(211 days)
This product to be used with insulin injector is a single use sterile insulin pen needle to be used for injecting insulin to patient with diabetes.
Sungshim insulin pen needle consist of a Sterile cap, Needle, Hub and Sterile paper. The Primary container and Sterile paper function to sustain sterilization of the product. The Hub can be connected with pen type insulin syringe. The Needle cap protects the Needle. This device is single use.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device, specifically an Insulin Pen Needle. It focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study of a novel AI/software-based device. Therefore, many of the requested criteria (e.g., acceptance criteria for AI performance, sample sizes for AI test/training sets, expert adjudication methods, MRMC studies, standalone algorithm performance, ground truth for AI) are not applicable to this type of regulatory submission.
The "device" in this context is a physical medical device (an insulin pen needle), not an AI algorithm. The performance evaluation is based on bench testing against established international standards for physical medical devices and direct comparison of physical characteristics with a predicate device.
Here's the information that can be extracted and how it relates to the provided document, noting the limitations due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document provides a table of "Test item," "Requirements," and "Results." These are the acceptance criteria and the reported performance for the physical device.
| Test item | Acceptance Criteria (Requirements) | Reported Device Performance (Results) |
|---|---|---|
| Inner/out side and structure | When it was tested accordingly to the standard specifications for medical device-"sterile hypodermic needles for single use" clause 2, it should satisfy the requirements. | Pass |
| Measurement | When it was tested accordingly to the standard specifications for medical device-"sterile hypodermic needles for single use" clause 3, it should satisfy the requirements. | Pass |
| Elasticity test | When it was tested accordingly to the standard specifications for medical device-"sterile hypodermic needles for single use" clause 4, it should satisfy the requirements. | Pass |
| Draw test | When it was tested accordingly to the standard specifications for medical device-"sterile hypodermic needles for single use" clause 6, it should satisfy the requirements. | Pass |
| Package | When it was tested accordingly to the standard specifications for medical device-"sterile hypodermic needles for single use" clause 11, it should satisfy the requirements. | Pass |
| Ethylene oxide sterilization residuals | According to ISO 10993-7: ETO≤ 25ppm / ECH≤ 25ppm / EG≤250ppm | Pass |
| Sterility test | When it was tested accordingly to ISO 11135:2007 | Pass |
| Extraction test - Appearance | The sample solution should be colorless and transparent and there should not be foreign materials. | Pass |
| Extraction test - pH | Difference in pH≤1.5 | Pass (Implied, as no value provided, only 'Pass' in the table) |
| Extraction test - KMnO4 Reducing agents | Difference in titers≤ 2.0ml | Pass (Implied, as no value provided, only 'Pass' in the table) |
| Extraction test - Evaporating residue | Difference in extractable≤ 1.0mg | Pass (Implied, as no value provided, only 'Pass' in the table) |
| Extraction test - heavy Pb,Fe,Sn,Zn metal Cd | Not greater than a combined total of 5mg/L of Pb, Fe, Sn and Zn; Shall be less than 0.1mg/L of Cd | Pass |
| Extraction test - UV-vis spectrum | Difference in absorbance (250nm~350nm)≤ 0.1 | Pass (Implied, as no value provided, only 'Pass' in the table) |
| Compatibility testing (with specific injectors) | Based on ISO 11608-2, ensuring compatibility with insulin injectors (Novo Nordisk A/S, Sanofi-Aventis Deutschland GmbH, Novo Nordisk A/S). (Specific quantitative criteria not detailed for "Pass") | Passed with all listed injectors |
2. Sample sizes used for the test set and the data provenance
- Sample sizes: The document does not specify the exact number of units/samples used for each bench test. It states that "Bench test were performed" and lists the standards. For physical device testing, sample sizes are typically determined by the relevant ISO standards (e.g., ISO 7864:1993, ISO 10993-7, ISO 11135:2007, ISO 11608-2). These standards outline the minimum number of samples for specific tests to achieve statistical confidence in performance.
- Data provenance: The tests were performed by Sungshim Medicare Co., Ltd., based in Sejong-si, Korea. The data would therefore be prospective as it's generated specifically for this submission, and the country of origin for the testing data is Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as this is a physical medical device. "Ground truth" in the context of AI refers to verified labels or diagnoses used to evaluate algorithm performance. For a physical device, performance is measured against engineering specifications and international standards, not against expert human interpretations or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used in clinical studies or for setting ground truth in AI/imaging studies where inter-reader variability exists. The device here is evaluated through objective bench tests according to specified 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
This question is not applicable. MRMC studies are used for evaluating the interaction of AI with human readers, typically in medical imaging diagnostics. This submission is for a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. There is no "algorithm" to be evaluated in a standalone manner for this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is the adherence to the specifications and requirements defined by international standards such as ISO 7864:1993, ISO 10993-7, ISO 11135:2007, and ISO 11608-2 for sterile hypodermic needles, biocompatibility, sterilization, and compatibility with pen injectors, respectively. This is a form of objective, standardized measurement rather than expert consensus on a diagnostic outcome.
8. The sample size for the training set
This question is not applicable. This is a physical device, and there is no "training set" in the machine learning sense. The manufacturing process is validated, and product quality is ensured through adherence to Good Manufacturing Practices (GMP) and testing against standards.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above. There is no concept of "ground truth" for a training set for this type of physical product.
§ 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).