(345 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 dose of U-100 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.
Category: U-100
Insulin syringe: 1/2cc and 1cc, 3/10cc, 1/2cc and 1cc
Needle Gauge: 28Gauge, 29Gauge, 30Gauge, 31Gauge
Needle Length: 1/2", 5/16"
Cap color: Needle cap: Orange, Plunger Cap: Orange or white
This device operates in the principles of a piston syringe fluid path is sterile (EO gas sterilization), single use disposable.
This document is a 510(k) Summary for the Sure-Fine Insulin Syringes, which is a regulatory submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not describe an acceptance criteria or a study designed to establish clinical performance of a novel device in the same way one might describe for a diagnostic AI algorithm.
Instead, the document details non-clinical testing to demonstrate that the Sure-Fine Insulin Syringes meet established performance and safety standards, proving substantial equivalence to a predicate device.
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 numerical thresholds for accuracy, sensitivity, or specificity as one would expect for an AI/diagnostic device. Instead, it lists the voluntary standards and clauses from those standards that the device was designed and tested to meet. The "reported device performance" is the conclusion that the device successfully met these requirements, thus demonstrating substantial equivalence.
| Standard/Test | Acceptance Criteria (implied by standard) | Reported Device Performance |
| 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| ------------------------------------------- |
| Performance Testing (per ISO 8537:2007) | Compliance with physical and functional requirements for sterile single-use hypodermic syringes for insulin. (e.g., freedom from extraneous matter, extraction, lubrication, range of sizes, graduated scale, barrel, piston/plunger, nozzle, needles, assembled syringe performance). | Successfully met the applicable requirements. |
| Biocompatibility Testing (per ISO 10993 Series) | Compliance with biological safety requirements for devices in contact with patients (e.g., in vitro cytotoxicity, irritation, sensitization, acute systemic toxicity, interaction with blood, pyrogenicity). | Successfully passed testing as outlined. |
| Sterilization & Shelf-life Testing (per ISO 11135, ISO 10993-7) | Sterility Assurance Level (SAL) of 10-6; maximum levels of ethylene oxide and ethylene chlorohydrins within limits; a 5-year shelf-life. | Validated sterilization with SAL = 10-6; EO/ECH levels did not exceed limits; 5-year shelf-life supported. |
Important Note: This is a traditional medical device (insulin syringe), not an AI/software device. Therefore, the questions related to AI-specific metrics, ground truth, expert consensus, and MRMC studies are not applicable. The device's performance is assessed through engineering and biological safety tests against established standards for its mechanical function and material safety.
The following questions are not applicable to this specific submission as it pertains to a physical medical device (insulin syringe) and not an AI or diagnostic software. Therefore, there are no details on test sets, ground truth establishment by experts, or MRMC studies.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a physical medical device. Testing involved physical samples of the syringe, not a "data test set." The document does not specify the number of samples tested for each engineering or biological test.
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)
- Not Applicable. There is no "ground truth" to be established by experts in the context of an insulin syringe's physical and functional properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable.
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 physical medical device, not an AI or diagnostic software. No human readers or AI assistance are involved in its primary function or evaluation for substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device; no algorithm is present.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable.
8. The sample size for the training set
- Not Applicable. This is a physical medical device; there is no "training set" in the context of an AI or machine learning model.
9. How the ground truth for the training set was established
- Not Applicable.
§ 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).