(91 days)
Not Found
No
The description mentions "TCD signal search algorithm" and "robotic probe positioning mechanism" which are standard control and signal processing techniques, not explicitly AI/ML. There is no mention of AI, ML, deep learning, or training data.
No
The device is described as assisting in the setup and acquisition of cerebral blood flow velocity and the occurrence of transient emboli; it is not intended to replace other means of evaluating vital patient physiological processes, indicating it is for diagnostic or monitoring purposes, not for treating a condition.
Yes
The device is intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity, which is a diagnostic purpose. It specifically assists in the acquisition of cerebral blood flow velocity (CBFV) data and can identify the occurrence of transient emboli within the bloodstream.
No
The device description clearly outlines three hardware subsystems: an Accessory Control Unit (ACU), a Robotic Control Unit (RCU), and a Patient Headmount Unit (PHU), which includes transducers and robotic actuators. While software is mentioned as being installed on the ACU and embedded in the RCU, the device is fundamentally a hardware system with software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Function: The NeuralBot System is an ultrasound device that directly interacts with the patient's body (placing transducers on the temporal regions) to measure and display cerebral blood flow velocity and detect emboli within the bloodstream. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a medical ultrasound device for assisting in the setup and acquisition of cerebral blood flow velocity via the patient's temporal windows. This is a direct measurement of a physiological process within the body.
Therefore, the NeuralBot System falls under the category of a medical device used for in vivo (within the living body) diagnostic imaging and measurement, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, ITX, OQQ
Device Description
The NeuralBot System is a cart mounted. robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleared Lucid M1 System (K160442) which assists the user in the acquisition of cerebral blood flow velocity (CBFV) data via the patient's temporal acoustic windows.
The NeuralBot System consists of the following three subsystems mounted on a cart
-
- Accessory Control Unit (ACU)
- The main accessory software including the, TCD signal search algorithm, and a. graphical user interface are installed on this subsystem.
-
- Robotic Control Unit (RCU)
- Contains the electronics and embedded software that control the robotic actuators of a. the patient headmount unit.
-
- Patient Headmount Unit (PHU)
- Comprised of the patient head interface, 2 MHz transducers, and the robotic probe a. positioning mechanism.
The NeuralBot System guides the operator in positioning the transducers in the PHU, one on each side of a patient's head, at their temporal regions. The 2 MHz transducers used in the NeuralBot System are the same transducers previously cleared for use with the Lucid M1 System (K160442). The NeuralBot System's probe positioning is accomplished using robotic actuators that adjust the translational and angular position of each transducer independently using TCD signal search algorithms. The accessory is designed to locate TCD signals at depths between 45 and 60 mm allowing the operator to monitor the CBFV of the vessels via the patient's temporal acoustic windows. The NeuralBot System identifies several candidate TCD signals and displays multiple signals from each side of the patient's head. At the end of the search, the NeuralBot System will then retrieve and track the best located signal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
temporal windows (for cerebral blood flow velocity)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals qualified by training in its safe and effective use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing to support thermal, mechanical, electromagnetic, and mechanical safety is conducted per the FDA Guidance Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, using applicable sections of the following voluntary standards:
- IEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, Edition 3.1
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, Edition 3.1
- IEC 60601-2-37:2015 Medical electrical equipment Part 2-37: Particular requirements . for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, Edition 2.1
- NEMA Standards Publication UD 2-2004(R2009) Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment Revision 3
- NEMA Standards Publication UD 3-2004(R2009) Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 2
- ISO 10993-1:2010 Biological evaluation of medical devices -- Part 1: Evaluation and ● testing within a risk management process, Fourth Edition
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 22, 2018
Neural Analytics, Inc. % Javad Seyedzadeh Cheif QA/RA 2440 S. Sepulveda Blvd., Suite 115 LOS ANGELES CA 90064
Re: K180455
Trade/Device Name: NeuralBot Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, OQQ Dated: April 17, 2018 Received: April 19, 2018
Dear Javad Seyedzadeh:
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image contains the logo for Neural Analytics. The logo consists of two large blue letters, 'N' and 'A', stacked on top of each other. Below the letters, the words 'NEURAL ANALYTICS' are written in smaller blue font, with a thin blue line underneath.
