(267 days)
The Cedic F 00126 ENFit to Reverse Luer Transition Connector is intended to connect an enteral female ENFit giving set to the "g" port of the AbbVie PEG-J enteral male Luer catheter.
The Cedic F 00128 Luer to ENFit Transition Connector is intended to connect the AbbVie Duopa Medication Cassette Reservoir delivery system to an enteral male ENFit catheter.
The Cedic Enteral ENFit Transition Connectors are designed to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors. This submission describes the Cedic ENFit to Reverse Luer Transition Connector and the Cedic Luer to ENFit Transition Connector. These Cedic ENFit Transition Connectors are intended for prescription use only. The two transition connectors introduced by means of this submission are intended only for use with specific products commercialized in the US by Abbvie Inc., North Chicago, IL 60064-1802, USA, these being the AbbVie PEG-J enteral male Luer catheter (cleared under K142816) and the AbbVie Duopa Medication Cassette Reservoir (details available in DMF 26089) respectively.
The provided document describes Cedic Enteral ENFit Transition Connectors, which are medical devices designed to facilitate connections between new ISO 80369-3 compliant enteral connectors and older, non-compliant legacy enteral connectors. The document primarily focuses on demonstrating the substantial equivalence of these devices to a legally marketed predicate device (AMT Enteral Transition Adapters).
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document refers to FDA-recognized standards for the design and testing of the connectors. The acceptance criteria are implicitly those defined by these standards, and the device performance is stated to be in compliance.
| Acceptance Criteria (from referenced standards) | Reported Device Performance |
|---|---|
| Design in compliance with ISO 80369-3 (ENFit ends) | Complies: "The ENFit (PGLock) ends of the connectors are designed in compliance with FDA-recognized standard ISO 80369-3" |
| Design in compliance with ISO 594-2 (Luer ends) | Complies: "The Luer ends of the connectors are designed in compliance with ISO 594-2." |
| Testing in accordance with ISO 80369-20 (Common test methods) | Complies: "[ENFit ends] tested in accordance with FDA-recognized standard ISO 80369-20" |
| Enteral connector misconnection assessment | Bench tests carried out. (Results not explicitly quantified in tables but implied to be compliant for equivalence.) |
| Human factors | Bench tests carried out. |
| Fluid leakage | Bench tests carried out. |
| Stress cracking | Bench tests carried out. |
| Resistance to separation from axial load | Bench tests carried out. |
| Resistance to separation from unscrewing | Bench tests carried out. |
| Resistance to overriding | Bench tests carried out. |
| Disconnection by unscrewing | Bench tests carried out. |
| Biocompatibility (in accordance with ISO 10993) | Complies: "Established in accordance with ISO 10993" |
| Material properties (e.g., modulus of elasticity in tension meets requirements of relevant FDA-recognized standard) | Complies: "the modulus of elasticity in tension for all materials meets the requirements of the relevant FDA-recognised standard." |
2. Sample size used for the test set and the data provenance
The document states, "Bench tests have been carried out on samples of the Cedic Transition Connectors." However, it does not specify the sample size used for these tests. The data provenance is from Cedic S.r.l. in Italy, and the tests appear to be prospective bench tests performed on the manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" for these types of devices typically relies on adherence to engineering standards and test specifications, rather than expert clinical consensus in the same way an imaging AI algorithm would.
4. Adjudication method for the test set
This information is not provided and is generally not applicable to bench testing against engineering standards. The tests are objective measurements against defined criteria.
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 comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that influence human interpretation. The Cedic device is a physical connector, not an AI algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not done. The device is a physical connector, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for performance assessment is primarily engineering specifications and test methods defined by FDA-recognized international standards (ISO 80369-3, ISO 594-2, ISO 80369-20, ISO 10993). This is based on objective, quantitative measurements and adherence to design requirements for medical device connectors, rather than human interpretation or clinical outcomes data in the usual sense.
8. The sample size for the training set
This information is not applicable as the device is a physical connector and does not involve AI or machine learning models that require training sets.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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.