(58 days)
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.
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.
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.
§ 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.