(300 days)
The Common Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
The Safety Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, after withdrawal of the Safety Type Insulin Pen Needle from the body, the attached needle safety shield automatically covers the needle to minimize the risk of accidental needlestick.
The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. The products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length.
The Common Type Insulin Pen Needle consists of needle shield, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication.
The Safety Type Insulin Pen Needle consists of needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication.
The user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used.
Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
Device: Verifine® Common Type Insulin Pen Needle and Verifine® Safety Type Insulin Pen Needle
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the conformance to various ISO standards and specific performance aspects. The document states "Passed" for all tests, indicating the device met the requirements.
| Test Category | Acceptance Criteria (Implied by Standards/Description) | Reported Device Performance |
|---|---|---|
| Material | Made of tubing materials specified in ISO 9626. | Passed |
| Dimensions | Needles fit the test apparatus specified in item 7.3 of ISO 11608-2. | Passed |
| Flow Rate | Tested in accordance with Annex A to ISO 11608-2. (Implies meeting specified flow rates for different gauges/lengths) | Passed |
| Bond (Hub & Needle Tube) | Union of hub and needle tube does not break when tested in accordance with Clause 9 of ISO 11608-2. | Passed |
| Needle Points | Fulfill the requirements of 4.5 of ISO 11608-2. | Passed |
| Freedom from Defects | Fulfill the requirements of ISO 7864:1993, 11.3. | Passed |
| Lubrication | Needle tube lubricated at both patient end and cartridge end, fulfilling 4.7 of ISO 11608-2. | Passed |
| Dislocation of Measuring Point Patient End | Dislocation of the cannula point at the patient end in accordance with Table 2 (ISO 11688-2) when tested in accordance with Clause 8 of ISO 11608-2. | Passed |
| Functional Compatibility with Needle-Based Injected Systems | Compatibility with any NIS claimed only after testing in accordance with Clause 11 of ISO 11608-2. | Passed |
| Ease of Assemble and Disassembly | Attachment of the needle possible without removing the needle from its opened unit packaging. Compliance checked according to the requirements of Clause 11 of ISO 11608-2. | Passed |
| Biocompatibility | Cytotoxicity: No cytotoxicity (ISO 10093-5) | |
| Sensitization: No evidence of sensitization (ISO 10993-10) | ||
| Intracutaneous Reactivity/Skin Irritation: No evidence of skin irritation (ISO 10993-10) | ||
| Hemocompatibility: No evidence of hemolysis (ISO 10993-4, ASTM F765) | ||
| Systemic Toxicity (acute): No systemic toxicity (ISO 10993-11) | ||
| Pyrogen: No pyrogen (ISO 10993 series) | Passed | |
| Safety Feature (Safety Type Insulin Pen Needle) | No needlestick injuries occurred and zero failure of the protective feature during simulated clinical use testing (per FDA guidance document of Medical Devices with Sharps Injury Prevention Features). | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily refers to "nonclinical testing" and "bench tests."
- Nonclinical Testing (General): The document does not specify a general sample size for all nonclinical tests for the proposed devices but states that "bench tests of Needle with 33G demonstrated conformances..." and "bench tests of Needles with 29G, 30G and 4mm, 6mm demonstrated conformances..." implying specific samples were used for these models.
- Simulated Clinical Use Testing (for Safety Type Insulin Pen Needle): 600 subject devices were chosen for this specific test.
- Data Provenance: The tests were conducted by Promisemed Hangzhou Meditech Co., Ltd. (China). The document does not specify if the testing was retrospective or prospective, but given it's for a 510(k) submission, it would be considered prospective testing for the purpose of demonstrating equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- None stated directly. The document refers to conformance with ISO standards and an FDA guidance document as the basis for evaluation,
rather than expert adjudication for ground truth. For technical performance, the "ground truth" is adherence to the standard's requirements. For the safety feature, the ground truth is the absence of needlestick injuries and feature failures, as observed in the simulated clinical use.
4. Adjudication Method for the Test Set
- None (in the sense of expert consensus on patient cases). The "adjudication" is by adherence to objective, measurable criteria defined by international standards (ISO) and observed performance in specific tests (e.g., the simulated clinical use test). The results are reported as "Passed," implying a direct comparison against the pre-defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study (MRMC) is typically relevant for interpretative devices (e.g., imaging AI) where multiple human readers assess cases, with and without AI assistance, to measure diagnostic performance. The devices in question are insulin pen needles, which are mechanical devices, not interpretative. Therefore, an MRMC study is not applicable or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical medical device (insulin pen needle), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant. The device's performance is inherently "standalone" in its mechanical function.
7. The Type of Ground Truth Used
- Adherence to International Standards and Observed Technical Performance. The ground truth for most tests is the objective fulfillment of requirements laid out in ISO standards (e.g., ISO 9626 for tubing materials, ISO 11608-2 for needle performance, ISO 10993 series for biocompatibility). For the safety feature, the ground truth is the direct observation of zero failures during the simulated clinical use testing as per FDA guidance.
8. The Sample Size for the Training Set
- Not applicable. As a physical medical device, there is no "training set" in the context of an algorithm or AI. The manufacturing processes and design principles are based on engineering standards and iterative design, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8. There is no training set for this type of 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).