(292 days)
smARTrack™ Feeding Tube System can guide operator to correctly re-position the tube.
The smARTrack™ Feeding Tube System is designed to aid qualified operators in the smARTrack Feeding Tube into the stomach of patients requiring enteral feeding. The smARTrack™ tube is equipped with sensors designed to provide information about the location of the tube tip relative to the lower esophageal sphincter (LES) thus assisting in reducing the incidence of misplacement during first positioning. The smARTrack™ tube also monitors the position continuously during the course of the feeding and automatically and in real time alerts of tube migration. The smARTrack equipped with a motorized mechanism which automatically and in real-time stops feeding tube moves out of position during ongoing use. Furthermore, smARTrack™ Feeding Tube System can guide operator to correctly re-position the tube.
The smARTrack™ Feeding Tube is intended for gastric decompression, gastric lavage, and the administration of nutrition, fluids and medications by the naso-enteric route for patients who have an intact gastrointestinal tract but are manage nutritional intake through normal mastication and deglutition.
The smARTrack™ Feeding Tube System is based on sensor-lined tubes that transmit real-time information to an external console. The information relayed to the console is used to transmit information about the location of the tube tip relative to the lower esophageal sphincter (LES).
The smARTrack™ System contains the following:
a) Feeding tube (multi-lumen, feeding inlet compatible with standard gravity bag unit and impedance sensors)
b) Electronic console which: indicate the location of the tube in the body, stops the feeding in case of overfeeding and keep a patient event log.
The provided text describes the smARTrack™ Feeding Tube System and smARTrack™ Feeding Tube, seeking 510(k) clearance. Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a tabular format with specific numerical targets. However, based on the performance data section and conclusions, the implied acceptance criteria revolve around:
- Correct tube placement: The system should guide the user to ensure the feeding tube is correctly placed into the stomach relative to the Lower Esophageal Sphincter (LES).
- Identification of tube malposition/migration: The system should continuously monitor the tube's position and alert in real-time if it moves out of position.
- Automatic feeding cessation: The motorized mechanism should automatically stop feeding if the tube moves out of position.
- Safety: The device should be safe for use, as demonstrated by biocompatibility, electrical safety, and the absence of unexpected adverse events in clinical trials.
- Functionality: All components and features (sensors, console, motorized mechanism) should function correctly as intended.
Here's a table summarizing the reported device performance against these implied criteria:
| Implied Acceptance Criterion | Reported Device Performance |
|---|---|
| Correct tube placement guidance | "In all cases the System successfully guided the user to ensure correct placement was achieved." (Clinical study) |
| "The study confirmed that the Feeding Tube position sensors work very well and identify the correct location of the LES." (Animal study) | |
| "No incorrect placements occurred while using the feeding tube." (Clinical study) | |
| Identification of tube malposition/migration | "The smARTrack™ tube also monitors the position continuously during the course of the feeding and automatically and in real time alerts of tube migration." (Indications for Use / Device Description) |
| "The system also correctly identifies tube movement and the automatic mechanism which stops the feeding has also been validated." (Comparison section) | |
| Automatic feeding cessation upon malposition | "The smARTrack console is equipped with a motorized mechanism which automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use." (Indications for Use / Device Description) |
| "The system also correctly identifies tube movement and the automatic mechanism which stops the feeding has also been validated." (Comparison section) | |
| Safe operation (Biocompatibility, Electrical Safety, EMC) | Biocompatibility: Successfully completed Cytotoxicity, Systemic Injection, Intracutaneous Study, Implantation, and Subacute Toxicity. |
| Electrical/EMC: Complies with IEC 60601-1:2005/EN 60601-1:2006 and IEC 60601-1-2:2007. | |
| Clinical: "No unexpected Adverse Events were reported." | |
| Overall functionality (sensors, console, motorized mechanism) | "Proper functionality of the sensors was confirmed." (Ex-Vivo Animal study) |
| "The study confirmed that the Feeding Tube position sensors work very well and identify the correct location of the LES." (In-Vivo Animal study) | |
| "The system has successfully demonstrated its ability to guide the user in correct feeding tube placement." (Comparison section) | |
| Software Verification and Validation | Conducted and documentation provided, determined as "moderate" level of concern. |
| Bench testing (bending, HCL, tensile properties, leakage, flow, misconnection, motorized mechanism performance) | All listed bench tests were "successfully completed." |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Test Set Sample Size: 10 healthy volunteers.
- Data Provenance: The document explicitly states "A feasibility study was conducted on 10 healthy volunteers." It does not specify the country of origin, but the applicant company is ART Healthcare Ltd. in Israel. The study appears to be prospective, as indicated by "was conducted."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states, "Correct placement of the tube was verified via X-Ray." It does not specify the number or qualifications of experts (e.g., radiologists) who interpreted the X-Rays to establish ground truth.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set results (e.g., 2+1, 3+1 for resolving discrepancies). It simply states that X-Ray was used for verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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. The clinical study was a feasibility study on 10 healthy volunteers to assess the system's functionality and safety, with X-Ray as independent verification for correct placement. It does not compare human reader performance with or without AI assistance, nor does it report an effect size for such a comparison. The device is a guiding system rather than an AI interpretation tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not conducted or reported. The device is explicitly designed as a "system" to "guide the operator," implying human-in-the-loop operation. The "automatic mechanism which stops feeding" is part of the integrated system and validated in that context.
7. The Type of Ground Truth Used
The primary ground truth used for verifying correct tube placement in the clinical study was X-Ray verification.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. This is a medical device clearance document, not a machine learning model submission, so the concept of a "training set" in the context of an AI/ML algorithm might not directly apply in the way it's typically understood for neural networks or similar models. The "software verification and validation testing" is mentioned, implying traditional software engineering approaches rather than specific machine learning training datasets. The system uses "impedance sensors" to provide information about tube location, suggesting a physics-based model or rule-based system validated through bench and animal studies, rather than a data-driven model requiring a large training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is mentioned in the context of a machine learning model, the method for establishing its ground truth is also not provided. The development and validation relied on:
- Engineering principles and testing (bench studies).
- Animal studies (Ex-Vivo and In-Vivo) where the "correct location of the LES" was identified through direct observation or established biological markers.
- Clinical feasibility study where X-Ray served as the ground truth for human-guided placement.
§ 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.