(81 days)
Medline Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets may include a bag to contain the feeding solution and/or spike to connect to a pre-filled container.
Medline Enteral Feeding Sets consist of the following three configurations:
- 1.) Medline Enteral Feeding Pump Bag Set (1000ml)
- 2.) Medline Enteral Feeding Pump Spike Set
- 3.) Medline Enteral Feeding Gravity Bag Set (1000ml)
The Medline Enteral Feeding Pump Bag Set (1000ml) is designed for use with Alcor Sentinel® and Nestle Compat® enteral feeding pump systems and features a 1000ml formula bag with 100ml graduations and a protective closure cap.
The Medline Enteral Feeding Gravity Bag Set (1000ml) uses the free flow of gravity to dispense enteral feeding solutions and features a 1000ml formula bag with 100ml graduations and a protective closure cap.
The Medline Enteral Feeding Pump Spike Set features a piercing spike used to connect the set to a prefilled container of enteral feeding solution. It is designed for use with Alcor Sentinel® and Nestle Compat® enteral feeding pump systems.
Medline Enteral Feeding Sets are single-use, non-sterile and disposable enteral feeding sets consiting of an enteral feeding bag, tubing, drip chamber, piercing spike, roller clamp and Distal Tip ENFit connectors.
The provided text describes a 510(k) premarket notification for Medline Enteral Feeding Sets, comparing them to a predicate device. The core of the submission is the replacement of a 4-step Distal Tip Connector with an ENFit connector, aiming to improve safety by mitigating misconnections.
Here's an analysis of the acceptance criteria and the study information, focusing on what is explicitly stated and what cannot be determined from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific quantitative thresholds. Instead, it lists various performance tests conducted and generally states that the results demonstrated the device's function and performance were not altered, and that it met requirements.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| Mitigate risks of misconnections (with ENFit connector) | "replacement... does not alter the function or performance of the devices and does not raise additional questions or compromise the safety and/or effectiveness of the device." |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization) | Passed ISO 10993 standards. |
| Absence of toxicological health risks (Leachable and Extractable) | Completed analysis with comprehensive Toxicological Health Risk Assessment. |
| Performance: | |
| Resistance to misconnection (Enteral Connector Misconnection Assessment Study, PG-Lock Misconnection Data, Human Factors Validation) | Tested and evaluated to show resistance to misconnection. (Specific quantitative results not given). |
| Functional performance (Falling Drop Positive Pressure Liquid Leakage, Stress Cracking, Resistance to Separation from Axial Load/Unscrewing/Overriding, Disconnection by unscrewing, ENFit Component Verification, Bond Strength, Connection Strength) | Tested and evaluated. "does not alter the function or performance..." (Specific quantitative results not given). |
| Compatibility with pumps (Pump Compatibility Testing) | Tested against predicate. (Specific results not given). |
| Flow rate similar to predicate (Flow Rate Testing) | Tested against predicate. (Specific results not given). |
| Bioburden control (Bioburden Testing) | Tested against predicate. (Specific results not given). |
| Manufacturing quality (Cross Cavity Metrology Testing) | Tested. (Specific results not given). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the performance tests. The document only lists the types of tests performed (e.g., "Enteral Connector Misconnection Assessment Study," "Human Factors Validation Study").
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be conducted by Medline Industries, Inc. or their contracted labs.
- Retrospective or Prospective: Not specified. Performance testing is typically prospective, but the document does not confirm this.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The document details engineering and performance testing, not a study requiring expert clinical assessment for ground truth. The "Human Factors Validation Study" might involve user evaluation, but the number or qualifications of "experts" are not mentioned.
4. Adjudication Method for the Test Set
This is not applicable as the studies described are performance and engineering tests, not clinical evaluations requiring adjudication of subjective assessments.
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
This is not applicable. This document describes a medical device (enteral feeding sets), not an AI/imaging diagnostic device that would typically undergo an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests would be established by the physical and chemical properties of the materials and component designs, and their adherence to engineering standards (e.g., ISO 80369-1 for ENFit connectors) and device specifications. For biocompatibility, it's defined by the pass/fail criteria of ISO 10993 standards.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device. There is no "training set" in the context of an algorithm or AI model development described here.
9. How the Ground Truth for the Training Set Was Established
This is not applicable (see point 8).
In summary, the provided text is a 510(k) summary for a physical medical device. It focuses on engineering performance, biocompatibility, and functional compatibility testing to demonstrate substantial equivalence to a predicate device, particularly concerning a design change to incorporate an ENFit connector. It does not contain information typically found in studies for AI/software as a medical device (SaMD) or clinical diagnostic studies that would involve "test sets," "training sets," "experts," or "adjudication."
§ 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.