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The DASH 3TM ENFit Syringe is a sugle use syninge indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nututional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral synnges 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.

The DASH 3TM Eccentric ENFit Syringe is a single use syringe indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syninges 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.

The DASH 3TM Low Volume Tip ENFit Syringe is a sungle use syringe indicated for use as a dispenser, a measuning device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syninges are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinicians, in all age groups.

The DASH 3M ENFit Syringe Cap allows the advance preparation and secure storage and transport of medication fluids or mutritional formula. The synnge cap will fit any size of the Single Use Synnges (DASH 3TM)

The DASH 3™ ENFit Syringe device family is a Single Use, in-hospital and home care (DASH 3TM ENFit Syringe, DASH 3TM Eccentric ENFit Syringe, DASH 3TM ENFit Low Dose Tip Syringe) device.

It is provided in sizes from 1 mL to 100 mL. The device incorporates a female ENFit connector for connection to an enteral access device with a male ENFit port specified in ISO 80369-3. The Low Dose Tip contains the low dose design feature specified in (Draft) ISO 20695.

The DASH 3TM ENFit accessories are designed to be compatible with ENFit connector devices. The DASH 3TM ENFit Syringe Caps fit any size of the Single Use ENFit Syringes (DASH 3™), which allows the advance preparation and secure storage and transport of medication/fluids or nutritional formula.

The provided text describes a medical device, the DASH 3™ ENFit Syringe family and its accessories, and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of diagnostic performance. Therefore, I cannot extract information related to sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to this type of device submission.

However, I can provide the acceptance criteria and confirmed performance based on the engineering and functional testing described in the document.

Acceptance Criteria and Reported Device Performance

The device performance is demonstrated through various tests designed to confirm compliance with ISO standards and other design specifications. The document states that the DASH 3™ Syringe device family and its accessories "met all acceptance criteria, as described in Section 17." The table below summarizes the listed tests, which serve as the acceptance criteria, and the reported outcome.

Details of the Study:

The studies conducted are primarily engineering and functional bench tests, and risk assessments.

• Sample sized used for the test set and the data provenance: The document does not specify exact sample sizes for each test. The data provenance is implied to be from internal testing conducted by the manufacturer, Intervene Group Limited, likely in the UK, given the address. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of engineering tests is typically defined by adherence to published international standards (e.g., ISO) and the device's design specifications, not by expert consensus on observational data.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Performance is measured against predefined objective standards and specifications.
• 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 not an AI/diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/diagnostic device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for these tests is the adherence to the requirements outlined in the cited ISO standards (ISO 80369-3, ISO 80369-20, ISO 7886-1, Draft ISO 20695) and the internal design specifications of the device.
• The sample size for the training set: Not applicable. This is not a machine learning device; therefore, there is no "training set."
• How the ground truth for the training set was established: Not applicable.

In conclusion, the study supporting the device's substantial equivalence consists of a series of bench tests and assessments confirming that the DASH 3™ ENFit Syringe family and its accessories meet established engineering and performance standards, thereby demonstrating that they perform as intended and do not raise new questions of safety or effectiveness compared to predicate devices.

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