(225 days)
The Cedic Enteral Distal End ENFit Transition Connector is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.
The Cedic Enteral ENFit Transition Connector for Medication Port is intended for connecting a male oral tip syringe to an enteral giving set or enteral catheter with an ENFit medication port.
The Cedic Enteral Funnel ENFit Transition Connector is intended for connecting an enteral giving set equipped with a stepped enteral distal end to an enteral catheter equipped with an ENFit connector.
Cedic Srl has designed three transition connectors that will allow specific connections between PGLock end connectors being used on new devices to some of the previously used end connectors that may still be in use in healthcare or home settings. The three transition connectors are:
- . Enteral Distal End ENFit Transition Connector, for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel. Available with and without end cap.
- . Enteral ENFit Transition Connector for Medication Port, for connecting a male oral tip syringe to an enteral giving set or enteral catheter with an ENFit medication port. Available with and without end cap.
- . Enteral Funnel ENFit Transition Connector, for connecting an enteral giving set equipped with a stepped enteral distal end to an enteral catheter equipped with an ENFit connector. Available with and without end cap.
All three Cedic ENFit Transition Connectors are intended for prescription use only.
The provided document is a 510(k) summary for Cedic ENFit Transition Connectors for Enteral Applications. It outlines the device's description, indications for use, and performance data to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information based on the provided text, categorized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document references FDA draft guidance for safety considerations for 510(k) submissions to mitigate misconnections with small-bore connectors for enteral applications. It discusses three key areas for performance data and how the Cedic ENFit Transition Connectors meet these recommendations.
| Acceptance Criteria (from FDA Draft Guidance) | Reported Device Performance and Compliance |
|---|---|
| A. Connector Materials: Enteral connectors should be made of rigid materials, as described in AAMI/ANSI/ISO 80369-1, Clause 4, with testing according to ASTM D747 or ASTM D790, or equivalent, to reduce the likelihood of forced fits. (Quote from Section VI.A of FDA Draft Guidance) | Compliance: "In this respect, the Cedic ENFit Transition Connectors are made of the appropriate rigid or semi-rigid materials." |
| Materials Used: ABS HF 380, LDPE (Riblene MM20), or soft PVC (Nakan FMA919N). One component (end cap) is colored with Remafin Violet PE43076356-ZT (2%). These materials were previously used for the Cedic Enteral Feeding Spike Adapter (K072652). | |
| B. Mechanical Testing of Enteral Connectors to Assess Incompatibility: Mechanical force testing following AAMI/ANSI/ISO 80369-1, Clause 5.8, Annex B methods, or an equivalent alternative, to demonstrate that enteral connectors are non-interconnectable with connectors from other health care applications. (Quote from Section VI.B of FDA Draft Guidance) | Compliance: "Bench tests have been carried out on samples of the Cedic ENFit Transition Connectors for Enteral Applications." |
| Specific Tests Performed: |
- Enteral connector misconnection assessment
- Human factors
- Fluid leakage
- Stress cracking
- Resistance to separation from axial load
- Resistance to separation from unscrewing
- Resistance to overriding
- Disconnection by unscrewing |
| C. Enteral Connector Risk Assessment: Submit a risk assessment to demonstrate effective mitigation of misconnection risk, with objective evidence that risks have been reduced to acceptable levels according to ISO 14971:2007 or equivalent. (Quote from Section VI.C of FDA Draft Guidance) | Compliance: "In this respect, this 510(k) submission includes a copy of the risk analysis for the three subject transition connectors." |
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 ENFit Transition Connectors for Enteral Applications." It does not specify the exact sample size for these tests. The data provenance is implied to be laboratory testing conducted by the manufacturer, Cedic S.r.l., which is based in Italy. The tests appear to be prospective, specifically performed for this 510(k) submission to demonstrate compliance with the referenced FDA guidance.
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 performance data described relates to mechanical and physical testing of the connectors, which typically does not involve expert readers or ground truth established by medical professionals in the same way, for example, an imaging diagnostic device would.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Mechanical and physical tests do not typically involve adjudication by multiple experts in the manner of clinical or imaging studies. The results of the bench tests would likely be based on objective measurements against predefined pass/fail 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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not applicable to this type of device. The devices are transition connectors for enteral feeding, not diagnostic imaging or AI-assisted diagnostic tools.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and therefore not provided in the document. The device is a physical connector, not an algorithm, so standalone algorithm performance is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. For the mechanical and physical tests performed, the "ground truth" or reference standard would be the specified technical requirements and performance parameters outlined in the AAMI/ANSI/ISO 80369-1 standard and the FDA's draft guidance. For example, for fluid leakage, the ground truth would be a defined maximum allowable leakage rate. For resistance to separation, it would be a minimum force or torque the connection must withstand.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device is a physical medical connector, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not provided and 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.