(452 days)
The Insulin Pen Needle (Ordinary Type) is intended for use with pen injector devices for the subcutaneous injection of insulin.
The Insulin Pen Needle (Safety Type) is sterile, single-use safety needle intended for use with pen injector devices for the subcutaneous injection of insulin.
The proposed devices, Insulin Pen Needle (Ordinary Type) and Insulin Pen Needle (Safety Type) are single use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. For the safety type, it is designed with a sharp injury prevention feature to minimize the risk from accidental needles sticks. The proposed device is available in 29G, 30G, 31G, 32G and 33G five different specifications with the needle length available in 4mm, 8mm, 10mm and 12mm for Insulin Pen Needle (Ordinary Type) and 4mm, 5mm, and 8mm for Insulin Pen Needle (Safety Type). The product is for single use and provided sterile (Irradiation). The shelf-life of the product is five-years.
This document describes the Insulin Pen Needle (Ordinary Type) and Insulin Pen Needle (Safety Type) by Tianjin Huahong Technology Co., Ltd. being substantially equivalent to predicate devices. The information provided heavily focuses on comparisons to predicate devices and adherence to various ISO standards and FDA guidelines, rather than presenting a standalone study with acceptance criteria and device performance in a typical clinical measurement context.
Here's an attempt to extract and synthesize the requested information, acknowledging that some details, especially concerning statistical performance measures for clinical efficacy, are not explicitly provided in this type of 510(k) summary. The document emphasizes adherence to technical standards and biocompatibility, which are critical for medical devices but different from performance metrics for diagnostic or therapeutic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to international standards and predicate device characteristics. Since this is a 510(k) submission for pen needles, the "performance" is generally about meeting physical, chemical, and biological safety requirements, rather than a diagnostic accuracy or treatment effectiveness metric as might be seen for other types of devices.
| Acceptance Criteria (Based on ISO Standards & Predicate Comparison) | Reported Device Performance (Summary of Test Results) |
|---|---|
| Physical & Mechanical: | |
| Needles conform to ISO 7864:2016 (Sterile hypodermic needles) | Conform with ISO 7864 standards |
| Needle tubing conforms to ISO 9626:2016 (Stainless steel tubing) | Complies with ISO 9626:2016 |
| Needles conform to ISO 11608-2:2012 (Needle-based injection systems, Part 2: Needles) | Complies with ISO 11608-2:2012. Bond between hub and needle tube: Clause 4.4 of ISO 11608-2:2012; Clause 4.12 of ISO 7864:2016. (For safety type, additional drawing force requirements: ≥ 22N (29G); ≥ 11N (30G-33G)) |
| Sharps injury protection features conform to ISO 23908:2011 (for Safety Type) | The results demonstrated that the proposed device met the pre-established criteria. (A simulated clinical use study was performed) |
| Biocompatibility (ISO 10993-1): | |
| Cytotoxicity | No Cytotoxicity |
| Sensitization | No skin sensitization |
| Irritation | No Irritation to Skin |
| Acute Systemic Toxicity | No Systemic Toxicity |
| Material-Mediated Pyrogenicity | No pyrogen |
| Subacute Toxicity | No Subacute Systemic Toxicity |
| Hemocompatibility (Hemolysis) | No hemolysis |
| Sterility & Shelf-Life: | |
| Sterility Assurance Level (SAL) | 10^-6 (Irradiation sterilized, dose 25kGy, validated per ISO 11137-2) |
| Endotoxin Limit | 20 EU per device (Utilizing USP LAL method) |
| Particulate Matter (USP ) | Met USP acceptance criteria |
| Shelf Life | 5 years (Validated using ASTM F1980-16) |
| Packaging Integrity | All packaging deemed acceptable for protection of product and sterility maintenance (tested via ASTM F88/F88-15 seal strength, ASTM F1929-15 dye penetration) |
| Material Composition: | |
| Needle Tube Material | Stainless Steel (SUS304) |
| Hub Material | Polypropylene |
| Lubricant | MDX4-4159 |
| Adhesive | UV glue |
| Compatibility with Pen Injectors | Tested with specified pen injectors (Autopen®, Novopen Echo®, Humapen and Humapen Ergo, Humapen Luxura, Humapen Memoir) |
2. Sample size used for the test set and the data provenance
-
Simulated Clinical Use Study (for Safety Type):
- Sample Size: 600 device samples.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but it was a "simulated clinical use study," implying prospective testing under controlled conditions.
-
Other Non-clinical Tests (e.g., physical, mechanical, biocompatibility, sterility):
- Specific sample sizes for each test are not provided in this summary. These tests are typically conducted on representative batches of the manufactured device.
- Data Provenance: These are laboratory-based, non-clinical tests, not involving human subjects or patient data. The manufacturer (Tianjin Huahong Technology Co., Ltd. in China) conducted or commissioned these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information (number and qualifications of experts for ground truth) is relevant for studies involving subjective assessment or interpretation (e.g., imaging devices, diagnostic algorithms). For physical medical devices like insulin pen needles, "ground truth" is typically established by objective measurements against established engineering standards and biological safety tests. Therefore, this information is not applicable and not provided in the document. The "ground truth" is the objective standard itself (e.g., SAL of 10^-6, absence of cytotoxicity).
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1 or 3+1 for resolving discrepancies in expert opinions) are used in studies where subjective evaluations are made. For pen needles, performance is assessed against objective, measurable criteria and 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
Not applicable. This is a medical device (insulin pen needle), not an AI-powered diagnostic or assistive technology that involves "human readers" or AI assistance.
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
The "ground truth" for the performance claims of these insulin pen needles is based on:
- International Standards: Adherence to established ISO standards (e.g., ISO 7864, ISO 9626, ISO 11608-2, ISO 23908) for physical, mechanical, and safety properties.
- Biocompatibility Standards: Adherence to ISO 10993 series for biological evaluation of medical devices.
- Pharmacopoeia Standards: Adherence to USP for particulate matter and USP for endotoxin limits.
- Engineering Specifications: Device specifications (e.g., material composition, dimensions, bond strength) measured against defined tolerances.
- Predicate Device Comparison: Establishing substantial equivalence by demonstrating that the proposed device performs comparably to legally marketed predicate devices regarding safety and effectiveness.
8. The sample size for the training set
Not applicable. "Training set" refers to data used to train machine learning models. This is a physical medical device submission, not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. As explained above, this is not an AI/ML 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).