(152 days)
Lucid M1 System, K160442
Yes
The device description explicitly mentions "TCD signal search algorithms" used by the robotic actuators to assist in positioning the transducers. While not explicitly stating "AI" or "ML," the use of algorithms for automated searching and positioning based on signal feedback strongly suggests the application of intelligent or machine learning-based control systems to optimize the ultrasound acquisition process. The term "Intelligent Ultrasound" in the product name also hints at advanced processing beyond standard ultrasound.
No.
The device is described as a diagnostic tool for measuring and displaying cerebral blood flow velocity and detecting emboli, intended to be used as an adjunct to standard clinical practices, not for treatment.
Yes
The device is intended for "measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the bloodstream," which is a diagnostic function assisting in the evaluation of vital patient physiological processes.
No
The device description explicitly states it is a "cart-mounted system" comprised of hardware components including a computer, Doppler Robotics Unit (DRU), probe pods, patient headmount unit (PHU), and two reusable transducers. This indicates it is a hardware system with integrated software, not a software-only device.
Based on the provided information, the NovaGuide 2 Intelligent Ultrasound is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The NovaGuide 2 is a non-invasive ultrasound system that directly measures and displays cerebral blood flow velocity and detects emboli within the bloodstream of the patient. It does not analyze samples taken from the patient.
- The intended use and device description clearly state its function is to measure and display physiological parameters directly from the patient. This is characteristic of in vivo diagnostic devices, not in vitro ones.
Therefore, the NovaGuide 2 Intelligent Ultrasound is an in vivo diagnostic device.
No
The provided input text does not contain any language indicating that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
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.
Product codes
IYN, ITX, OQQ
Device Description
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.
NovaGuide 2 Traditional is an adjunctive portable, non-ionizing radiation, point-ofcare TCD ultrasound system. It is designed to measure and display cerebral blood flow velocities and detect emboli within the arteries of the head and neck. NovaGuide 2 Traditional Configuration does not contain the robotic Patient Headmount Unit; therefore, it can only be used in manual mode using the supplied 2MHz handheld transducers.
The all-in-one computer hosts the NovaGuide 2 application software. The software processes TCD data and provides Graphical User Interface (GUI), and, for NovaGuide 2, setup and procedural and algorithmic search commands to the PHU via the DRU.
NovaGuide View is an optional and supplemental accessory to NovaSignal medical ultrasound systems. NovaGuide View is intended to transfer, store, convert formats, enhance, and display transcranial Doppler (TCD) ultrasound exam data and results, originating from NovaSignal ultrasound systems. In addition, it allows qualified healthcare personnel to add and approve interpretations of exam data and remotely view live streaming of exams.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cerebral blood flow (head and neck, via patient's temporal acoustic windows, foramen magnum, and transorbital windows)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals qualified by training in its safe and effective use. The device is not intended to be used inside the sterile field.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Nonclinical Testing:
NovaGuide 2 performance was established through nonclinical testing conducted either externally by a qualified facility or internally by NovaSignal Corp. Assessment of basic safety and essential performance of ultrasonic diagnostic equipment occurred in accordance with IEC 60601-2-37. For evaluation of acoustic output, an Acoustic Power and Intensity measurement system (API) was used to measure acoustic power output while the NovaGuide 2 DRU and transducer operated in PW-Mode and at settings that produced maximum power output. The system generated passing results. Acoustic temperature was also evaluated 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 was also performed for signal search, depth and velocity, ALARA precaution messaging and controls, VMR Index, Shunt Grade Assist, and enhanced Emboli Finder. Step-bystep execution of each parameter was confirmed during simulated use operation. Expected outcomes were obtained for each parameter.
NovaGuide 2 safety and effectiveness was confirmed as evidenced by passing results obtained for all nonclinical testing.
Biocompatibility Testing:
NovaGuide 2 components are intended to contact intact skin for limited duration (≤ 24 hour). None of the materials in NovaGuide 2 differ from those existing and described in 510(k)s for the primary predicate device (NeuralBot, K180445) and the reference device (Lucid M1 System, K160442). Therefore, a table of summary biocompatibility evaluation is provided in Section 17.
Electromagnetic Compatibility and Electrical Safety:
NovaGuide 2 underwent equivalent Electromagnetic Compatibility (EMC) and electrical safety testing as did the predicate device. NovaGuide 2 complies with IEC 60601-1 and IEC 60601-1-2.
