(58 days)
Not Found
Yes
The summary mentions the development and validation of an "algorithm to determine if the tip of the feeding tube is in the respiratory tract" in an animal study. While the term "AI" or "ML" isn't explicitly used, the description of an algorithm designed to interpret sensor data (impedance and temperature) to make a determination about the tube's location strongly suggests the use of some form of computational intelligence, which could fall under the umbrella of AI/ML, particularly for pattern recognition or classification based on sensor inputs.
No
The device aids in the administration of nutrition and fluids, but does not itself treat or cure a disease or condition. Its purpose is supportive, not therapeutic.
No
The device is a feeding tube system that aids in the placement and monitoring of a feeding tube. While it provides "information about the tube tip relative to the stomach" and "alerts of tube migration," this information serves to guide a procedure rather than to diagnose a medical condition.
No
The device description explicitly states that the system consists of a feeding tube with embedded sensors and a portable electronic monitor, indicating the presence of hardware components beyond just software.
Based on the provided information, the Entarik Feeding Tube System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the administration of nutrition, fluids, and medications directly into the gastrointestinal tract. It also aids in the placement and monitoring of the feeding tube's position within the body. This is a therapeutic and monitoring function, not a diagnostic one performed on samples taken from the body.
- Device Description: The device consists of a feeding tube and a monitor that measures physical parameters (impedance and temperature) within the body to determine the tube's location. It does not analyze biological samples (blood, urine, tissue, etc.) to diagnose a disease or condition.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, reagents, or diagnostic assays, which are hallmarks of IVD devices.
Therefore, the Entarik Feeding Tube System falls under the category of a medical device used for treatment and monitoring, not for in vitro diagnosis.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The Entarik Feeding Tube is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.
The Entarik Feeding Tube System is designed to aid, in conjunction with institutional protocols, qualified operators in the placement of the Entarik Enteral Feeding Tube (Entarik FT) into the stomach of patients requiring enteral feeding. The Entarik FT is equipped with sensors designed to provide information about the location of the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik Monitor also monitors the feeding tube position continuously during the course of feeding and automatically and in real-time alerts of tube migration.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
The Entarik Feeding Tube System (Entarik System) consists of the Enteral Feeding Tube and the Entarik Monitor. The Entarik Feeding Tube is a nasogastric feeding tube with a single lumen for the administration of nutrition, fluids and medications. The Entarik Feeding Tube includes impedance and temperature sensors embedded within the tube, with wires located in the wall of the feeding tube. The Entarik Monitor is a portable electronic device that serves to measure and record impedance and temperature data from the sensors on the Feeding Tube and provides information to the operator to aid in initial placement and monitoring of feeding tube position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach
nasoenteric route
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified operators
institutional protocols
simulated clinical setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Bench testing performed on the Entarik Feeding Tube included 1) Gastric Soak and Preconditioning, 2) Dimensional. 3) Impedance and Temperature Accuracy and Sensing Rate. 4) Insertion and Withdrawal, 5) Flow and Pressure, 6) Buckle and Kink, 7) Tensile Integrity, 8) Simulated Use, 9) Radiopacity, 10) Product and Label Durability, and 11) Usability.
The Entarik Feeding Tube System was evaluated by fifteen (15) intended users in a simulated clinical setting. Tasks were assessed through observation during simulated use and through user knowledge assessments about the device's labeling and procedure steps that were not amendable to simulated use testing. Additionally, the test subjects completed a survey.
An animal study was conducted to develop and validate an algorithm to determine if the tip of the feeding tube is in the respiratory tract, in a porcine model. After induction of general anesthesia and placement of an endotracheal tube, the feeding tube was intentionally placed in the respiratory tract of eight pigs at various depths of insertion.
A feasibility validation study was conducted in 10 healthy volunteers to assess the functionality and safety of the system. Correct placement of the tube was verified via X-Ray.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing: Confirmed that the device performed as intended per product specifications and demonstrated substantial equivalence to the predicate device.
Human Factors: Evaluated 15 intended users in a simulated clinical setting. Demonstrated that the device labeling and training allowed for proper use and that identified risks were acceptable with no new risks identified.
Animal Study: Conducted in 8 pigs to develop and validate an algorithm to detect if the feeding tube tip is in the respiratory tract. The algorithm was successful in detecting respirations in all eight pigs and at all depths of insertion.
Clinical Study: Feasibility validation study conducted in 10 healthy volunteers. Tube insertions were successful in all subjects with no major issues reported. The procedure was well tolerated, and no unexpected adverse events were reported. Correct placement was verified via X-Ray, and no incorrect placements occurred.
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.
smARTrack™ Feeding Tube System (K142327)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 24, 2023
Gravitas Medical, Inc. Saheel Sutaria Chief Executive Officer 101 Mississippi St San Francisco, CA 94107
Re: K230206
Trade/Device Name: Entarik Feeding Tube System; Entarik Feeding Tube Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: KNT Dated: January 24, 2023 Received: January 25, 2023
Dear Saheel Sutaria:
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
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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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 -S
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) K230206
Device Name EntarikTM Feeding Tube
Indications for Use (Describe)
The Entarik Feeding Tube is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.
| 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)
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Indications for Use
510(k) Number (if known) K230206
Device Name EntarikTM Feeding Tube System
Indications for Use (Describe)
The Entarik Feeding Tube System is designed to aid, in conjunction with institutional protocols, qualified operators in the placement of the Entarik Feeding Tube (Entarik FT) into the stomach of patients requiring enteral feeding, The Entarik FT is equipped with sensors designed to provide information about the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik Monitors the feeding tube position continuously during the course of feeding and in real-time alerts of tube migration.
| 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) |
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."
