(145 days)
The InnerSense Esophageal Temperature Probe/Feeding Tube is a dual function, single-use sterile device which simultaneously provides continuous monitoring of esophageal temperature and delivers oral medications and/or enteral nutrition in neonatal and pediatric patients oro/nasogastrically, as directed by a physician for up to 30 days. The InnerSense device can be used solely for the purpose of monitoring esophageal temperature in situations where invasive monitoring is indicated.
The InnerSense Esophageal Temperature Probe/ Feeding Tube is a single- use, disposable, sterile device designed for nasogastric or orogastric placement in neonatal or pediatric patients. It is used to continuously monitor esophageal temperature, deliver oral medications and/or provide enteral feeding to a patient for up to 30 days. The InnerSense Esophageal Temperature Probe/ Feeding Tube can be used in neonates or children solely for temperature monitoring; it is not intended to be exclusively used for children who require enteral feeding. The device should be applied only under direct supervision of a licensed physician or healthcare provider and be safely connected only to an enteral giving set or syringe and the compatible patient monitor.
{
"1. A table of acceptance criteria and the reported device performance": "| Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) | Notes on Comparison | Status |\n|----------------------------------------|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|\n| **Temperature Accuracy Range:** | | | |\n| ± 0.1°C from 25°- 45°C | ± 0.1°C from 32°- 43°C | The thermistor type is identical. The minor difference in range is due to different testing standards (EN 12470-4 for predicate, ISO 80601-2-56 for proposed). The proposed device meets the clinical accuracy range of ISO 80601-2-56, applicable to the indicated patient population, and is considered substantially equivalent. | Met |\n| **Feeding Connector Materials:** | | | |\n| Polyvinyl Chloride (PVC)-Orange colorant | Polyurethane-Orange colorant; Polyurethane-Purple colorant | Tested in accordance with ISO 10993. Biocompatibility testing proved the patient-contacting materials for the proposed device have the same toxicological, sensitization, irritation, and acute toxicity profile as the previously cleared device, deemed substantially equivalent. | Met |\n| **Catheter Materials:** | | | |\n| Clear Polyurethane-Orange colorant + ink | Clear Polyurethane-White (TiO2) + ink | Tested in accordance with ISO 10993. Biocompatibility testing proved the patient-contacting materials for the proposed device have the same toxicological, sensitization, irritation, implantation, and acute toxicity profile as the previously cleared device, deemed substantially equivalent. | Met |\n| **Distal Tip:** | | | |\n| One lateral eye, one end eye in catheter tip | 2 offset lateral eyes, closed catheter tip | Tested in accordance with EN 1615 and ISO 80601-2-56. Results showed equivalent tensile strength properties to the predicate device and equivalent performance. All tests passed, deemed substantially equivalent. | Met |",
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document describes bench testing and verification, not clinical studies with a test set of patient data. Therefore, this information is not applicable in this context. The testing involved materials and performance criteria based on ISO and EN standards.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable. The ground truth for the performance testing was established by adherence to recognized international standards (e.g., ISO, EN) for medical device evaluation, rather than expert consensus on a test set of cases.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The device's performance was evaluated through bench testing against established standards, not through clinical adjudication by experts on a test set.",
"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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (esophageal temperature probe/feeding tube), not an AI diagnostic or assistance tool that would involve human readers.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This device is a physical medical device and does not involve an algorithm for standalone performance evaluation.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth for the device's performance was established through adherence to recognized international standards for medical devices, specifically: \n- **ISO 80601-2-56:2009** for clinical thermometers.\n- **EN1615: 2000** for enteral feeding catheters.\n- **ISO 80369-1-1: 2010** for small-bore connectors.\n- **ISO 11607-1-1: 2006** for packaging.\n- **ISO 10993 series** for biological evaluation (cytotoxicity, local effects, residuals, irritation, systemic toxicity, chemical characterization).",
"8. The sample size for the training set": "Not applicable. This device is a physical medical device, not a machine learning or AI model that requires a training set.",
"9. How the ground truth for the training set was established": "Not applicable. This device is a physical medical device and does not involve a training set."
}
§ 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.