(257 days)
The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. The intended user population of insulin pen needle is for "Adult Use Only" (ages 21yrs old and above).
The proposed device, Insulin pen needle and insulin injection pen are use cooperatively to inject insulin into the human body. The Insulin Pen Needle is composed of a needle container, a needle shield, a needle hub, a needle tube. The insulin pen needle for single use is offered in various gauge sized and length. The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 106.
The provided document is a 510(k) summary for an Insulin Pen Needle. It details the device, its intended use, comparison with a predicate device, and performance data from non-clinical tests.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists standards that the device conforms to, and states that testing results were in conformance or met acceptance criteria. Specific quantitative acceptance criteria or reported performance values are generally not provided in this 510(k) summary format, which often focuses on demonstrating compliance with recognized standards rather than presenting raw data or detailed performance metrics.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ISO 11608-2: 2012 (Bench Testing) | In conformance with the standard |
| ISO 9626: 2016 (Bench Testing) | In conformance with the standard |
| ISO 7864: 2016 (Bench Testing) | In conformance with the standard |
| ISO 11135 (Sterilization) | Validated in compliance with ISO 11135 |
| ISO 10993-7 (EO Residual) | EO residual doesn't exceed the limit |
| ASTM F1980-16 (Shelf-life via accelerated aging) | Verified the claimed 5 years shelf-life |
| ASTM D3078-02 (Package: Vacuum Leak Test) | Performed in compliance with the standard |
| ASTM F1929-15 (Package: Dye Penetration Test) | Performed in compliance with the standard |
| DIN 58953-6: 2016 (Package: Microbial Barrier Properties Test) | Performed in compliance with the standard |
| ASTM F88/F88M-21 (Package: Seal Strength Test) | Performed in compliance with the standard |
| ISO 10993 series (Biocompatibility) | Conforms to the ISO 10993 series of standards (Patient-contact material) |
| Cytotoxicity (Biocompatibility) | No Cytotoxicity |
| Sensitization (Biocompatibility) | No Skin Sensitization |
| Irritation (Biocompatibility) | No Irritation to Skin |
| Systemic Toxicity (Biocompatibility) | No Systemic Toxicity (Acute and Subacute) |
| Hemolysis (Biocompatibility) | No Hemolysis |
| Pyrogen (Biocompatibility) | No pyrogen |
| Particulate Matter (USP ) | Met the USP acceptance criteria |
| FDA Guidance: Medical Devices with Sharps Injury Prevention Features, August 9, 2005 (Simulated Clinical Use Testing) | Conducted in compliance with the FDA Guidance |
| Bond between hub and needle tube (Clause 4.4 of ISO 11608-2:2012; Clause 4.12 of ISO 7864:2016) | Adherence to these clauses |
| Needle tip configuration (ISO 7864 standards) | Conform with ISO 7864 standards |
| SAL (Sterility Assurance Level) | 10-6 |
| Endotoxin Limit | 20 EU per device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the tests conducted. It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. It only mentions that the manufacturer is in Anhui, China, and the correspondent is in Shanghai, China, implying the tests were likely performed or managed from China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the document. The device is an Insulin Pen Needle, which is a physical medical device. Its performance is evaluated through bench testing against recognized standards (e.g., ISO, ASTM, USP) and biocompatibility testing, not through expert-reviewed diagnostic outputs that require a "ground truth" derived from human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. As explained above, the device's performance is determined by objective physical and chemical tests, not by human interpretation or clinical adjudication.
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 information is not applicable and not provided. MRMC studies are relevant for diagnostic imaging devices or AI-assisted diagnostic tools, not for a physical device like an Insulin Pen Needle. The document explicitly states "Clinical testing: Not Applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This question pertains to AI/algorithm performance. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable for this device. Ground truth is generally used in diagnostic studies or AI performance evaluations against a known correct answer. For an Insulin Pen Needle, performance is assessed against established engineering and biological standards.
8. The sample size for the training set
This information is not applicable and not provided. A training set is used for machine learning algorithms. The device is a physical medical device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This question pertains to machine learning.
§ 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).