(197 days)
No
The summary explicitly states that the device "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." It also mentions that acquired signals are intended to be analyzed by a physician using FDA cleared third party software. There is no mention of AI or ML in the device description or performance studies.
No.
Explanation: The device is described as acquiring, transmitting, displaying, and storing physiological signals (EEG, EOG, ECG, EMG, accelerometer). Its intended use is to provide visual indications to ensure high-quality data are obtained and saved for analysis by a physician using third-party software. There is no mention of the device administering any form of therapy or treatment to the patient.
No
The device description explicitly states: "The X-Series 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." It captures physiological data but does not perform analysis or provide diagnostic interpretations. The acquired signals are intended to be analyzed by a physician using separate, FDA-cleared third-party software.
No
The device description explicitly states that the X-Series System is comprised of hardware (X10 and X24 Headsets, BT receiving unit) and software, and that it combines hardware, firmware, and software to acquire physiological signals.
Based on the provided information, the X-Series 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, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- X-Series System Function: The X-Series System acquires, transmits, displays, and stores physiological signals (EEG, EOG, ECG, EMG, accelerometer) directly from the patient's body. It does not process or analyze specimens taken from the body.
- Intended Use: The intended use is to acquire and display physiological signals, with the analysis being performed by a physician using separate, FDA-cleared third-party software. The device itself does not perform diagnostic analysis on biological samples.
Therefore, the X-Series System falls under the category of a medical device that acquires physiological signals in vivo (within the living body), rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The X-Series System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, transmit, display and store physiological signals from patients ages 6 and older. The X-Series system requires operation by a trained technician. The X-Series System acquires, transmits, displays and stores electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer signals. The X-Series 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)
GWQ, OMC
Device Description
The X-Series System is indicated for acquiring, transmitting, displaying and storing physiological data in patients. It can be used with ambulatory patients in the home, health care facility, or clinical research environment. The X-Series system requires operation by a trained technician.
The X-Series System.is comprised the X10 and X24 Headsets and accessories, Synapse Cream, X-Series Basic Software and BT receiving unit. The X-Series Basic Software is also compatible with the Models X4-E, and X4-M (K130013) when used in wireless mode.
The X-Series System combines hardware, firmware and software to acquire physiological signals. It acquires physiological data through a battery powered headset worn by the patient and provides a flexible platform for applying sensors using synapse cream and acquiring signals from multiple locations on the head or body, transmitting and recording the signals and providing visual indications to ensure high quality data are obtained.
Model X24 provides for acquisition of twenty channels of electroencephalography (EEG) and four optional channels connected to two sensors via a dual-lead connector. Model X10 provides for acquisition of nine channels of electroencephalography (EEG) and an optional channel connected to two sensors via a dual-lead connector. Both models measure movement and position measured via a 3-D accelerometer. The device is designed so it can be affixed by a technician and displays the signals via a wireless connection during acquisition. The X-Series Basic software monitors signal quality to ensure that the sensors are properly applied and that high quality signals are being acquired.
The X-Series Basic software provides a means to: a) initiate a study and track patient information, b) acquire and wirelessly transmit signals from the device, c) visually inspect the signal quality.
The acquired signals are saved in a universal data format (European Data Format Plus, EDF+) that is intended to be analyzed by a Physician using FDA cleared third party software, i.e. Persyst Software (K011397).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp/Chest
Indicated Patient Age Range
ages 6 and older
Intended User / Care Setting
Trained technician; Home, Healthcare facility, 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)
Summary of Non-Clinical Tests:
Bench tests were conducted using an oscilloscope and signal generator to compare performance of the X-Series to the predicate device. These comparison tests confirm the EEG and optional dual-lead (for ECG) analog signals between the X-Series and predicate devices were equivalent. The X-Series and X4 were placed in a jig that held the devices in eight unique angles to confirm that the measures obtained from the 3D actigraphs were equivalent. While the X-Series System is not a cardiac monitor as defined in the scope of ANSI/AAMI EC 13, the standard was referenced and requirements and test methods applicable to the electrocardiogram acquired and displayed by X-Series was applied. These tests demonstrated the equivalence of the X-Series system to the predicate device for EEG, ECG and actigraph performance.
