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510(k) Data Aggregation
(152 days)
NovaGuide 2 Intelligent Ultrasound is a medical ultrasound system intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the bloodstream. The system assists the user in the setup and acquisition of cerebral blood flow velocity via the patient's temporal windows.
NovaGuide 2 Intelligent Ultrasound is intended to be used by healthcare professionals qualified by training in its safe and effective use. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
NovaGuide 2 is a mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) ultrasound system. It is intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the bloodstream. NovaGuide 2 is intended to be used by healthcare professionals qualified by training in its safe and effective use. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
NovaGuide 2 is a cart-mounted system for use in hospitals or clinics. The system is comprised of a computer, Doppler Robotics Unit (DRU), probe pods, patient headmount unit (PHU) and two reusable, non-sterile 2-MHz transducers that can be operated in either robotic or manual modes. When used in robotic mode, the operator is guided in positioning the two transducers, one on each side of the patient's head. The transducers are positioned using robotic actuators that adjust the translational and angular positions using TCD signal search algorithms, which assists the operator in monitoring the blood flow velocity of the vessels via the patient's temporal acoustic windows. Visualization and detection of emboli occur through High-Intensity Transient Signals (HITS) in the display of the TCD blood flow.
The NovaGuide 2 Intelligent Ultrasound device underwent nonclinical testing to establish its performance and safety. As such, no clinical study was performed. The nonclinical testing included assessment of basic safety, essential performance, acoustic output, acoustic temperature, and functional testing of specific features.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Basic Safety & Essential Performance | Compliance with IEC 60601-2-37 for ultrasonic diagnostic equipment. | Passed. |
| Acoustic Output | Maximum derated ISPTA < 720mW/cm². Maximum MI < 1.0. | NovaGuide 2 global maximum derated ISPTA is < 720mW/cm². NovaGuide 2 global maximum MI is < 1.0. |
| Acoustic Temperature | Temperature rise within limits as per IEC 60601-2-37 in simulated use and still air conditions. | NovaGuide 2 temperature rise for both conditions remained within limits, producing passing results. |
| Functional Testing | Expected outcomes for: | Expected outcomes obtained for each parameter (signal search, depth and velocity, ALARA precaution messaging and controls, VMR Index, Shunt Grade Assist, and enhanced Emboli Finder). |
| - Signal search | ||
| - Depth and velocity | ||
| - ALARA (As Low As Reasonably Achievable) precaution messaging and controls | ||
| - VMR (VasoMotor Reactivity) Index | ||
| - Shunt Grade Assist (detection of embolic events in Bubble exams) | ||
| - Enhanced Emboli Finder (enhanced emboli detection capability during Emboli exams) | ||
| Biocompatibility | Materials of components contacting intact skin for limited duration (≤ 24 hour) are equivalent to those existing in previously cleared devices (NeuralBot, K180445; Lucid M1 System, K160442). | No new materials were introduced compared to the predicate and reference devices. A summary biocompatibility evaluation was provided. |
| Electromagnetic Compatibility (EMC) & Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-1-2. | Complies with IEC 60601-1 and IEC 60601-1-2. |
| Software Verification and Validation | Software treated as "moderate" level of concern. Documentation provided as recommended by FDA's guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Proper verification and validation were conducted. | Software verification and validation testing were conducted, and documentation is provided. The software for this device was considered to have a "moderate" level of concern. Passed per Sections 18.12 and 18.27 (not provided in this excerpt). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the primary basis for performance validation was nonclinical testing (simulation, bench testing, and engineering assessments) rather than a clinical study with a patient test set.
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, as no clinical test set requiring expert ground truth establishment was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was used.
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, as no MRMC study was performed. The device's performance was established through nonclinical testing.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the functional testing described (signal search, depth and velocity, ALARA precaution messaging and controls, VMR Index, Shunt Grade Assist, and enhanced Emboli Finder) represents a standalone performance evaluation of the algorithms and device functionalities. The testing confirmed that "Expected outcomes were obtained for each parameter."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the nonclinical testing was based on:
- Engineering specifications and standards: For acoustic output, temperature, electrical safety, and biocompatibility, performance was compared against established engineering limits and regulatory standards (e.g., IEC 60601-2-37).
- Expected functional outcomes: For specific software features like signal search, VMR Index, and Emboli Finder, the ground truth was the predefined correct operation and output as per the device's design and intended functionality.
8. The sample size for the training set
Not applicable. The provided information does not describe a machine learning model that would require a distinct training set in the conventional sense for the device's approval. The validation focused on the functional and safety performance of the integrated system.
9. How the ground truth for the training set was established
Not applicable, as no machine learning training set is explicitly mentioned or relevant for the described nonclinical testing approach.
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