(253 days)
The DropSafe Safety Pen Needles are sterile, single-use safety needles intended for use with pen injector devices for the injection of drugs.
DropSafe Safety Pen Needles are sterile, single-use safety needles intended for use with pen injector devices for the injection of drugs. DropSafe Safety Pen Needles are OTC devices intended to be used by clinical and non-clinical users. DropSafe Safety Pen Needles are offered in one gage - 31 G and in two lengths: 6mm and 8 mm. DropSafe Safety Pen Needles are gamma sterilized, non-toxic single use devices.
The device is designed to minimize the risk from accidental needle sticks with a used needle by application of a sharps injury prevention feature. Following use, the needle is locked out preventing reuse. The shield also serves to hide the needle before and after injection.
Each DropSafe safety pen needle is individually packaged in a sealed container. The DropSafe safety pen needle is used by removing the seal and attaching it to the pen injector device to administer a drug subcutaneously. While inserting the needle into the skin at a 90° angle, the slides into the shield. While the slider glides into the shield, 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 safety pen needle is in the locked mode, it cannot be reused. The safety pen needle is detached from the pen injector device and disposed of into a sharps container.
The pen needle assembly consists of a double-ended cannula that is assembled into an injection molded hub using an adhesive. The hub has internal threads which allows it to be screwed onto the pen injector device. This allows the cartridge end of the needle to penetrate through the rubber septum of the cartridge. The patient-end and the cartridge end of the cannula are lubricated using a silicone-based lubricant for ease of injection and rubber septum penetration. An injection molded inner shield is assembled over the patient end of the cannula to prevent needle point damage and accidental needle-sticks. This needle assembly is inserted into a protective injection molded container and sealed with a peel away medical grade paper tab which provides a sterility barrier and tamper evident seal.
The provided text describes a 510(k) premarket notification for a medical device called "DropSafe Safety Pen Needles." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the information provided primarily addresses design verification and validation testing of the device's physical properties and safety features, and not a study proving the device meets high-level acceptance criteria through, for instance, a multi-reader multi-case clinical study or algorithm-only performance.
Based on the provided text, here's a breakdown of the requested information, highlighting what is present and what is not applicable or not detailed for this type of submission:
1. A table of acceptance criteria and the reported device performance:
The document lists "Non-Clinical Performance Data" and "Clinical Performance Data" which serve as acceptance criteria based on established standards and guidance.
| Test parameter | Requirement – ISO 11608-2:2012 / FDA Guidance | Reported Device Performance (Result) |
|---|---|---|
| Non-Clinical Performance Data (ISO 11608-2:2012) | ||
| Materials | The needle shall be made of tubing materials specified in ISO 9626. | Meets standard |
| Dimensions | The needles shall fit the test apparatus specified in clause 7.3 of ISO 11608-2. | Meets standard |
| Determination of flow rate through the needle | The needle was tested in accordance with Annex A to ISO 11608-2 to determine flow rate through the needle. | Meets standard |
| Bond between hub and needle tube | The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2. | Meets standard |
| Freedom from defects | The needle tube shall fulfill the requirements of ISO 7864, clause 11.3. | Meets standard |
| Lubrication | The needle tube should be lubricated at both the patient end and the cartridge end. The lubricant shall not, under normal or corrected-to-normal vision, be visible as droplets of fluid on the outside surface of the needle tube. | Meets standard |
| Dislocation of measuring point at patient end | Dislocation of the cannula point at the patient end shall be in accordance with Table 2 [not included in excerpt] when tested in accordance with Clause 8 (of ISO 11608-2). | Meets standard |
| Determination of functional compatibility with needle-based injection systems | Compatibility with any NIS shall be claimed only after testing in accordance with Clause 11. | Meets standard |
| Ease of assembly and disassembly | Attachment of the needle shall be possible without removing the needle from its opened unit packaging. Compliance is checked according to the requirements of clause 11. | Meets standard |
| Pre-conditioning of needles | All requirements of the standard related to preconditioning of needles were met. | Meets standard |
| Clinical Performance Data (FDA GUIDANCE Medical Devices with Sharps Injury Prevention Features, August 9, 2005) | ||
| Function of safety feature in simulated clinical environment | Evaluate the function of the safety feature with participation of both clinical and non-clinical users. | "As evidenced in the study, the use of this device does not affect the injection technique or the functionality of the pen injector and is safe and effective when used as per the Instructions for Use." |
| Validation of Instructions For Use (IFU) | Validate IFU with participation of clinical and non-clinical users. | "As evidenced in the study, the use of this device does not affect the injection technique or the functionality of the pen injector and is safe and effective when used as per the Instructions for Use." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the numerical sample sizes for the non-clinical performance tests (e.g., number of needles tested for flow rate, bond strength, etc.) nor for the "Simulated Use Study" involving clinical and non-clinical users. It merely states that "Testing was performed" and "All testing met the applicable requirements."
- Data Provenance: The tests are described as being conducted in compliance with ISO standards and FDA guidance. The manufacturer, HTL-Strefa S.A., is located in Poland. The text doesn't explicitly state the location of the testing, but it can be inferred to have been conducted by or for the manufacturer. The studies described are likely prospective tests performed specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. For this type of device (a hypodermic needle), "ground truth" is established through engineering and performance testing against objective standards (ISO 11608-2:2012) and simulated user studies. Expert consensus or ground truth derived from a panel of medical specialists (like radiologists) is not relevant for this device's validation. The "Simulated Use Study" involved "clinical and non-clinical users," but their number or specific qualifications (beyond being "clinical users") are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in studies where human readers are interpreting images or data, and their disagreements need to be resolved to establish ground truth. For the physical and functional tests of a pen needle, objective measurements against established standards are the norm, not 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:
Not applicable. This device is a mechanical medical device (a safety pen needle), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or performed for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or AI system. Its performance is inherent to its physical design, manufacturing, and user interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by:
- Compliance with international standards (ISO 11608-2:2012) for physical and functional properties (e.g., materials, dimensions, flow rate, bond strength, lubrication, compatibility).
- Compliance with FDA guidance for sharps injury prevention features, validated through a "Simulated Use Study" to confirm the safety feature's function and IFU effectiveness with users.
- The primary ground truth is the ability of the device to meet specified engineering and performance requirements for safe and effective use, rather than a clinical diagnosis.
8. The sample size for the training set:
Not applicable. This is a mechanical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for a mechanical device.
§ 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).