(288 days)
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.
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.
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.
The Seer Home device, an electroencephalographic system, did not report any clinical study for assessing device performance against acceptance criteria. The submission states, "There is no clinical testing required to support the medical device as the indications for use are equivalent to the predicate device." It relies on technical evaluations and non-clinical performance data to demonstrate substantial equivalence to the predicate device, MobileMedTek ElectroTek (K170441).
The non-clinical performance data and findings are summarized as follows:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical/Technical):
| Characteristic | Acceptance Criteria (Seer Home) | Reported Device Performance (Seer Home) | Predicate Device (ElectroTek K170441) |
|---|---|---|---|
| Technical - EEG | |||
| CMRR (Common Mode Rejection Ratio) | > 80 dB (EEG standard requirement) | > 84 dB | > 110 dB |
| Noise | < 6 µV peak to peak (EEG standard requirement) | < 6 µV peak to peak (from 0.5 Hz to 60 Hz) | < 2.5 µV peak to peak (from 0.5 Hz to 60 Hz) |
| Input Impedance | > 100 MΩ | > 100 MΩ | > 100 MΩ |
| Low Filter | Comply with American Clinical Neurophysiology Society EEG filter guideline of 1 Hz | 0.5 Hz to 10 Hz (complies with 1 Hz guideline) | 0.05 Hz to 39.8 Hz (complies with 1 Hz guideline) |
| High Filter | Comply with American Clinical Neurophysiology Society EEG filter guideline of 70 Hz | 15 Hz to 70 Hz (complies with 70 Hz guideline) | 1 Hz to 200 Hz (complies with 70 Hz guideline) |
| Notch Filter | 50 / 60 selectable | 50 / 60 selectable | 50 / 60 selectable |
| A/D Conversion | 24 bit | 24 bit | 24 bit (reported as 12 bit then 24 bit in two different sections, assuming 24 bit as per comparison text) |
| Sampling Rate (EEG) | 500 Hz (IEC standard requirement) | 500 Hz | 500 Hz |
| Trigger Mode | Manual event marker | Manual event marker | Manual event marker |
| Safety Standards | |||
| Medical Electrical Safety Standard | IEC 60601-1 ed3.1 | Complies | IEC 60601-1 ed3.1 |
| EMC | IEC 60601-1-2 ed4.0 | Complies | IEC 60601-1-2 ed3.0 |
| Medical Home Usage | IEC 60601-1-11 ed2.0 | Complies | Not specified for predicate |
| ECG | IEC 60601-2-25 ed2.0 | Complies | Not specified for predicate |
| EEG | IEC 60601-2-26 ed3.0 | Complies | IEC 60601-2-26 ed3.0 |
| Biocompatibility | ISO 10993-1 ed5.0 2018 | Complies | ISO 10993-1:2009 |
| Cytotoxicity | ISO 10993-5 | Complies | Not explicitly detailed for predicate |
| Sensitization & Irritation | ISO 10993-10 | Complies | Not explicitly detailed for predicate |
| Software | |||
| Software documentation | FDA Guidance for Software in Medical Devices ("Moderate" level of concern) & IEC 62304 | Complies | Complies |
| Usability | |||
| Usability evaluation | FDA Guidance, IEC 62366-1:2015 | Complies | Not explicitly detailed for predicate |
| Device Specific Verification | |||
| Package Drop | ASTM D5276 | Complies | Not explicitly detailed for predicate |
| Input Impedance tests | (Not explicitly stated, assumed to be part of >100MΩ) | Complies | Not explicitly detailed for predicate |
| Filter verifications | (Not explicitly stated, but verified) | Complies | Not explicitly detailed for predicate |
| Home Use compliance | IEC 60601-1-11 | Complies | Not explicitly detailed for predicate |
| Other verification tests | Event triggers, battery monitoring, audio/visual feedback | Complies | Not explicitly detailed for predicate |
2. Sample size used for the test set and the data provenance:
No clinical test set was reported. The technical evaluations mentioned were performed on the device itself as part of verification and validation processes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical test set was reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no clinical test set was reported.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was reported. The device is for acquisition, display, and storage of EEG signals; it "does not draw any diagnostic conclusions" and as such, does not incorporate AI for diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a system for signal acquisition and display, not an AI algorithm performing diagnosis or analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable as no clinical test set with ground truth was reported. For technical evaluations, the ground truth was based on established industry standards and regulatory guidance for medical devices, such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-25, IEC 60601-2-26, ISO 10993-1/5/10, ASTM D5276, and FDA/IEC guidance for software and usability.
8. The sample size for the training set:
Not applicable as no machine learning algorithm development with a training set was reported.
9. How the ground truth for the training set was established:
Not applicable as no training set was reported.
