(109 days)
The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during surgery and parasurgical care only, with any compatible monitoring system, for continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.
The Neurovision Ink Printed Endotracheal Tube Electrode is an endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring during surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The Neurovision Ink Printed Endotracheal Tube Electrode is provided as a sterile, single use disposable accessory that connects to a compatible EMG monitor to provide an open airway for patient ventilation during EMG neuromonitoring of the Recurrent Laryngel Nerve (RLN).
The provided 510(k) summary for K130806, the Neurovision Ink Printed Endotracheal Tube Electrode, does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the manner typically expected for AI/ML devices. This submission for the Neurovision Ink Printed Endotracheal Tube Electrode is a Special 510(k), which is used for modifications to a legally marketed device where the modification does not affect the device's fundamental scientific technology. In such cases, the primary focus is on demonstrating that the modified device remains substantially equivalent to the predicate device and that the modifications do not introduce new questions of safety or effectiveness.
The document states that nonclinical testing was performed to demonstrate substantial equivalence. These tests focused on the functional and material characteristics of the modified device in comparison to the predicate device.
Here's an analysis of the provided information, focusing on aspects that might loosely correspond to "acceptance criteria" and "study results" in the context of this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
(Note: The document does not explicitly list "acceptance criteria" with quantitative targets as one might find for a new AI/ML device. Instead, it focuses on demonstrating equivalence to the predicate device through various non-clinical tests.)
| Characteristic/Test Performed | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Device Name | No change from Predicate Device | No Change |
| Indicated Use | No change from Predicate Device | No Change |
| Operating Principle | No change from Predicate Device (Receives EMG signal) | No Change |
| Shelf Life | 3 years (same as Predicate Device) | No Change (Implied to meet 3 years) |
| Reinforcing Material | Functionally equivalent to Predicate Device's dielectric coating | Dielectric coating attached to tube by non-phthalate PVC adhesive (Modified, but presumably equivalent performance) |
| Valve functionality | Functionally equivalent to Predicate Device's valve functionality | Demonstrated to be substantially equivalent to the predicate. |
| Electrode Impedance | Performance equivalent to Predicate Device's electrode impedance | Demonstrated to be substantially equivalent to the predicate. |
| Bend Tests | Performance equivalent to Predicate Device's bend performance | Demonstrated to be substantially equivalent to the predicate. |
| Biocompatibility (Systemic Toxicity, Intracutaneous Sensitivity, Irritation and Skin Sensitization) | Meet ISO 10993-1, 10993-10, 10993-11 standards (as applicable to the predicate) | Pass (Testing included these standards) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "test set" sample size in terms of patient data or clinical cases. The tests described (valve functionality, electrode impedance, bend tests, biocompatibility) are non-clinical, bench-top tests performed on device samples. The specific number of device units tested for each non-clinical test is not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data for this submission. The tests are non-clinical (bench testing and biocompatibility).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The ground truth for the non-clinical tests (e.g., whether a valve functions, impedance values, bend resistance, biocompatibility) is established through standardized testing protocols and measurements, not expert human interpretation of clinical data or images.
4. Adjudication Method for the Test Set
- Not applicable. There is no human adjudication for non-clinical, objective measurements like impedance or bend tests.
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
- Not applicable. This device is not an AI/ML diagnostic or assistive technology for human readers. It is a medical device for EMG monitoring.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical tests is based on objective, quantifiable measurements against established engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and functional equivalence to the legally marketed predicate device.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device is not an AI/ML algorithm.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" described in the 510(k) summary is a collection of nonclinical tests designed to demonstrate that the modified Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to its predicate device (K110989 Neurovision Ink Printed Endotracheal Tube Electrode) and that the modification (change in reinforcing material's attachment adhesive) does not alter the fundamental safety or effectiveness.
The document states:
"Nonclinical testing, including valve functionality, electrode impedance and bend tests demonstrated that the subject Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to the predicate."
Additionally, biocompatibility testing was performed following ISO standards:
"Biocompatibility testing included ISO 10993-11 Systemic Toxicity, ISO 10993-10 Intracutaneous Sensitivity and ISO 10993-10 Irritation and Skin Sensitization."
These tests, by demonstrating equivalence in critical functional aspects and meeting safety standards for biological interaction, serve as the evidence that the modified device "meets acceptance criteria" in the context of a Special 510(k) submission. The inherent acceptance criteria for such a submission are successful completion of these tests, confirming that the device performs functionally the same as the predicate and is safe for its intended use, despite the minor material modification.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.