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510(k) Data Aggregation
(210 days)
Gravitas Medical, Inc.
Entarik NI Feeding Tubes (FTs) are intended for the administration, fluids and medications by the nasoenteric or orogastric route for neonatal patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.
The Entarik NI Feeding Tube System (Entarik NI System) is designed to aid, in conjunction with institutional protocols, qualified operators in the placement of the Entarik NI Feeding Tube (FT) into the stomach of neonatal patients requiring enteral feeding. The Entarik FTs are 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 NI FTs are provided sterile.
The Entarik NI System also monitors the feeding tube position continuously during the course of feeding and automatically and in real time alerts of tube migration.
The Entarik NI System provides continuous monitoring of gastric and esophageal temperature. The Entarik device can be used solely for the purpose of monitoring gastric and esophageal temperature in situations where invasive monitoring is indicated.
The Entarik NI system is intended to record, store, view and analyze impedance in the pharynx and stomach.
The Entarik NI Feeding Tube System (Entarik NI System) consists of the Entarik NI Feeding Tube (disposable) and the Entarik NI Monitor (reusable) with Power Supply. The Entarik NI System is designed for enteral feeding and to aid in the placement of the Entarik NI Enteral Feeding Tube into the stomach of neonatal patients requiring enteral feeding. The Entarik NI System also continuously monitors feeding tube position, gastric and esophageal temperature, and gastrointestinal impedance and reflux. The feeding tubes are single use devices intended for prolonged use (less than 30 days). The Entarik NI Feeding Tubes are provided sterile.
The provided text describes the acceptance criteria and study proving the device meets those criteria for the Entarik NI Feeding Tube System.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various tests performed and states that the device was found to be "safe and effective". We can infer the "acceptance criteria" from the fact that no issues were raised during these tests, indicating successful outcomes for all mentioned evaluations.
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Sterilization | Validation performed per ISO 11135-1 and ISO 10993-7. |
| Biocompatibility | Evaluation performed per ISO 10993-1:2018 and FDA guidance. Leveraged existing tests from primary predicate due to identical materials and manufacturing processes (Cytotoxicity, Intracutaneous Irritation, Maximization Sensitization, Acute Systemic Toxicity, Sub-acute Systemic Toxicity, Intramuscular Implantation, Material Mediated Pyrogenicity were successfully demonstrated). |
| Software Quality | Verification and validation testing performed per IEC 62304:2015, demonstrating safety and performance. |
| Electrical, Mechanical, and Thermal Safety, and EMC | Designed to comply with AAMI/ANSI ES60601-1, IEC 60601-1-6, IEC 60601-1-8, IEC 80601-2-49, ISO 80601-2-56, and IEC 60601-1-2. |
| Device Performance (Bench) | Bench tests performed: Dimensional Verification, Impedance and Temperature Accuracy and Sensing Rate, Insertion and Withdrawal, Flow and Pressure, Buckle and Kink, Tensile Integrity, Viscous Feed Testing, Radiopacity, Product and Label Durability. All tests implicitly passed as no failures are indicated. |
| Clinical Performance | In the validation study, the system was "safe and effective in all eleven neonatal participants to aid qualified operators in the placement of the Entarik FT into the stomach of patients, and monitor the feeding tube position continuously and automatically and in real-time alert of tube migration." |
2. Sample Sizes and Data Provenance
- Training Set Sample Size: 16 subjects.
- Test Set Sample Size: 11 subjects for the validation study.
- Data Provenance: The document does not explicitly state the country of origin. The studies appear to be prospective clinical studies, as they involved the placement and monitoring of the device in new participates for the purpose of the study.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing ground truth. It mentions that the validation study's placement confirmation was "per institutional standard of care," which implies reliance on qualified medical professionals within the clinical setting.
4. Adjudication Method
The document does not describe a specific adjudication method (e.g., 2+1, 3+1, none) for the test set. It mentions "placement was confirmed per institutional standard of care," suggesting that the medical institution's standard procedures were followed for verifying tube placement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of how much human readers improve with AI vs. without AI assistance. The study focuses on the device's ability to aid operators and monitor position, not on comparing human reader performance with and without AI.
6. Standalone (Algorithm Only) Performance
The document describes two clinical studies. The first (observational study) collected data silently for algorithm training and optimization without providing placement guidance. This suggests an initial phase where the algorithm was developed and refined, but standalone performance against a ground truth is not explicitly reported in terms of metrics like sensitivity/specificity for tube placement. The second (validation study) involved the device aiding qualified operators, indicating a human-in-the-loop scenario rather than a purely standalone algorithm evaluation of performance directly supporting a diagnostic claim.
7. Type of Ground Truth Used
- For the validation study's tube placement: "placement was confirmed per institutional standard of care." This likely refers to methods such as X-ray confirmation, pH testing of aspirate, or visual confirmation, as standard practice in clinical settings for feeding tube placement. While not explicitly stated, this would be a clinical ground truth established by medical professionals following established protocols.
- For continuous monitoring of tip location: The device itself automatically and in real time alerts of tube migration. The validation study confirmed this functionality was "safe and effective," implying these alerts were indeed accurate relative to actual tube migration conditions (though the specific ground truth for judging "tube migration" during continuous monitoring is not detailed).
8. Sample Size for the Training Set
The training set for the algorithm involved 16 subjects.
9. How the Ground Truth for the Training Set was Established
In the observational study for algorithm training and optimization, the Entarik NI Monitor "did not provide any placement guidance or verification. It collected impedance and temperature data silently that was used to train and optimize the placement and monitoring algorithm." This implies that while the device collected its data, the true tube position (ground truth) during this training phase was independently established by standard clinical methods (e.g., X-ray) by the clinicians or institution, and this independent ground truth was then used to train the algorithm. The document doesn't explicitly state the method for ground truth establishment during the training phase, but it must have been an independent reference standard.
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(58 days)
Gravitas Medical, Inc.
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.
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