(74 days)
The Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which reduce the risk of accidental connection of an I.V. system to the enteral system, or the enteral system to an I.V. system.
The Enteral Only Extension Set consists of flexible PVC tubing designed to connect existing feeding tubes (nasogastric, gastric, etc.) to various delivery systems including pumps and syringes. The basic set consists of tubing with an enteral connector (catheter tip) and either a luer lock connector or an oral syringe connector. Other variations include the basic sets with the addition of a stop cock or Y site, to allow the clinician to attach other equipment. One configuration (Model 95017-D) utilizes luer lock connections on either end of the extension set, to allow for the connection to existing enteral feeding tubes with luer fittings. Note that in this configuration set does not utilize an oral syringe connection, to minimize the possibility of oral feeding solutions to be delivered into an IV line.
The provided text describes a medical device, the "Enteral Only Extension Set," and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.
Instead, the document details a 510(k) submission for regulatory clearance, which focuses on demonstrating substantial equivalence to already legally marketed predicate devices. The "study" mentioned refers to "Design verification tests" which were performed to ensure the device met "required acceptance criteria," but these acceptance criteria are not explicitly defined in terms of specific performance outcomes to be measured.
Here's a breakdown of what is and is not present based on your request:
1. Table of acceptance criteria and the reported device performance:
- Not Available: The document states, "All tests were verified to meet the required acceptance criteria," but it does not specify what those acceptance criteria were (e.g., minimum tensile strength, flow rate) nor does it provide a table of the reported numerical performance data from these tests. The tests are general "Design verification tests" resulting from risk analysis and product requirements, rather than a clinical or performance study with defined metrics.
2. Sample size used for the test set and the data provenance:
- Not Applicable/Not Available: This type of information (sample size, country of origin, retrospective/prospective) is typically associated with clinical or performance studies evaluating diagnostic or therapeutic efficacy, which is not what this document describes. The verification tests performed were likely engineering/design tests, not studies on a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Available: Ground truth, experts, and their qualifications are relevant to studies where the device's output (e.g., a diagnosis, a measurement) is compared against a definitive standard. This document focuses on the design and manufacturing of an extension set, not on its diagnostic or therapeutic outcome.
4. Adjudication method for the test set:
- Not Applicable/Not Available: Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments to establish consensus, which is not relevant to this device's verification.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable/Not Available: This device is an enteral feeding extension set, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI-assisted performance improvements are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable/Not Available: As above, this is not an AI algorithm.
7. The type of ground truth used:
- Not Applicable/Not Available: Because this is a physical medical device (an extension set) and not a diagnostic or AI-driven tool, the concept of "ground truth" (expert consensus, pathology, outcomes data) as typically applied to performance studies does not directly apply to its design verification. The "ground truth" for the verification tests would be defined engineering specifications and functional requirements.
8. The sample size for the training set:
- Not Applicable/Not Available: The term "training set" is used for machine learning or AI models. This device is a physical product, not an AI system.
9. How the ground truth for the training set was established:
- Not Applicable/Not Available: See point 8.
In summary:
The provided text from the 510(k) submission describes a design verification process rather than a clinical performance study with specific acceptance criteria related to diagnostic accuracy or clinical outcomes. The "acceptance criteria" referred to are likely engineering and functional specifications for the physical device, which were "met" during the design verification tests. The document aims to establish substantial equivalence to predicate devices based on design and material properties, not on comparative performance metrics in a clinical setting.
§ 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.