(88 days)
Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.
Sure-fine Insulin syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy. The syringes are available in the following sizes and cap color. The modified Sure-Fine Insulin syringe is substantially equivalent to the predicate device (Sure-Fine Insulin Syringes, K152879). The biggest difference between the modified device and predicate device is the addition of needle gauge (27G) and the addition of needle length (1/4"). The devices operate in the principles of a piston syringe fluid path is sterile (EO gas sterilization), Non-toxic, Non-pyrogenic and single use disposable.
This document is a 510(k) Pre-market Notification for "Sure-Fine Insulin Syringes." It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K152879) rather than presenting a standalone study with acceptance criteria and device performance metrics in the typical sense of AI/software device evaluation.
The changes in the current device (K191531) compared to the predicate device (K152879) are primarily the addition of a new needle gauge (27G) and a new needle length (1/4").
Therefore, the "acceptance criteria" and "study" described in the document are about demonstrating that these new configurations and the overall modified device continue to meet established standards for insulin syringes.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a typical "acceptance criteria" table with specific quantitative thresholds. Instead, it refers to compliance with recognized international standards for medical devices, which inherently contain the acceptance criteria for various tests. The "reported device performance" is essentially the finding that the device complies with these standards.
| Acceptance Criteria Category/Standard | Reported Device Performance |
|---|---|
| ISO 7864: Sterile hypodermic needles for single use – Requirements and test methods | Complies with ISO 7864 (for the added needle gauge/length) |
| ISO 9626: Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Complies with ISO 9626 (for the added needle gauge/length) |
| ISO 8537: Sterile single-use syringes, with or without needle, for insulin | Complies with ISO 8537 (for the overall device) |
| Biocompatibility (Conform ISO 10993-1) | Conforms to ISO 10993-1 |
| Sterilization method and S.A.L (Sterilized by ethylene oxide gas SAL = 10$^{-6}$) | Sterilized by ethylene oxide gas SAL = 10$^{-6}$ |
| Indications for Use | Substantially equivalent to the predicate device |
| Technological Characteristics | Substantially equivalent to the predicate device |
| Materials | Identical or substantially equivalent to predicate device |
| Design (Syringe and Needle) | Design features and sizing compared, found substantially equivalent, with additions of 27G needle gauge and 1/4" needle length. |
Note: The document states "appropriate testing was completed to demonstrate that the syringes comply with the following FDA recognized standards". It does not provide the raw data or specific test results for each of these standards in this summary. The "reported performance" is the claim of compliance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for the testing conducted against the ISO standards. This information would typically be found in the full test reports, not in the 510(k) summary.
- Data Provenance: The document doesn't explicitly state the country of origin for the testing data itself, but the manufacturer is SHINA MED CORPORATION in South Korea (Rep. of Korea). The testing would presumably be conducted by or for the manufacturer, either in Korea or by a certified testing lab. The study is prospective in the sense that the testing was performed to support this specific submission for the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable to this type of device submission. Insulin syringes are physical medical devices, and their performance is evaluated through engineering and biological testing against established international standards (like ISO standards), not by human expert interpretation or ground truth labeling in the way an AI/software device would be.
4. Adjudication Method for the Test Set
- This question is not applicable. There is no "test set" that requires adjudication by human experts. Device performance is determined by objective measurements against specified physical and chemical properties and functional requirements outlined in the ISO 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. This submission is for an insulin syringe, which is a physical medical device, not an AI/software device that involves human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is defined by the requirements and test methods specified in the referenced international standards (ISO 7864, ISO 9626, ISO 8537, ISO 10993-1). Compliance with these standards serves as the "ground truth" that the device is safe and effective for its intended use. For example, a needle's sharpness or a syringe's dose accuracy would be measured against specific, quantifiable criteria in these standards.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable. As there is no training set for a physical device.
In summary: The acceptance criteria and "study" for this device are based on demonstrating compliance with recognized international standards for medical devices, particularly those related to sterile hypodermic needles and insulin syringes. The document asserts that "appropriate testing was completed" to show this compliance, thereby proving the device meets the acceptance criteria for substantial equivalence to its predicate for its intended use, including the newly added specifications.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).