(29 days)
Not Found
No
The document explicitly states that the device "only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals". It also mentions that the acquired data is available for analysis by separate software ("Advanced Brain Monitoring's Sleep Profiler software application"), but this 510(k) is for the acquisition device itself, not the analysis software. There is no mention of AI or ML in the description of the X4 System's functionality.
No
The device is used to acquire, record, transmit, and display physiological signals, which are diagnostic functions, not therapeutic.
No
The device acquires, records, transmits, and displays physiological signals but explicitly states "no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability" and that the acquired signals are "available for analysis by Advanced Brain Monitoring's Sleep Profiler software application." The X4 System itself does not perform diagnostic analysis.
No
The device description explicitly details hardware components (Model X4-E, Model X4-M, sensors, acoustic microphone, 3-D accelerometer) that acquire physiological signals. While software is a crucial part of the system for data management and display, it is not the sole component.
Based on the provided information, the X4 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the X4 System is for acquiring, recording, transmitting, and displaying physiological signals (EEG, EOG, ECG, EMG, accelerometer, acoustical, and photoplethesmographic). It explicitly states that "no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability." This indicates it's a signal acquisition and display device, not a device that performs tests on biological samples to provide diagnostic information.
- Device Description: The description focuses on the hardware and software for acquiring and managing physiological signals. It mentions saving data in a universal format (EDF) for potential analysis by other software (Advanced Brain Monitoring's Sleep Profiler software application), but the X4 System itself does not perform this analysis.
- Lack of IVD Characteristics: IVD devices typically involve testing biological samples (blood, urine, tissue, etc.) to diagnose diseases or conditions. The X4 System interacts with the patient's body to measure electrical and other physiological signals, which is characteristic of a physiological monitoring device, not an IVD.
Therefore, the X4 System falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The X4 System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit and display physiological signals from adult patients. The X4 System acquires, records, transmits and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), accelerometer, acoustical and photoplethesmographic signals. The X4 system only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.
Product codes (comma separated list FDA assigned to the subject device)
OMC
Device Description
The X4 system is used for configurable acquisition of physiological signals. Model X4-E provides for acquisition of three channels of electroencephalography (EEG) and one photoplethesmographic (PPG) signal from a head strip, with an optional channel connected to two sensors via a dual-lead connector with twice the gain. Model X4-M provides four channels of EEG with the dual-lead connector providing the input for reference sensors. Both models measure sound via an acoustic microphone, and movement and position measured via a 3-D accelerometer. The device is designed so it can be affixed by the patient and to record data. Alternatively, a technician can affix the device and display the signals via a wireless connection during acquisition. The X4 system firmware monitors signal quality to ensure that the sensors are properly applied and that high quality signals are being acquired.
The X4 software provides a means to: a) initiate a study and track patient information, b) acquire and save signals to the memory of the device, c) acquire and wirelessly transmit signals from the device, d) upload data saved in the memory of the device to a PC, and e) visually inspect the signal quality.
The acquired signals are saved in a universal data format (European Data Format - EDF). The study record, once saved on the PC, is available for analysis by Advanced Brain Monitoring's Sleep Profiler software application. The X4's downloaded study will reside on either or local PC or a cloud server, which can be a physical or virtual server. Software on the cloud server is accessed via web portal software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Prescription use in the home, healthcare facility, or clinical research environment.
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)
The modifications to the X4 System that are the subject of this premarket submission did not require clinical studies to support substantial equivalence. The functionality of the modified device was completely evaluated by performing nonclinical verification and validation.
Support for the substantial equivalence of the X4 System was provided as a result of risk management and software testing.
The X4 software has been thoroughly tested through verification of specifications and validation, including software validation. The key metric for software verification/validation was confirmation of identical performance using either the desktop or portal for the key functions associated with the Device Manager software:
- . format the device for a new patient,
- . enter and upload study identification information to the device,
- . download study information to data storage, and
- . upload new firmware.
The results of the verification and validation activities that have been performed demonstrate that the software meets requirements for safety, function, and intended use.
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.
K120447 X4 System, K112514 Apnea Risk Evaluation System (ARES), Model 610
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
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
Advanced Brain Monitoring, Inc. X4 System
510(k) Summary
JAN 3 1 2013
In accordance with 21 CFR 807.92 the following summary of information is provided:
DATE: December 28, 2012
SUBMITTER:
Advanced Brain Monitoring 2237 Faraday Avenue, Suite 100 Carlsbad, CA 92008 T 760.720.0099 F 760.720.3337
PRIMARY CONTACT PERSON:
Adrienne Lenz, RAC Founder Pathway Regulatory Consulting, LLC T 262-290-0023
SECONDARY CONTACT PERSON:
Dan Levendowski President and Co-founder Advanced Brain Monitoring, Inc.