The cleaning and disinfection procedures of the X-Series acquisition device have been validated by testing in accordance with AAMI TIR 12-94 Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Manufacturers and AAMI TIR 30: 2003 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices. Acceptance criteria established by Advanced Brain Monitoring and the TIR are >= log 3.0 reduction in bioburden after cleaning according to the instructions for use. All tests passed and demonstrate that the cleaning methods are appropriate for ensuring the X-Series acquisition device is clean between uses.
Biocompatibility was assessed following FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Replaces #G87-1 #8294) (blue book memo)". Per Table 1 of this guidance, the X-Series System is a Surface device with limited contact (Category A, less than 24 hours contact). As such, cytotoxicity, sensitization, and irritation or intracutaneous reactivity tests were selected. Test methods were in compliance with the corresponding standard from the ISO 10993 series for Biological Evaluation of Medical Devices. Test articles were comprised of all patient contacting components of the X-Series System, including the X-Series Strip with disposable foam and synapse cream, X-Series Strap and X-Series enclosure. Results of biocompatibility testing are summarized in table 2 and demonstrate that materials of the device in contact with the patient are biocompatible.
The firmware in the X-Series System and the X-Series Basic software have been thoroughly tested through verification of specifications and validation, including software validation. Software documentation is available per FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document (May 11, 2005). The results of the verification and validation activities that have been performed demonstrate that the software meets requirements for safety, function, and intended use.
Electromagnetic compatibility and electrical safety testing of the X-Series was conducted following recognized standards Compliance to IEC 60601-2-26:2002 - Particular requirements for the safety of electroencephalographs was also demonstrated. The X-Series System has additionally been tested per 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 to demonstrate operational and mechanical performance is not negatively affected by various mechanical and environmental hazards encountered in the home-use environment. All test results are passing demonstrating the compliance of the X-Series system to FDA recognized standards for electro-medical equipment as defined in Table 3.
The disposable EEG electrodes used with the X-Series System have been tested to demonstrate their electrical performance. While the scope of the standard does not cover EEG electrodes, testing using applicable methods defined in chapter 4 of AAMI/ANS1 EC12:2000 (R)2010 Disposable ECG electrodes has been conducted, similarly to other cleared EEG electrodes including Model 4310 PSarray2 EEG electrode (K020670). The results demonstrate electrical performance of the EEG electrodes used with the X-Series System is acceptable.
Summary of Clinical Tests:
To provide additional support for use in ages 6 and older, a subset of data from a research study was analyzed to establish use of the X-10 and X-24 headsets to acquire EEG in this patient population. Data from seven children ages 6-8 were compared to data from seven adults. The subjects were set-up by a technician with the X-Series strip appropriate based on their head measurements as described in the labeling. Technicians were able to quickly set-up subjects and resolve any high impedance issues as displayed by the X-Series Software. None of the subjects complained of discomfort or agitation in wearing the strips and the sensors remained in contact with the scalp for the duration of testing. 100% of all EEG sessions contained appropriate EEG recordings that could be further examined in third party software, and when data acquired from children are compared to an equivalent adult population, the data quality were equivalent.
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.
K130013 X4 System
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
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
DATE: November 26, 2013
SUBMITTER:
·
Advanced Brain Monitoring 2237 Faraday Avenue, Suite 100 Carlsbad, CA 92008 T 760.720.0099 . F 760.720.3337
NOV 27 2013
PRIMARY CONTACT PERSON:
Adrienne Lenz, RAC Member Pathway Regulatory Consulting, LLC T 262-290-0023
SECONDARY CONTACT PERSON:
Dan Levendowski President and Co-founder Advanced Brain Monitoring, Inc.
DEVICE:
TRADE NAME: X-Series System
COMMON/USUAL NAME: X10 / X24
CLASSIFICATION NAMES: 882.1400 Electroencephalograph
PRODUCT CODE: GWQ, OMC
PREDICATE DEVICE(S):
K130013 X4 System
1
DEVICE DESCRIPTION:
The X-Series System is indicated for acquiring, transmitting, displaying and storing physiological data in patients. It can be used with ambulatory patients in the home, health care facility, or clinical research environment. The X-Series system requires operation by a trained technician.
The X-Series System.is comprised the X10 and X24 Headsets and accessories, Synapse Cream, X-Series Basic Software and BT receiving unit. The X-Series Basic Software is also compatible with the Models X4-E, and X4-M (K130013) when used in wireless mode.
The X-Series System combines hardware, firmware and software to acquire physiological signals. It acquires physiological data through a battery powered headset worn by the patient and provides a flexible platform for applying sensors using synapse cream and acquiring signals from multiple locations on the head or body, transmitting and recording the signals and providing visual indications to ensure high quality data are obtained.