Software Verification and Validation Testing:
Software verification and validation testing were conducted, and documentation is provided as recommended by FDA's guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered to have a "moderate" level of concern, since failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Clinical Testing:
Nonclinical testing was considered appropriate to confirm safety and effectiveness of NovaGuide 2; therefore, clinical testing was not performed.
Key Metrics
Not Found
Predicate Device(s)
NeuralBot, K180455
Reference Device(s)
Lucid M1 Transcranial Doppler Ultrasound System, K160442
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
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NovaSignal Corporation % Carrene Plummer Senior Regulatory Affairs Manager 2440 S. Sepulveda Blvd., Ste 115 LOS ANGELES CA 90064
Re: K213279
Trade/Device Name: NovaGuide 2 Intelligent Ultrasound Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, ITX, OQQ Dated: January 24, 2022 Received: January 26, 2022
March 2, 2022
Dear Carrene Plummer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb, Ph.D. Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213279
Device Name NovaGuide 2 Intelligent Ultrasound
Indications for Use (Describe)
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.
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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7 510(K) SUMMARY
K213279
7.1 Submitter Information
Submitter: NovaSignal Corporation
Address: 2440 South Sepulveda Blvd., Ste. 115, Los Angeles, CA 90064
Establishment Registration Number: 3013368530
Contact Person: Raajdeep (Raaj) Venkatesan
Phone: (323) 252-4762
Facsimile: (310) 819-1676
Email: raaj@novasignal.com
Date Prepared: October 7, 2021
7.2 Name of Device and Classification
Trade Name: NovaGuide 2 Intelligent Ultrasound
Common Name: NovaGuide 2
Model Numbers:
NSC-NVGSYS2 – NovaGuide 2 Intelligent Ultrasound NSC-TCDNG2 - NovaGuide 2 Traditional
Classification Name: Ultrasonic pulsed doppler imaging system (21 CFR 892.1550); Transducer, Ultrasonic, Diagnostic (21 CFR 892.1570); Diagnostic Ultrasonic Transducer, Robotic (21 CFR 892.1570)
Product Codes: IYN, ITX, OQQ
7.3 Predicate Device
Primary Predicate Device: NeuralBot, NovaSignal Corporation (K180455)
Reference Device: Lucid M1 Transcranial Doppler Ultrasound System, NovaSignal Corporation (K160442)
7.4 Device Description
7.4.1 NovaGuide 2 Configuration
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.
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Image /page/4/Picture/0 description: The image shows the logo for NovaSignal. The logo consists of a blue circle with three smaller white circles inside, followed by the text "NovaSignal" in a simple, sans-serif font. A small trademark symbol appears to the upper right of the word "Signal".
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.
7.4.2 NovaGuide 2 Traditional Configuration
NovaGuide 2 Traditional is an adjunctive portable, non-ionizing radiation, point-ofcare TCD ultrasound system. It is designed to measure and display cerebral blood flow velocities and detect emboli within the arteries of the head and neck. NovaGuide 2 Traditional Configuration does not contain the robotic Patient Headmount Unit; therefore, it can only be used in manual mode using the supplied 2MHz handheld transducers.
7.4.3 Software Description
7.4.3.1 NovaGuide 2 Software
The all-in-one computer hosts the NovaGuide 2 application software. The software processes TCD data and provides Graphical User Interface (GUI), and, for NovaGuide 2, setup and procedural and algorithmic search commands to the PHU via the DRU.
7.4.3.2 NovaGuide View™ Software Accessory
NovaGuide View is an optional and supplemental accessory to NovaSignal medical ultrasound systems. NovaGuide View is intended to transfer, store, convert formats, enhance, and display transcranial Doppler (TCD) ultrasound exam data and results, originating from NovaSignal ultrasound systems. In addition, it allows qualified healthcare personnel to add and approve interpretations of exam data and remotely view live streaming of exams.
7.5 Indications for Use
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.
