(67 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 iniector devices for the 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, 5mm, 6mm, 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.
The provided text describes the acceptance criteria and study for an Insulin Pen Needle (Ordinary Type, Safety Type), not an AI/algorithm-based device. Therefore, many of the requested points, such as MRMC studies, training set details, or expert ground truth establishment for AI, are not applicable.
However, I can extract the information relevant to the medical device's performance and testing as described in the 510(k) summary.
Here's a breakdown based on the provided document:
Device Type: Insulin Pen Needle (Ordinary Type, Safety Type) - This is a physical medical device, not a software/AI device.
1. A table of acceptance criteria and the reported device performance:
The document refers to adherence to various ISO standards and specific test results, but does not present a single consolidated table of "acceptance criteria" vs. "reported performance" in a quantitative manner for all aspects. Instead, it states that the device "met all design specifications" and "complies with the following standards."
Here's an attempt to extract the closest information, primarily by listing the standards the device claims to conform with for performance characteristics:
| Feature/Test | Acceptance Criteria (as per standards/claims) | Reported Performance |
|---|---|---|
| General Performance: | ||
| Bond between hub and needle tube (Ordinary Type) | Clause 4.4 of ISO 11608-2:2012; Clause 4.12 of ISO 7864:2016 | Complies with standards (Stated implicitly by "met all design specifications") |
| Needle tip configuration (Ordinary Type) | Conform with ISO 7864 standards | Complies with standards |
| Bond between hub and needle tube (Safety Type) | Drawing force ≥ 22N (29G); Drawing force ≥ 11N (30G-33G); Clause 4.4 of ISO 11608-2:2012; Clause 4.12 of ISO 7864:2016 | Complies with standards and specified drawing forces (Stated implicitly by "met all design specifications") |
| Needle tip configuration (Safety Type) | Conform with ISO 7864 standards | Complies with standards |
| Biocompatibility: | ||
| Cytotoxicity | No Cytotoxicity | Met (Stated "No Cytotoxicity") |
| Intracutaneous reactivity / Irritation | No Irritation to Skin | Met (Stated "No Irritation to Skin") |
| Skin Sensitization | No skin sensitization | Met (Stated "No skin sensitization") |
| Acute Systemic Toxicity | No Systemic Toxicity | Met (Stated "No Systemic Toxicity") |
| Pyrogen | No pyrogen | Met (Stated "No pyrogen") |
| Hemolysis | No hemolysis | Met (Stated "No hemolysis") |
| Subacute Systemic Toxicity | No Subacute Systemic Toxicity | Met (Stated "No Subacute Systemic Toxicity") |
| Sterility: | ||
| Sterility Assurance Level (SAL) | 10⁻⁶ | Achieved 10⁻⁶ |
| Endotoxin Limit | 20 EU per device | Met (Stated "20 EU per device") |
| Shelf-life: | ||
| Shelf life | 5 years | Validated for 5 years |
| Sharps Injury Protection (Safety Type): | ||
| Sharps injury prevention feature | Meet pre-established criteria per ISO 23908:2011 and FDA Guidance | Met pre-established criteria (Tested in simulated clinical use) |
| General Quality: | ||
| Particulate matter | USP acceptance criteria | Met USP acceptance criteria |
| Package integrity | Acceptable for protection and sterility maintenance | All packaging deemed acceptable |
2. Sample size used for the test set and the data provenance:
- Simulated Clinical Use Study (Safety Type only): 600 device samples.
- Data Provenance: Not specified in terms of country of origin for testing data. The manufacturer is in Tianjin, China. The testing appears to be non-clinical, laboratory-based performance testing rather than human clinical study data. It is a non-clinical study, not a retrospective or prospective human data study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical medical device. "Ground truth" in the context of AI/machine learning data is not relevant here. Performance is assessed against engineering standards (e.g., ISO, USP) and physical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is not a study requiring human interpretation or labeling of data (like medical imaging), there's no adjudication method in the described testing.
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 not an AI/software device. No human-in-the-loop studies or MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/software device. "Standalone performance" in this context would refer to the device's adherence to its design specifications and relevant standards, which was evaluated through non-clinical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For a physical device, "ground truth" is defined by established engineering and biological standards (e.g., ISO, USP), material specifications, and physical measurements. The "truth" is whether the device physically meets these specifications and passes the required tests.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning model.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set." The performance of the device is assessed against pre-defined engineering standards and test methods.
§ 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).