Cerebra Sleep System

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July 6, 2022 Cerebra Medical Ltd. % Mary Vater Associate Regulatory Consultant Medical Device Academy Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738 Re: K213007 Trade/Device Name: Cerebra Sleep System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC, OLV, OLZ Dated: June 3, 2022 Received: June 6, 2022 Dear Mary Vater: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) Device Name Cerebra Sleep System #### Indications for Use (Describe) The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. The system uses polysomnography (PSG) to record the electroencephalogram (EBG), electroculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), accelerometry, acoustic signals, nasal airflow, thoracic and abdomen respiratory effort, pulse rate, and oxyhemoglobin saturation, depending on the sleep study configuration. The Creebra Sleep System is for prescription use in a home or healthcare facility. The Cerebra Sleep System is intended to be used as a support tool by physicians and PSG technologists to aid in the evaluation and diagnosis of sleep disorders. It is intended to provide sleep-related information that is interpreted by a qualified physician to render findings and/or diagnosis, but it does not directly generate a diagnosis. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☑</span> | |----------------------------------------------|-----------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | □ | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ SUBMITTER l. # 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92: | Cerebra Medical Ltd. | |--------------------------------| | 1470 Willson Place, Unit B | | Winnipeg, Manitoba, CA R3T 3N9 | | +1.431.801.0332 | | Contact Person: | Mary Vater | |-----------------|--------------| | Date Prepared: | July 6, 2022 | II. DEVICE | Name of Device: | Cerebra Sleep System | |------------------------------|------------------------------------------------| | Classification Name: | Reduced-Montage Standard Electroencephalograph | | Regulation: | 21 CFR §882.1400 | | Regulatory Class: | Class II | | Product Classification Code: | OMC, OLV, OLZ | III. PREDICATE DEVICE | Primary Predicate Manufacturer: | Advanced Brain Monitoring, Inc. | |-----------------------------------|-------------------------------------------------------------------------------------------------------| | Primary Predicate Trade Name: | X8 System - Sleep Profiler (SP40), X8 System – Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) | | Primary Predicate 510(k): | K152040 | | Secondary Predicate Manufacturer: | Younes Sleep Technologies | | Secondary Predicate Trade Name: | Michele Sleep Scoring Systems | | Secondary Predicate 510(k): | K112102 | No reference devices were used in this submission. #### IV. DEVICE DESCRIPTION The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. It is for prescription use in a home or healthcare facility and is used by physicians and polysomnographic (PSG) technologists as a support tool to aid in the evaluation and diagnosis of sleep disorders. A PSG tecnologist must edit, score, and review the data before sleep reports are generated. The Cerebra Sleep System is capable of collecting data required for Level 2 PSG and Level 3 HSAT studies. A Level 3 HSAT study is a home sleep apnea test with a minimum of 4 channels that include oxygen saturation, electrocardiogram (ECG) or heart rate, airflow (e.g., nasal flow), and respiratory effort (e.g., chest band). A Level 2 PSG study is an unattended sleep test with a minimum of 7 channels that include electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG) or heart rate, chin electromyogram (EMG), and all signals from Level 3. Sleep {4}------------------------------------------------ The Cerebra Sleep System (CSS) is comprised of three main areas: - Prodigy: This is a PSG recorder capable of performing Level 2 and Level 3 sleep studies. It ● includes the Head Mounted Unit (HMU), which is worn on the patient's head, the Chest Mounted Unit (CMU), which is affixed to a chest effort belt, the Table Top Unit (TTU), which receives data wirelessly, and third party accessories including an oximeter. - Cerebra Analytics Suite (CAS): The CAS has 4 components Web Processing (for signal ● processing of data), Web Scoring (for generating scoring results, which encompasses autoscoring), Cerebra Viewer (for viewing and editing PSG studies and scoring results) and Web Reporting (for generating reports). A PSG technician must edit, score, and review the data before reports are generated. These components utilize well-defined file formats to enable communication; communication with each component is done through the internet, via the Cerebra Portal. - Cerebra Portal: All areas of the CSS product are managed by the Portal software. The Portal is used to configure a study on the TTU and allows sleep analysis service providers to manage inventory, patients, and sleep studies. It also configures Prodigy system hardware for an individual sleep study to be performed by a patient. #### V. INDICATIONS FOR USE The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. The system uses polysomnography (PSG) to record the electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), accelerometry, acoustic