(52 days)
Not Found
No
The description focuses on signal processing and tracking technology, with no mention of AI or ML terms or concepts.
No.
The device assists in guiding the placement of feeding tubes, but it does not directly treat a disease or condition. Its function is diagnostic/guidance-oriented rather than therapeutic.
No
The device assists in guiding the placement of feeding tubes, but it does not diagnose medical conditions. Its purpose is procedural assistance, not detection or identification of a disease/condition.
No
The device description explicitly details hardware components like a transmitting stylet with a coil winding, an externally positioned receiver unit, and a Monitor unit. It is described as an "electrical device."
Based on the provided information, the Avanos* CORTRAK*2 Enteral Access System (EAS) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CORTRAK*2 EAS is a device used to guide the placement of a feeding tube within the patient's body. It tracks the physical location of the tube tip using electromagnetic technology.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It interacts with the feeding tube and the patient's body externally to determine the tube's position.
Therefore, the CORTRAK*2 EAS falls under the category of a medical device used for a procedural purpose, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
KNT
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.
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 clinicians; clinical environment
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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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
1
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
2
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
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.
4
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
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.
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 Indication
for Use
(K191340) | Predicate Intended
Use
(K191340) | Subject Indication
for Use (K220558) | Subject Intended Use
(K220558) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| CORTRAK2
Equilateral EAS
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 | CORTRAK2
Equilateral EAS
Assists qualified
operators to guide
NG/NI feeding tubes
into stomach or small
bowel. | Avanos CORTRAK2
EAS
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 | Avanos* CORTRAK*2
EAS
Assists qualified
clinicians to guide
NG/NI feeding tubes
into stomach or small
bowel. |
5
| Predicate Indication
for Use
(K191340) | Predicate Intended
Use
(K191340) | Subject Indication
for Use (K220558) | Subject Intended Use
(K220558) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------|
| CORTRAK2
Equilateral EAS | CORTRAK2
Equilateral EAS | Avanos* CORTRAK2
EAS | Avanos CORTRAK2
EAS |
| 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. | | greater into the
stomach or small
bowel of patients
requiring enteral
feeding. | |
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.