(517 days)
This is a single use sterile insulin pen-injector needle to be used by diabetic patients for the purpose of injecting insulin.
CPL insulin pen needle consist of a sterile cap, needle, hub and blister paper. The sterile cap and blister paper function to sustain sterilization of the product. The hub can be connected with pen type insulin syringe. The needle cap protects the needle. This device is single use.
The document describes a 510(k) premarket notification for the "CPL Insulin Pen Needle" and its substantial equivalence to a predicate device. It details performance data to demonstrate this equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with numerical or categorical targets followed by "reported device performance" in the format typically used for AI/ML device evaluations. Instead, it lists various tests performed and states that the device "demonstrated equivalent performance to the predicate devices" or "is substantially equivalent" to the predicate.
However, we can infer the acceptance criteria and performance from the tests conducted against international standards (ISO).
| Acceptance Criteria (Inferred Standard Compliance) | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1 series) | |
| Cytotoxicity | Performed and suitable |
| Sensitization | Performed and suitable |
| Intracutaneous reactivity (Acute) | Performed and suitable |
| Systemic toxicity (Acute) | Performed and suitable |
| Pyrogenicity | Performed and suitable |
| Hemolysis | Performed and suitable |
| Physical/Mechanical Performance (ISO 11608-2 & ISO 9626) | |
| Inner/outside and structure | Performed and demonstrated equivalent performance |
| Dimension | Performed and demonstrated equivalent performance |
| Draw test | Performed and demonstrated equivalent performance |
| Elasticity test | Performed and demonstrated equivalent performance |
| Flexural rigidity | Performed and demonstrated equivalent performance |
| Inner and outside of needle | Performed and demonstrated equivalent performance |
| Size designation | Performed and demonstrated equivalent performance |
| Elasticity of the needle tube | Performed and demonstrated equivalent performance |
| Pull | Performed and demonstrated equivalent performance |
| Lubricant | Performed and demonstrated equivalent performance |
| Limits for acidity and alkalinity | Performed and demonstrated equivalent performance |
| Stiffness | Performed and demonstrated equivalent performance |
| Resistance to breakage (ISO 7864) | Performed and demonstrated equivalent performance |
| Resistance to corrosion | Performed and demonstrated equivalent performance |
| Determination of flow rate through the needle (ISO 9626) | Performed and demonstrated equivalent performance |
| Bond between hub and needle tube | Performed and demonstrated equivalent performance |
| Freedom from defects | Performed and demonstrated equivalent performance |
| Penetration resistance | Performed and demonstrated equivalent performance |
| Cap-hub fitting strength | Performed and demonstrated equivalent performance |
| Dislocation of measuring point at patient end | Performed and demonstrated equivalent performance |
| Needle dose accuracy test | Performed and demonstrated equivalent performance |
| Needle hub torque removal | Performed and demonstrated equivalent performance |
| Ease of assembly and disassembly test | Performed and demonstrated equivalent performance |
| Compatibility with needle-based injection systems | Performed and demonstrated equivalent performance and a list of compatible pens is provided |
| Sterilization effectiveness | EO Gas sterilization, stated as "Same" as predicate |
| Packaging integrity | Sterile cap(PP)+sterile paper, stated as "Similar" |
The key acceptance criterion is that the "CPL Insulin Pen Needle" demonstrates substantially equivalent performance to the predicate device (K080904 Feel Fine Insulin Pen Needle) based on compliance with relevant ISO standards and a series of bench tests.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the bench tests. It also does not specify the data provenance (e.g., country of origin or whether the data was retrospective or prospective) for these performance tests. The tests are described as "bench tests," implying laboratory testing of the physical devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable in the context of this 510(k) submission. The CPL Insulin Pen Needle is a physical medical device, not an AI/ML diagnostic or predictive algorithm where expert ground truth for a test set would be established. The "ground truth" here is defined by the technical specifications and performance requirements outlined in the ISO standards and the comparative performance against the predicate device.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in cases of subjective interpretation (e.g., medical image reading), not for objective physical device performance testing against defined standards.
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
This is not applicable. The CPL Insulin Pen Needle is a physical medical device (an insulin pen needle), not an AI-assisted diagnostic or therapeutic system. Therefore, an MRMC study related to human readers improving with AI assistance would not be performed for this type of device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As explained for point 5, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is established by international standards (e.g., ISO 10993-1, ISO 11608-2, ISO 7864, ISO 9626) and the demonstrated performance of the legally marketed predicate device (K080904 Feel Fine Insulin Pen Needle). The product's performance is compared against these objective benchmarks and the predicate device's established performance to determine substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning. The device's design, manufacturing, and quality control processes are informed by engineering principles and compliance with standards, not by AI model training.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as point 8.
§ 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).