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.

Device Description

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.

AI/ML Overview

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.

Summary

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April 22, 2022

Avanos Medical, Inc. % Angela Cushman Senior Vice President, QA/RA (Interim) 5405 Windward Parkway Alpharetta, GA 30004

Re: K220588

Trade/Device Name: Avanos* CORTRAK* 2 Enteral Access System (EAS) Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: Class II Product Code: KNT Dated: February 28, 2022 Received: March 1, 2022

Dear Angela Cushman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220588

Device Name Avanos* CORTRAK* 2 Enteral Access System (EAS)

Indications for Use (Describe)

The Avanos* CORTRAK*2 Enteral Access System (EAS) utilizes tube tracking technology to assist, in conjunction with institution protocols, qualified clinicians in guiding placement of Avanos Medical CORTRAK *2 feeding tubes of 8FR or greater into the stomach or small bowel of patients requiring enteral feeding.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K220588 Page 1 of 3 5405 Windward Parkway Alpharetta, GA 30004

T 1-844-4AVANOS www.avanos.com

510(k) SUMMARY - K220558

Avanos* CORTRAK* 2 Enteral Access System (EAS)

1. SUBMITTER

Avanos Medical, Inc. 5405 Windward Parkway Alpharetta, Georqia 30004, U.S.A.

Correspondent Name: Angela Cushman Senior VP, RAQA (Interim) 706-344-8678 angela.cushman@avanos.com

Date Prepared: April 7, 2022

2. Device

Name of Device: Common or Usual Name: Classification Name: Regulation: Regulatory Class: FDA Product Code:

Avanos* CORTRAK* 2 Enteral Access System (EAS) Enteral Access Device Gastrointestinal tube and accessories 21 CFR § 876.5980 = KNT

3. Predicate Device

CORTRAK* 2 Equilateral EAS (K191340)

4. Description of Device

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5. Intended Use

The Avanos* CORTRAK*2 Enteral Access System (EAS) assists qualified clinicians to guide NG/NI feeding tubes into the stomach or small bowel of patients requiring enteral feeding.

6. Indications for Use

7. Technological Characteristics

The Avanos* CORTRAK* 2 Enteral Access System is substantially equivalent to the predicate device CORTRAK* 2 Equilateral EAS (K191340).

The only change to the subject device involves labeling updates. Labeling updates include a change to the indications for use to clarify the inclusion of a secondary confirmatory method for tube placement per institution protocols, and enhanced warnings in a consolidated organized section.

There were no other changes in the design, materials, performance, and technological characteristics from the predicate device.

The difference in the updated labeling has no impact on the intended use, technological principles, safety, or effectiveness of the subject device when compared to the predicate device.

8. Substantial Equivalence Discussion

Intended Use Comparison

Predicate Indicationfor Use(K191340)	Predicate IntendedUse(K191340)	Subject Indicationfor Use (K220558)	Subject Intended Use(K220558)
CORTRAK2Equilateral EASCORTRAK 2Equilateral EnteralAccess System is anelectrical devicedesigned to aidqualified operators inthe placement ofAvanos NG feedingtubes of 8 FR orgreater into thestomach or smallbowel of patients	CORTRAK*2Equilateral EASAssists qualifiedoperators to guideNG/NI feeding tubesinto stomach or smallbowel.	Avanos* CORTRAK2EASThe AvanosCORTRAK2 EnteralAccess System (EAS)utilizes tube trackingtechnology to assist, inconjunction withinstitution protocols,qualified clinicians inguiding placement ofAvanos MedicalCORTRAK2 feedingtubes of 8FR or	Avanos* CORTRAK*2EASAssists qualifiedclinicians to guideNG/NI feeding tubesinto stomach or smallbowel.

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Predicate Indicationfor Use(K191340)	Predicate IntendedUse(K191340)	Subject Indicationfor Use (K220558)	Subject Intended Use(K220558)
CORTRAK*2Equilateral EAS	CORTRAK*2Equilateral EAS	Avanos* CORTRAK*2EAS	Avanos* CORTRAK*2EAS
requiring enteralfeeding. CORTRAK* 2Equilateral EnteralAccess System can beused to confirmplacement of feedingtubes prior tocommencing thedelivery of enteralnutrition.		greater into thestomach or smallbowel of patientsrequiring enteralfeeding.

Conclusion:

The change in the Indications for Use does not change the Intended Use of assisting qualified operators to quide NG/NI feeding tubes into the stomach or small bowel.

The Indications for Use change does not raise different or new questions of safety and effectiveness.

Technologic Characteristics Comparison

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. The device design, material, and operating principle remain the same as the predicate device CORTRAK* 2 Equilateral EAS (K191340).

9. Summary of Non-Clinical Testing

Non-clinical verification of the labeling change was conducted through the risk management process according to ISO 14971:2019. The risk management file was updated to eliminate risks associated with the use of Avanos* CORTRAK2 EAS as a confirmatory method for the placement of CORTRAK2 NG/NI feeding tubes. The risk profile of the device system did not have a significant impact due to the labeling updates.

There were no other non-clinical tests performed for the labeling updates for the subject device.

10. Conclusion

The difference between the predicate CORTRAK* 2 Equilateral Enteral Access Device (K191340) and subject Avanos* CORTRAK2 Enteral Access System (EAS) (K220588) do not raise any new or different questions of safety or effectiveness. The subject Avanos CORTRAK2 Enteral Access System (EAS) is substantially equivalent to the predicate CORTRAKEquilateral Enteral Access Device cleared under K191430 with respect to the intended use, technology, operating principle, material composition, and performance.

Regulation Number and Section

§ 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.