7.6 Intended Use
NovaGuide 2 Intelligent Ultrasound is intended to be used during diagnostic exams and surgical interventions as an adjunct to the standard clinical practices for measuring and displaying cerebral
NovaGuide 2 510(k): K213279
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Image /page/5/Picture/0 description: The image contains the logo for NovaSignal. The logo consists of a blue circle with three smaller white circles inside, followed by the text "NovaSignal" in a simple, sans-serif font. The word "NovaSignal" is written in black, and there is a trademark symbol to the upper right of the word.
blood flow velocity within the major conducting arteries of the head and neck. Cerebral blood flow velocity within these arteries is visualized using non-invasive pulsed transcranial Doppler ultrasound (TCD). This includes, but is not limited to, insonation of the middle, anterior and posterior cerebral arteries via the temporal windows, the vertebral and basilar arteries via the foramen magnum, and the ophthalmic arteries and internal carotid artery siphons via the patient's transorbital windows.
TCD is a common tool for the visualization of cerebral blood flow velocity and the detection of emboli which present as High-Intensity Transient Signals (HITS) in the display of the TCD blood flow.
7.7 Predicate Device Comparison
- 7.7.1 Device Comparison Similarities
| Technological
Characteristic | NovaGuide 2 Intelligent
Ultrasound | Lucid M1 Transcranial Doppler
Ultrasound System (Lucid M1
System) - Lucid TCD | NeuralBot when connected to the
Lucid M1 System - NovaBot |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SUBMISSION DEVICE | (Reference Device)
K160442 | (Primary Predicate)
K180445 |
| Product Code,
Class | IYN, ITX, OQQ
Class II | IYN, ITX
Class II | IYN, ITX, OQQ
Class II |
| Indications for
Use | 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.
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. | The Lucid M1 System is a medical
ultrasound system intended for use
as an adjunct to the standard clinical
practices for measuring and
displaying cerebral blood flow
velocity within the major
conducting arteries and veins of the
head and neck. Additionally, The
Lucid M1 System measures the
occurrence of transient emboli
signals within the blood stream.
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. | The NeuralBot when used with
Lucid M1 System is a medical
ultrasound device which assists the
user in the setup and acquisition of
cerebral blood flow velocity via the
patient's temporal windows. 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 blood stream.
The NeuralBot 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. |
| Energy Used/
Delivered | Ultrasound Energy | Ultrasound Energy | Ultrasound Energy |
| Design | 1. Base Ultrasound Unit (touch
screen display, integrated PC Board,
TCD ultrasound driver sub-system) | 1. Base Ultrasound Unit (touch
screen display, integrated PC Board,
TCD ultrasound driver sub-system) | Not Applicable to this System |
| Technological
Characteristic | NovaGuide 2 Intelligent
Ultrasound
SUBMISSION DEVICE | Lucid M1 Transcranial Doppler
Ultrasound System (Lucid M1
System) - Lucid TCD
(Reference Device)
K160442 | NeuralBot when connected to the
Lucid M1 System - NovaBot
(Primary Predicate)
K180445 |
| | 2. Reusable, non-sterile 2-MHz
handheld transducer or headset with
2 reusable, non-sterile 2-MHz
monitoring transducers
3. Software/firmware
4. Algorithm | 2. Reusable, non-sterile 2-MHz
handheld transducer or headset with
2 reusable, non-sterile 2-MHz
monitoring transducers
3. Software/firmware
4. Algorithm | |
| Mechanism of
Action | Doppler Ultrasound with the
following modes: Unilateral,
Bilateral, Multichannel, Monitoring,
M-mode, Modified M-mode | Doppler Ultrasound with the
following modes: Unilateral,
Bilateral, Multichannel, Monitoring,
M-mode, Modified M-mode | Doppler Ultrasound with the
following modes: Unilateral,
Bilateral, Multichannel, Monitoring,
M-mode |
| Performance | Sample Volume: 2 to 12mm in 1mm
steps
Depth: 23 to 151mm
Power %: 0 to 100% where
100% represents Ispta.3 upper-
tolerance limit 720 mW/cm² | Sample Volume: 2 to 12mm in 1mm
steps
Depth: 23 to 151mm
Power %: 0 to 100% where
100% represents Ispta.3 upper-
tolerance limit 720 mW/cm² | Sample Volume: 10mm
Depth: 45 to 60 mm
Power %: 0 to 100% where 100%
represents Ispta.3 upper-tolerance limit
575 mW/cm² |
| Acoustic Output | NovaGuide 2 global maximum
derated ISPTA is designed to be