(206 days)
FUID LAVAGE DEVICE THE COMBIPORT TO FLUSH FLUID INTO IS INTENDED DURING GASTRIC LAVAGE THE STOMACH PROCEDURES.
The CombiPort is a device intended to fluid into the stomach during gastric lavage procedure.
This document describes a 510(k) submission for the CombiPort Fluid Lavage Device. This is a medical device and not an AI/ML powered device. As such, the typical acceptance criteria and study data points requested (e.g., sample size for test set/training set, ground truth, MRMC studies, standalone performance) are not applicable in the usual sense for software or AI/ML.
The provided text focuses on demonstrating substantial equivalence to a predicate device and ensuring the device's safety and effectiveness through material testing and manufacturing quality control.
Here's an attempt to answer the questions based on the available information, noting where the requested information is not relevant or directly provided for a traditional AI/ML study:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (fluid lavage device), acceptance criteria are primarily related to material biocompatibility, functional performance (e.g., ability to flush fluid, connection integrity), and manufacturing quality. The document does not provide a quantitative table of specific performance metrics with target values.
| Acceptance Criteria Category | Reported Device Performance (Summary from Text) |
|---|---|
| Material Biocompatibility | "...materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product." |
| Functional Performance | Implied: The device is "intended to fluid into the stomach during gastric lavage procedure." The testing described below would confirm this. |
| Manufacturing Quality & Reliability | "All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product). The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications." |
| Substantial Equivalence | "The CombiPort Fluid Lavage Device is similar in intended use to the Easi-Lav cleared by Ballard Medical Products. There are no new issues of safety or effectiveness raised by The CombiPort Fluid Lavage Device." |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a physical medical device, not a software or AI/ML product evaluated on a "test set" of data. The "testing" refers to manufacturing quality control and material biocompatibility, which would involve samples of the device and its materials. The document does not specify general sample sizes for these tests, as these are typically defined by internal quality procedures.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the context of expert consensus is relevant for AI/ML diagnostic or predictive tools. For a fluid lavage device, the "ground truth" for its functional performance is based on engineering specifications and physical testing, not expert interpretation of outputs.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human readers or experts when establishing ground truth for AI/ML validation. This device undergoes physical and material testing, not human-read evaluation in this manner.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. MRMC studies are specific to evaluating the clinical impact of AI/ML systems on human reader performance, particularly in diagnostic imaging. This device does not involve AI assistance for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Engineering Specifications: The design parameters and functional requirements for the device (e.g., flow rate, material strength, connection integrity).
- Material Standards: Biocompatibility standards like ISO 10993.
- Quality Control Test Procedures: Established methods to verify that each manufactured unit meets specifications.
8. The Sample Size for the Training Set
Not applicable. There is no training set for a traditional medical device like this, as it's not an AI/ML model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set for an AI/ML model.
§ 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.