(52 days)
The Avanos* CORTRAK2 Enteral Access System (EAS) utilizes tube tracking technology to assist, in conjunction with institution protocols, qualified clinicians in guiding placement of Avanos Medical CORTRAK2 feeding tubes of 8FR or greater into the stomach or small bowel of patients requiring enteral feeding.
Avanos* CORTRAK* 2 Enteral Access System (EAS) device is designed to track the path of an 8 Fr or greater Avanos Medical feeding tube tip during the patient placement procedure. A coil winding at the distal end of the transmitting stylet acts as a transmitter, and its signal is detected by the externally positioned receiver unit. The received signals are input to the attached Monitor unit. The resulting raw data is processed, recorded, and presented to the operator in a meaningful and intuitive screen tracing. The Avanos* CORTRAK*2 EAS device is an electrical device that does not contact the patient, is not sterilized, and is reusable. Like the predicate device, it is intended to be used in a clinical environment by qualified trained clinicians.
This document, K220588, is a 510(k) summary for the Avanos* CORTRAK* 2 Enteral Access System (EAS). It asserts substantial equivalence to a predicate device (CORTRAK* 2 Equilateral EAS, K191340) and focuses on labeling updates, particularly a clarification in the indications for use.
Based on the provided text, the device itself has not undergone a study to prove it meets acceptance criteria for altered performance characteristics, because there were no changes to its design, materials, or performance. The 510(k) submission states: "There were no other changes in the design, materials, performance, and technological characteristics from the predicate device." and "The labeling changes have no effect on the technologic characteristics. The labeling difference has no impact on the intended use, technological principles, safety, or effectiveness of the subject device when compared to the predicate device."
Therefore, much of the requested information about acceptance criteria and study details for device performance cannot be extracted from this document, as a performance study demonstrating new acceptance criteria for the device itself was not conducted. Instead, the submission focuses on verifying that labeling changes do not negatively impact safety or effectiveness.
Here’s an breakdown of the requested information based on what is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
As no performance changes were made to the device in this 510(k) submission, and the submission is focused on labeling updates, there isn't a table of new acceptance criteria for device performance or new reported device performance data presented. The device's performance is assumed to be consistent with the predicate device (K191340).
The key "criteria" addressed are that the labeling changes should not raise new or different questions of safety or effectiveness.
| Acceptance Criteria (for Labeling Change) | Reported Device Performance (regarding labeling change impact) |
|---|---|
| Labeling updates should not change the Intended Use of the device. | The change in the Indications for Use does not change the Intended Use of assisting qualified operators to guide NG/NI feeding tubes into the stomach or small bowel. |
| Labeling updates should not raise different or new questions of safety and effectiveness. | The Indications for Use change does not raise different or new questions of safety and effectiveness. The labeling difference has no impact on the intended use, technological principles, safety, or effectiveness of the subject device when compared to the predicate device. |
| Risk profile should not have a significant impact due to labeling updates. | The risk management file was updated to eliminate risks associated with the use of Avanos* CORTRAK*2 EAS as a confirmatory method. The risk profile of the device system did not have a significant impact due to the labeling updates. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new clinical or performance test set data was generated or analyzed for the device itself as part of this 510(k) given that the changes were limited to labeling. The evaluation focused on risk analysis related to labeling.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No new test set requiring expert-established ground truth was part of this submission. The evaluation was primarily regulatory and risk management based on labeling changes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set requiring adjudication was part of this submission.
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
Not applicable. This device is an "Enteral Access System" that uses "tube tracking technology" to guide feeding tube placement. It is not an AI-assisted diagnostic imaging device for which MRMC studies are typically conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an Enteral Access System that assists clinicians, implying human-in-the-loop operation. No standalone algorithm performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new ground truth was established for the device's performance given the nature of the submission (labeling changes only). The "ground truth" for the predicate device would have been established during its original clearance process, likely through clinical studies verifying accurate tube placement. For this submission, the "truth" being assessed was whether the labeling changes impacted the established safety and effectiveness.
8. The sample size for the training set
Not applicable. This document describes a 510(k) for an Enteral Access System with labeling changes, not an AI/ML device that requires training sets.
9. How the ground truth for the training set was established
Not applicable. This document describes a 510(k) for an Enteral Access System with labeling changes, not an AI/ML device that requires training sets.
§ 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.