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The EndoVive™ Low Profile Replacement Gastrostomy Tube is indicated in adult and pediatric populations for use in percutaneous placement of an Enteral feeding tube for feeding and/or administration of medication in conjunction with an established GI stoma tract. The replacement tube may also be used for decompression.

The EndoVive™ Low Profile Replacement GastrostomyTube is constructed primarily of silicone. The device consists of a tri-port funnel which is overmolded onto a previously extruded bi-lumen shaft. A retention bolster is molded separately and placed over the shaft. At the proximal end, a silicone balloon is bonded to the shaft using a silicone RTV. The shaft is filled with a radiopague barium RTV. In use, the balloon end of the catheter is inserted into an established stoma, the balloon inflated with 3 mL saline, and the bolster slide down to the skin to secure the device in place. There are two versions of the bolster, a straight version and a right angle

This document describes a 510(k) submission for the EndoVive™ Low Profile Replacement Gastrostomy Tube.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not list explicit numerical acceptance criteria for performance metrics (e.g., tensile strength, leak rate, burst pressure) or report specific quantitative device performance values against such criteria. Instead, the study's primary objective was to demonstrate substantial equivalence to predicate devices.

2. Sample Size and Data Provenance:

The document refers to "bench test results" but does not specify any sample sizes for these tests. There is no information about the country of origin of the data, and the nature of "bench testing" inherently implies a prospective collection of data under controlled laboratory conditions, rather than retrospective data from patients.

3. Number of Experts and Qualifications for Ground Truth:

This submission does not involve human clinical data or expert-established ground truth in the way typically seen for diagnostic AI/ML devices. The "ground truth" here is established through engineering and material science principles, comparing the new device against existing, legally marketed predicate devices through bench testing. Therefore, there are no "experts" in the context of clinical evaluation of patient data, nor their qualifications, mentioned.

4. Adjudication Method for the Test Set:

Not applicable. As described above, there is no test set involving human interpretation or clinical outcomes that would require an adjudication method. Bench testing results are typically evaluated against engineering specifications.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is specifically designed for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not relevant to this medical device (a gastrostomy tube).

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable. This device is a physical medical device (gastrostomy tube), not an algorithm or software. Therefore, the concept of a "standalone algorithm performance" study is not relevant. The "standalone" performance could be interpreted as the device's intrinsic mechanical and material performance, which was assessed via bench testing.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance, in the context of demonstrating substantial equivalence, is based on:

• Engineering specifications and measurements: For properties like material composition, dimensions, and functional performance (e.g., balloon inflation, fluid flow through the tube, mechanical integrity).
• Comparison to predicate device performance: The critical "ground truth" is that the new device performs identically or acceptably similarly to the legally marketed predicate devices, as demonstrated through bench testing.

8. Sample Size for the Training Set:

Not applicable. This device is a physical medical device and does not involve an algorithm that requires a "training set" in the context of machine learning.

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

Not applicable, as there is no training set for an algorithm.

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This urological catheter is intended for the infusion of Sterile solution into the b ladder to irrigate, cleanse, or drain thecontents of the bladder during surgical procedures.

Both the device in this submission and the predicate device are used to irrigate and drain the bladder. Both devices use an inflation balloon to retain the Catheter in the bladder. Both devices are 3-way foley Catheters.

The provided text describes a 510(k) premarket notification for a medical device called "MRI's All Silicone Irrigation 3-Way Foley Catheter." However, it does not contain any information about acceptance criteria, device performance testing, study design, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

The documents are a 510(k) summary and the FDA's clearance letter, which focus on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, rather than a detailed performance study with acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving their fulfillment. The provided information is insufficient to answer your prompt.

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Ask a specific question about this device