Who is the manufacturer of Seer Home?

Seer Medical Pty, Ltd. filed the 510(k) submission for Seer Home (K212788).

What is the FDA product code for Seer Home?

GWQ. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Seer Home?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Seer Home?

ElectroTek (Trackit EEG hardware & RENDR software) (K170441).

Who can help prepare an FDA 510(k) submission like Seer Home?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Seer Home

K212788 · Seer Medical Pty, Ltd. · GWQ · Jun 16, 2022 · Neurology

Device Facts

Record ID	K212788
Device Name	Seer Home
Applicant	Seer Medical Pty, Ltd.
Product Code	GWQ · Neurology
Decision Date	Jun 16, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2

Intended Use

The electroencephalographic system Seer Home is intended to acquire, display, and store the electro-physiological signals of the patient's brain obtained by placing electrodes on the patient scalp. The Seer Home is intended to be used for such studies as electroencephalograph (EEG) and video EEG recording to aid in diagnosis of neurological disorders. The Seer Home does not draw any diagnostic conclusions. Seer Home is not intended for use as life support equipment such as vital signs monitoring in intensive care units. Seer Home is only to be used under the direction and supervision of a physician or EEG technologist or clinician.

Device Story

Ambulatory EEG system for home use (up to one week). Input: EEG signals via 22 scalp electrodes (10-20 system) and ECG signals via 3 chest electrodes. Wearable 'Seer Sense' device records and wirelessly transmits data to 'Seer Sight Video Monitoring Hub'. Hub records synchronized video and stores data. Post-study, data downloaded to Seer Cloud Platform for review, annotation, and reporting by clinicians. Device aids diagnosis of neurological disorders by providing EEG/ECG/video data; does not provide automated diagnostic conclusions. Benefits include long-term ambulatory monitoring outside clinical settings.

Clinical Evidence

No clinical testing performed. Substantial equivalence supported by non-clinical bench testing (electrical safety, EMC, biocompatibility, software verification/validation, and usability evaluation) and clinical literature review confirming safety and efficacy of ambulatory EEG devices.

Technological Characteristics

Ambulatory EEG system. Materials: Biocompatible per ISO 10993-1/5/10. Sensing: 22 EEG channels, 2 ECG channels. Connectivity: Wireless transmission to hub, Ethernet to cloud platform. Power: Mains (100-240 VAC) or internal battery. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home use), IEC 60601-2-26 (EEG), IEC 60601-2-25 (ECG). Software: Moderate level of concern, compliant with IEC 62304.

Indications for Use

Indicated for patients requiring monitoring of physiological signals to assist in the diagnosis of neurological disorders. For use by neurological and other related healthcare professionals in home or hospital/clinic environments. Not for use in intensive care or life support situations.

Regulatory Classification

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.

Predicate Devices

ElectroTek (Trackit EEG hardware & RENDR software) (K170441)

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Submission Summary (Full Text)

