CORTRAK* 2 Equilateral Enteral Access System is an electrical device designed to aid qualified operators in the placement of Avanos NG feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. CORTRAK* 2 Equilateral Enteral Access System can be used to confirm placement of feeding tubes prior to commencing the delivery of enteral nutrition.

Device Description

CORTRAK* 2 Equilateral Enteral Access System (EAS) device is designed to track the path of an 8 Fr or greater Avanos 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 All-In-One Monitor unit. The resulting raw data is processed, recorded, and presented to the operator in a meaningful and intuitive screen tracing. The CORTRAK*2 Equilateral 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 use in clinical environment.

AI/ML Overview

The provided document describes a device modification for the CORTRAK® 2 Equilateral Enteral Access System. However, it does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic performance or clinical effectiveness.

The document focuses on demonstrating substantial equivalence to a predicate device (K113351) by showing that the changes made (updated PC Single Board Computer, Display Processor Module, Operating System, GUI, removal of USB boot, removal of battery conditioning requirement) do not alter the intended use, safety, or effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment as it is not present in the provided text.

Here is what I can extract based on the information provided, explaining why certain sections cannot be filled:

A table of acceptance criteria and the reported device performance
- Not Available. The document outlines "nonclinical testing" which focuses on compliance with standards (IEC 60601-1, IEC 60601-1-2, IEC 62366-1, IEC 62304) to demonstrate that the modified device continues to meet performance specifications and that the changes do not raise new safety or effectiveness issues. It does not present specific diagnostic performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics against such criteria. The "Results" column in the table only states "Pass" for compliance with these standards.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The nonclinical testing mentioned does not involve a "test set" in the context of clinical performance or diagnostic accuracy. It refers to engineering and software verification tests.
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 Available. Ground truth establishment by experts is not relevant to the type of nonclinical testing described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available. Adjudication methods are not relevant to the nonclinical testing described.
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. The device described (CORTRAK® 2 Equilateral Enteral Access System) is an electrical device designed to aid operators in placing feeding tubes and confirming placement. It is not an AI-assisted diagnostic tool that would typically involve human readers or MRMC studies for improved diagnostic effectiveness. The changes are technical updates to electronics and software.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. As mentioned above, this device "aids qualified operators." It is not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth in the context of diagnostic/clinical performance is not discussed. The nonclinical testing refers to compliance with engineering and quality standards.
The sample size for the training set
- Not Available. The document does not describe the development of an AI algorithm or a "training set."
How the ground truth for the training set was established
- Not Available. As there is no described AI algorithm or training set, this information is not present.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 4, 2019

Avanos Medical, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd. Warren, NJ 07059

Re: K191340

Trade/Device Name: CORTRAK* 2 Equilateral Enteral Access System Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: May 14, 2019 Received: May 20, 2019

Dear Dave Yungvirt:

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.

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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 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-regulatoryinformation/postmarketing-safety-reporting-combination-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. Acting Assistant Division 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191340

Device Name

CORTRAK*2 Equilateral Enteral Access System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

Special 510(K): Device Modification CORTRAK* 2 *Denotes trademark

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S10(K) SUMMARY - SPECIAL 510(k)

Preparation Date: May 14, 2019

Submitter's/Manufacturer's Name, Address, Telephone, Contact Person

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

Correspondent Name: Monica King, MBA, Associate Director, Regulatory Affairs, Avanos Medical 678-477-4165 (Phone) Monica.king@avanos.com

1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Trade/Device Name:	CORTRAK* 2 Equilateral Enteral Access System
Common/Usual Name:	Enteral Access Device
Regulation Name:	Gastrointestinal tube and accessories
Regulation Number:	21 CFR § 876.5980
FDA Product Code:	KNT
Regulatory/Device Class:	Class II

2. PREDICATE DEVICE

CORTRAK 2* Enteral Access Device, (K113351)

3. INDICATIONS FOR USE

4. DEVICE DESCRIPTION

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K191340 Page 2 of 5

5. TECHNOLOGICAL CHARACTERISTICS

The CORTRAK*2 Equilateral Enteral Access Device is substantially equivalent to the predicate device. The following changes from the predicate device were made:

Updated PC Single Board Computer o
Updated Display Processor Module o
o Updated Operating System
Graphical User Interface (GUI) updated to better match current display O conventions (e.g., button shapes, font, etc.)
Removed ability to boot system from USB port o
Removed requirement for battery conditioning O

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

SUBSTANTIAL EQUIVALENCE DISCUSSION 6.

