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

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

The proposed TTP Jejunostomy Tube consists of a three-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 TTP Jejunostomy Tube is available in two tip configurations (pigtail and bent tip) and may be placed by either a pullwire (pull) or guidewire (push) technique. The proposed device is available within a kit which contains the following: a stiffening cannula, a guidewire, lubricating jelly, gauze, a double barbed fitting (attached to stiffening cannula), and a cable tie.

The provided document is a 510(k) summary for a medical device called the "TTP Jejunostomy Tube Kit." This type of submission is for demonstrating substantial equivalence to a predicate device, not for a novel device requiring extensive performance studies with acceptance criteria and ground truth validation in the way that an AI/ML medical device would.

Therefore, the information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth for training/testing sets is not applicable to this document.

Here's why and what the document does state:

• Type of Device: The TTP Jejunostomy Tube Kit is a physical medical device (like a tube and associated accessories) for enteral access. It is not an AI/ML-driven diagnostic or prognostic tool.
• Purpose of Submission (510(k)): The 510(k) submission seeks to demonstrate that the new device is "substantially equivalent" to predicate devices already on the market. This means it has the same intended use, technological characteristics, and safety/effectiveness profiles as devices already cleared by the FDA.
• Performance Data (Section 7): The document explicitly states: "As this is a request to clarify the indication the performance testing presented in K971906 was not repeated." This means that the current submission relied on the performance data of a previous version of the device (K971906) and other predicate devices, rather than conducting new performance studies for this specific submission. The clarification of indication itself did not necessitate new performance testing.
• Conclusion (Section 8): The conclusion reinforces that the device is substantially equivalent based on its identical technological characteristics to K971906 and its indication to K971906 and K042303.

In summary, there are no acceptance criteria, device performance tables, sample sizes for test/training sets, or details about expert consensus/ground truth determination as would be found for an AI/ML device study, because this submission pertains to a physical medical device seeking substantial equivalence based on prior device data.

Ask a specific question about this device