(37 days)
The Medline ENFit Transition Connecting an enteral feeding set with an ENFit connector to a gastronomy tube with funnel.
The Medline ENFit G-Tube Connector is intended for connecting an enteral feeding set equipped with a stepped enteral distal end to a gastronomy tube equipped with an ENFit connector.
In an effort to mitigate the risk of misconnections associated with enteral feeding devices, manufacturers have recently began to adopt a uniform connector for enteral devices, called an ENFit connector, which is based upon the ISO 80369 series of standards and is in accordance with FDA Final Guidance for Industry: Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications (February 11, 2015). This uniform ENFit connector provides a locking feature that signals the appropriate connection to stay in place. In addition, the ENFit connector features a female mating component end for enteral feeding sets and a male mating component end for gastronomy feeding tubes, which allows for the interconnection of these devices.
However, it will take time for enteral devices with this uniform ENFit connector to become widely available and fully adopted across healthcare settings, as existing enteral devices with previouslydesigned "legacy" connectors, which are not compliant with ISO 80369-1, still remain in inventory. Therefore, to prevent an interruption or delay in patient care when an enteral device with an AAMI/CN3:2014 (PS) compliant ENFit connector must be connected to an existing enteral device with a non-AAMI/ANSI/ISO 80369-1 compliant connector, a temporary need has emerged for an adapter that can facilitate connection between enteral devices with these incompatible end connectors.
The Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector address this temporary need and facilitate enteral-specific connections between AAMI/CN3:2014 (PS) compliant enteral connectors and non-AAMI/ANSI/ISO 80369-1 compliant connectors to ensure that patient enteral feeding is not impeded when an enteral feeding device with an AAMI/CN3:2014 (PS) compliant ENFit connector must be connected to a previously-designed, existing enteral feeding device with a non-AAMI/ANSI/ISO 80369-1 compliant end connector.
The Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector, which are described in further detail below, allow specific connections between enteral feeding devices with AAMI/CN3:2014 (PS) compliant ENFit connectors (also known as "PGLock" connectors) and enteral feeding devices with non-AAMI/ANSI/ISO 80369-1 compliant, legacy connectors that are still available for use in healthcare settings. To facilitate this connection, the Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector are both designed with the mating component of an AAMI/CN3:2014 (PS)-compliant ENFit connector at one end and the mating component of a previously-used, legacy connector at its other end.
Specifically, the two designs of ENFit transition adapters that are within the scope of this 510(k) Premarket Notification submission are:
1.) The Medline ENFit Transition Connector
The Medline ENFit Transition Connector allows fitment of newly-released enteral feeding sets with AAMI/ CN3:2014 (PS) compliant ENFit connectors to existing gastronomy tubes with non-AAMI/ ANSI/ISO 80369-1 compliant end connectors, referred to as "funnel feeding ports," which are still available for use in healthcare settings. Specifically, to facilitate the interconnection between newlyreleased feeding sets, which are equipped with female ENFit connectors, and the funnel feeding ports of previously-designed gastronomy tubes, this adapter provides the mating component of an ENFit female connector, designed and tested in accordance with AAMI/ CN3:2014 (PS) and AAMI/CN20:2014 (PS), at one of its ends, and the mating component of a non-AAMI/ANSV/ISO 80369-1 compliant funnel feeding port, a stepped Distal Tip connector, at its other end.
2.) The Medline ENFit G-Tube Connector
The Medline ENFit G-Tube Connector allows fitment of newly-released gastronomy tubes (or "Gtubes") with AAMI/CN3:2014 (PS) compliant ENFit connectors to previously-designed enteral feeding sets with non-AAMI/ANSI/ISO 80369-1 compliant connectors, which still may be available for use in healthcare settings. To facilitate the compatibility between gastronomy tubes with ENFit male connectors and the stepped Distal Tip connector of existing enteral feeding sets, the Medline ENFit G-Tube Connector provides the mating component of an ENFit male connector, designed and tested based upon AAMI/ CN3:2014 (PS) and AAMI/CN20:2014 (PS), at one of its ends, and the mating component of a stepped Distal Tip connector, a funnel feeding port, at its other end.