{0}------------------------------------------------ June 16, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Seer Medical Pty. Ltd. David Mitchell Quality and Regulatory Manager 278 Queensberry Street, Melbourne 3000, Victoria, Australia Re: K212788 Trade/Device Name: Seer Home Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Dated: July 28, 2021 Received: September 1, 2021 Dear David Mitchell: 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 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 {1}------------------------------------------------ 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, 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) K212788 Device Name Seer Home Indications for Use (Describe) The electroencephalographic system Seer Home is intended to acquire, display, and store the electro-physiological signals of the patient's brain obtained by placing electrodes on the patient scalp. The Seer Home is intended to be used for such studies as electroencephalograph (EEG) and video EEG recording to aid in diagnosis of neurological disorders. The Seer Home does not draw any diagnostic conclusions. Seer Home is not intended for use as life support equipment such as vital signs monitoring in intensive care units. Seer Home is only to be used under the direction and supervision or EEG technologist or clinician. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|-----------------------------------------------| | X Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CER 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}------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | Document No. Rev 1 # 510(k) Summary The following 510(k) summary is being submitted in accordance with 21 CFR 807.92 #### Device Information: | Submitter: Address: | Seer Medical Pty. Ltd. 278 Queensberry Street, Melbourne 3000, Victoria, Australia Tel: +61 (0) 3 7035 5736 | |--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Contact Person | David Mitchell – Quality and Regulatory Manager Tel: +61 (0) 3 7035 5736 Email: david@seermedical.com | | Date prepared: | 28th July 2021 | | Trade or Proprietary Name: Device Type: Product Code: Device Class: Regulation numbers: Regulation description: | Seer Home Full-Montage Standard Electroencephalograph GWQ II 21 CFR 882.1400 Electroencephalograph | ### Leqally Marketed Predicate Device Information: | Trade or Proprietary Name: | ElectroTek (Trackit EEG hardware & RENDR software) | |----------------------------|---------------------------------------------------------------------------| | Manufacturer Name: | MobileMedTek 1205 E. Washington St., Suite 115 Louisville, KY 40206 | | Device Type: | Full-Montage Standard Electroencephalograph | | 510(k) Number: | K170441 | | Product Code: | GWQ | | Device Class: | II | | Regulation numbers: | 21 CFR 882.1400 | | Regulation description: | Electroencephalograph | ### Device Description: The Seer Medical - Seer Home is an ambulatory electroencephalograph system designed to be used at the patient's home for up to week-long studies. The ambulatory EEG recorder (called "Seer Sense" or "Wearable") is worn around the patient shoulders. The Wearable has a single cable exiting from the bottom of the device and is routed inline to 3 disposable ECG electrodes which are positioned on the chest for ECG recording. Exiting from the rear of the Wearable is single flexible cable which has a junction at the top of the patient's head connected to the 22 EEG electrodes (disposable) which are positioned in the international '10-20' system for EEG recording. | 001_510(k) Summary | 510(k) Summary | |------------------------|----------------| | © Seer Medical Pty Ltd | Page 1 of 8 | {4}------------------------------------------------ | | Document No. | Heading | Rev | |------------------|--------------------|----------------------------------------------------------------------------------------|-----| | Image: Seer logo | 001_510(k) Summary | Traditional 510(k) Premarket Submission Seer Medical Pty. Ltd. Device: Seer Home | 1 | The Wearable records the EEG and ECG signals and wirelessly transmits them to a nearby "Seer Sight Video Monitoring Hub" in the patient's house. The Video Monitoring Hub has two roles, first to store the wireless data from the wearable, and the second is to record video from an in-built camera that is synchronized to the EEG/ECG data. The use of the recorded video data provides additional information to the physician (such as body movement artifacts) to assist in diagnosis in the neurological conditions. At the end of the study period (up to a week) the Wearable and Hub are returned back to the clinic for data download. The Seer Cloud Platform software downloads the data, stores the data, displays the EEG/ECG signals and video for reviewers to interpret, make annotations, and produce reports. The Seer Home