(127 days)
No
The document explicitly states that the device only acquires and displays physiological signals, and no claims are made for analysis of the acquired signals. It also mentions that the acquired signals are intended to be analyzed with third-party software. There are no mentions of AI, ML, or related terms in the provided text.
No.
The device acquires, records, transmits, and displays physiological signals and is intended for diagnosis and monitoring, not for delivering therapy.
No
The device acquires, records, transmits, and displays physiological signals but explicitly states that "no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability." It provides data in a universal format to be analyzed by third-party software, including diagnostic software, but does not perform diagnostic analysis itself.
No
The device description explicitly details hardware components (Model X4-E, Model X4-M, sensors, dual-lead connector, acoustic microphone, 3-D accelerometer) that are integral to the device's function of acquiring physiological signals. While software is mentioned for data management and display, it is part of a larger system that includes hardware.
Based on the provided information, the X4 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- X4 System Function: The X4 System acquires, records, transmits, and displays physiological signals directly from the patient's body (EEG, EOG, ECG, EMG, accelerometer, acoustical, and photoplethesmographic signals). It does not process or analyze specimens taken from the body.
- Intended Use: The intended use clearly states the system is for acquiring, recording, transmitting, and displaying physiological signals. It explicitly states "no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability." This further reinforces that the device's primary function is data acquisition, not diagnostic analysis of biological samples.
The X4 System is a physiological signal acquisition and monitoring device, not an IVD.
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
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) that is intended to be analyzed with third party software, including Advanced Brain Monitoring's Sleep Profile Software (K120450).
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 X4 has been the subject of clinical testing to demonstrate it can be used by patients in the home. The results support that over 90% of studies recorded overnight with the X4 are interpretable and behave as expected. The X4 instructions were applied without difficulty, allowing all subjects to properly apply the device so that it remained in the proper position and allowing any problems that triggered an audio alarm to be properly resolved.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K112514 Apnea Risk Evaluation System (ARES), Model 610
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
(120447
In accordance with 21 CFR 807.92 the following summary of information is provided:
DATE: May 25, 2012
SUBMITTER:
ﻷﻛﺴ
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):
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) that is intended to be analyzed with third party software, including Advanced Brain Monitoring's Sleep Profile Software (K120450).
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), 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.
TECHNOLOGY:
The X4 System uses the same fundamental technology as the ARES Model 610 for most features including the electrophysiological (EEG), photoplethesmographic (PPG) and actigraphy signals. Acquisition of the electrocardiograph signal requires minor modification to the band pass filters and is equivalent to the Compumedics Somte. Wireless acquisition of the physiological signals is equivalent to the Infinite Biomedical Technologies 1200 two-channel EEG system. 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 testing which included electrical and biological safety, performance and software tests. This testing includes conformity to FDA recognized consensus standards and voluntary standards as follows:
| Standard Number | Standard Title |
|---|---|
| IEC 60601-1-1:1988+A1: | |
| 1991+A2: 1995 | Medical Electrical Equipment - Part 1: General requirements for safety |
| IEC 60601-1-2: 2007 | Medical Electrical Equipment Part 1-2: Collateral standard: Electromagnetic |
| compatibility - requirements and tests | |
| ISO 10993-1: 2009 | Biological evaluation of medical devices Part 1 |
| IEC 60601-1-11: 2010 | Medical electrical equipment - Part 1-11: General requirements for basic |
| safety and essential performance - Collateral Standard: Requirements for | |
| medical electrical equipment and medical electrical systems used in the | |
| home healthcare environment | |
| IEC 60601-2-26:2002 | Particular requirements for the safety of electroencephalographs |
Additional verification and validation testing confirmed:
- All features of the X4 System were compliant with the system level requirements. .
- Signals acquired with the X4 System provide similar information as compared to the predicate . device that would allow a physician to interpret the signals.
SUMMARY OF CLINICAL TESTS:
The X4 has been the subject of clinical testing to demonstrate it can be used by patients in the home. The results support that over 90% of studies recorded overnight with the X4 are interpretable and behave as expected. The X4 instructions were applied without difficulty, allowing all subjects to properly apply the device so that it remained in the proper position and allowing any problems that triggered an audio alarm to be properly resolved.
CONCLUSION:
Advanced Brain Monitoring considers the X4 System to be as safe, as effective, and substantially equivalent to the predicate devices.
3
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 0 2012
Advanced Brain Monitoring, Inc. C/O Ms. Adrienne Lenz Pathway Regulatory Consulting, LLC Regulatory Affairs Consulting W324 S3649 County Road E Dousman, Wisconsin 53118
Re: K120447
Trade/Device Name: X4 System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMC Dated: May 25, 2012 Received: May 30, 2012
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
Page 2 - Ms. Lenz
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
hr for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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):
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
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
(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)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120447