(100 days)
The X8 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. All X8 models (SP40, SP29, and XS29) acquire, record, transmit, and/or display electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals. Model SP29 additionally includes a nasal pressure transducer and cannula (for airflow), thoracic and abdomen respiratory effort, and pulse rate and oxyhemoglobin saturation from the finger. The X8 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 X8 System is indicated for acquiring, recording/storing, transmitting, and displaying physiological data in patients. It can be used by patients in the home, healthcare facility, or clinical research environment. Patients can move within their home or healthcare environment without having to remove the device (e.g. walk to the restroom).
The X8 System is comprised of the X8 device which is worn on the patient's head and body, accessories, the Device Manager software, and the X-Series Basic-Utility Software. The study records are saved to the PC in EDF format and are available for analysis by third party software applications, such as Persyst Reveal (K011397).
The X8 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 and acquiring signals from multiple locations on the head or body, transmitting and recording the signals, and providing visual and auditory indications to ensure high quality data are obtained.
Model SP40 Sleep Profiler is applied by the patient to acquire and record electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals during sleep. This model utilizes the X8 Sleep Profiler Strip.
Model SP29 Sleep Profiler PSG2 is applied by the patient to acquire and record electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals during sleep. This model additionally includes a nasal pressure transducer and cannula (for airflow), thoracic and abdomen respiratory effort, and pulse rate and oxyhemoglobin saturation from the finger. This model utilizes the X8 Sleep Profiler Strip.
Model XS29 X8 Stat is applied by a technician to acquire, record, transmit, and/or display electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals acquired during non-sleep conditions. This model utilizes either the X8 Midline or the X8 Referential strip.
The Device Manager software application provides a means to communicate with the X8 Device, transfer study data, and format a device. The software transfers data saved in the memory of the X8 device using either a PC application or a web-based data entry application operating in a cloud server environment.
The X-Series Basic-Utility Software acquires, presents, and stores physiological signals from the X8 Device. The software has a modular architecture that allows the users to interact using either the Graphical User Interface (GUI) provided with the installation, or programmatically via a Software Development Kit. Additional functionalities provided by X-Series Basic-Utility Software include impedance measurements, custom markers, and interface with the Bluetooth Receiving Dongle.
Here's a breakdown of the acceptance criteria and study details based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Device: X8 System (Sleep Profiler (SP40), Sleep Profiler PSG2 (SP29), Stat X8 (XS29))
Study Type: Prospective Comparison and Self-Application Study of X8 System Model SP29
| Acceptance Criterion (Primary Endpoint) | Reported Device Performance and Outcome |
|---|---|
| A) Comparison of Signals (X8 System airflow and respiratory effort vs. predicate device Compumedics Somte (K072201)) | |
| No more than 10% of the breathing events recorded with the X8-PSG2 airflow signal were inferior to predicate signal. | Achieved: No events recorded with the X8-PSG2 airflow signal (0%) were found inferior to the predicate signal. |
| No more than 20% of the breathing events recorded with the X8-PSG2 respiratory effort will be inferior to the predicate signal. | Achieved: The X8 thorax and abdomen belts were inferior to the predicate in only 4.0% (9/225) and 1.3% (3/232) of the events, respectively (both well below 20%). |
| B) Demonstrate that high quality signals can be obtained when the X8 System is self-applied with the user instructions. | |
| At least 80% of subjects will be able to acquire at least one night of data (i.e., the entire period they were in bed). | Achieved: 91% (10 of 11 subjects) were able to acquire at least one night of data for the entire night. |
| At least 70% of each night of recording time will be valid across the oximetry, nasal pressure, and effort belt signals. (While not identified as a primary endpoint for cardio-respiratory signal quality, high EEG quality was also assessed.) | Achieved: The percentage of good data obtained for oximetry, nasal pressure (airflow), and respiratory effort (thorax and abdomen) exceeded 90% on each night. High EEG quality was also obtained in over 90% of the recording time on each night. |
| At least 70% of subjects did not report X8-PSG2 audio alerts (for signal quality) substantially affected (i.e., strongly agreed) their ability to stay asleep. | Achieved: 90% (9 of 10 subjects) did not "strongly agree" that the PSG2 made it difficult for them to stay asleep. (Note: One subject was excluded from this calculation, resulting in 10 subjects for this specific endpoint, even though 11 were initially reported for data acquisition ability). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For comparison of airflow and respiratory effort signals (part A of the study): The specific number of breathing events analyzed is provided (225 for thorax, 232 for abdomen), but the number of subjects contributing to these events is not explicitly stated.