is intended to be used by qualified operators or physicians trained in the interpretation of EEG/ECG signals and visual cues of patient movements - and is viewed as a part of a range of assessments used by Neurologists to assist in making diagnosis of neurological conditions. The accessories used with the Seer Home are disposable EEG electrodes, disposable ECG electrodes, Transport/Carry case, Medical Grade Power Adapter, IFU, and Rechargeable Batteries. #### Indications for Use: The electroencephalographic system Seer Home is intended to acquire, display, and store the electro-physiological signals of the patient's brain obtained by placing electrodes on the patient scalp. The Seer Home is intended to be used for such studies as electroencephalograph (EEG) and video EEG recording to aid in diagnosis of neurological disorders. The Seer Home does not draw any diagnostic conclusions. Seer Home is not intended for use as life support equipment such as vital signs monitoring in intensive care units. Seer Home is only to be used under the direction and supervision of a physician or EEG technologist or clinician. #### Technological Characteristics: The Seer Home is an ambulatory electroencephalograph system and has similar indication for use statement as the predicate device. The Seer Home also has similar technological characteristic as the predicate device. Listed on Table 1. Is a summarized version of the technological comparison between the Seer Home and predicate device. The table has same format and data as the predicate device K170441 510(k) Summary, with the addition of a comparison column. | 001_510(k) Summary | 510(k) Summary | |------------------------|----------------| | © Seer Medical Pty Ltd | Page 2 of 8 | {5}------------------------------------------------ | Image: Seer Logo | Document No. | Heading | Rev | |------------------|--------------------|----------------------------------------------------------------------------------------|-----| | | 001_510(k) Summary | Traditional 510(k) Premarket Submission Seer Medical Pty. Ltd. Device: Seer Home | 1 | Table 1: Summary of the technological characteristics of the device compared to the predicate device | Characteristics | Subject Device: Seer Medical Seer Home™ (K212788) | Predicate Device MobileMedTek ElectroTek (K170441) | Similarities, differences, impact | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. Indication | | | | | 1.1 INDICATIONS FOR USE | The electroencephalographic system Seer Home is intended to acquire, display, and store the electro-physiological signals of the patient's brain obtained by placing electrodes on the patient scalp. The Seer Home is intended to be used for such studies as electroencephalograph (EEG) and video EEG recording to aid in diagnosis of neurological disorders. | The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient's brain obtained by placing electrodes on the patient scalp. The ElectroTek is intended to be used for such studies as electroencephalogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions. | Same. Both systems are indicated for Video EEG studies with similar intended use which do not draw any diagnostic conclusions. | | | The Seer Home does not draw any diagnostic conclusions. | | | | | Seer Home is not intended for use as life support equipment such as vital signs monitoring in intensive care units. | | | | | Seer Home is only to be used under the direction and supervision of a physician or EEG technologist or clinician. | | | | 1.2 WARNINGS | Items related to off-label use or misuse | Items related to off-label use or misuse | Same. Standard warnings for EEG device. | | 1.3 CONTRAINDICATIONS | Items related to design and indicated use limitations, such as, not for use in the presence of flammable anesthetic's or in conjunction with defibrillation or electro-surgical equipment. | Items related to design and indicated use limitations, such as, not for use in the presence of flammable anesthetic's or in conjunction with defibrillation equipment. | Same. Not be used in the presence of flammable gases, defibrillation equipment or electro- surgical equipment stated in IFU and labelling. | | 1.4 Clinical Indications for Use | Assisting in the diagnosis of neurological disorders. | Assisting in the diagnosis of neurological disorders. | Same. Both systems are used for assisting in the diagnosis of neurological disorders. | | 1.5 Intended Patient Population | Patients requiring monitoring of their physiological signals to assist in diagnosis. | Patients requiring monitoring of their physiological signals to assist in diagnosis. | Same intended patient population. | | 1.6 Intended Users | For use by neurological and other related healthcare professionals. | For use by neurological and other related healthcare professionals. | Same intended users. | | 1.7 Environment of Use | For use in