(29 days)
SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.
SureFine Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility of the needle because primary container covers the hub and needle cap with blister paper sealed on the opening hole of primary container.
The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube.
SureFine Pen Needle is offered in various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (EO gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.
The SureFine Pen Needle device, K250658, is a Class II hypodermic single lumen needle intended for use with a pen injector for the subcutaneous injection of insulin. The information provided is from an FDA 510(k) Clearance Letter.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SureFine Pen Needle are based on compliance with international standards ISO 9626, ISO 11608-2, and ISO 10993-1, 10993-4, 10993-5, 10993-7, 10993-10, and 10993-11 for biocompatibility and sterilization validation according to ISO 11135.
| Test Item | Acceptance Criteria (from referenced ISO standards) | Reported Device Performance |
|---|---|---|
| ISO 9626 (Needle Characteristics) | All criteria specified in ISO 9626 for hypodermic needles | Pass |
| Materials | Conformance to specified material properties | Pass |
| Cleanliness | Conformance to cleanliness standards | Pass |
| Limits for acidity and alkalinity | Conformance to pH limits | Pass |
| Size designation | Accurate representation of gauge and length | Pass |
| Dimension | Conformance to specified dimensional tolerances | Pass |
| Stiffness | Conformance to stiffness requirements | Pass |
| Resistance to breakage | Resistance to breakage under specified conditions | Pass |
| Resistance to corrosion | Resistance to corrosion under specified conditions | Pass |
| ISO 11608-2 (Needle-Based Injection Systems) | All criteria specified in ISO 11608-2 for pen needles | Pass |
| Dimension | Conformance to specified dimensional tolerances | Pass |
| Flow rate | Conformance to prescribed flow rate | Pass |
| Bond between hub and needle tube | Secure bond between components | Pass |
| Needle point freedom from defects lubrication | Absence of defects and proper lubrication | Pass |
| Dislocation of measuring point at patient | Minimal dislocation to ensure accurate delivery | Pass |
| Compatibility of needles and injector system | Functional compatibility with pen injectors | Pass |
| Biocompatibility (ISO 10993 Series) | All evaluation acceptance criteria | Met |
| Cytotoxicity test | Satisfy requirements of ISO 10993-5 (in vitro cytotoxicity) | Pass |
| Hemolysis test | Satisfy requirements of ISO 10993-4 (hemolytic properties) | Pass |
| Intracutaneous reactivity test | Satisfy requirements of ISO 10993-10 (intracutaneous reactivity) | Pass |
| Skin sensitization test | Satisfy requirements of ISO 10993-10 (skin sensitization) | Pass |
| Acute systemic toxicity test | Satisfy requirements of ISO 10993-11 (acute systemic toxicity) | Pass |
| Pyrogen Test | Satisfy requirements of ISO 10993-11 (material-mediated pyrogens) | Pass |
| Sterilization & Shelf-life | Max levels of EO/ECH within ISO 10993-7 limits; adequate mitigation of bacterial endotoxins; 5-year shelf-life stability. | Conforms to ISO 11135 validated half-cycle method. EOx/ECH levels meet ISO 10993-7. LAL testing performed. Supports 5-year shelf-life. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test mentioned (ISO 9626, ISO 11608-2, Biocompatibility). However, it indicates that "Bench tests for the device's performance were conducted" and "Biocompatibility of the SureFine Pen Needle was evaluated". The testing was conducted by Shina Med Corporation, a company based in the Republic of Korea. The nature of these tests (bench testing, lab-based biocompatibility) suggests they are prospective tests performed on manufactured samples of the device. The data provenance is primarily from internal testing and validation by the manufacturer, following international standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth for the "test set" in the context of device performance. The testing performed is against established international standards (ISO 9626, ISO 11608-2, ISO 10993 series), which themselves represent a form of "ground truth" for device safety and performance criteria. The evaluation results are reported as "Pass" or "Met," implying adherence to these predefined standards rather than an expert panel establishing a de novo ground truth for each specific test.
4. Adjudication Method for the Test Set
No information is provided regarding an adjudication method (such as 2+1, 3+1, none). The evaluation is based on objective measurements and established criteria set forth by the ISO standards. For instance, a flow rate test would have a pass/fail threshold, not require expert adjudication in the traditional sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes bench tests and biocompatibility evaluations for a medical device (pen needle), not a diagnostic or AI-assisted system that would typically undergo an MRMC comparative effectiveness study involving human readers. Therefore, there is no mention of an effect size of human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical medical instrument (a pen needle), not a software algorithm or AI system. Therefore, the concept of "standalone performance" in the context of algorithms is not applicable here.
7. The Type of Ground Truth Used
The ground truth used for demonstrating the device's performance is adherence to established international standards and regulatory requirements:
- ISO 9626: Specifies requirements for stainless steel needle tubing for the manufacture of hypodermic needles.
- ISO 11608-2: Specifies requirements and test methods for single-use needles used with pen-injectors.
- ISO 10993 series: Biological evaluation of medical devices, covering various aspects of biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, pyrogenicity).
- ISO 11135: Specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices.
- ISO 10993-7: EtO residual limits.
- LAL testing: To ensure absence of bacterial endotoxins.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning or AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical 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).