- For self-application and signal quality (part B of the study): 11 subjects.
- For audio alerts acceptance criterion: 10 subjects (one subject was excluded from this analysis).
- Data Provenance: The study was described as "prospective," indicating that the data was collected specifically for this study under controlled conditions defined prior to data collection. The document does not specify the country of origin for the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth for this comparative study. However, the ground truth for part A (comparison of signals) was implicitly the readings from the predicate device, Compumedics Somte (K072201), an FDA-cleared device. For part B (self-application and signal quality), the ground truth for signal quality likely involved assessment against predefined criteria or by qualified personnel, but this is not detailed.
4. Adjudication Method for the Test Set
The document does not specify an explicit adjudication method (e.g., 2+1, 3+1). For the comparative study (part A), the comparison was against an "FDA cleared device," implying the predicate device's output served as the reference standard. For self-application (part B), signal quality was assessed, presumably against accepted norms for such physiological signals, but no multi-expert adjudication process is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or described in this document. The X8 System "acquires and displays physiological signals; no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability." Therefore, this device does not involve AI analysis or human reader interpretation for diagnostic claims, but rather accurate signal acquisition.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device's intended use is to "acquire, record, transmit, and display physiological signals." It does not include automated analysis or diagnostic algorithms. Therefore, a standalone algorithm performance study was not applicable and not done. The focus of the performance study was on the quality and equivalence of the acquired physiological signals.
7. The Type of Ground Truth Used
- For comparison of airflow and respiratory effort signals (Part A): The ground truth was based on the signals obtained from an FDA-cleared predicate device (Compumedics Somte (K072201)).
- For self-application and signal quality (Part B): The ground truth for "valid" recording time and "high EEG quality" would have been established by assessing the acquired physiological signals against accepted physiological standards and criteria for signal integrity, likely by trained professionals. The specific method of establishing this ground truth is not detailed beyond the term "good data."
8. The Sample Size for the Training Set
The document describes "prospective studies" for verification and validation. Given that the device's function is signal acquisition and display, and no claims for analysis accuracy or reliability are being made, there isn't a "training set" in the context of machine learning. The studies described are performance evaluations of the hardware and software's ability to accurately capture and transmit signals.
9. How the Ground Truth for the Training Set Was Established
As noted above, no "training set" in the machine learning sense is described for this device. The ground truth for performance evaluation was established through comparison with a predicate FDA-cleared device and assessment against physiological signal quality standards.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2015
Advanced Brain Monitoring, Inc. % Adrienne Lenz Member Pathway Regulatory Consulting, LLC W324S3649 County Road E Dousman, Wisconsin 53118
Re: K152040
Trade/Device Name: X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC, OLV Dated: July 17, 2015 Received: July 22, 2015
Dear Adrienne 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152040
Device Name
X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)
Indications for Use (Describe)
The X8 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. All X8 models (SP40, SP29, and XS29) acquire, record, transmit, and/or display electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals. Model SP29 additionally includes a nasal pressure transducer and cannula (for airflow), thoracic and abdomen respiratory effort, and pulse rate and oxyhemoglobin saturation from the finger. The X8 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
DATE: September 24, 2015
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 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: X8 System (Sleep Profiler, Sleep Profiler PSG2, X8 Stat)
COMMON/USUAL NAME: X8
CLASSIFICATION NAMES: 882.1400 Electroencephalograph
REVIEW PANEL: Neurology
PRODUCT CODE: OMC
PREDICATE DEVICE(S):
K130013 X4 System
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DEVICE DESCRIPTION:
The X8 System is indicated for acquiring, recording/storing, transmitting, and displaying physiological data in patients. It can be used by patients in the home, healthcare facility, or clinical research environment. Patients can move within their home or healthcare environment without having to remove the device (e.g. walk to the restroom).
The X8 System is comprised of the X8 device which is worn on the patient's head and body, accessories, the Device Manager software, and the X-Series Basic-Utility Software. The study records are saved to the PC in EDF format and are available for analysis by third party software applications, such as Persyst Reveal (K011397).