Model X24 provides for acquisition of twenty channels of electroencephalography (EEG) and four optional channels connected to two sensors via a dual-lead connector. Model X10 provides for acquisition of nine channels of electroencephalography (EEG) and an optional channel connected to two sensors via a dual-lead connector. Both models measure movement and position measured via a 3-D accelerometer. The device is designed so it can be affixed by a technician and displays the signals via a wireless connection during acquisition. The X-Series Basic software monitors signal quality to ensure that the sensors are properly applied and that high quality signals are being acquired.
The X-Series Basic software provides a means to: a) initiate a study and track patient information, b) acquire and wirelessly transmit signals from the device, c) visually inspect the signal quality.
The acquired signals are saved in a universal data format (European Data Format Plus, EDF+) that is intended to be analyzed by a Physician using FDA cleared third party software, i.e. Persyst Software (K011397).
INTENDED USE:
The X-Series System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, transmit, display and store physiological signals from patients ages 6 and older. The X-Series system requires operation by a trained technician. The X-Series System acquires, transmits, displays and stores electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer signals. The X-Series 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.
2
TECHNOLOGY:
The X-Series System uses the same fundamental technology as the X4 System for most features including the electrophysiological (EEG, EOG, ECG, EMG, ), wireless acquisition, and actigraphy. The technologies used in the X-Series are used in the same manner as the predicate products · and do not raise new questions of safety and effectiveness.
| Specification | X-Series System | X4 System (K120447) |
|---|---|---|
| Indications for | ||
| Use | The X-Series System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, transmit, display and store physiological signals from patients ages 6 and older. The X-Series system requires operation by a trained technician. The X-Series System acquires, transmits, displays and stores electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer signals. The X-Series 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. | 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 |
| Patient | ||
| Population | Ages 6 and older | Adults |
| User | Trained Technician | Trained technician or patient for recording of sleep data. |
| Anatomical | ||
| Sites | Scalp/Chest | Forehead/Chest |
| Environment of | ||
| Use | Home (data acquisition) | |
| Healthcare facility (data acquisition, analysis and reporting) | ||
| Clinical Research Environment | Home (data acquisition) | |
| Healthcare facility (data acquisition, and analysis.) | ||
| Clinical Research |
TABLE 1 COMPARISON OF X-SERIES TO PREDICATE DEVICE
3
| Specification | X-Series System | X4 System (K120447) |
|---|---|---|
| User Interface | User control, visual indicators | User control, visual and audio |
| indicators | ||
| Accessories | EEG and ECG electrodes. | EEG and ECG electrodes. |
| Signals | ||
| Acquired | Scalp EEG 3-D actigraphy Optional channels | |
| ECG/EEG/EOG/EMG | Scalp EEG Infra-red (IR) optical signal Microphone 3-D actigraphy Optional channel | |
| ECG/EEG/EOG/EMG | ||
| Acquisition | ||
| modes | Monitor only | Record or Monitor |
| Power Supply | 2 to 4 240mAH 3.7 Li-Ion batteries | 1 x 600 mAH 3.7V Li-ION battery |
| Battery | ||
| Charging | Via JED Connector connected to USB | |
| port or USB wall charger | Via USB cable connected to USB port | |
| or USB wall charger | ||
| Typical | ||
| Charging Time | 0.5-5.0 hours | 0.5 - 3.0 hours |
| Operating | ||
| Time | Monitoring Days after Charge Hours | |
| of Use 0-4 Days: 16 to 17 hours 5-10 Days: 14 to 15 hours | Recording Days after Charge Hours | |
| of Use 0-4 Days: 13.0 to 15.5 hours 5-10 Days: 11.5 to 14.8 hours Monitoring Days after Charge Hours | ||
