Search Results

The Pediation Enteral Feeding tubes are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. They are intended for nasogastric or orogastric placement, limited to

The proposed modification to the Pediatric Enteral Feeding Tubes and accessories is to add additional materials that the feeding tube may be made from, i.e., PVC, silicone, and polyurethane. In addition, we offer accessories: an enteral feeding extension set and syringe with non-IV connector. These may be sold with the Enteral Feeding tubes or separately. There is an option of the connectors to be provided as standard IV luer lock or a non-IV connector. In all cases the feeding tube and accessories are marked "For enteral feeding only".

The enteral feeding tubes are provided in various diameters (4, 5, 6.5, 8, 10 Fr) and various lengths. They have an integral female fitting. There are 2 eyelets near the tip of the tube. They have markings along the shaft of the tubing and an integral radiopaque line. They are provided sterile.

The Enteral extension sets are provided in various lengths and various configurations of components.

The provided text describes a 510(k) premarket notification for a Pediatric Enteral Feeding Tube and Accessories. This document focuses on demonstrating substantial equivalence to predicate devices through design comparisons and performance testing based on industry standards, rather than a clinical study comparing the device's performance against specific acceptance criteria in a user setting.

Therefore, many of the requested details, such as specific acceptance criteria for diagnostic performance, sample sizes for test sets, expert qualifications for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details, are not applicable to this type of submission. The submission is primarily about demonstrating that the device meets safety and basic performance standards through bench testing and material comparisons.

Here's a breakdown of the information that can be extracted or inferred from the provided text, with an explanation for the N/A answers:

1. A table of acceptance criteria and the reported device performance

   This document does not present acceptance criteria in a typical quantitative performance metric format for a diagnostic device. Instead, it lists performance testing performed in accordance with industry standards. The "reported device performance" is the statement that the device "met the requirements of the industry standards."

   Acceptance Criteria (Industry Standard Requirement)	Reported Device Performance
   ISO 594/1 (Gauging of 6% luer conical fittings)	Met the requirements
   BS EN 1615:2000 (Gauging of non-luer conical fittings)	Met the requirements
   BS EN 1615:2000 (Tensile strength and properties of tubing and connectors)	Met the requirements
   BS EN 1615:2000 (Air leakage test of tubing and connectors)	Met the requirements
   BS EN 1615:2000 (Liquid leakage test of tubing and connectors)	Met the requirements
   BS EN 1618:1997 (Separation force)	Met the requirements
   BS EN 1618:1997 (Stress cracking)	Met the requirements
   BS EN 1618:1997 (Unscrewing torque of fitting assembly)	Met the requirements
   BS EN 1618:1997 (Ease of assembly)	Met the requirements
   BS EN 1618:1997 (Resistance to overriding the threads of lugs of the fitting)	Met the requirements

2. Sample size used for the test set and the data provenance

   • Sample Size: Not specified. The testing described is bench testing of physical attributes of the device components, not a clinical test set with patient data.
   • Data Provenance: Not applicable, as it's not clinical data. The tests were performed in accordance with industry standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   • Number of Experts: Not applicable. Ground truth, in the context of device design and materials, is established by adherence to engineering specifications and industry standards for material properties and connector compatibility. It's not a clinical judgment requiring experts to establish diagnostic ground truth.
   • Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Adjudication Method: None. Adjudication is not relevant for bench testing against engineering standards. The compliance with standards is typically verified by qualified engineers or technicians and documented in test reports.

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

   • MRMC Study: No. This device is a medical tube and accessories, not an AI-powered diagnostic tool.
   • Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Standalone Performance: No. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Type of Ground Truth: The "ground truth" for this device's performance is compliance with published industry standards (ISO, BS EN) for physical and functional properties of medical tubing and connectors. This involves objective measurements against predefined limits set by those standards.

8. The sample size for the training set

   • Sample Size for Training Set: Not applicable. This device does not use machine learning or AI, so there is no training set in that context.

9. How the ground truth for the training set was established

   • Ground Truth Establishment for Training Set: Not applicable.

Ask a specific question about this device