities.
- A "Simulated Use Study" also evaluated the function of the safety feature, which in a sense tests the "standalone" operation of the safety mechanism in a simulated but human-involved environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Non-Clinical Performance Data," the ground truth is established by well-defined international standards (ISO). These standards define specific measurement methodologies, performance limits, and material requirements.
- For the "Sharps injury protection" and "Simulated Use Study", the ground truth is based on the requirements of ISO 23908 and the functionality validation against the Instructions For Use (IFU) with the participation of clinical users. This implies a functional ground truth rather than a consensual interpretation of data.
8. The sample size for the training set:
- This information is not applicable as the device is a physical medical device (hypodermic needle) and not an AI or machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable as the device is a physical medical device and does not involve a training set.
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