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510(k) Summary (21 CFR § 807.92(c))
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 510(k) Number: | K230206 |
|---|---|
| Date Prepared: | January 24, 2023 |
| Applicant Information: | Gravitas Medical, Inc |
| 101 Mississippi St. | |
| San Francisco, CA 94107 | |
| Contact: | Saheel Sutaria |
| Office Number: | 415-926-8616 |
| Email: | ssutaria@gravitasmedinc.com |
Device Information:
| Trade/Device Name: | Entarik™ Feeding Tube System
Entarik™ Feeding Tube |
|--------------------|-------------------------------------------------------|
| Common Name: | Feeding Tube and Accessories |
| Regulation Number: | 21 CFR 870.5980 |
| Regulation Name: | Gastrointestinal Tube and Accessories |
| Regulatory Class: | Class II |
| Product Code: | KNT |
| Panel: | Gastrointestinal and Urology Devices |
| Predicate Device: | smARTrack™ Feeding Tube System (K142327) |
Device Description
The Entarik Feeding Tube System (Entarik System) consists of the Enteral Feeding Tube and the Entarik Monitor. The Entarik Feeding Tube is a nasogastric feeding tube with a single lumen for the administration of nutrition, fluids and medications. The Entarik Feeding Tube includes impedance and temperature sensors embedded within the tube, with wires located in the wall of the feeding tube. The Entarik Monitor is a portable electronic device that serves to measure and record impedance and temperature data from the sensors on the Feeding Tube and provides information to the operator to aid in initial placement and monitoring of feeding tube position.
Indications for Use
Entarik Feeding Tube
The Entarik Feeding Tube is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.
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Entarik Feeding Tube System
The Entarik Feeding Tube System is designed to aid, in conjunction with institutional protocols, qualified operators in the placement of the Entarik Enteral Feeding Tube (Entarik FT) into the stomach of patients requiring enteral feeding. The Entarik FT is equipped with sensors designed to provide information about the location of the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik Monitor also monitors the feeding tube position continuously during the course of feeding and automatically and in real-time alerts of tube migration.
Functional and Technological Comparison
The Entarik Feeding Tube System and smARTrack Feeding Tube System are both comprised of an electronic console which holds the system software and serves as the guiding interface to the user during initial tube placement as well as during ongoing use. The consoles both provide an alert when the system senses that the tube has moved out of position during ongoing use. Both the Entarik and smARTrack Feeding Tubes incorporate wired impedance sensors which transmit real-time information to the console regarding the feeding tube location.
There are some technological differences between the Entarik and smARTrack Feeding Tube Systems. The smARTrack device automatically stops feeding using a motorized mechanism in the event of tube dislodgement, whereas the Entarik device does not have that feature. The Entarik Feeding Tube System has an alert to notify the user in event of tube dislodgement. In addition to impedance sensors, the Entarik Feeding Tubes also incorporature sensors for additional information. The number, size, and location of the sensors, and the algorithms to determine tip location, are different between the Entarik and smARTrack systems.
To address the technological differences, the Entarik Feeding Tube System has undergone bench, pre-clinical, and clinical testing to ensure it functions correctly and achieves proper placement as well as correctly identifies tube malposition during the course of use. The performance data is provided in various sections of this submission. The Entarik System has successfully demonstrated its ability to guide the user in correct feeding tube placement. The system also correctly identifies tube movement. In the clinical study which was conducted, tube placement was initially verified with the Entarik System and a confirmatory X-Ray ("gold standard" placement verification) was performed. In all cases the Entarik System successfully guided the user to ensure correct placement was achieved. The available performance data supports the safety and effectiveness profile of the system and negates the technological differences between the Entarik System and the predicate device.
The Entarik feeding tubes are available in 8 and 12 Fr. The smARTrack feeding tube is available in 14Fr only. There are many FDA cleared feeding tubes which are available in various sizes ranging from 6 to 21 Fr. Therefore, this difference in tube diameter does not raise any new safety or effectiveness concerns as both devices are intended to be used in adult patients. Furthermore, biocompatibility tests were also performed to ensure the tubes are safe for use.
Performance Data
Below is a list of the tests that have been performed and successfully completed for the Entarik Feeding Tube System.
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Biocompatibility:
The biocompatibility evaluation for the Entarik System Feeding Tube was conducted in accordance with the FDA Guidance "Use of ISO 10993 –1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (June 2016) and International Standard ISO 10993-1:2018 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The Entarik Enteral Feeding Tube (FT) is considered to fall under the guidelines for a surface contacting device with direct mucosal tissue contact for a prolonged patient contact duration (>24 hours to 30 days) per the ISO/FDA guidelines and an actual patient exposure duration of less than