510(k) Summary
| Date Prepared | February 16, 2018 |
|---|---|
| Manufacturer | Neural Analytics, Inc. |
| 2440 S Sepulveda Blvd, Suite 115 | |
| Los Angeles, CA 90064 | |
| Phone: (914) 473-1678 | |
| Facsimile: (877) 638-7251 | |
| Internal Contact: Javad Seyedzadeh | |
| Email: javad@neuralanalytics.com | |
| Official | |
| Correspondent | Javad Seyedzadeh |
| Chief of QA/RA | |
| (914) 473-1678 | |
| javad@neuralanalytics.com | |
| Trade Name | NeuralBot |
| Common Name(s) | NeuralBot System, |
| NeuralBot Guided Headmount Accessory, | |
| NeuralBot Guided Headmount Accessory for the Lucid M1 System | |
| Project Name | Apollo Beta |
| Model Number(s) | NA-RBT-1 NeuralBot |
| NA-DSP2 NeuralBot Procedural Set | |
| Federal Regulation | |
| Number | 21 CFR 892.1550 |
| 21 CFR 892.1570 | |
| Product Codes | IYN, ITX, OQQ |
| Class | Class II Device |
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Image /page/4/Picture/0 description: The image contains the logo for Neural Analytics. The logo consists of two large blue letters, 'N' and 'A', stacked on top of each other. Below the letters, the words 'NEURAL ANALYTICS' are written in smaller, blue font. The logo is simple and modern, with a focus on the company's name.
| Predicate Devices | K122710 |
|---|---|
| Shenzhen Delicate Electronics Co., Ltd. | |
| Transcranial Doppler with Robotic Probe Headband, EMS-9UA | |
| Class II | |
| 21 CFR 892.1550, IYN | |
| 21 CFR 892.1570, ITX and OQQ | |
| K160442 | |
| NEURAL ANALYTICS, INC. | |
| Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) With 2MHz Transducers | |
| Class II | |
| 21 CFR 892.1550, IYN | |
| 21 CFR 892.1570, ITX | |
| Performance Standards | There are no required performance standards under the Federal Food, Drug and Cosmetic Act. Voluntary standards to which we will conform include: IEC 60601-1, IEC 60601-1-2, IEC, IEC 60601-2-37, IEC 62133 (RCU rechargeable battery and ACU internal battery), ISO 10993-1, and ISO 62304. |
| Special Controls | There are no special controls as a special report is no longer required. The guidance referenced is “Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers” dated September 9, 2008. |
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Image /page/5/Picture/1 description: The image shows a logo for Neural Analytics. The logo consists of two large blue letters, "N" and "A", stacked on top of each other. Below the letters, in smaller blue font, is the text "NEURAL ANALYTICS". The letters are bold and stylized, with the "N" slightly overlapping the "A".
Submission Focus:
The submission will focus on the NeuralBot System. The NeuralBot System consists of the following elements:
- . Accessory Control Unit (ACU)
- Robotic Control Unit (RCU)
- Patient Headmount Unit (PHU)
- . Cart
This system connects to the Lucid M1 System as an accessory.
Information from the Lucid M1 System (K160442) is provided in this submission for the purpose of clarification where deemed appropriate.
Device Description
The NeuralBot System is a cart mounted. robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleared Lucid M1 System (K160442) which assists the user in the acquisition of cerebral blood flow velocity (CBFV) data via the patient's temporal acoustic windows.
The NeuralBot System consists of the following three subsystems mounted on a cart
-
- Accessory Control Unit (ACU)
- The main accessory software including the, TCD signal search algorithm, and a. graphical user interface are installed on this subsystem.
-
- Robotic Control Unit (RCU)
- Contains the electronics and embedded software that control the robotic actuators of a. the patient headmount unit.
-
- Patient Headmount Unit (PHU)
- Comprised of the patient head interface, 2 MHz transducers, and the robotic probe a. positioning mechanism.
The NeuralBot System guides the operator in positioning the transducers in the PHU, one on each side of a patient's head, at their temporal regions. The 2 MHz transducers used in the NeuralBot System are the same transducers previously cleared for use with the Lucid M1 System (K160442). The NeuralBot System's probe positioning is accomplished using robotic actuators that adjust the translational and angular position of each transducer independently using TCD signal search algorithms. The accessory is designed to locate TCD signals at depths between 45 and 60 mm allowing the operator to monitor the CBFV of the vessels via the patient's temporal acoustic windows. The NeuralBot System identifies several candidate TCD signals and displays multiple signals from each side of the patient's head. At the end of the search, the NeuralBot System will then retrieve and track the best located signal.