either a home or hospital/clinic environment. | For use in either a home, hospital/clinic environment. | Same environment of use. | | | The Seer Home is not for use in intensive care or other life support situations. | The ElectroTek is not for use in intensive care or other life support situations. | | | 1.8 Components of the System | Seer Sense wearable. Monitoring Hub. Seer Cloud Platform software. | ElectroTek - Trackit Amplifier Trackit F (Laptop, Camera, and Case) RENDR EEG software | Same. The Seer wearable performs the same function as the Trackit amplifier, the Monitoring Hub the same as the Trackit F Laptop/Camera, and the | | 001_510(k) Summary | 510(k) Summary | |------------------------|----------------| | © Seer Medical Pty Ltd | Page 3 of 8 | {6}------------------------------------------------ | | Document No. | Heading | | Rev | |---------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----| | | 001_510(k) Summary | Traditional 510(k) Premarket Submission Seer Medical Pty. Ltd. Device: Seer Home | | 1 | | | | | | | | Characteristics | Subject Device: Seer Medical Seer Home™ (K212788) | Predicate Device MobileMedTek ElectroTek (K170441) | Similarities, differences, impact | | | | | | Seer Cloud Platform software performs the same functions as the RENDR EEG software. | | | 1.9 Duration/application of use | Normal use is up to a week. | Usage depends on battery life which is 72 hours for the battery pack. | Same. Both devices are used for longer term home usage (> 24 hours). Seer Home has longer duration of use primarily driven by longer battery life. | | | 1.10 Portable / ambulatory | Yes | Yes | Same. Both devices are portable / ambulatory. | | | 2. Technical - Overview | | | | | | 2.1 GENERAL SYSTEMS APPROACH | Computer based equipment with dedicated hardware peripherals / Components | Computer based equipment with dedicated hardware peripherals / components | Same. Display and Analysis software operates on standard computer hardware. Acquisition is performed on dedicated medical hardware. | | | 2.2 USER INPUT DEVICE | Window mouse / keyboard / graphic interface. Simple user interface. | Window mouse / keyboard / touch panel driven graphic interface with dedicated control panel | Same. Display and Analysis software operates on standard computer hardware using GUI/keyboard/mouse. | | | | | | Different: The Amplifier UI interface is slightly different having a color-coded LEDs instead of LCD, this difference is minor and is assessed in the Usability assessment and found not to affect safety and effectiveness. | | | 2.3 USER OUTPUT DEVICE | Digital color display and optional network printer connectivity | Digital color display and optional network printer connectivity | Same. Display and Analysis software operates on standard computer hardware. | | | 2.4 PATIENT INPUTS | Up to 22 channels EEG and 2 channels ECG | Up to 32 channels EEG/EMG | Same. Both systems allow complete 10-20 positioning of scalp electrodes. Different. Additional electrodes for other electro- physiological inputs - ECG inputs for the Seer Home and EMG for ElectroTek. The additional inputs do not affect safety or performance for product code GWQ or impact the indications for use. | | | 2.5 SIGNAL ACQUISITION | Analog to digital conversion at fixed sample rate | Analog to digital conversion at variable sample rate | Different. Maximum sampling rates are the same: 500Hz. Predicate allows for selection of other lower frequency fixed rates. The sampling rate of 500 Hz is a requirement for compliance to the international EEG standard, so the difference does not affect safety or performance. | | | 2.6 TRIGGER INPUT | Yes | Yes | Same. Trigger input for patient event recording. | | | 001_510(k) Summary | 510(k) Summary | |------------------------|----------------| | © Seer Medical Pty Ltd | Page 4 of 8 | {7}------------------------------------------------ | | Document No. | Heading | Rev | |------------------|--------------------|----------------------------------------------------------------------------------------|-----| | Image: Seer logo | 001_510(k) Summary | Traditional 510(k) Premarket Submission Seer Medical Pty. Ltd. Device: Seer Home | 1 | | Characteristics | Subject Device: Seer Medical Seer Home™ (K212788) | Predicate Device MobileMedTek ElectroTek (K170441) | Similarities, differences, impact | |----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2.7 TRIGGER OUTPUT | No | Yes | Different. No external interface to third party devices. This does not affect intended use, or safety of effectiveness. | | 2.8 USE OF STANDARD SOFTWARE PLATFORM (Operating System) | Yes, Microsoft Windows Platform: SEER CLOUD display and analysis software | Yes, Microsoft Windows: RENDR display and analysis software | Same. Display and analysis software operate on same operating system and perform similar functions | | 2.9 CUSTOMIZATION