(90 days)
The Cedic Oral/Luer Enteral ENFit Transition Connector for is intended for connecting a male oral tip syringe or a male Luer slip tip syringe to an enteral giving set or enteral catheter with an ENFit medication port.
The Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port is a transition connector intended for connecting a male oral tip syringe or a male Luer slip tip syringe to an enteral giving set or enteral catheter with an ENFit medication port. This connector is available with and without end cap. It operates by providing a means of interconnecting incompatible enteral feeding device end fittings together. The PGLock end of the connector is designed in compliance with ISO 80369-1:2010 and ISO/IEC AAMI/CN3 (PS):2014. It is manufactured by injection molding from ABS HF 380.
The provided document describes a medical device, the "Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port," and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study data, sample sizes for test or training sets, information on ground truth establishment, or multi-reader multi-case study results.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed de novo device study.
Therefore, much of the requested information cannot be extracted from this document. I will provide what is available and indicate where information is missing.
Acceptance Criteria and Device Performance:
The document refers to FDA recommendations for enteral connectors and the associated mechanical testing. It states that the device was tested to demonstrate compliance with these recommendations. Specific quantitative acceptance criteria (e.g., minimum force for separation) and the exact reported device performance values are not explicitly provided in a table format within this document. The document primarily states what types of tests were conducted and that the device "is made of the appropriate rigid or semi-rigid materials" and that "Bench tests have been carried out."
| Acceptance Criteria (Referenced from FDA Draft Guidance) | Reported Device Performance (Summary from Document) |
|---|---|
| A. Connector Materials: Made of rigid or semi-rigid materials (as described in AAMI/ANS//ISO 80369-1, Clause 4, with testing according to ASTM D747 or ASTM D790, or equivalent) to reduce the likelihood of forced fits between flexible connectors not intended to connect. | The Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port is manufactured by injection molding from ABS HF 380, which is stated to be an "appropriate rigid or semi-rigid material." The materials are identical to those used for the selected predicate device. |
| B. Mechanical Testing for Incompatibility: Mechanical force testing following AAMI/ANSVISO 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. Bench tests performed to assess: - Enteral connector misconnection - Human factors - Fluid leakage - Stress cracking - Resistance to separation from axial load - Resistance to separation from unscrewing - Resistance to overriding - Disconnection by unscrewing (Includes testing of the Luer part to demonstrate compliance with ISO 594-1). | "Bench tests have been carried out on samples of the Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port." The document implies these tests demonstrate compliance (e.g., "this 510(k) submission includes a copy of the risk analysis for the subject transition connector," suggesting risks were mitigated through such testing), but quantitative results are not presented. |
| C. Enteral Connector Risk Assessment: Provide a risk assessment to demonstrate effective mitigation of misconnection risks, with objective evidence that risks have been reduced to acceptable levels according to ISO 14971:2007 or equivalent. | "this 510(k) submission includes a copy of the risk analysis for the subject transition connector." This implies the risk assessment confirmed acceptable risk levels. |
Detailed Study Information:
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Sample size used for the test set and the data provenance:
- Sample Size: The document states that "Bench tests have been carried out on samples" but does not specify the sample size used for these tests.
- Data Provenance: The tests were conducted internally by the manufacturer (Cedic S.r.l. Biomedical Division, Italy) or a contracted lab on behalf of the manufacturer. The data is retrospective in the sense that the tests were performed before the 510(k) submission. There is no mention of country of origin of the data beyond the manufacturer's location.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device and study. This is a mechanical device, and "ground truth" would be established by objective physical measurements according to specified standards, not expert consensus on interpretations.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation tasks (e.g., image reading) where consensus among experts establishes ground truth. For mechanical tests, results are typically objective measurements against a standard.
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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:
- This is not applicable. This document describes a mechanical connector device, not an AI-assisted diagnostic tool or an imaging system that would involve human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This device is a passive mechanical connector, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is objective measurement of its physical properties and mechanical behavior against established engineering standards (e.g., ISO 80369-1, ISO 594-1, ASTM D747, ASTM D790) and the FDA's draft guidance recommendations for misconnection mitigation. It's essentially compliance with predefined technical specifications.
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The sample size for the training set:
- This is not applicable. This device is a mechanical product, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- This is not applicable as there is no training set.
§ 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.