DEVICE:
TRADE NAME: X4 System
COMMON/USUAL NAME: X4
CLASSIFICATION NAMES: 882.1400 Electroencephalograph
PRODUCT CODE: OMC
PREDICATE DEVICE(S):
K120447 X4 System
K112514 Apnea Risk Evaluation System (ARES), Model 610
1
DEVICE DESCRIPTION:
The X4 system is used for configurable acquisition of physiological signals. Model X4-E provides for acquisition of three channels of electroencephalography (EEG) and one photoplethesmographic (PPG) signal from a head strip, with an optional channel connected to two sensors via a dual-lead connector with twice the gain. Model X4-M provides four channels of EEG with the dual-lead connector providing the input for reference sensors. Both models measure sound via an acoustic microphone, and movement and position measured via a 3-D accelerometer. The device is designed so it can be affixed by the patient and to record data. Alternatively, a technician can affix the device and display the signals via a wireless connection during acquisition. The X4 system firmware monitors signal quality to ensure that the sensors are properly applied and that high quality signals are being acquired.
The X4 software provides a means to: a) initiate a study and track patient information, b) acquire and save signals to the memory of the device, c) acquire and wirelessly transmit signals from the device, d) upload data saved in the memory of the device to a PC, and e) visually inspect the signal quality.
The acquired signals are saved in a universal data format (European Data Format - EDF). The study record, once saved on the PC, is available for analysis by Advanced Brain Monitoring's Sleep Profiler software application. The X4's downloaded study will reside on either or local PC or a cloud server, which can be a physical or virtual server. Software on the cloud server is accessed via web portal software.
INTENDED USE:
The X4 System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit and display physiological signals from adult patients. The X4 System acquires, records, transmits, and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG); and accelerometer, acoustical, and The X4 system only acquires and displays physiological signals, no photoplethesmographic signals. claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.
TECHNOLOGY:
The X4 System is identical to the previously cleared X4 System (K120447). A Device Manager Module was developed to run via a web portal as an alternative to the identical functions provided in the PC software. The Device Manager module running on the cloud server uses the same fundamental technology as the ARES Model 610 portal (K112514). The technologies used in the X4 are used in the same manner as the predicate products and do not raise new questions of safety and effectiveness.
2
DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
SUMMARY OF NON-CLINICAL TESTS:
Support for the substantial equivalence of the X4 System was provided as a result of risk management and software testing.
The X4 software has been thoroughly tested through verification of specifications and validation, including software validation. The key metric for software verification/validation was confirmation of identical performance using either the desktop or portal for the key functions associated with the Device Manager software:
- . format the device for a new patient,
- . enter and upload study identification information to the device,
- . download study information to data storage, and
- . upload new firmware.
The results of the verification and validation activities that have been performed demonstrate that the software meets requirements for safety, function, and intended use.
SUMMARY OF CLINICAL TESTS:
The modifications to the X4 System that are the subject of this premarket submission did not require clinical studies to support substantial equivalence. The functionality of the modified device was completely evaluated by performing nonclinical verification and validation.
CONCLUSION:
Advanced Brain Monitoring considers the X4 System to be as safe, as effective, and substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31 2013
Advanced Brain Monitoring, Incorporated C/O Ms. Adrienne Lenz, RAC Pathway Regulatory Consulting, Limited Liability Company W324 S3649 County Road East DOUSMAN, WI 53118
Re: K130013
Trade/Device Name: X4 System Regulation Number: 21 CFR 882.1400 Regulation Name: Neurological Diagnostic Devices Regulatory Class: II Product Code: OMC Dated: December 31, 2012 Received: January 29, 2013
Dear Ms. Lenz:
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.
4
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
hor
Harshitio.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Advanced Brain Monitoring, Inc. X4 System
510(k) Number (if known): K130013
Device Name:
X4 System
Indications for Use:
The X4 System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit and display physiological signals from adult patients. The X4 System acquires, records, transmits and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), accelerometer, acoustical and photoplethesmographic signals. The X4 system only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.
Prescription Use X AND/OR
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lester W. Schultheis Jr 2013.01.31 08:33:39 -05'00'
Division Sign-Off) Division of Anesthesiology, General Hospital intection Control, Dental Devices
510(k) Number: K130013