(210 days)
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.
§ 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.