OF PROTOCOLS | Via storage / retrieval of user defined settings | Via storage / retrieval of user defined settings | Same. Display and analysis software perform similar function and user configuration settings | | 2.10 APPLICATION FLEXIBILITY / EXPANDABILITY | Via SEER CLOUD software update | Via RENDR software update | Same. Display and analysis software updated via cloud platform | | 2.11 SAFETY STANDARDS | IEC 60601-1 ed3.1, IEC 60601-1-2 ed4.0, IEC 60601-1-11 ed2.0 IEC 60601-2-26 ed3.0, IEC 60601-2-25 ed2.0, ISO 10993-1 ed5.0 2018 | IEC 60601-1 ed3.1, IEC 60601-1-2 ed3.0, IEC 60601-2-26 ed3.0, IEC 60601-2-40:1998, ISO 10993-1:2009 | Same. Primary Standards - Safety, EMC, EEG, and Biocompatibility. Difference. Seer Home has additional compliance with (1-11) Medical Home Usage standard, and (2-25) ECG. ElectroTek has additional compliance with (2-40) EMG. The additional compliance, and not having compliance to (2-40) EMG does not affect safety or performance for product code GWQ or impact the indications for use. | | 2.12 PATIENT CIRCUITRY ISOLATION | Transformer and wireless comms isolation | Transformer | Same. Electrical Isolation is provided by transformer isolation and wireless comms for the wearable that is isolated from the mains by an internal battery. | | 2.13 SYSTEM COMPONENTS | Wearable EEG internal amplifier & recorder including trigger input, Wireless comms. Portable Hub computer, Wireless comms, and USB video camera. | Base console including trigger input/output, LED interface/photic stimulator; Control panel; internal amplifier; laptop computer with integrated display, USB video camera, keyboard and trackpad. | Same. Key components of the system are the same: EEG amplifier, acquisition computer system and video camera. | | 2.14 SYSTEM - COMPUTER INTERFACE | Ethernet | USB | Same. Wired digital communication link. Ethernet being faster and having transformer isolation. | | 2.15 SYSTEM POWER SUPPLY 2.16 AMPLIFIER POWER SUPPLY | Mains (100-240 VAC) thru an isolated power supply 3.7 VDC from internal battery | Mains (100-240 VAC) thru an internal isolated power supply +/- 3 VDC from base console | Same. Certified isolated mains power supply. Same. Low voltage powered EEG amplifiers; both are battery powered. | | 2.17 SIZE (L/W/D) cm | 22 x 22 x 7 cm Amplifier 84 x 36 x 23 cm (Hub unit - unit) | 14 x 9.5 x 3 cm Amplifier 53.10 x 26.95 x 4.45 cm (base console + laptop) | Same. Similar form-factor: a wearable Amplifier and portable acquisition | | 001_510(k) Summary | 510(k) Summary | |------------------------|----------------| | © Seer Medical Pty Ltd | Page 5 of 8 | {8}------------------------------------------------ | Image: Seer logo | Document No. | Heading | Rev | |------------------|--------------------|----------------------------------------------------------------------------------------|-----| | | 001_510(k) Summary | Traditional 510(k) Premarket Submission Seer Medical Pty. Ltd. Device: Seer Home | 1 | | Characteristics | Subject Device: Seer Medical Seer Home™ (K212788) | Predicate Device MobileMedTek ElectroTek (K170441) | Similarities, differences, impact | | | | |-----------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|----------------------------|----------------| | 2.18 WEIGHT kg | 225 g (amplifier) 15 kg (hub) | 56 x 36 x 23 cm (Trackit F - case) 575 g (amplifier) 3.987 kg (base console) | Different. Predicate acquisition computer weighs less than Seer Home Hub, but conversely wearable predicate amplifier weighs more than Seer Home. The usability study considers the weight of the wearable and hub on patient study and were found not affect intended use, safety of effectiveness. | | | | | 3. Technical – EEG | | | | | | | | 3.1 NUMBER OF CHANNELS | Up to 24 channels | Up to 32 channels | Same. Both systems allow 10-20 electrode placement to perform EEG study. Different. After allocation of channels to 10-20 placement the predicate will have unused spare channels for additional inputs. Seer Home not having spare channels will not affect safety or performance for product code GWQ or impact the indications for use. | | | | | 3.2 CMRR Common Mode Rejection Ratio | > 84 dB | > 110 dB | Same. Both systems meet CMRR requirement of the EEG standard > 80 dB | | | | | 3.3 NOISE | < 6uV peak to peak (from 0.5 Hz to 60 Hz) | < 2.5uV peak to peak (from 0.5 Hz to 60 Hz) | Same. Both systems meet noise requirement of the EEG standard < 6 uVpp. | | | | | 3.4 INPUT IMPEDANCE | > 100 MΩ | > 100 MΩ | Same. Both systems have high input impedance >100M. | | | | | 3.5 LOW FILTER | 0.5 Hz to 10 Hz | 0.05 Hz to 39.8 Hz | Different. The low-end filter range is not defined by the international EEG standard. Both subject and predicate comply with the American Clinical Neurophysiology Society EEG filter guideline of 1 Hz. The difference in filter range does not affect safety and effectiveness. | | | | | 