(15 days)
Not Found
No
The description focuses on signal processing and tracking based on electromagnetic principles, with no mention of AI/ML terms or concepts.
No
The device aids in the placement and confirmation of feeding tubes, but it does not directly treat a disease or condition for therapeutic benefit.
Yes
The device aids in confirming the placement of feeding tubes, which is a diagnostic function to ensure the correct location before commencing enteral nutrition.
No
The device description explicitly states it is an "electrical device" and includes hardware components like a transmitting stylet with a coil winding and an externally-positioned receiver unit. It also mentions an "All-In-One Monitor unit" for processing and displaying data.
Based on the provided information, the CORTRAK* 2 Equilateral Enteral Access System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- CORTRAK 2 Function:* The CORTRAK* 2 system is used to aid in the placement of feeding tubes within the patient's body. It tracks the physical location of the tube tip using electrical signals. It does not analyze any biological specimens.
- Device Description: The description explicitly states it's an "electrical device" that "does not contact the patient" and "tracks the path of an... feeding tube tip during the patient placement procedure." This aligns with a device used for a procedural aid, not for analyzing biological samples.
Therefore, the CORTRAK* 2 Equilateral Enteral Access System falls under the category of a medical device used for a procedural aid or guidance, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KNT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach or small bowel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified operators in the placement of Avanos NG feeding tubes
For use within clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
Compliance to IEC 60601-1 (Medical Electrical Equipment - General Requirements for basic safety and essential performance 2012, Edition 3.1. Class 1.) - Pass
Compliance to IEC 60601-1-2 (Medical Electrical Equipment - General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.) - Pass
Compliance to IEC 62366-1:2015 (Part 1: Application of Usability Engineering to Medical Devices.) - Pass
Compliance to IEC 62304:2006 (Medical device software - software life cycle processes) - Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
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
(K113351) | Subject Device | Comments |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Indications for Use | The CORTRAK* 2 System
is an electrical device
designed to aid qualified
operators in the placement
of the CORPAK
MedSystems feeding
tubes of 8 FR or greater
into the stomach or small
bowel of patients requiring
enteral feeding.
CORTRAK* 2 can be used
to confirm placement of
feeding tubes prior to
commencing the delivery
of enteral nutrition. | CORTRAK* 2 Equilateral
Enteral Access System is
an electrical device
designed to aid qualified
operators in the placement
of Avanos 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. | Same
(updated only
to reflect new
branding) |
| Contraindications | DO NOT use the
CORTRAK* 2 Enteral
Access System for
patients with implanted
medical devices that may
be affected by
electromagnetic fields. | DO NOT use the
CORTRAK* 2 Equilateral
Enteral Access System for
patients with implanted
medical devices that may
be affected by
electromagnetic fields. | Same |
| Acceptable NG
Tube size | 8 Fr or greater | 8 Fr or greater | Same |
| Prescription
Status | Rx Only | Rx Only | Same |
5
| Environment of
Use | For use within clinical
setting | For use within clinical
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
(K113351) | Subject Device | Comments |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Sterilization | Non-Sterile | Non-Sterile | Same |
| Electronics | PC Single Board Computer,
Qseven, 1.6GHz Intel Atom
Z530, 1GB DDR2 memory,
SATA | PC Single Board Computer,
Qseven, 1.75 GHz Dual Core
Intel Atom E3827, 2GB DDR3,
4GB eMMC. BIOS: Congatec
Utility version 1.5.6 | Updated to
resolve
obsolescence
of
components |
| Software - Display
Processor Module
Software -
Operating
System | Slackware distribution of the
Linux Operating System. The
OS is a custom build of the
Slackware kernel version
2.6.34. | Changed to QNX Medical
Kernel version 1.1 to enable use
of new Single Board Computer
and to improve future expansion
and maintenance. | Updated to
resolve
obsolescence
of
components |
| Software - IT
Security | Bootable from USB | Not bootable from USB | Security
Enhancement |
| Software -
Graphical User
Interface | Device displays a Graphical
User Interface on a touch
screen. Platform is an FLTK
based application | Device displays a Graphical
User Interface on a touch
screen. Minor changes in look
and feel, including button
shapes and font. | Updated to
resolve
obsolescence
of
components |
| Power
Requirements | External Power Supply
Input: 100-250 Volts AC, 50-60
Hz, 140 VA
Output: 15 VDC, 4A
Battery: 11.1 Volts, 6.6 Ampere-
hour Li-lon rechargeable smart
battery with thermal overload
protection. | External Power Supply
Input: 100-250 Volts AC, 50-60
Hz. 140 VA
Output: 15 VDC, 4A
Battery: 11.1 Volts, 6.6 Ampere-
hour Li-lon rechargeable smart
battery with thermal overload
protection. | Same |
| Property | Predicate Device
(K113351) | Subject Device | Comments |
| Battery
Operation | New battery, when fully
charged, will operate the
device in continuous
placement mode for
approximately two hours.
Charging an empty
rechargeable battery to full
capacity will take
approximately 4-6 hours
when the Monitor Unit is off.
The expected life for a
rechargeable battery is
approximately 2 years. | New battery, when fully
charged, will operate the
device in continuous
placement mode for
approximately two hours.
Charging an empty
rechargeable battery to full
capacity will take
approximately 4-6 hours
when the Monitor Unit is off.
The expected life for a
rechargeable battery is
approximately 2 years. | Same |
| Battery
Conditioning | Present | Not Present in unit since
battery is self-conditioning | Battery
conditioning
occurs in
both |
| Environmental
Operating
Conditions | Operating Temperature
Range: 59°F (15°C) to 100°F
(38°C).
Relative Humidity Range:
30% to 90%. | Operating Temperature
Range: 59°F (15°C) to 100°F
(38°C).
Relative Humidity Range:
30% to 90%. | Same |
| Dimensions | All-In-One Monitor: 12.20" W
x 13.30" H x 3.30" D
Smart Receiver Unit: 5.60"
W x 5.60" H x 1.90" D | All-In-One Monitor: 12.20" W
x 13.30" H x 3.30" D
Smart Receiver Unit: 5.60"
W x 5.60" H x 1.90" D | Same |
| Weight | All-In-One Monitor with Pole
Clamp: Approx. 8.0 lbs.
Smart Receiver Unit:
Approx. 0.5 lbs.
Utility Basket: Weight
capacity 10 lbs. | All-In-One Monitor with Pole
Clamp: Approx. 8.0 lbs.
Smart Receiver Unit: Approx.
0.5 lbs.
Utility Basket: Weight
capacity 10 lbs. | Same |
| System security
requires user
passwords for
access | Present | Present | Same |
| Interface to
clinical
information
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 | |
| Equipment - General Requirements for basic | |
| safety and essential performance 2012, Edition | |
| 3.1. Class 1.) | Pass |
| Compliance to IEC 60601-1-2 (Medical | |
| Electrical Equipment - General requirements for | |
| basic safety and essential performance - | |
| Collateral standard: Electromagnetic | |
| compatibility - Requirements and tests. | Pass |
| Compliance to IEC 62366-1:2015 (Part 1: | |
| Application of Usability Engineering to Medical | |
| Devices.) | Pass |
| Compliance to IEC 62304:2006 (Medical device | |
| software - 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.