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The BaroSense Endogastric Tube (EGT) is indicated for use with an endoscope where multiple endoscopic intubations are anticipated.

The EGT is a reusable overtube used in hospitals or surgery centers to provide a channel for the delivery and removal of endoscopic devices from the mouth to the stomach. It is intended for use when multiple endoscopic intubations, or endoscopic instrument/tool exchanges, are anticipated. A flexible Introducer Bougie has a tapered tip to assist in introduction of the EGT through the mouth and esophagus. The bougie has an internal lumen to accommodate a 5 mm endoscope. The EGT and Introducer Bougie are supplied non-sterile. The predicate device has identical technological characteristics. However, the predicate EGT is provided as a single-patient-use, disposable unit, with an internal bougie introducer included in the package. The modified device is provided as a reusable overtube and single-use bougie. The predicate device working tube is a PVC tube with an embedded stainless steel reinforcement coil, whereas the modified device is a Tecoflex tube with an embedded stainless steel reinforcement coil. The proximal handle of the modified device has an added feature to allow the endogastric tube to grip and seal to Introducer Bougie or other endoscopic devices. This gripping action prevents relative motion between the overtube and the other devices, e.g., the Introducer Bougie.

The BaroSense Endogastric Tube (EGT) is a reusable overtube used with an endoscope where multiple endoscopic intubations are anticipated. The 510(k) summary indicates that the device's safety and effectiveness were established through a series of bench and animal tests. However, it does not provide acceptance criteria, reported performance values, or specific details for these studies.

Here's a breakdown of the requested information based on the provided text, and where information is not available, it is noted:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text only mentions "bench and animal tests" but does not specify sample sizes for any test sets or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence to a predicate device through bench and animal testing.

6. Standalone (Algorithm Only) Performance Study

This device is a medical instrument (Endogastric Tube), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

7. Type of Ground Truth Used

The ground truth for the "safety and effectiveness" appears to be based on the results of "bench and animal tests" and comparison to known biocompatibility standards (ISO 10993). However, the specific metrics for ground truth are not detailed.

8. Sample Size for the Training Set

As this is a physical medical device and not an AI or algorithm, there is no concept of a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/algorithm-based device.

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