CORTRAK* 2 Equilateral Enteral Access System

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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. {1}------------------------------------------------ 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 {2}------------------------------------------------ | 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) 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. 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 {3}------------------------------------------------ # 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 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. #### 4. 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. {4}------------------------------------------------ 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<br>(K113351) | Subject Device | Comments | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------| | Indications for Use | The CORTRAK* 2 System<br>is an electrical device<br>designed to aid qualified<br>operators in the placement<br>of the CORPAK<br>MedSystems feeding<br>tubes of 8 FR or greater<br>into the stomach or small<br>bowel of patients requiring<br>enteral feeding.<br>CORTRAK* 2 can be used<br>to confirm placement of<br>feeding tubes prior to<br>commencing the delivery<br>of enteral nutrition. | CORTRAK* 2 Equilateral<br>Enteral Access System is<br>an electrical device<br>designed to aid qualified<br>operators in the placement<br>of Avanos feeding tubes of<br>8 FR or greater into the<br>stomach or small bowel of<br>patients requiring enteral<br>feeding. CORTRAK* 2<br>Equilateral Enteral Access<br>System can be used to<br>confirm placement of<br>feeding tubes prior to<br>commencing the delivery of<br>enteral nutrition. | Same<br>(updated only<br>to reflect new<br>branding) | | Contraindications | DO NOT use the<br>CORTRAK* 2 Enteral<br>Access System for<br>patients with implanted<br>medical devices that may<br>be affected by<br>electromagnetic fields. | DO NOT use the<br>CORTRAK* 2 Equilateral<br>Enteral Access System for<br>patients with implanted<br>medical devices that may<br>be affected by<br>electromagnetic fields. | Same | | Acceptable NG<br>Tube size | 8 Fr or greater | 8 Fr or greater | Same | | Prescription<br>Status | Rx Only | Rx Only | Same | {5}------------------------------------------------ | Environment of<br>Use | For use within clinical<br>setting | For use within clinical<br>setting | 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<br>(K113351) | Subject Device | Comments | |-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | Sterilization | Non-Sterile | Non-Sterile | Same | | Electronics | PC Single Board Computer,<br>Qseven, 1.6GHz Intel Atom<br>Z530, 1GB DDR2 memory,<br>SATA | PC Single Board Computer,<br>Qseven, 1.75 GHz Dual Core<br>Intel Atom E3827, 2GB DDR3,<br>4GB eMMC. BIOS: Congatec<br>Utility version 1.5.6 | Updated to<br>resolve<br>obsolescence<br>of<br>components | | Software - Display<br>Processor Module<br>Software -<br>Operating<br>System | Slackware distribution of the<br>Linux Operating System. The<br>OS is a custom build of the<br>Slackware kernel version<br>2.6.34. | Changed to QNX Medical<br>Kernel version 1.1 to enable use<br>of new Single Board Computer<br>and to improve future expansion<br>and maintenance. | Updated to<br>resolve<br>obsolescence<br>of<br>components | | Software - IT<br>Security | Bootable from USB | Not bootable from USB | Security<br>Enhancement | | Software -<br>Graphical User<br>Interface | Device displays a Graphical<br>User Interface on a touch<br>screen. Platform is an FLTK<br>based application | Device displays a Graphical<br>User Interface on a touch<br>screen. Minor changes in look<br>and feel, including button<br>shapes and font. | Updated to<br>resolve<br>obsolescence<br>of<br>components | | Power<br>Requirements | External Power Supply<br>Input: 100-250 Volts AC, 50-60<br>Hz, 140 VA<br>Output: 15 VDC, 4A<br>Battery: 11.1 Volts, 6.6 Ampere-<br>hour Li-lon rechargeable smart<br>battery with thermal overload<br>protection. | External Power Supply<br>Input: 100-250 Volts AC, 50-60<br>Hz. 140 VA<br>Output: 15 VDC, 4A<br>Battery: 11.1 Volts, 6.6 Ampere-<br>hour Li-lon rechargeable smart<br>battery with thermal overload<br>protection. | Same | | Property | Predicate Device<br>(K113351) | Subject Device | Comments | | Battery<br>Operation | New battery, when fully<br>charged, will operate the<br>device in continuous<br>placement mode for<br>approximately two hours.<br>Charging an empty<br>rechargeable battery to full<br>capacity will take<br>approximately 4-6 hours<br>when the Monitor Unit is off.<br>The expected life for a<br>rechargeable battery is<br>approximately 2 years. | New battery, when fully<br>charged, will operate the<br>device in continuous<br>placement mode for<br>approximately two hours.<br>Charging an empty<br>rechargeable battery to full<br>capacity will take<br>approximately 4-6 hours<br>when the Monitor Unit is off.<br>The expected life for a<br>rechargeable battery is<br>approximately 2 years. | Same | | Battery<br>Conditioning | Present | Not Present in unit since<br>battery is self-conditioning | Battery<br>conditioning<br>occurs in<br>both | | Environmental<br>Operating<br>Conditions | Operating Temperature<br>Range: 59°F (15°C) to 100°F<br>(38°C).<br>Relative Humidity Range:<br>30% to 90%. | Operating Temperature<br>Range: 59°F (15°C) to 100°F<br>(38°C).<br>Relative Humidity Range:<br>30% to 90%. | Same | | Dimensions | All-In-One Monitor: 12.20" W<br>x 13.30" H x 3.30" D<br>Smart Receiver Unit: 5.60"<br>W x 5.60" H x 1.90" D | All-In-One Monitor: 12.20" W<br>x 13.30" H x 3.30" D<br>Smart Receiver Unit: 5.60"<br>W x 5.60" H x 1.90" D | Same | | Weight | All-In-One Monitor with Pole<br>Clamp: Approx. 8.0 lbs.<br>Smart Receiver Unit:<br>Approx. 0.5 lbs.<br>Utility Basket: Weight<br>capacity 10 lbs. | All-In-One Monitor with Pole<br>Clamp: Approx. 8.0 lbs.<br>Smart Receiver Unit: Approx.<br>0.5 lbs.<br>Utility Basket: Weight<br>capacity 10 lbs. | Same | | System security<br>requires user<br>passwords for<br>access | Present | Present | Same | | Interface to<br>clinical<br>information<br>systems | None | None | Same | {6}------------------------------------------------ # 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 {7}------------------------------------------------ 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 Electrical<br>Equipment - General Requirements for basic<br>safety and essential performance 2012, Edition<br>3.1. Class 1.) | Pass | | Compliance to IEC 60601-1-2 (Medical<br>Electrical Equipment - General requirements for<br>basic safety and essential performance -<br>Collateral standard: Electromagnetic<br>compatibility - Requirements and tests. | Pass | | Compliance to IEC 62366-1:2015 (Part 1:<br>Application of Usability Engineering to Medical<br>Devices.) | Pass | | Compliance to IEC 62304:2006 (Medical device<br>software - software life cycle processes) | Pass | #### OVERALL PERFORMANCE CONCLUSIONS 8. The above nonclinical studies demonstrate CORTRAK*2 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 CORTRAK*2 Equilateral Enteral Access Device do not raise any new or different questions of safety or effectiveness. The subject CORTRAK*2 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.