Search Results

The 2-Port TTP Jejunostomy Tube Kit is intended to provide enteral access for decompression and delivery of nutrition and/or medication.

The 2-Port TTP Jejunostomy Tube consists of a two-port device designed to be placed through a Boston Scientific gastrostomy tube to provide enteral access for decompression and delivery of nutrition and/or medication. The 2-Port TTP Jejunostomy Tube is available with a pigtail tip and in two lengths, 80cm and 105cm. It may be placed by either a pullwire (pull) or guidewire (push) The proposed device is available within a kit which contains the following: a technique. stiffening cannula with female luer fitting, a guidewire, lubricating jelly, gauze, a female-to-female luer adapter, port caps, and a retention ring.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Summary of Device Performance Study

The provided text details a 510(k) submission for the 2-Port Through-The-PEG (TTP) Jejunostomy Tube Kit (referred to as EndoVive Two-Port Through The PEG (TTP) Jejunal Feeding Tube (J-Tube) Kit in the FDA letter). The submission aims to demonstrate substantial equivalence to a predicate device, the 3-Port Through-The-PEG (TTP) Jejunostomy Tube Kit (K072476).

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not specified in the provided text. The text only mentions "in-vitro testing."
• Data Provenance: Not specified. It's likely the in-vitro testing was conducted internally by Boston Scientific Corporation, but no country of origin or whether it was retrospective/prospective is mentioned.

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

• Not applicable. The study involved in-vitro testing against required specifications, not human expert evaluations of a test set with ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. As this was in-vitro testing, there was no adjudication method involving human experts.

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

• No, a MRMC comparative effectiveness study was not done. The study focused on in-vitro performance and substantial equivalence to a predicate device, not on comparing human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):

• This is not applicable as the device is a medical tube kit, not an algorithm or AI system. The "performance" refers to the physical and functional attributes of the device.

7. Type of Ground Truth Used:

• The "ground truth" for this device's performance was the "required specifications" for its components, subassemblies, and full devices established through in-vitro testing. It's based on engineering and design specifications rather than expert consensus, pathology, or outcomes data in a clinical setting.

8. Sample Size for the Training Set:

• Not applicable. As this is not an AI/ML device, there is no "training set."

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

• Not applicable. There is no training set for this type of medical device.

Ask a specific question about this device