(167 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specifications for all components, subassemblies, and/or full devices met. | "In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." |
| Device is substantially equivalent to the predicate device (K072476). | "Boston Scientific Corporation has demonstrated that the proposed 2-Port Through-The-PFG (TTP) Jejunostomy Tube Kit is substantially equivalent to Boston Scientific Corporation's currently marketed 3-Port Through-The-PEG (TTP) Jejunostomy Tube Kit (K072476)." |
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.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.