| of Use 0-4 Days: 6.5 to 7.8 hours 5-10 Days: 6.0 to 7.3 hours | ||
| Data Storage | Not used. The X-Series system does | |
| not include a record mode where | ||
| data is stored on the recorder. | 2 GB Micro-SD memory card | |
| File size per 8 | ||
| hr recording | 512 MB | 72 MB |
| Dimensions | 5.0" long, 2.25"wide, 1.0" deep | 2.1" long, 1.5"wide, 0.75" deep |
| Weight | 3.9 ounces with two batteries | 2.5 ounces with battery |
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| Specification | X-Series System | X4 System (K120447) |
|---|---|---|
| Cleaning | Cleaned and disinfected by rubbing | |
| with isopropyl alcohol. | Cleaned and disinfected by rubbing | |
| with isopropyl alcohol. | ||
| Wireless data | ||
| transfer | Blue tooth 2.0 | Blue tooth 2.0 |
| Maximum | ||
| Bluetooth | ||
| wireless | ||
| transfer | ||
| distance and | ||
| rate | Transfer distance 10 meters line of | |
| sight, maximum transfer rate 3 | ||
| Mbaud | Transfer distance 10 meters line of | |
| sight, maximum transfer rate 3 | ||
| Mbaud | ||
| EEG | ||
| Definition | Up to 20 differential or referential | |
| channels | 3 or 4 differential or referential | |
| channels | ||
| Signal | ||
| processing | ||
| techniques | ||
| (e.g. filtering, | ||
| etc.) | Sampling Rate: 256 s/s |
0.1 Hz High Pass, hardware
100 Hz Low Pass, hardware | Sampling Rate: 256 s/s
0.1 Hz High Pass, hardware
100 Hz Low Pass, hardware |
| Accuracy,
variance and
error of
measurements,
in comparison
to standard
techniques of
measuring
identical
physiologic
variables | Sampling rate: 256Hz
Dynamic range: +/- 1000μV
Resolution 0.03 µV
Peak to peak noise: 3.7 µV (typical)
110dB Common Mode Rejection
Ratio (typically)
Input Impedance: 100GOhm | Sampling rate: 256Hz
Dynamic range: +/- 1000μV
Resolution 0.03 µV
Peak to peak noise: 3.7 µV (typical)
110dB Common Mode Rejection
Ratio (typically)
Input Impedance: 100GOhm |
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| Specification | X-Series System | X4 System (K120447) |
|---|---|---|
| Aux - EOG/EMG | ||
| Definition | Up to 4 optional single channel | |
| either dual lead electrooculogram | ||
| (EOG) or electromyogram (EMG) | Optional single channel either dual | |
| lead electrooculogram (EOG) or | ||
| electromyogram (EMG) | ||
| Signal | ||
| processing | ||
| techniques | ||
| (e.g. filtering, | ||
| etc.) | Sampling rate 256 Hz | |
| 0.1 Hz High Pass, hardware | ||
| 100 Hz Low Pass, hardware | Sampling rate 256 Hz | |
| 0.1 Hz High Pass, hardware | ||
| 100 Hz Low Pass, hardware | ||
| Accuracy, | ||
| variance and | ||
| error of X4 | ||
| System | ||
| measurements, | ||
| in comparison | ||
| to standard | ||
| techniques of | ||
| measuring | ||
| identical | ||
| physiologic | ||
| variables | ECG: | |
| Dynamic range: +/- 2000μV | ||
| Resolution: 0.06 μV | ||
| Peak to peak noise: 4.2 μV | ||
| EMG/EOG: | ||
| Dynamic range: +/- 1000μV | ||
| Resolution 0.03 μV | ||
| Peak to peak noise: 3.7 μV (typical) | EOG: | |
| Dynamic range: +/- 2000μV | ||
| Resolution: 0.06 μV | ||
| Peak to peak noise: 4.2 μV | ||
| EMG: | ||
| Dynamic range: +/- 1000μV | ||
| Resolution 0.03 μV | ||
| Peak to peak noise: 3.7 μV (typical) |
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6
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| Specification | X-Series System | X4 System (K120447) |
|---|---|---|
| Aux.- ECG | ||
| Definition | Dual lead electrocardiogram | Dual lead electrocardiogram |
| Number: Single Channel (optional) | Number: Single Channel (optional) | |
| Bandwidth: 0.1 to 100Hz -3dB | ||
| bandwidth | Bandwidth: 0.1 to 100Hz -3dB | |
| bandwidth | ||
| Notch Filters: 50, 60Hz, software | Notch Filters: 50, 60Hz, software | |
| Common Mode Rejection Ratio: | ||
| 110dB | Common Mode Rejection Ratio: | |
| 110dB | ||
| Input Impedance: 100GOhm | Input Impedance: 100GOhm | |
| Input Range: +/-4mV | Input Range: +/-4mV | |
| Accuracy: 16 bits over input range | Accuracy: 16 bits over input range | |
| Noise: |