Intended Use Comparison

The following table provides a comparison between the intended use of the subject device and predicate device.

Property	Predicate Device(K113351)	Subject Device	Comments
Indications for Use	The CORTRAK* 2 Systemis an electrical devicedesigned to aid qualifiedoperators in the placementof the CORPAKMedSystems feedingtubes of 8 FR or greaterinto the stomach or smallbowel of patients requiringenteral feeding.CORTRAK* 2 can be usedto confirm placement offeeding tubes prior tocommencing the deliveryof enteral nutrition.	CORTRAK* 2 EquilateralEnteral Access System isan electrical devicedesigned to aid qualifiedoperators in the placementof Avanos feeding tubes of8 FR or greater into thestomach or small bowel ofpatients requiring enteralfeeding. CORTRAK* 2Equilateral Enteral AccessSystem can be used toconfirm placement offeeding tubes prior tocommencing the delivery ofenteral nutrition.	Same(updated onlyto reflect newbranding)
Contraindications	DO NOT use theCORTRAK* 2 EnteralAccess System forpatients with implantedmedical devices that maybe affected byelectromagnetic fields.	DO NOT use theCORTRAK* 2 EquilateralEnteral Access System forpatients with implantedmedical devices that maybe affected byelectromagnetic fields.	Same
Acceptable NGTube size	8 Fr or greater	8 Fr or greater	Same
PrescriptionStatus	Rx Only	Rx Only	Same

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Environment ofUse	For use within clinicalsetting	For use within clinicalsetting	Same

Discussions of differences in Indications for Use Statement

The Indications for Use statement was modified to reflect the new ownership and branding of the subject device (i.e., Avanos Medical). These differences have no impact on the intended use, safety, or effectiveness of the subject device when compared to the predicate device.

Technological Characteristics Comparison

The following tables provides a comparison between the technological characteristics of the subject device and predicate device.