signals, nasal airflow, thoracic and abdomen respiratory effort, pulse rate, and oxyhemoglobin saturation, depending on the sleep study configuration. The Cerebra Sleep System is for prescription use in a home or healthcare facility. The Cerebra Sleep System is intended to be used as a support tool by physicians and PSG technologists to aid in the evaluation and diagnosis of sleep disorders. It is intended to provide sleep-related information that is interpreted by a qualified physician to render findings and/or diagnosis, but it does not directly generate a diagnosis. {5}------------------------------------------------ #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI. The following characteristics were compared between the subject devices in order to demonstrate substantial equivalence: | | Cerebra Sleep System | X8 System (K152040) | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | OMC, OLV, OLZ | OMC, OLV | | Regulation | Same as predicate. | 21 CFR 882.1400<br>Electroencephalograph<br>An electroencephalograph is a device used to measure and<br>record the electrical activity of the patient's brain obtained by<br>placing two or more electrodes on the head. | | Indications for Use | The Cerebra Sleep System is an integrated diagnostic platform that<br>acquires, transmits, analyzes, and displays physiological signals<br>from adult patients, and then provides for scoring (automatic and<br>manual), editing, and generating reports. The system uses<br>polysomnography (PSG) to record the electroencephalogram<br>(EEG), electrooculogram (EOG), electrocardiogram (ECG),<br>electromyogram (EMG), accelerometry, acoustic signals, nasal<br>airflow, thoracic and abdomen respiratory effort, pulse rate, and<br>oxyhemoglobin saturation, depending on the sleep study<br>configuration. The Cerebra Sleep System is for prescription use in a<br>home or healthcare facility.<br>The Cerebra Sleep System is intended to be used as a support tool<br>by physicians and PSG technologists to aid in the evaluation and<br>diagnosis of sleep disorders. It is intended to provide sleep-related<br>information that is interpreted by a qualified physician to render<br>findings and/or diagnosis, but it does not directly generate a<br>diagnosis. | The X8 System is intended for prescription use in the home,<br>healthcare facility, or clinical research environment to acquire,<br>record, transmit, and display physiological signals from adult<br>patients. All X8 models (SP40, SP29, and XS29) acquire,<br>record, transmit, and/or display electroencephalogram (EEG),<br>electrooculogram (EOG), electrocardiogram (ECG), and/or<br>electromyogram (EMG) signals, with optional accelerometer,<br>acoustical, and photoplethysmographic signals. Model SP29<br>additionally includes a nasal pressure transducer and cannula<br>(for airflow), thoracic and abdomen respiratory effort, and<br>pulse rate and oxyhemoglobin saturation from the finger. The<br>X8 system only acquires and displays physiological signals; no<br>claims are being made for analysis of the acquired signals with<br>respect to the accuracy, precision, and reliability." | | Patient Population | Same as predicate. | Adults | | Anatomical Sites | Forehead, Head, Chest, Abdomen, Chin, Legs and Finger | Forehead, Head, Chest, Abdomen, Chin and Finger | | Environment of Use | Home (data acquisition), Healthcare facility (data acquisition, analysis and reporting) | Home (data acquisition), Healthcare facility (data acquisition, analysis and reporting),<br>Clinical Research Environment | | User Control | ON/OFF – Tablet End Study | ON/OFF | | Visual Indicator | Blue, Green, Yellow, Red Light Pipe. | Green and yellow LED | | Audio Indicator | None | Speaker. Voice messages alert user to problems during<br>recording. | | EEG Electrodes | Ambu 720 Series AM-72000S/E (K970639) | Vermed VersaTrode Sensor 40- 4305 (K781430) | | EOG Electrodes | King Lead, Touch Proof, Single Snap, KM-S020, (HC 99983)<br>Ambu 720 Series AM-72000S/E (K970639) | Vermed VersaTrode Sensor 40- 4305 (K781430) | | ECG Electrodes | King Lead, Touch Proof, Single Snap, KM-S020, (HC 99983)<br>Ambu 720 Series AM-72000S/E (K970639) | Vermed VersaTrode Sensor 40-4305 (K781430) | | EMG Electrodes | King Lead, Touch Proof, Single Snap, KM-S021, (HC 99983)<br>King Lead, Touch Proof, Single Snap, KM-S022, (HC 99983)<br>King Lead, Touch Proof, Single Snap, KM-S008, (HC 99983)<br>Ambu 720 Series AM-72000S/E, (K970639)<br>Natus 019-429400 (K850108)<br>Kendall CV-31112/E (Exempt) | Vermed NeuroPlus Sensors A10041-60 (K010638) | | Linked Mastoid Sensors | King Lead, Touch Proof, Single Snap, KM-S011, (HC 99983)<br>Ambu 720 Series AM-72000S/E, (K970639) | MBS (3BF3) Disposable Ag/Cl sensors with adhesive<br>(K842514) | | Respiratory Accessory | Same as predicate. | Nasal Cannula and nasal pressure sensor<br>Chest and abdomen effort belts | | Signals Acquired | Forehead/head EEG<br>● Infra-red (IR) and red optical signal<br>● Acoustic microphone<br>● 3-D Actigraphy<br>● Optional channel<br>● (ECG/EEG/EOG/EMG)<br>● Nasal Pressure & cannula (airflow)<br>Respiratory Effort | Forehead/head EEG<br>● Infra-red (IR) optical signal<br>● Acoustic microphone<br>● 3-D actigraphy<br>● Optional channel<br>● (ECG/EEG/EOG/EMG)<br>● Nasal Pressure & cannula (airflow)<br>● Respiratory Effort<br>● Photoplethysmography | | Power Supply…