(67 days)
The One Step Button device is intended to provide nutrition to a patient directly into the stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The EndoVive Low Profile Replacement Button Gastrostomy device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The Right Angle Feeding Set is intended to provide nutrition to a patient directly into the stomach through a gastrostomy tube. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The Bolus Feeding Set is intended to provide nutrition to a patient directly into the stomach through a gastrostomy tube. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The Right Angle Decompression Tube is intended to provide stomach decompression through a gastrostomy tube. It is indicated for use on patients who require enteral feeding as a means of nutritional support
The purpose of this Traditional 510(k) is to demonstrate that the proposed changes to the Y-Port and Bolus/Decompression accessories that are included in the devices identified above do not raise new questions of safety or effectiveness and that the devices are substantially equivalent to the currently marketed EndoVive™ Button kit and Accessory products.
The Y-Port and Bolus/Decompression accessories that are included in the devices identified above have two connections. One is located the distal end and the other is at the proximal end. The connector on the proximal end is identical in design to the ENFit threaded connector of the Y-Port accessory which was cleared via K150679. The Y-Port and Bolus/Decompression accessories are also identical in materials to the Y-Port device which was cleared via K150679. All of the performance and biocompatibility testing that was presented in K150679 to support the ENFit threaded connector is applicable to the Y-Port and Bolus/Decompression accessories of the proposed device. The scope of this submission is to demonstrate that the changes to the distal end of the Y-Port and Bolus/Decompression accessories are substantially equivalent to the predicate device. Neither the Button feeding tube nor the accessories used for tube placement within these kits is changing. The Button feeding tube and placement accessories in the kits are identical to the predicates.
The provided text describes a 510(k) premarket notification for gastrointestinal tubes and accessories, focusing on changes made to comply with new connector standards. This document is a regulatory submission demonstrating substantial equivalence between a new device and a legally marketed predicate device, rather than a study proving the device meets specific performance acceptance criteria in a clinical or analytical setting.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or explicitly stated in this type of regulatory document. I will extract the information that is present and indicate where information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present acceptance criteria in a quantitative table format with corresponding device performance results for clinical or analytical endpoints. Instead, it describes compliance with regulatory standards and bench testing for the connectors.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Standards Compliance | - AAMI CN3:2014 (PS)/ ISO/DIS 80369-3.2 Small bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications | Complies with AAMI CN3:2014 (PS)/ ISO/DIS 80369-3.2 |
| - AAMI CN20:2014 (PS)/ ISO 80369-20 gases in healthcare applications - Part 20: Common test methods | Complies with AAMI CN20:2014 (PS)/ ISO 80369-20 | |
| Material | ENFit threaded connector made of "more rigid material" (compared to predicate) | Bench testing supports compliance to material principles of ISO 80369-1:2010. |
| Non-interconnectability | Reduce the risk of misconnection with non-enteral feeding devices. | Bench testing supports compliance to non-interconnectability principles of ISO 80369-1:2010. ENFit Misconnection data with FMEA presented. |
| Tensile Strength | (No specific quantitative criteria stated) | Bench testing including tensile strength performed. |
| Flow Rate | (No specific quantitative criteria stated) | Bench testing including flow rate performed. |
| Liquid Leakage | (No specific quantitative criteria stated) | Bench testing including liquid leakage performed. |
| Safety and Effectiveness | "Do not raise new questions of safety or effectiveness" and "The differences in the technological characteristics are minor and do not present any new issues of safety or effectiveness." | Substantially equivalent to predicate, implying equivalent safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "bench testing" and "performance assessment" but does not provide details on the number of samples or units tested for each specific test (e.g., tensile strength, flow rate).
- Data Provenance: The bench testing and performance assessment appear to be internal to Boston Scientific Corporation and conducted for regulatory submission purposes. No specific country of origin for the data is mentioned, but typically such testing would be done in-house or by contracted labs. The data is retrospective in the sense that it supports the premarket notification based on completed tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This document describes engineering bench testing and regulatory compliance, not studies requiring expert review or ground truth establishment in a clinical context. The "Human Factors Validation Study" mentioned might involve interaction with users, but the details are not provided.
4. Adjudication Method for the Test Set
- Not Applicable. As above, this is an engineering and regulatory compliance document for a medical device connector, not a study involving human interpretation or adjudication.
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. This device is a gastrointestinal tube and accessories; it is not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This document describes a physical medical device.
7. The Type of Ground Truth Used
- For the bench testing, the "ground truth" would be the specifications and requirements outlined in the AAMI/ISO standards (e.g., a connector either meets the tensile strength requirement or it doesn't; it either misconnects or it doesn't). It's based on engineering measurements against defined performance thresholds, rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Not Applicable. This is not a machine learning or AI-driven device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (See above)
§ 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.