Search Results

The Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube is intended for direct placement into the small bowel. The tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with a functioning gut who require short- to moderate-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom mainutrition exists, or may result, secondary to an underlying disease or condition.

The Gabriel Blue Tube serves as a conduit through which enteral feeding solutions are directly infused into the patient's small bowel. The device will be marketed in one length (50" [127cm]) and one French size (11 Fr). The feeding tube contains a stylet which has magnets attached to its tip. An external magnet is used to capture the tip and guide the device to the duodenum. A reed switch and light indicate when the magnet has been captured and can be guided to its final location.

Here's a breakdown of the acceptance criteria and study information for the Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube based on the provided document:

This 510(k) submission is a "Special 510(k)", which is used for modifications to a legally marketed device where the modifications do not affect the intended use or fundamental scientific technology of the device. Consequently, the provided information focuses on performance tests confirming the substantial equivalence of the modified device to its predicate, rather than a de novo clinical study with extensive details about ground truth establishment, reader studies, or training sets typical of entirely new AI/ML devices.

Acceptance Criteria and Reported Device Performance

Conclusion: The results of the laboratory tests demonstrated that the device is as safe and effective as the legally marketed predicate devices. This implies the new device met performance benchmarks inherent to the predicate device's established safety and effectiveness.

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The document does not explicitly state the sample sizes for each performance test (Tensile, Flow, Flexibility, Biocompatibility). It refers to "Tests were performed," indicating internal laboratory testing.
   • Data Provenance: The tests were "laboratory tests," implying internal testing conducted by the manufacturer, Syncro Medical Innovations, Inc. No information is provided regarding the country of origin for the data or whether it was retrospective or prospective in terms of patient data, as these tests are primarily materials and functional performance evaluations rather than patient-based clinical trials.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not applicable in the context of this 510(k) submission. "Ground truth" in this scenario would relate to the established engineering specifications and benchmarks for the physical and biological properties of the feeding tube. These are typically defined by industry standards and regulatory requirements, not by expert consensus on clinical images or diagnoses.

3. Adjudication Method for the Test Set:

   • Not applicable. The "adjudication method" is typically relevant for studies involving human interpretation or clinical endpoints, where discrepancies between evaluators need to be resolved. For material and functional performance tests, results are typically quantitative and compared against predefined specifications.

4. 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:

   • No MRMC comparative effectiveness study was done. This type of study is not relevant for a device like a magnetically guided enteral feeding tube, which is a physical medical device and not an AI/ML diagnostic tool or software.

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

   • Not applicable. This device is a physical medical device, not an algorithm or AI system.

6. The type of ground truth used:

   • For this device, the "ground truth" for the performance tests would be established engineering specifications, material standards, and regulatory requirements for tensile strength, flow rate, flexibility, and biocompatibility. These are objective measurements compared against predefined limits or against the performance of the legally marketed predicate device.

7. The sample size for the training set:

   • Not applicable. There is no training set mentioned or implied as this is a physical medical device being evaluated for substantial equivalence based on its physical properties and performance, not an AI/ML model.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set exists for this type of device submission.

Ask a specific question about this device