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 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.

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.

AI/ML Overview

The provided text describes the Entarik Feeding Tube System and its evaluation for FDA clearance. However, it does not contain specific acceptance criteria with performance metrics in a table format, nor does it detail a comparative effectiveness study (MRMC) comparing human readers with and without AI assistance. The document focuses on demonstrating substantial equivalence to a predicate device through various tests.

Based on the provided text, here is an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria with specific quantitative performance metrics. Instead, it describes various tests performed and states that the device "successfully completed" or "performed as intended."

Summary of Reported Device Performance (Qualitative):

Test Category	Description of Performance
Biocompatibility	Evaluated in accordance with FDA Guidance and ISO 10993-1:2018. The battery of specified tests (Cytotoxicity, Intracutaneous Irritation, Maximization Sensitization, Acute Systemic Toxicity, Sub-acute Systemic Toxicity, Intramuscular Implantation, Material Mediated Pyrogenicity) were performed. (Implied: All tests passed as per standard requirements, as the conclusion states the system is "as safe and effective" as the predicate).
Electrical Safety and EMC	The system was tested and found to comply with IEC 60601-1:2005/EN 60601-1:2006 (3rd Ed) and IEC 60601-1-2:2007. (Implied: Passed all requirements of these standards).
Software V&V Testing	Conducted and documentation provided as recommended by FDA guidance. Software level of concern considered "moderate." (Implied: Verification and validation were successfully completed).
Bench Testing	Included Gastric Soak and Preconditioning, Dimensional, Impedance and Temperature Accuracy and Sensing Rate, Insertion and Withdrawal, Flow and Pressure, Buckle and Kink, Tensile Integrity, Simulated Use, Radiopacity, Product and Label Durability, and Usability. Performance Statement: "These bench performance studies confirm that the device performed as intended per the product specifications and also demonstrated that the Entarik Feeding Tube System is substantially equivalent to the smARTrack Feeding Tube System predicate device." (Implied: All tests met pre-defined specifications for performance and equivalence).
Human Factors	Evaluated by fifteen (15) intended users in a simulated clinical setting. Performance Statement: "The human factors assessment demonstrated that the device labeling and training provided to the intended users allowed for the proper use of the Entarik Feeding Tube System in its intended use environment. Further, this assessment confirmed that all identified risks were considered acceptable and that no new risks were identified."
Animal Study (Respiratory)	An algorithm to determine if the tube tip is in the respiratory tract was developed and validated in a porcine model. Performance Statement: "the algorithm was successful in detecting respirations in all eight pigs and at all depths of insertion."
Clinical Study (Placement)	A feasibility validation study was conducted in 10 healthy volunteers. Performance Statement: "Tube insertions in all subjects were successful with no major issues reported. The entire procedure was well tolerated by the subjects. No unexpected adverse events were reported... No incorrect placements occurred while using the feeding tube. Correct placement of the tube was verified via X-Ray." (Implied: 100% accurate placement confirmed by X-Ray).
Clinical Study (Monitoring)	The system "monitors the feeding tube position continuously during the course of feeding and automatically and in real-time alerts of tube migration." Performance Statement: "The system also correctly identifies tube movement." (No specific metrics provided for accuracy or timeliness of alerts).

2. Sample sizes used for the test set and the data provenance

Human Factors Test Set: Fifteen (15) intended users.
Animal Study Test Set: Eight (8) pigs (porcine model).
Clinical Study Test Set: 10 healthy volunteers.
Data Provenance: The document does not explicitly state the country of origin for the human or animal study data. The studies appear to be prospective in nature ("A feasibility validation study was conducted in 10 healthy volunteers," "A study was conducted to develop and validate the algorithm in a porcine model").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number or qualifications of experts used to establish ground truth for the human factors, animal, or clinical studies.

For the clinical study, "Correct placement of the tube was verified via X-Ray." This suggests radiologists or other qualified medical personnel interpreted the X-rays, but details are not provided.

4. Adjudication method for the test set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test sets. For the clinical study, it simply states that X-ray was used for confirmation of tube placement.

5. 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

No, the document explicitly states that the predicate device (smARTrack) automatically stops feeding using a motorized mechanism in the event of tube dislodgement, whereas the Entarik device does not have that feature. The Entarik system has an alert. This implies the Entarik system is primarily an aid to operators, but the study described is not an MRMC comparative effectiveness study with human readers assisted by AI vs. unassisted human readers. The clinical study's focus was on initial placement guidance and the system's ability to identify tube movement, not on measuring improvements in human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, implicitly.

Animal Study: The animal study appears to be a standalone (algorithm only) validation for detecting respiratory tract placement: "A study was conducted to develop and validate the algorithm in a porcine model... the algorithm was successful in detecting respirations in all eight pigs and at all depths of insertion." This suggests the algorithm's performance was evaluated directly without human intervention during the detection process.
Clinical Study (Monitoring): The statement "The Entarik Monitors the feeding tube position continuously during the course of feeding and in real-time alerts of tube migration... The system also correctly identifies tube movement" suggests standalone algorithm performance in detecting migration, though the exact metrics are not provided.