3.6 HIGH FILTER | 15 Hz to 70 Hz | 1 Hz to 200 Hz | Different. The high-end filter range is not defined by the international EEG standard. Both subject and predicate comply with the American Clinical Neurophysiology Society EEG filter guideline of 70 Hz. The difference in filter range does not affect safety and effectiveness. | | | | | 3.7 NOTCH FILTER | 50 / 60 selectable | 50 / 60 selectable | Same. Same mains notch filter selection frequencies. | | | | | 3.8 A/D CONVERSION | SIG/AD CONVERSION | 24 bit | 12 Bit | 24 bit | Same: Same ADC resolution. | Same. Same ADC | | 001_510(k) Summary | 510(k) Summary | |------------------------|----------------| | © Seer Medical Pty Ltd | Page 6 of 8 | {9}------------------------------------------------ | Image: seer logo | Document No. | Heading | Rev | |-------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------| | | 001_510(k) Summary | Traditional 510(k) Premarket Submission Seer Medical Pty. Ltd. Device: Seer Home | 1 | | Characteristics | Subject Device: | Predicate Device | Similarities, differences, | | Characteristics | Subject Device: Seer Medical Seer Home ™ (K212788) | Predicate Device MobileMedTek ElectroTek (K170441) | Similarities, differences, impact | | 3.9 SAMPLING RATE | 500 Hz (EEG) | 500 Hz (EEG) | Same. Sampling rate the same as determined by IEC standard. | | 3.10 TRIGGER MODE | Manual event marker | Manual event marker | Same. Manual event marker. | Further details of the technological characteristics that are similar with the predicate device are listed in the predicate comparison section provided in the device 510(k) submission. #### Non-Clinical Performance Data: The device development and verification have been carried out in accordance with FDA requlations for electroencephalographs 21 CFR 882.1400. The device was tested against recommended consensus standards for EEG's and applicable voluntary consensus standards. Electrical Safety and EMC testing were performed, the system complies with the Medical Electrical Safety Standard IEC 60601-1, and the relevant device specific Part 2 standards IEC 60601-2-25 (ECG) and IEC 60601-2-26 (EEG). EMC Testing was also performed to the IEC 60601-1-2 standard for Electromagnetic Compatibility. The biocompatibility evaluation for the Seer Home was conducted in accordance with the ISO 10993-1 standard for Biocompatibility, and applicable materials were tested to ISO 10993-5 for Cytotoxicity, and ISO 10993-10 for Sensitization & Irritation. Software verification and validation testing were performed and documentation following the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. The software documentation is compliant with IEC 62304. The usability evaluation for Seer Home was conducted in accordance with the FDA quidance document "Applying Human Factors and Usability Engineering to Medical Devices" February 3, 2016, and IEC 62366-1:2015 as recognized by FDA. Device specific verification tests include package Drop testing to ASTM D5276, Input Impedance tests, Filter verifications, Home Use compliance to IEC 60601-1-11, and other verification tests not directly covered by the IEC 60601-1 such as event triggers, battery monitoring, audio and visual feedback tests. The electrical, software, biocompatibility, and device testing results support that all specifications have met the acceptance criteria. The Seer Home has passed all the required testing. The tests support the claims of substantial equivalence and safe operation. | 001_510(k) Summary | 510(k) Summary | |------------------------|----------------| | © Seer Medical Pty Ltd | Page 7 of 8 | {10}------------------------------------------------ | | Document No. | Heading | Rev | |------------------|--------------------|----------------------------------------------------------------------------------------|-----| | Image: Seer logo | 001_510(k) Summary | Traditional 510(k) Premarket Submission Seer Medical Pty. Ltd. Device: Seer Home | 1 | #### Clinical Performance Data: There is no clinical testing required to support the medical device as the indications for use are equivalent to the predicate device. The clinical literature review performed, demonstrates that ambulatory electroencephalographs, including the predicate device have been on the market for many years with proven safety and efficacy for the indicated use. The verification testing of the device was found to be acceptable and supports the claims of substantial equivalence. #### Conclusion: Based on the technical evaluations, non-clinical and clinical performance data described above, the Seer Home™ has been demonstrated to be substantially equivalent as the predicate device - MobileMedTek ElectroTek (K170441) and raises no safety or effectiveness issues. | 001_510(k) Summary | 510(k) Summary | |------------------------|----------------| | © Seer Medical Pty Ltd | Page 8 of 8 |