Here's a breakdown of the acceptance criteria and study information for the Medline ENFit G-Tube Connector and Medline ENFit Transition Connector, based on the provided FDA 510(k) summary:
This device is not an AI/ML powered device, so many of the requested fields are not applicable. The device is a physical medical connector.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details the testing performed to demonstrate substantial equivalence, focusing on the physical and functional properties of the connectors. The acceptance criteria are implicitly met by successful completion of these tests in accordance with relevant standards.
| Acceptance Criterion (Implicitly derived from tests) | Reported Device Performance (Successful completion of tests) |
|---|---|
| No misconnections with other connector types | Enteral Connector Misconnection Assessment Study (Successful) |
| User safety and ease of use | Human Factors Validation Study: Enteral Connectors Final Report (Successful) |
| Prevention of misconnections identified in FMEA | PG-Lock Misconnection Data with Failure Modes and Effects Analysis (FMEA) (Addressed) |
| Acceptable risk profile | Internal Risk Analysis (Acceptable) |
| Low microbial load | Bioburden Testing (Successful) |
| Conforms to dimensional specifications | Metrology Testing (Successful) |
| Maintains integrity over time | Stability (Shelf-Life) Testing (Successful) |
| Acceptable chemical leachates/extractables | Leachables and Extractables (L&E) Analysis with Toxicological Health Risk Assessment (Successful) |
| Biocompatible (non-toxic, non-irritating, non-sensitizing) | Biocompatibility Testing: Cytotoxicity, Irritation, Delayed-Type Hypersensitivity (Successful) |
| Resistance to positive pressure liquid leakage | ISO 80369-20 Testing: Positive Pressure Liquid Leakage (Successful) |
| Resistance to stress cracking | ISO 80369-20 Testing: Stress Cracking (Successful) |
| Resistance to separation from axial load | ISO 80369-20 Testing: Resistance to Separation from Axial Load (Successful) |
| Resistance to separation from unscrewing | ISO 80369-20 Testing: Resistance to Separation from Unscrewing (Successful) |
| Resistance to overriding | ISO 80369-20 Testing: Resistance to Overriding (Successful) |
| Prevention of inadvertent disconnection by unscrewing | ISO 80369-20 Testing: Disconnection by Unscrewing (Successful) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test. It refers to "non-clinical verification" and successful completion of various studies and tests.
- Sample Size for Test Set: Not explicitly stated for individual tests.
- Data Provenance: The studies were conducted by Medline Industries, Inc. (the manufacturer). The data comes from non-clinical (laboratory/bench) testing of the devices themselves, rather than human or animal data. The country of origin of testing facilities is not specified, but the manufacturer is based in the USA. The data is prospective in the sense that the tests were conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is Not Applicable (N/A) because the device is a physical connector, not an AI/ML algorithm that requires expert ground truth labeling of medical images or data. The "ground truth" for these tests refers to established engineering standards and safety requirements (e.g., ISO 80369-20, FDA guidance on misconnections). The tests themselves evaluate the device's adherence to these objective, measurable standards.
4. Adjudication Method for the Test Set
N/A. As the "truth" is based on objective engineering standards and observed performance in non-clinical tests, there's no need for expert adjudication in the context of this type of device submission. Test results are typically evaluated against predefined pass/fail criteria from the standards.
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
N/A. This device is a physical medical connector, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This is not an algorithm or AI system. The tests performed are standalone in the sense that they evaluate the device itself (its physical properties and function) without human interaction being a variable in determining "performance" in the way an AI algorithm's standalone performance might be measured.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of these connectors is based on:
- Established engineering standards: Primarily ISO 80369-20, and AAMI/CN3:2014 (PS), AAMI/CN20:2014 (PS).
- FDA guidance documents: Specifically, "Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications (February 11, 2015)."
- Objective physical and chemical test results: Measurements of leakage, strength, biocompatibility, dimensions, etc.
8. The Sample Size for the Training Set
N/A. This device is a physical connector, not an AI/ML algorithm that requires a training set. The "training" for the device's design is implicitly the engineering design process guided by the standards and predicate device.
9. How the Ground Truth for the Training Set was Established
N/A. As there is no AI/ML training set, this question is not applicable. The design "ground truth" would be established by the engineering and regulatory requirements for safe and effective medical device connectors. The predicate device (Cedic ENFit Transition Connectors for Enteral Applications, K140581) also serves as a benchmark for established safety and effectiveness.
§ 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.