(29 days)
The CareFine Pen Needle™ is intended for use with a pen injector device for the subculaneous injection of insulin
CareFine™ Pen Needles are single use, sterile medical devices designed to be used in conjunction with pen injectors and pen cartridges for the subcutaneous injection of insulin. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and the blue needle shield will be offered in 8mm length. CareFine™ Pen Needles are sterile by EtO terminal sterilization, and they are non-toxic and non-pyrogenic.
The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient-end and the cartridgeend 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 protect the point from damage and accidental needle-sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away label to provide a sterile barrier and tamper evident seal. The peel-away label is pre-printed with information, which includes the lot number, needle gauge and needle length.
The individual needle assemblies are packaged in cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to a SAL of 10° by EtO terminal sterilization.
The purpose of this Special 510(k) is to request modification to our CareFine™ Pen Needle family to include blue colored inner needle shield to distinguish the 8mm needle length.
The intended use for the modified device remains the same as the predicate device.
This document describes a Special 510(k) submission for a modification to an insulin pen needle, specifically the addition of a blue colored inner needle shield to distinguish an 8mm needle length. It is not a study that proves the device meets acceptance criteria in the typical sense of a clinical trial for efficacy or diagnostic performance. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
For this specific submission (K141749), which is a Special 510(k) for a color change, the "acceptance criteria" are primarily related to proving that the modification does not raise new issues of safety or effectiveness and that the device remains substantially equivalent to the predicate. The performance data presented are for the original CareFine™ Pen Needle (K133100), not specifically for the blue shield modification.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (Reference to K133100 and K140568) |
|---|---|
| Similar Indication for Use | Identical indication for use: "The CareFine™ Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin." |
| No Labeling Changes Affecting Intended Use | No labeling changes that affect the intended use of the device. |
| No Alteration to Fundamental Scientific Technology | Does not alter the fundamental scientific technology. |
| Same Basic Design | Incorporates the same basic design. |
| Same Operating Principles | Uses the same operating principles. |
| Manufactured from Same Materials (except for color additive) | Manufactured from the same materials (the only difference is the blue color additive to the inner needle shield). |
| Sterilized with Same SAL | Sterilized with a resulting SAL of 10^-6 (EtO terminal sterilization). |
| Same Unit and Case Materials for Packaging | Packaged using same unit and case materials. |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Toxicity, Hemocompatibility) | Performed and submitted with The CareFine™ Pen Needle Traditional 510(k) (K133100) according to ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-4. |
| Needle Shield Assembly Strength | Performed and submitted with The CareFine™ Pen Needle Traditional 510(k) (K133100) according to ASTM F756-8 and an internal test method. |
| Conformance with Applicable Standards & GMP | Manufactured in accordance with the requirements of current Good Manufacturing Practices (21 CFR Subpart C "Design Controls"). All verification and validation activities identified by the risk analysis were performed to demonstrate continued conformance with applicable conformance standards (referenced for K133100). |
| No new safety/effectiveness issues | Based on comparisons, the blue colored inner needle shields "do not raise any new issues of safety and effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a separate "test set" sample size for the color change modification. The referenced non-clinical performance data (biocompatibility, needle shield strength) was performed for the original CareFine™ Pen Needle (K133100). The sample sizes for those specific tests are not provided in this summary.
- Data Provenance: Not explicitly stated for specific test cases, but the tests performed are standard biocompatibility and mechanical tests for medical devices, generally conducted in controlled laboratory environments. The manufacturer is Facet Technologies, LLC, located in Kennesaw, GA, USA, suggesting the data would likely originate domestically or from certified testing labs. The data is retrospective relative to this Special 510(k), as it refers to data submitted with the earlier Traditional 510(k) (K133100).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information (experts establishing ground truth for a test set) is typically relevant for studies involving subjective interpretation (e.g., image analysis, clinical diagnosis). For this device, which is a physical medical device (insulin pen needle) with a minor aesthetic modification, "ground truth" is established through objective engineering and biocompatibility testing against defined specifications and recognized international standards (e.g., ISO 10993, ASTM F756-8). Therefore, the concept of "experts establishing ground truth" in the way described for AI/diagnostic studies does not apply here. The "experts" would be the certified lab technicians and engineers performing these tests, and the regulatory bodies approving the test methods and results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and submission. Adjudication methods are typically used in clinical trials or studies where subjective assessments or discrepancies in expert opinion need to be resolved. This document focuses on objective performance and equivalence to a predicate device.
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 is a physical medical device (pen needle), not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies and the concept of "human readers improving with AI" are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for demonstrating the safety and effectiveness of the original pen needle (K133100) was established through objective laboratory testing against recognized standards (ISO, ASTM) and internal test methods to demonstrate physical integrity, sterility, and biocompatibility. For this Special 510(k), the "ground truth" is the demonstrated substantial equivalence to previously cleared devices based on the technical characteristics and the determination that the color change does not impact safety or effectiveness.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set for an AI/ML model is involved.
§ 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).