6
Image /page/6/Picture/0 description: The image shows the logo for Neural Analytics. The logo consists of two large blue letters, 'N' and 'A', stacked on top of each other. Below the letters, in smaller blue font, is the text 'NEURAL ANALYTICS'. A thin blue line underlines the text.
Communication between the Lucid M1 System (K160442) and the NeuralBot System occurs via a USB to Ethernet cable that connects the ACU to the Lucid M1 System using its digital streaming feature. The 2 MHz transducers of the PHU are connected to the Lucid M1 System's TCD probe connections (K160442).
Indications for Use
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.
Equivalence Discussion:
The NeuralBot System and Lucid M1 System (K160442):
A full comparison of the technological characteristics of the NeuralBot System when connected to the Lucid M1 System and the Lucid M1 System was made. Both are TCD ultrasound flow systems with monitoring functions. Both systems monitor cerebral blood flow velocity and the occurrence of transient emboli within the blood stream via the temporal windows.
Both systems have equivalent modes and use pulsed wave Doppler (PWD) using color M-Mode for location of the vessel of interest.
Additionally, both devices:
- Are transcranial Doppler ultrasound systems used for cerebral blood flow analysis
- Monitor the cerebral blood flow velocity and the occurrence of transient emboli within ● the blood stream via the temporal windows
- Utilize two transducers which are attached via a headset for cephalic monitoring
- Use substantially equivalent operating modes ●
- Measure equivalent hemodynamic indices
- Have equivalent monitoring functions ●
- Transducers are substantially equivalent
- Are manufactured to meet applicable physical, mechanical, and electrical safety requirements
- . Display TIC, velocity spectrum, M-Mode, velocity envelope, Mean velocity, Minimum velocity, Maximum velocity, Pulsatility index, and emboli count (in emboli and bubble exams of the Lucid M1 System)
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Image /page/7/Picture/0 description: The image shows the logo for Neural Analytics. The logo consists of two large, blue letters "N" and "A" that are connected at the top. Below the letters, the words "NEURAL ANALYTICS" are written in a smaller, blue font, with a horizontal line above the words.
The NeuralBot System and the Transcranial Doppler with Robotic Probe Headband, EMS-9UA (K122710):
A full comparison of the technological characteristics of the NeuralBot System when connected to the Lucid M1 System and the Transcranial Doppler with Robotic Headband was made. Both are Robotic Probe systems intended for obtaining the information of CBFV by using a noninvasive ultrasonic technique. This method of measurement is particularly useful for examining the major arteries supplying blood to the brain via the temporal window.
Both systems have equivalent modes and use pulsed wave Doppler (PWD) using color M-Mode for location of the vessel of interest. Both systems can automatically adjust the position of the ultrasonic transducers during monitoring according to the signal intensity of CBFV via the patient's temporal windows.
Summary of Non-Clinical Testing and Reliance on Standards
The NeuralBot System when used with the Lucid M1 system is evaluated for acoustic output, biocompatibility, and accuracy, as well as thermal, electromagnetic, and mechanical safety. Non-clinical testing to support thermal, mechanical, electromagnetic, and mechanical safety is conducted per the FDA Guidance Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, using applicable sections of the following voluntary standards:
- IEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, Edition 3.1
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, Edition 3.1
- IEC 60601-2-37:2015 Medical electrical equipment Part 2-37: Particular requirements . for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, Edition 2.1
- . NEMA Standards Publication UD 2-2004(R2009) Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment Revision 3
- . NEMA Standards Publication UD 3-2004(R2009) Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 2
- ISO 10993-1:2010 Biological evaluation of medical devices -- Part 1: Evaluation and ● testing within a risk management process, Fourth Edition
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Image /page/8/Picture/1 description: The image shows the logo for Neural Analytics. The logo consists of the letters "NA" in a large, bold, sans-serif font, stacked on top of each other. The letters are in blue. Below the letters, the words "NEURAL ANALYTICS" are written in a smaller, sans-serif font, also in blue.
Conclusion
The documentation provided demonstrates that:
- The NeuralBot System is substantially equivalent to the predicate devices. ●
- . There are no new questions of safety and effectiveness concerning the NeuralBot System.
- The NeuralBot System is designed to be as safe and effective as the predicate devices.
- The NeuralBot System is designed to perform as well as the predicate devices. ●
Accordingly, the NeuralBot System is believed to be substantially equivalent to the predicate devices of the same type which are lawfully distributed in interstate commerce in the United States.