The X8 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 and acquiring signals from multiple locations on the head or body, transmitting and recording the signals, and providing visual and auditory indications to ensure high quality data are obtained.
Model SP40 Sleep Profiler is applied by the patient to acquire and record electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals during sleep. This model utilizes the X8 Sleep Profiler Strip.
Model SP29 Sleep Profiler PSG2 is applied by the patient to acquire and record electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals during sleep. This model additionally includes a nasal pressure transducer and cannula (for airflow), thoracic and abdomen respiratory effort, and pulse rate and oxyhemoglobin saturation from the finger. This model utilizes the X8 Sleep Profiler Strip.
Model XS29 X8 Stat is applied by a technician to acquire, record, transmit, and/or display electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals acquired during non-sleep conditions. This model utilizes either the X8 Midline or the X8 Referential strip.
The Device Manager software application provides a means to communicate with the X8 Device, transfer study data, and format a device. The software transfers data saved in the memory of the X8 device using either a PC application or a web-based data entry application operating in a cloud server environment.
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The X-Series Basic-Utility Software acquires, presents, and stores physiological signals from the X8 Device. The software has a modular architecture that allows the users to interact using either the Graphical User Interface (GUI) provided with the installation, or programmatically via a Software Development Kit. Additional functionalities provided by X-Series Basic-Utility Software include impedance measurements, custom markers, and interface with the Bluetooth Receiving Dongle.
INTENDED USE:
The X8 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. All X8 models (SP40, SP29, and XS29) acquire, record, transmit, and/or display electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals. Model SP29 additionally includes a nasal pressure transducer and cannula (for airflow), thoracic and abdomen respiratory effort, and pulse rate and oxyhemoglobin saturation from the finger. The X8 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 X8 System has similar indications for use and uses the same fundamental technology as the X4 System for most features including the electrophysiological (EEG, EOG, ECG, EMG), wireless acquisition, and actigraphy. Like the X4 System, the X8 system acquires, records and transmits EEG, EOG, ECG, EMG, accelerometer, acoustical and photoplethysmographic signals. Additional respiratory signals acquired by the X8 system use similar technology as reference device ARES Model 610. The technologies used in the X8 System are used in the same manner as the predicate and reference products and do not raise new questions of safety and effectiveness. A comparison of key specifications is presented in the following table:
| Specification | X8 System (New) | Predicate Device X4 System (K130013) | Reference Device ARES Model 610 (K112514) |
|---|---|---|---|
| Patient Population | Adults | Adults | Adults |
| Anatomical Sites | Forehead, Head, Chest, Abdomen, Chin and Finger | Forehead, Chest, Chin | 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, analysis and reporting)Clinical Research Environment | Home (data acquisition)Healthcare facility (data acquisition, analysis and reporting) |
| User Control | ON/OFF | ON/OFF | ON/OFF |
| Specification | X8 System (New) | Predicate DeviceX4 System (K130013) | Reference DeviceARES Model 610 (K112514) |
| Visual Indicator | Green and yellow LED | Green and yellow LED | Green LED |
| Audio Indicator | Speaker. Voice messages alert user to problems during recording. | Speaker. Voice messages alert user to problems during recording. | Speaker. Voice messages alert user to problems during recording. |
| EEG Electrodes | Vermed VersaTrode Sensor 40-4305 (K781430) | Kendall Meditrace Mini 230 (K960968)Kendall Meditrace Mini 533 (K945479) | Kendall Meditrace Mini 130 (K864722) |
| EOG Electrodes | Vermed VersaTrode Sensor 40-4305 (K781430) | Kendall Meditrace Mini 130 (K864722) | Kendall Meditrace Mini 130 (K864722) |
