(212 days)
The use of this device is to gain additional access to an Enteral Gastrostomy Tube or Nasogastric Tube for the purpose of irrigation or the administration of medications without having to disconnect the Enteral Feeding Administration Set from the patients feeding tube.
The consistent connection or reconnection to a feeding tube each time a patient must be medicated or irrigated can not only cause patient discomfort, but also can cause the feeding tube to leak at the connection due to wear.
RPI DUAL PORT IRRIGATION ADAPTER
The provided text is a 510(k) clearance letter from the FDA for the "PiPI Dual Port Enteral Irrigation Adapter" (K964920). This document grants market clearance based on substantial equivalence to a predicate device, which is a regulatory pathway for low-to-moderate risk medical devices.
Crucially, a 510(k) clearance does not typically require the comprehensive clinical studies with detailed acceptance criteria, ground truth establishment, sample sizes, and expert reviews that are characteristic of premarket approval (PMA) applications or more complex AI/CAD device submissions. The information requested in your prompt (especially regarding acceptance criteria tables, sample sizes for test sets, expert consensus, MRMC studies, standalone performance, and training set details) is largely irrelevant to a 510(k) clearance of this type of device.
Therefore, based on the provided document, I cannot fulfill your request for the following reasons:
- No Acceptance Criteria or Performance Data: The document does not contain acceptance criteria for device performance or any reported performance data. The device is a "Dual Port Enteral Irrigation Adapter," a mechanical device for medical tubing. Its "performance" would likely be assessed through bench testing for leak resistance, material compatibility, and proper connection, rather than diagnostic accuracy metrics.
- No "Study" in the requested sense: A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, energy used, and performance characteristics (often through bench testing or minor animal/clinical studies if needed to support equivalence, but not a full-scale clinical trial as implied by your questions).
- No AI/CAD Component: The device is a simple mechanical adapter. It does not involve any artificial intelligence, machine learning, or computer-aided detection (CAD) algorithms. Therefore, questions about training sets, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable.
- No Ground Truth Establishment: For a mechanical adapter, "ground truth" as it pertains to diagnostic accuracy (e.g., presence or absence of a disease) is not relevant.
However, I can extract the following relevant information from the document:
1. Device Name and Purpose:
- Device Name: PiPI Dual Port Enteral Irrigation Adapter (also referred to as "RPI DUAL PORT IRRIGATION ADAPTER" in the Indications for Use page).
- Indications For Use: "The use of this device is to gain additional access to an Enteral Gastrostomy Tube or Nasogastric Tube for the purpose of irrigation or the administration of medications without having to disconnect the Enteral Feeding Administration Set from the patients feeding tube."
- Problem Addressed: "The consistent connection or reconnection to a feeding tube each time a patient must be medicated or irrigated can not only cause patient discomfort, but also can cause the feeding tube to leak at the connection due to wear."
2. Regulatory Information:
- 510(k) Number: K964920
- Regulatory Class: II
- Procode: 78 KNT
- CFR: 21 CFR 876.5980 (Gastroenterology-Urology Endoscopes and Accessories)
- Date Cleared: July 9, 1997
- Regulatory Pathway: Substantial Equivalence (510(k))
In summary, the provided document is a notification of substantial equivalence for a non-diagnostic, non-AI medical device. The detailed questions about acceptance criteria, study design, expert review, and AI performance are not applicable to this type of regulatory submission.
§ 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.