Search Results

The Monoject™ Enteral Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids, either orally or enterally, into the gastrointestinal system of a patient. The orallenteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

Not Found

This document is an FDA 510(k) clearance letter for the Monoject™ Enteral Syringe with ENFit Connector. It does not contain any information regarding acceptance criteria or a study proving that a device meets those criteria for software or AI/ML-enabled devices.

The letter is a regulatory document indicating that the FDA has determined the device to be substantially equivalent to a legally marketed predicate device. This process primarily focuses on comparing the new device's intended use, technological characteristics, and safety and effectiveness to an existing, legally marketed device.

Therefore, I cannot provide the requested information from this document. The document discusses regulatory aspects like:

• Trade/Device Name
• Regulation Number and Name
• Regulatory Class
• Product Code
• Indications for Use
• General controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling, misbranding, adulteration)
• Quality System (QS) regulation requirements
• Unique Device Identification System (UDI Rule)
• Medical Device Reporting (MDR)
• Contact information for the FDA.

However, none of these sections detail acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications as typically provided for AI/ML device submissions.

Ask a specific question about this device