(115 days)
The CareFine™ Pen Needle is intended for use with a pen injector device for the subcutaneous 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 lengths (4mm, 5mm, 6mm, 8mm, and 12.7mm). CareFine™ Pen Needles are sterile (EtO terminal sterilization), 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 sterility barrier and tamper evidence seal. The peel-away label is pre-printed with information, which includes the lot number and needle gauge and 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 provided document is a 510(k) summary for the CareFine™ Pen Needles. It does not present a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/ML device would.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed devices, rather than establishing de novo safety and effectiveness through a dedicated study with defined acceptance criteria for novel performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not applicable to this type of submission.
However, I can extract the information that is present and explain why other points are not available in this context.
Acceptance Criteria and Device Performance (Not applicable - Substantial Equivalence Submission)
For a device like CareFine™ Pen Needles, the "acceptance criteria" are typically defined by recognized standards for medical devices of this type (e.g., ISO standards for sterile medical devices, specific performance tests for needles) and the performance characteristics of the predicate devices. The submission aims to show that the new device meets these standards and is comparable to the predicates, rather than proving a specific novel performance metric against pre-defined thresholds.
| Performance Characteristic | Predicate Device Performance / Standard (Implied Acceptance) | CareFine™ Pen Needles Reported Performance |
|---|---|---|
| Biocompatibility | Meets appropriate biocompatibility standards | Meets appropriate biocompatibility tests |
| Sterility | Sterile with SAL of 10-6 | Sterile with SAL of 10-6 |
| Needle Sharpness | Comparable to predicate devices | Tested and comparable to predicates |
| Needle Length | Matches predicate devices | Matches predicate devices |
| Needle Gauge | Matches predicate devices | Matches predicate devices |
| Needle Shield Color | Matches predicate devices | Matches predicate devices |
| Needle Shield Dimensions | Matches predicate devices | Matches predicate devices |
| Needle Shield Strength | Comparable to predicate devices | Tested and comparable to predicates |
| Hub/Needle Bond Strength | Comparable to predicate devices | Tested and comparable to predicates |
| Materials | Same/similar to predicate devices | Same/similar materials |
| Packaging | Same/similar to predicate devices | Same/similar unit and case materials |
Study Details (Not applicable for this context of 510(k) for substantial equivalence)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This submission does not describe a "test set" in the context of an AI/ML device evaluation with a defined sample size for performance validation. The evaluation involved "predicate product comparative tests and performance tests" but specific sample sizes for these engineering/bench tests are not provided in the summary.
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):
- Not applicable. "Ground truth" in the sense of expert consensus for medical image interpretation or similar complex diagnostic tasks is not relevant to this device. Bench testing and adherence to standards are the primary evaluation methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication process for decision-making or truth establishment is described or implied for this type of device submission.
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 needles), not an AI-assisted diagnostic tool.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Implicit. The "ground truth" for a pen needle's performance is established by engineering specifications, recognized industry standards (e.g., ISO, ASTM for needle strength, sterility), and comparison to the performance of predicate devices which have already proven safety and effectiveness.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set exists for this device.
Summary of what the document does provide regarding device evaluation:
- Non-Clinical Performance Data: The CareFine™ Pen Needle was manufactured in accordance with Current Good Manufacturing Practices and underwent:
- Appropriate biocompatibility tests
- Sterility tests (to a SAL of 10-6)
- Predicate product comparative tests (e.g., needle sharpness, length, gauge, shield dimensions, shield strength, hub/needle bond strength)
- Performance tests
- Compliance: The test results are stated to be in compliance with existing domestic and international standards.
- Conclusion: Based on the design equivalency to predicate devices and the functional testing performed, Facet Technologies determined the CareFine™ Pen Needles are substantially equivalent and do not raise new issues of safety and effectiveness.
- Clinical Performance Data: Clinical data was not required for this 510(k) submission, indicating that the non-clinical and comparative performance data were deemed sufficient by the FDA for establishing substantial equivalence.
§ 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).