7. The type of ground truth used

Animal Study (Respiratory Tract Detection): Ground truth was established by intentional placement of the feeding tube in the respiratory tract at various depths.
Clinical Study (Initial Placement): Ground truth for correct tube placement in the stomach was established using X-Ray ("gold standard" placement verification).
Clinical Study (Tube Migration): The text states "The system also correctly identifies tube movement," but it doesn't specify how the ground truth for "tube movement" was independently established (e.g., another imaging modality, direct observation, or a different sensor).

8. The sample size for the training set

The document does not explicitly state the sample size used for the training set for any of the algorithms. It mentions that clinical studies were conducted "to develop an algorithm to guide feeding tube placement into the stomach" but does not separate development/training data from validation data. The animal study was also for "developing and validating" the respiratory tract algorithm.

9. How the ground truth for the training set was established

The document combines the description of algorithm development and validation. For the development of the algorithm to guide feeding tube placement, it states that "clinical studies were conducted to develop an algorithm to guide feeding tube placement into the stomach." It implies that data collected during these "development" studies (potentially similar to the 10 healthy volunteers study) with X-ray confirmation would have served as the ground truth for training.

For the respiratory tract detection algorithm, it was developed in a porcine model, and ground truth would have been established by known, intentional placement of the tube into the respiratory tract.

Summary

{0}------------------------------------------------

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

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K230206

Device Name EntarikTM Feeding Tube

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."

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K230206

Device Name EntarikTM Feeding Tube System

Indications for Use (Describe)

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.

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."

{4}------------------------------------------------

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, Inc101 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 SystemEntarik™ 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

Indications for Use

Entarik Feeding Tube

{5}------------------------------------------------

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.

{6}------------------------------------------------

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 <30 days in the clinical application.

The battery of testing included the following tests:

-Cytotoxicity Study Using the ISO Elution Method
ISO Intracutaneous Irritation Test -
-ISO Maximization Sensitization Test
-ISO Acute Systemic Toxicity Study
ISO Sub-acute Systemic Toxicity Study -
-ISO Intramuscular Implantation Test
-ISO Material Mediated Pyrogenicity

Electrical safety and electromagnetic compatibility (EMC):

The system was tested and found to comply with IEC 60601-1:2005/EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 3rd Ed and IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.

Software Verification and Validation Testing:

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", (issued May 11, 2005). The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could result in minor injury to the patient.

Bench:

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. These bench performance studies confirm that the device performed as intended per the product specifications and also demonstrated that the Entarik Feeding Tube System is substantially equivalent to the smARTrack Feeding Tube System predicate device.

Human Factors:

{7}------------------------------------------------

The Entarik Feeding Tube System was evaluated by fifteen (15) intended users in a simulated clinical setting. This testing was conducted pursuant to the applicable requirements of FDA's Guidance Document titled "Applying Human Factors and Usability Engineering to Medical Devices (issued February 3, 2016)." For this evaluation, the users were trained by Gravitas personnel. Post training, users were provided with the Entarik Feeding Tube System and the proposed Instructions for Use. 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. The human factors assessment demonstrated that the device labeling and training provided to the intended users allowed for the proper use of the Entarik Feeding Tube System in its intended use environment. Further, this assessment confirmed that all identified risks were considered acceptable and that no new risks were identified.

Animal:

The Entarik Monitor contains an algorithm to determine if the tip of the feeding tube is in the respiratory tract. A study was conducted to develop and validate the algorithm 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, and the algorithm was successful in detecting respirations in all eight pigs and at all depths of insertion.

Clinical:

Clinical studies were conducted to develop an algorithm to guide feeding tube placement into the stomach. A feasibility validation study was conducted in 10 healthy volunteers to assess the functionality and safety of the system. Tube insertions in all subjects were successful with no major issues reported. The entire procedure was well tolerated by the subjects. No unexpected adverse events were reported. Most patients that undergo feeding tube insertion experience some pain and discomfort and therefore none of the feedback that was received from the healthy volunteers was unexpected. It should be noted that the main target population for the system would be unconscious or anesthetized patients for whom minor pain and discomfort would be negligible. Furthermore, according to the patients' subjective feedback, throughout the procedure, no severe pain or discomfort was recorded. The convenience of the feeding tube insertion was assessed via questionnaires completed by the clinical staff. Correct placement of the tube was verified via X-Ray. No incorrect placements occurred while using the feeding tube.

Conclusion:

The Entarik Feeding Tube System has a similar intended use as the smARTrack predicate device. The Entarik Feeding Tube System is similar in technological and performance characteristics to the smARTrack predicate. The minor technological differences do not raise any new safety and effectiveness risks or concerns. It can be concluded that the Entarik Feeding Tube System is as safe and effective as the predicate device for the intended use, and is substantially equivalent.

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.