(123 days)
The sets are intended to deliver liquid nutrition formulas or water to an enteral access device (a feeding tube).
The subject of this 510(k) is a modified proximal connector for Abbott Nutrition enteral feeding sets. The proximal connector connects the tubing of the enteral feeding set to the source of the nutrition (i.e., the container of the enteral nutritional formula). The modified design is the Safety Screw Connector and is compliant with the new AAMI/ISO Standard 80369-1 (Small-bore connectors for liguids and gases in healthcare applications – Part 1: General Requirements). This same design is being used for currently marketed competitive enteral nutrition sets.
The provided text is a 510(k) Premarket Notification for the "Safety Screw Connector," a component of enteral feeding sets. It describes the device, its intended use, and the performance tests conducted to demonstrate substantial equivalence to existing devices.
Here's an analysis of the acceptance criteria and study data based on the provided text, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Non-interconnectable Characteristics | Compliance with ANSI/AAMI/ISO 80369-1:2010 for preventing misconnection with other types of connectors. | "Mechanical test for verifying non-interconnectable characteristics of Safety Screw Connector and other connectors (ANSI/AAMI/ISO 80369-1:2010)" was conducted. The conclusion states, "The new design reduces the risk of unintentional misconnection to another type of tube." This implies the connector met the standard's requirements for non-interconnectability with other types of connectors. |
| Delivery Accuracy & Feeding System Performance | The device should not negatively impact the accurate delivery of liquid nutrition formulas or water. | "Delivery accuracy and feeding system performance assessment testing of Safety Screw Connector" was conducted. The conclusion states, "Performance testing showed that the new designs are equivalent to currently marketed devices." This implies that the device maintained delivery accuracy and overall feeding system performance comparable to existing systems. |
| Biocompatibility | The device materials should be biocompatible and not cause adverse biological reactions when in contact with fluids. | "Biocompatibility testing for the Safety Screw Connector and the RTH Adapter Cap" was conducted. While no specific results are detailed, the general conclusion that "new designs are equivalent to currently marketed devices" and the statement "the new connector does not raise new questions of safety and effectiveness" suggest the biocompatibility criteria were met. |
| Tensile Strength (Bond Junction) | The bond between the Safety Screw Connector and the tubing should be strong enough to withstand expected forces without separation. | "Tensile strength testing for the bond junction between the Safety Screw Connector and tubing" was conducted. Although no specific numerical result is provided, the conclusion "new designs are equivalent to currently marketed devices" indicates that the tensile strength of the bond junction met the required performance standards for safety and effectiveness, similar to predicate devices. |
| Overall Safety and Effectiveness | The device should be as safe and effective as legally marketed predicate devices and introduce no new safety concerns. | The document explicitly states: "The new design reduces the risk of unintentional misconnection to another type of tube. The risk analysis showed that the new connector does not raise new questions of safety and effectiveness. Performance testing showed that the new designs are equivalent to currently marketed devices." This is the overarching acceptance criterion, concluding that the device is substantially equivalent to predicate devices, thus meeting safety and effectiveness expectations. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each test (mechanical, delivery accuracy, biocompatibility, tensile strength). Nor does it specify the data provenance (e.g., country of origin, retrospective or prospective) for these performance tests. It implies these tests were conducted as part of the device development and validation by Abbott Nutrition/Abbott Laboratories.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the given text. The tests described (mechanical, delivery accuracy, biocompatibility, tensile strength) are typically objective engineering and laboratory tests, not requiring expert "ground truth" in the way a diagnostic AI might. The "ground truth" for these tests would be the established specifications and standards (e.g., ANSI/AAMI/ISO 80369-1:2010), and the results are quantitatively measured and compared against these benchmarks.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The performance tests are objective laboratory and engineering tests, not involving subjective interpretation or adjudication by multiple human observers.
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
An MRMC study is not applicable as this device is a physical connector, not an AI-powered diagnostic or assistive tool for human readers. Therefore, no information on human reader improvement with or without AI assistance is provided or relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical connector, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for the performance tests was based on established engineering standards and specifications (e.g., ANSI/AAMI/ISO 80369-1:2010) against which the device's measured performance was compared. For biocompatibility, the ISO 10993 series would typically serve as the ground truth framework. For delivery accuracy and tensile strength, the ground truth would be the performance of legally marketed predicate devices and internal/industry specifications deemed safe and effective.
8. The Sample Size for the Training Set
This question is not applicable. The Safety Screw Connector is a physical medical device, not a machine learning or AI model. Therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this type of 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.