(221 days)
The Navina Systems are indicated for use for children (2 -
The subject Navina Smart System is an electronically controlled, trans-anal irrigation system. The subject Navina Smart System consists of an electronic control unit, a water container and tubing set for water instillation, single-use, disposable rectal balloon catheters in two sizes (regular or small), and a disposable rectal cone catheter. The water container, tubing set and the regular (size) rectal balloon catheter utilized with the Navina Smart System are identical to the same components cleared under the original clearance of the predicate Navina Classic System in premarket notification, K170487.
With the Navina Smart control unit, the user controls water volume, irrigation speed, and rectal catheter balloon inflation. The Navina Smart system includes a mobile application in which users can save treatment data and rate their irrigation. The Navina Smart mobile application facilitates tracking of TAI treatment data (e.g., treatment duration, water volume used, rectal balloon size, etc.) but does not function in any way to control the function of the Navina Smart System itself.
The Navina Classic System is a manually operated trans-anal irrigation (TAI) system. The Navina Classic System, as subject of this "bundled" 510(k), consists of a manual control unit, a water container and tubing set for water instillation, single-use, disposable rectal balloon catheters in two sizes (regular or small), and a disposable rectal cone catheter. The water container, tubing set, and regular (size) rectal balloon catheter are identical to the same Navina Classic System components that were cleared under the system's original clearance in the predicate premarket notification, K170487.
This document describes the Dentsply Sirona Navina Smart System and Navina Classic System, trans-anal irrigation (TAI) systems. The submission is a 510(k) premarket notification (K190977) for the introduction of the Navina Smart System and modification of the Navina Classic System.
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance values. Instead, it lists the types of performance tests conducted and states that "The results of the testing conducted in conformity with applicable standards support substantial equivalence." This implies that the devices met the performance requirements defined by these standards.
Here's an organized view of the performance testing categories:
| Acceptance Criteria Category (Implied by Test Type) | Reported Device Performance (Implicitly Met) |
|---|---|
| Control Unit Performance | |
| Control of air leakage | Met applicable standards |
| Complete deflation of balloon (air release) | Met applicable standards |
| Ability to instantly stop waterflow | Met applicable standards |
| Control of water flow rate | Met applicable standards |
| Control of water back flow | Met applicable standards |
| Setting of balloon size (Navina Smart System) | Met applicable standards |
| Small Rectal Catheter Performance | |
| Balloon burst volume | Met applicable standards |
| Flexibility | Met applicable standards |
| Even balloon inflation | Met applicable standards |
| Balloon burst diameter | Met applicable standards |
| Rectal catheter flow rate | Met applicable standards |
| Rectal catheter after catheter kink | Met applicable standards |
| Hydrophilic coating | Met applicable standards |
| Conical Rectal Catheter Performance | |
| Hydrophilic coating at insertion and withdrawal | Met applicable standards |
| Bonding strength between the catheter body and conical component | Met applicable standards |
| Software Verification & Validation | |
| Compliance with IEC 60601-1 (Basic safety and essential performance) | Met applicable standards |
| Compliance with IEC 60601-1-11 (Home healthcare environment) | Met applicable standards |
| Compliance with IEC 60601-1-2 (Electromagnetic disturbances) | Met applicable standards |
| Compliance with IEC 60601-1-6 (Usability) | Met applicable standards |
| Compliance with IEC 62304 (Software Life Cycle Processes) | Met applicable standards |
| Compliance with IEC 62133 (Secondary Cells and Batteries Saftey) | Met applicable standards |
| Compliance with IEC 62366-1 (Usability Engineering) | Met applicable standards |
| Biocompatibility | |
| Simulated use extraction (ISO 10993-12) | Supported substantial equivalence |
| Chemical characterization | Supported substantial equivalence |
| Toxicological analysis and assessment | Supported substantial equivalence |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance testing and does not provide details on the sample sizes for these tests. It states that the testing was conducted to support substantial equivalence and addressed new components not part of the original clearance (K170487).
Regarding data provenance, the testing appears to be internal performance testing conducted by the manufacturer, Dentsply Sirona. The tests are for device components and software, not human subject data. Therefore, notions of "country of origin of the data" or "retrospective/prospective" studies are not directly applicable in the sense of clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance testing described is non-clinical, focusing on engineering and safety standards for the device itself. Therefore, the concept of "ground truth" as established by medical experts for a diagnostic or clinical outcome is not directly relevant here.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given that the performance testing is non-clinical and related to engineering standards, an adjudication method in the context of human interpretation or clinical endpoints would not typically be applicable. The tests likely have objective pass/fail criteria based on measured parameters and compliance with stated standards.
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, an MRMC comparative effectiveness study was not done. The Navina Smart System and Navina Classic System are trans-anal irrigation devices, not diagnostic AI systems that assist human readers in interpreting medical images or data. The Navina Smart system includes a mobile application for tracking data, but it does not function to control the device or provide AI assistance to human readers for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The Navina Smart System includes an "electronically controlled, trans-anal irrigation system" with a control unit that manages water volume, irrigation speed, and balloon inflation. It also has a mobile application for tracking treatment data.
While the control unit operates with programmed logic (an "algorithm"), the performance testing described (Control of air leakage, Complete deflation of balloon, Ability to instantly stop waterflow, Control of water flow rate, Control of water back flow, Setting of balloon size) represents a form of standalone testing for the functions controlled by the device's embedded software. This is not "algorithm only" in the sense of an AI model making a recommendation, but rather the functional performance of the electromechanical system. The mobile application facilitates tracking but does not function in any way to control the function of the Navina Smart System itself. So, the core function of water instillation and balloon inflation is a standalone device operation.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the non-clinical performance testing described, the "ground truth" would be the engineering specifications and applicable international standards (e.g., IEC 60601 series, IEC 62304, IEC 62133, IEC 62366-1, ISO 10993-12). The devices are tested against physical and functional requirements defined by these standards and the manufacturer's design specifications.
8. The Sample Size for the Training Set
This information is not provided as there is no mention of a "training set" in the context of machine learning or AI model development. The Navina Smart System and Navina Classic System are medical devices with electromechanical components and software, not AI algorithms that are trained on large datasets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for an AI model mentioned in the document.
§ 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.