| ECG Electrodes | Vermed VersaTrode Sensor 40-4305 (K781430) | Kendall Meditrace Mini 533 (K945479) | None |
| EMG Electrodes | Vermed NeuroPlus Sensors A10041-60 (K010638) | Kendall Meditrace Mini 130 (K864722) | None |
| Linked MastoidSensors | MBS (3BF3) Disposable Ag/Cl sensors with adhesive (K842514) | MBS (3BF3) Disposable Ag/Cl sensors with adhesive (K842514) | None |
| 2-pin Leadwire | 2-pin leadwire with touch-proof connector | 2-pin leadwire with touch-proof connector | 2-pin leadwire with touch-proof connector |
| 3-pin Leadwire | 3-pin leadwire with touch-proof connector | 3-pin leadwire with touch-proof connector | None |
| RespiratoryAccessory | Nasal Cannula and nasal pressure sensorChest and abdomen effort belts | None | Nasal Cannula and nasal pressure sensorChest effort belt |
| Signals Acquired | Forehead/head EEG Infra-red (IR) optical signal Microphone 3-D actigraphy Optional channel (ECG/EEG/EOG/EMG) Nasal Pressure & cannula Respiratory Effort | Forehead/head EEG Infra-red (IR) optical signal Microphone 3-D actigraphy Optional channel (ECG/EEG/EOG/EMG) | Forehead EEG Red and infra-red (IR) optical signals Microphone 3-D actigraphy Derived EOG and EMG Nasal Pressure & cannula Respiratory Effort |
| Power Supply | 1 x 600 mAH 3.7V Li-ION battery | 1 x 600 mAH 3.7V Li-ION battery | 2 x 250 mAH 3.7V Li-Ion batteries |
| Specification | X8 System (New) | Predicate DeviceX4 System (K130013) | Reference DeviceARES Model 610 (K112514) |
| BatteryCharging | Patients - external batterypackTechnicians - Via USB cableconnected to USB port or USBwall charger | Via USB cable connected toUSB port or USB wall charger | Via USB cable connected toUSB port or USB wall charger |
| Typical ChargingTime | 0.5 - 3.0 hours | 0.5 - 3.0 hours | 0.5 - 2.5 hours |
| Acquisitionmodes | Record or Monitor | Record or Monitor | Record only |
| Operating Time | Hours of Use:0-4 days after charging:Model SP40 Record: 16.0 -18.5Model XS29 Monitor: 10.5 -12.5Model SP29 Record: 11.5 -13.55-10 days after charging:Model SP40 Record: 14.0 -16.5Model XS29 Monitor: 9.5 -12.0Model SP29 Record: 10.0 -13.0 | Hours of Use:0-4 days after charging:Record: 13.0 - 15.5Monitor: 6.5 - 7.85-10 days after charging:Record: 11.5 - 14.8Monitor: 6.0 - 7.3 | Hours of Use:0-4 days after charging:Record: 19.0 hours5-10 days after charging:Record: 17.0 hours |
| Data Storage | 8 GB Micro-SDHC memory cardor greater capacity | 2 GB Micro-SD memory card | 2 GB Micro-SD memory card |
| File size per 8 hrrecording | Standard mode - 72 MBPSG2 Mode - 134 MB | 72 MB | 31.2 MB |
| Dimensions | 2.1" long, 1.5"wide, 0.75" deep | 2.1" long, 1.5"wide, 0.75" deep | 2.5" long x 2" wide x 1" deep |
| Weight | 2.5 ounces with battery | 2.5 ounces with battery | 4 ounces with batteries |
| Cleaningenclosures andEEG Strip | Cleaned and disinfected byrubbing with alcohol-basedhand sanitizer and isopropylalcohol. | Cleaned and disinfected byrubbing with alcohol-basedhand sanitizer and isopropylalcohol. | Cleaned and disinfected byrubbing with alcohol-basedhand sanitizer and isopropylalcohol. |
| Cleaningenclosure strap | Cleaned and disinfected bywashing with dish soap. | Cleaned and disinfected bywashing with dish soap. | Single patient use. |
| Specification | X8 System (New) | Predicate DeviceX4 System (K130013) | Reference DeviceARES Model 610 (K112514) |
| Nasal PressureTransducer | Pressure transducerincorporated into airflowadapter,Affixes to USB connectorSize: 3.5 (l) x 2.5 (w) x 1.5 (d) cmWeight - 5.5 grams | Not available | Pressure transducerincorporated into mainenclosure |
| Oximeter | Bluetooth (BT) used to obtainpulse and SpO2 acquired withwrist oximeter.Nonin WristOx2 Wireless PulseOximeter (K102350) | Not available | Pulse and oximeterincorporated into mainenclosure |
| Respiratoryeffort belts | Uses 3rd party respiratoryinduced plethysmography (RIP)thorax and abdomen effortbeltsPhilips/Pro-Tech ezRIPRespiratory Effort Sensors(K913395), and AmbuSleepMate RIPmateRespiratory Effort Sensor(K903300) | Not available | Single piezzo chest belt |
| Data transferfrom SD card | Native USB | Native USB | Native USB |
| USB datatransfer rate | > 250 MB per minute | > 250 MB per minute | > 250 MB per minute |
| Wireless datatransfer | Bluetooth | Bluetooth | N/A |
| MaximumBluetoothwireless transferdistance andrate | Transfer distance 10 metersline of sight, maximum transferrate 3 Mbaud | Transfer distance 10 metersline of sight, maximum transferrate 3 Mbaud | N/A |
