(435 days)
The Edi catheter ENFit is intended for:
- . Administrating nutrition, fluids and medications via the naso-gastro-enteric route
- . Aspiration via the naso-gastroenteric route
- . Transfers electrical activity (Edi signals) to compatible SERVO ventilator systems on which NAVA and NAVA NIV are available
The Edi Catheter ENFit is a sterile, single use nasogastric feeding tube that carries electrode rings that record diaphragm electrical activity (Edi signal). The Edi Catheter ENFit is an accessory to be used with patients in the range of neonates, infants, and adults together with the SERVO ventilator system. The Edi signal is used as an additional detector to improve the synchrony between the patient and the ventilator and to give the patient corresponding ventilatory support in the ventilation modes NAVA and NIV NAVA.
As a nasogastric feeding tube, the Edi Catheter ENFit is used for administration of nutrition, fluids and medications, as well as and aspiration via the naso-gastroenteric route. For the 12 Fr and 16 Fr catheters, a sump lumen is available for air venting the feeding tube to the atmosphere.
The new ENFit connector which is compliant with ISO 80369-3 is introduced in order to avoid misconnections with small-bore connectors used for other healthcare applications than enteral feeding.
This document is a 510(k) Summary for a medical device called the "Edi Catheter ENFit." It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria and a study demonstrating the device meets those criteria in the context of diagnostic performance or clinical effectiveness with human readers or AI.
The document focuses on engineering and material changes from a predicate device, primarily the adoption of a new ENFit connector, and verifies that these changes do not compromise the device's basic function or safety.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of evaluation (e.g., diagnostic accuracy, reader study) than what is presented here.
Here's what can be answered based on the provided text, and where gaps exist:
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Table of acceptance criteria and the reported device performance
- Acceptance Criteria (as related to the changes in the device): The document outlines several non-clinical tests performed to ensure the new ENFit connector and other minor design changes meet safety and performance standards. These are implicit acceptance criteria related to engineering and material properties, not diagnostic performance.
- Fluid Leakage
- Stress Cracking
- Resistance to separation from axial load
- Resistance to separation from unscrewing
- Resistance to overriding
- Disconnection by unscrewing
- Biocompatibility (conformance to ISO 10993-1:2009)
- Stability after accelerated aging
- Usability validation for the ENFit connector
- Reported Device Performance: The document states, "The testing demonstrates that the proposed device conform to all requirements of the Edi Catheter ENFit." It also notes that biocompatibility testing "demonstrated the biological safety of all parts of the proposed feeding tubes that have contact with the patient." Specific quantitative performance values for each of the listed tests are not provided in this summary.
- Acceptance Criteria (as related to the changes in the device): The document outlines several non-clinical tests performed to ensure the new ENFit connector and other minor design changes meet safety and performance standards. These are implicit acceptance criteria related to engineering and material properties, not diagnostic performance.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this type of submission. The testing described is primarily non-clinical engineering and material testing, not a clinical study involving a test set of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" establishment by medical experts described for this type of engineering and safety testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or adjudication process is described.
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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
- No. This device is a nasogastric feeding tube with electrodes to transfer electrical activity of the diaphragm (Edi signals). It is not an imaging device or an AI-powered diagnostic tool, and no MRMC study or AI-related improvement is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for the non-clinical testing would be the engineering specifications and ISO standards themselves. Biological safety relies on conformance to ISO 10993-1.
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The sample size for the training set
- Not applicable. No training set is mentioned as this device is not an AI/ML algorithm.
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How the ground truth for the training set was established
- Not applicable. No training set is mentioned.
§ 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.