Search Results

ENFit Nutrifit™ enteral syringes deliver enteral fluids to the gastrointestinal system of a patient who is physically unable to eat and swallow. The 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 to administer enteral fluids. ENFit Nutrifit™ enteral syringes are single use devices. ENFit Nutrifit™ enteral syringes are intended for pediatric and adult use.

An enteral syringe consists of a syringe barrel with integral tip (ENFit), plunger, gasket, barrel lubricant and can be supplied with or without a syringe tip cap. Only the 5mL single use syringe can be connected with compatible enteral syringe-driver pumps; the other syringes are for manual use.

The provided document is a 510(k) Premarket Notification for ENFit enteral syringes, which are medical devices used for delivering enteral fluids. It outlines the regulatory process for clearance, not a study proving the device meets acceptance criteria for an AI/ML powered medical device. The document primarily focuses on establishing substantial equivalence to a predicate device through bench testing and conformance to established standards, rather than clinical studies with human participants.

Therefore, I cannot provide the information requested in the prompt's structured format (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, ground truth types, training set details) because this document does not describe such a study for an AI/ML powered device.

The document details the following about the device's testing and intended performance:

• Device Type: ENFit enteral syringes (NUTRIFIT™)
• Intended Use: Delivering enteral fluids to the gastrointestinal system of patients unable to eat and swallow. Intended for use in clinical or home care settings by laypersons (under supervision) and clinicians, for pediatric and adult use.
• Regulatory Class: Class II (Product Code: PNR, Regulation Number: 21 CFR 876.5980 - Gastrointestinal tube and accessories).
• Predicate Device: ENFit enteral pump syringes PENTA™/ENFit enteral pump syringes NUTRIFIT™ (K161141).
• Testing and Evaluation:
  • Performance test: According to ISO 7886-1/-2 & ISO 80369-3/-20, including testing after simulated clinical use and cleaning.
  • Biocompatibility tests: According to ISO 10993 series requirements.
  • Sterility validation and tests: According to ISO 11135.
  • Packaging validation and tests: According to ISO 11607-1/-2.
  • Labeling requirements: According to ISO 15223-1 and FDA Guidance "Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications."
• Conclusion: The tests demonstrated that the ENFit enteral syringes NUTRIFIT™ are safe and effective, meet their intended use, and are similar to the predicate device in terms of intended use, indications for use, and medical technique.

The document emphasizes compliance with international standards (ISO) and FDA guidance for medical devices, specifically for physical characteristics, sterility, biocompatibility, and packaging, rather than performance metrics related to diagnostic accuracy, image interpretation, or other tasks that would involve AI/ML algorithms and require the types of studies outlined in your request.

Ask a specific question about this device