| Compatibility | Personal computer with2.4GHz (Pentium 4) Processoror better, 2 GB RAM or higher(or equivalent) with Windows7, 8, or Mac iOS OperatingSystem | Personal computer withPentium 4, 2 GB RAM or higherprocessor (or equivalent) withWindows 7 Operating System | Personal computer withPentium 4, 1 GB RAM orhigher processor (orequivalent) with Windows XPOperating System |
| Estimated filesize per minute | Standard Mode: 150 KB/MinPSG2 Mode: 280 KB/Min | 150 KB/Min | 67 KB/Min |
| File format type | European Data Format (EDF) | European Data Format (EDF) | Proprietary |
| Specification | X8 System (New) | Predicate DeviceX4 System (K130013) | Reference DeviceARES Model 610 (K112514) |
| Presents rawsignals duringacquisition inmonitoringmode | Yes | Yes | Yes |
| Presentspreviouslyacquired signals | No | Yes | Yes |
| Specification | X8 System (New) | Predicate DeviceX4 System (K130013) | Reference DeviceARES Model 610 (K112514) |
| Desktopinterfaceminimumcomputerrequirements | 1. Processor : 2.4 GHz2. Operating System:Windows 7 or 83. RAM: 2GB4. USB port: 1 | 1. Processor : 2.4 GHz2. Operating System:Windows 73. RAM: 2GB4. USB port: 1 | 1. Processor : 2.4 GHz2. Operating System:Windows XP3. RAM: 1GB4. USB port: 1 |
| Web interfaceminimumcomputerrequirements | 1. Processor : Minimum 2.4 GHz2. Operating System:Windows 7 or 8, Mac iOS3. Java version 6 or greater4. RAM: 1GB5. USB port: 16. Internet connection:constant7. Web browser: InternetExplorer, Firefox, Opera,Chrome, or Safari | 1. Processor : Minimum 2.4 GHz2. Operating System:Windows XP or 73. Java version 6 or greater4. RAM: 1GB5. USB port: 16. Internet connection:constant7. Web browser: InternetExplorer, Firefox, Opera, orChrome | 1. Processor : Minimum 2.4 GHz2. Operating System:Windows XP or 73. JAVA version 6 or greater4. RAM: 1GB5. USB port: 16. Internet connection:constant7. Web browser: InternetExplorer, Firefox, orChrome |
| Web interfaceserverrequirements. | Virtual Server:1. Processor: > 2 GHz2. Operating system: WinServer 2008.3. RAM: > 2GB4. Certificates: Signed SSL5. .NET framework:version 2.0 - web serverversion 3.5 - processingserveror Win Server 20086. Database: SQL server2005 | Virtual Server:1. Processor: > 2 GHz2. Operating system: WinServer 2008.3. RAM: > 2GB4. Certificates: Signed SSL5. .NET framework:version 2.0 - web serverversion 3.5 - processingserveror Win Server 20086. Database: SQL server 2005 | Virtual server:1. Processor: > 2 GHz2. Operating system: WinServer 2008.3. RAM: > 2GB4. Certificates: Signed SSL5. .NET framework:version 2.0 - web serverversion 3.5 - processingserveror Win Server 20086. Database: SQL server2005 |
| Physical Server:1. Processor: > 2 GHz2. Operating system: WinServer 2008 Enterpriseedition (for virtualservers).3. RAM: > 2GB | Physical Server:1. Processor: > 2 GHz2. Operating system: WinServer 2008 Enterpriseedition (for virtual servers)3. RAM: > 2GB | Physical server:1. Processor: > 2 GHz2. Operating system: WinServer 2008 Enterpriseedition (for virtualservers).3. RAM: > 2GB | |
| Specification | X8 System (New) | Predicate DeviceX4 System (K130013) | Reference DeviceARES Model 610 (K112514) |
| Computer/portalSecurity | 1. The person installing theJava applet must haveadministrator privileges.2. User must have rights tothe account and group toaccess data via the portal.3. The firewall is notconfigured to preventinput or outputcommunication withaccess to the server viaports 22 and 30-39. | 1. The person installing theJava applet must haveadministrator privileges.2. User must have rights to theaccount and group toaccess data via the portal.3. The firewall is notconfigured to prevent inputor output communicationwith access to the servervia ports 22 and 30-39. | 1. The person installing theJava applet must haveadministrator privileges.2. User must have rights tothe account and group toaccess data via theportal.3. The firewall is notconfigured to preventinput or outputcommunication withaccess to the server viaports 22 and 30-39. |
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DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
SUMMARY OF NON-CLINICAL TESTS:
