(406 days)
Insulin Syringe is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device.
The provided document is a 510(k) summary for an Insulin Syringe and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device.
Key points from the document regarding studies and testing:
- No AI/ML Component: The device described is an "Insulin Syringe," a physical medical device, not an AI/ML algorithm. Therefore, none of the requested information regarding AI/ML performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies are applicable or present in this document.
- Non-Clinical Studies: The document details non-clinical studies performed to demonstrate substantial equivalence to a predicate device. These include:
- Performance Testing: Conducted according to ISO 8537:2016 for sterile single-use syringes for insulin.
- Biocompatibility Testing: Conducted according to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-4, ASTM F 756-17, and USP (Pyrogen test), USP (Particulate matters).
- Sterilization and Shelf-life Testing: Validated according to ISO 11135, with residue levels meeting ISO 10993-7. Shelf-life testing supported a 5-year shelf life.
- No Clinical Studies: The document explicitly states: "No prospective clinical trials were conducted in support of this 510(K)."
Since the request pertains to the acceptance criteria and study proving an AI/ML device meets them, and the provided document describes a conventional medical device (insulin syringe), the requested information cannot be extracted.
§ 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).