Property	Predicate Device(K113351)	Subject Device	Comments
Sterilization	Non-Sterile	Non-Sterile	Same
Electronics	PC Single Board Computer,Qseven, 1.6GHz Intel AtomZ530, 1GB DDR2 memory,SATA	PC Single Board Computer,Qseven, 1.75 GHz Dual CoreIntel Atom E3827, 2GB DDR3,4GB eMMC. BIOS: CongatecUtility version 1.5.6	Updated toresolveobsolescenceofcomponents
Software - DisplayProcessor ModuleSoftware -OperatingSystem	Slackware distribution of theLinux Operating System. TheOS is a custom build of theSlackware kernel version2.6.34.	Changed to QNX MedicalKernel version 1.1 to enable useof new Single Board Computerand to improve future expansionand maintenance.	Updated toresolveobsolescenceofcomponents
Software - ITSecurity	Bootable from USB	Not bootable from USB	SecurityEnhancement
Software -Graphical UserInterface	Device displays a GraphicalUser Interface on a touchscreen. Platform is an FLTKbased application	Device displays a GraphicalUser Interface on a touchscreen. Minor changes in lookand feel, including buttonshapes and font.	Updated toresolveobsolescenceofcomponents
PowerRequirements	External Power SupplyInput: 100-250 Volts AC, 50-60Hz, 140 VAOutput: 15 VDC, 4ABattery: 11.1 Volts, 6.6 Ampere-hour Li-lon rechargeable smartbattery with thermal overloadprotection.	External Power SupplyInput: 100-250 Volts AC, 50-60Hz. 140 VAOutput: 15 VDC, 4ABattery: 11.1 Volts, 6.6 Ampere-hour Li-lon rechargeable smartbattery with thermal overloadprotection.	Same
Property	Predicate Device(K113351)	Subject Device	Comments
BatteryOperation	New battery, when fullycharged, will operate thedevice in continuousplacement mode forapproximately two hours.Charging an emptyrechargeable battery to fullcapacity will takeapproximately 4-6 hourswhen the Monitor Unit is off.The expected life for arechargeable battery isapproximately 2 years.	New battery, when fullycharged, will operate thedevice in continuousplacement mode forapproximately two hours.Charging an emptyrechargeable battery to fullcapacity will takeapproximately 4-6 hourswhen the Monitor Unit is off.The expected life for arechargeable battery isapproximately 2 years.	Same
BatteryConditioning	Present	Not Present in unit sincebattery is self-conditioning	Batteryconditioningoccurs inboth
EnvironmentalOperatingConditions	Operating TemperatureRange: 59°F (15°C) to 100°F(38°C).Relative Humidity Range:30% to 90%.	Operating TemperatureRange: 59°F (15°C) to 100°F(38°C).Relative Humidity Range:30% to 90%.	Same
Dimensions	All-In-One Monitor: 12.20" Wx 13.30" H x 3.30" DSmart Receiver Unit: 5.60"W x 5.60" H x 1.90" D	All-In-One Monitor: 12.20" Wx 13.30" H x 3.30" DSmart Receiver Unit: 5.60"W x 5.60" H x 1.90" D	Same
Weight	All-In-One Monitor with PoleClamp: Approx. 8.0 lbs.Smart Receiver Unit:Approx. 0.5 lbs.Utility Basket: Weightcapacity 10 lbs.	All-In-One Monitor with PoleClamp: Approx. 8.0 lbs.Smart Receiver Unit: Approx.0.5 lbs.Utility Basket: Weightcapacity 10 lbs.	Same
System securityrequires userpasswords foraccess	Present	Present	Same
Interface toclinicalinformationsystems	None	None	Same

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Discussions of technological differences

The changes that resulted in technological differences were made to resolve obsolescence of certain electronic componentry and software. These differences have

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no impact on the intended use, technological principles, safety, or effectiveness of the subject device when compared to the predicate device.

7. SUMMARY OF NONCLINICAL TESTING

Performance testing on the device under submission was conducted to demonstrate the modified device continued to meet performance specifications. Results of design verification and validation activities did not raise any new issues of safety or effectiveness. Non-clinical verification was conducted through the risk management process according to ISO 14971:2012. The following verification tests were conducted:

Testing Requirements	Result
Compliance to IEC 60601-1 (Medical ElectricalEquipment - General Requirements for basicsafety and essential performance 2012, Edition3.1. Class 1.)	Pass
Compliance to IEC 60601-1-2 (MedicalElectrical Equipment - General requirements forbasic safety and essential performance -Collateral standard: Electromagneticcompatibility - Requirements and tests.	Pass
Compliance to IEC 62366-1:2015 (Part 1:Application of Usability Engineering to MedicalDevices.)	Pass
Compliance to IEC 62304:2006 (Medical devicesoftware - software life cycle processes)	Pass

OVERALL PERFORMANCE CONCLUSIONS 8.

The above nonclinical studies demonstrate CORTRAK2 Equilateral Enteral Access Device is substantially equivalent to the predicate CORTRAK 2 Enteral Access Device (K113351) in intended use, design, materials, performance, and biocompatibility attributes. There are no new questions of safety and effectiveness as compared to the predicate device.

9. CONCLUSION

The differences between the predicate CORTRAK* 2 Enteral Access Device (K113351) and subject CORTRAK2 Equilateral Enteral Access Device do not raise any new or different questions of safety or effectiveness. The subject CORTRAK2 Equilateral Enteral Access Device is substantially equivalent to the predicate CORTRAK*Enteral Access Device cleared under K113351 with respect to the indications for use, technology, 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.