Support for the substantial equivalence of the X8 System was provided as a result of risk management and testing which included comparison of signals to the predicate device, electrical safety, electromagnetic compatibility and software tests. This testing includes conformity to FDA recognized consensus standards and voluntary standards as follows:
| Standard Number | Standard Title |
|---|---|
| IEC 60601-1:2005 (3rd Edition) | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| 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 |
| 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 60601-2-26:2012 | Particular requirements for the basic safety and essential performance of electroencephalographs |
| IEC 62133: 2012 | Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications |
| ISO 14971:2007 | Medical devices - Application of risk management to medical devices |
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Additional analysis, verification and validation testing confirmed:
- Instructions for disinfecting the reusable parts of the X8 System and the materials used ● in the reusable portions of the X8 System (i.e. Sensor strip forehead, sensor strip head, and enclosure strap) are identical to those used in the previously cleared X4 System (K120047) and X-Series System (K131383). The remaining reusable portions (i.e. Respiratory Effort Belts and Wireless finger pulse oximeter) of the X8 System are cleared on their own by the supplier. The size and shape of the device enclosure of the X8 System is identical to that of the previously cleared X4 System and the material used is the same Black ABS. The Airflow Adapter enclosure is made of the same Black ABS as the device enclosure. Advanced Brain Monitoring evaluated the differences between the X8 System and the X-Series and X4 Systems and concluded that previously performed cleaning validation was also applicable to the X8 System.
- All materials of the X8 System are identical to materials tested for biocompatibility in the predicate X4 System and reference device X-Series System (K131383).
- 0 All features of the X8 System were compliant with the system and software level requirements.
- Signals acquired with the X8 System provide equivalent information as compared to the predicate device that would allow a physician to interpret the signals.
SUMMARY OF CLINICAL TESTS:
Advanced Brain Monitoring has conducted prospective studies to: A) compare equivalence of signals obtained with X8 System airflow and respiratory effort signals with an FDA cleared device, Compumedics Somte (K072201), and B) demonstrate that high quality signals can be obtained when the X8 System is self-applied with the user instructions. X8 System Model SP29 was used for both portions of the study.
The following endpoints were successfully achieved:
- No more than 10% of the breathing events recorded with the X8-PSG2 airflow signal were inferior to predicate signal. No events recorded with the X8-PSG2 airflow signal (0%) were found inferior to the predicate signal.
- o No more than 20% of the breathing events recorded with the X8-PSG2 respiratory effort will be inferior to the predicate signal. The X8 thorax and abdomen belts were inferior to the predicate in only 4.0% (9/225) and 1.3% (3/232) of the events, respectively.
- At least 80% of subjects will be able to acquire at least one night of data (i.e., the entire period they were in bed). The results demonstrated that 91% (10 of 11 subjects) were able to acquire at least one night of data for the entire night.
- . At least 70% of each night of recording time will be valid across the oximetry, nasal pressure, and effort belt signals. The percentage of good data obtained for oximetry, nasal pressure (airflow) and respiratory effort (thorax and abdomen) exceeded 90% on each night. While not identified as a primary endpoint for the assessment of cardio-
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respiratory signal quality, high EEG quality was also obtained in over 90% of the recording time on each night.
- • At least 70% of subjects did not report X8-PSG2 audio alerts (for signal quality) substantially affected (i.e., strongly agreed) their ability to stay asleep. The results demonstrated that 90% (9 of 10 subjects) did not "strongly agree" that the PSG2 made it difficult for them to stay asleep.
CONCLUSION:
Advanced Brain Monitoring considers the X8 System to be substantially equivalent to the predicate devices.
§ 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).