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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
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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) |
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|---|
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, AustraliaTel: +61 (0) 3 7035 5736 |
|---|---|
| Contact Person | David Mitchell – Quality and Regulatory ManagerTel: +61 (0) 3 7035 5736Email: david@seermedical.com |
| Date prepared: | 28th July 2021 |
| Trade or Proprietary Name:Device Type:Product Code:Device Class:Regulation numbers:Regulation description: | Seer HomeFull-Montage Standard ElectroencephalographGWQII21 CFR 882.1400Electroencephalograph |
Leqally Marketed Predicate Device Information:
| Trade or Proprietary Name: | ElectroTek (Trackit EEG hardware & RENDR software) |
|---|---|
| Manufacturer Name: | MobileMedTek1205 E. Washington St., Suite 115Louisville, 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 |
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| Document No. | Heading | Rev | |
|---|---|---|---|
| Image: Seer logo | 001_510(k) Summary | Traditional 510(k) Premarket SubmissionSeer 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 |
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| Image: Seer Logo | Document No. | Heading | Rev |
|---|---|---|---|
| 001_510(k) Summary | Traditional 510(k) Premarket SubmissionSeer 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 MedicalSeer Home™ (K212788) | Predicate DeviceMobileMedTekElectroTek (K170441) | Similarities, differences,impact |
|---|---|---|---|
| 1. Indication | |||
| 1.1 INDICATIONS FORUSE | The electroencephalographicsystem Seer Home is intendedto acquire, display, and storethe electro-physiologicalsignals of the patient's brainobtained by placing electrodeson the patient scalp.The Seer Home is intended tobe used for such studies aselectroencephalograph (EEG)and video EEG recording to aidin diagnosis of neurologicaldisorders. | The electroencephalographicsystem ElectroTek is intended toacquire, display, and store theelectrical activity of apatient's brain obtained byplacing electrodes on the patientscalp.The ElectroTek is intended to beused for such studies aselectroencephalogram (EEG)and video EEG recording to aidindiagnosis. The ElectroTek doesnot draw any diagnosticconclusions. | Same. Both systems areindicated for Video EEGstudies with similar intendeduse which do not draw anydiagnostic conclusions. |
| The Seer Home does not drawany diagnostic conclusions. | |||
| Seer Home is not intended foruse as life support equipmentsuch as vital signs monitoringin intensive care units. | |||
| Seer Home is only to be usedunder the direction andsupervision of a physician orEEG technologist or clinician. | |||
| 1.2 WARNINGS | Items related to off-label use ormisuse | Items related to off-label use ormisuse | Same. Standard warningsfor EEG device. |
| 1.3CONTRAINDICATIONS | Items related to design andindicated use limitations, suchas, not for use in the presenceof flammable anesthetic's or inconjunction with defibrillation orelectro-surgical equipment. | Items related to design andindicated use limitations, suchas, not for use in the presence offlammable anesthetic's or inconjunction with defibrillationequipment. | Same. Not be used in thepresence of flammablegases, defibrillationequipment or electro-surgical equipment stated inIFU and labelling. |
| 1.4 Clinical Indicationsfor Use | Assisting in the diagnosis ofneurological disorders. | Assisting in the diagnosis ofneurological disorders. | Same. Both systems areused for assisting in thediagnosis of neurologicaldisorders. |
| 1.5 Intended PatientPopulation | Patients requiring monitoring oftheir physiological signals toassist in diagnosis. | Patients requiring monitoring oftheir physiological signals toassist in diagnosis. | Same intended patientpopulation. |
| 1.6 Intended Users | For use by neurological andother related healthcareprofessionals. | For use by neurological andother related healthcareprofessionals. | Same intended users. |
| 1.7 Environment ofUse | For use in either a home orhospital/clinic environment. | For use in either a home,hospital/clinic environment. | Same environment of use. |
| The Seer Home is not for usein intensive care or other lifesupport situations. | The ElectroTek is not for use inintensive care or other lifesupport situations. | ||
| 1.8 Components of theSystem | Seer Sense wearable. Monitoring Hub. Seer Cloud Platformsoftware. | ElectroTek - TrackitAmplifier Trackit F (Laptop,Camera, and Case) RENDR EEG software | Same. The Seer wearableperforms the same functionas the Trackit amplifier, theMonitoring Hub the same asthe Trackit FLaptop/Camera, and the |
| 001_510(k) Summary | 510(k) Summary |
|---|---|
| © Seer Medical Pty Ltd | Page 3 of 8 |
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| Document No. | Heading | Rev | ||
|---|---|---|---|---|
| 001_510(k) Summary | Traditional 510(k) Premarket SubmissionSeer Medical Pty. Ltd.Device: Seer Home | 1 | ||
| Characteristics | Subject Device:Seer MedicalSeer Home™ (K212788) | Predicate DeviceMobileMedTekElectroTek (K170441) | Similarities, differences,impact | |
| Seer Cloud Platformsoftware performs the samefunctions as the RENDREEG software. | ||||
| 1.9Duration/applicationof use | Normal use is up to a week. | Usage depends on battery lifewhich is 72 hours for the batterypack. | Same. Both devices areused for longer term homeusage (> 24 hours). SeerHome has longer duration ofuse primarily driven bylonger battery life. | |
| 1.10 Portable /ambulatory | Yes | Yes | Same. Both devices areportable / ambulatory. | |
| 2. Technical - Overview | ||||
| 2.1 GENERALSYSTEMS APPROACH | Computer based equipmentwith dedicated hardwareperipherals /Components | Computer based equipment withdedicated hardware peripherals /components | Same. Display and Analysissoftware operates onstandard computerhardware. Acquisition isperformed on dedicatedmedical hardware. | |
| 2.2 USER INPUTDEVICE | Window mouse / keyboard /graphic interface. Simple userinterface. | Window mouse / keyboard /touch panel driven graphicinterface with dedicated controlpanel | Same. Display and Analysissoftware operates onstandard computer hardwareusing GUI/keyboard/mouse. | |
| Different: The Amplifier UIinterface is slightly differenthaving a color-coded LEDsinstead of LCD, thisdifference is minor and isassessed in the Usabilityassessment and found notto affect safety andeffectiveness. | ||||
| 2.3 USER OUTPUTDEVICE | Digital color display andoptional network printerconnectivity | Digital color display and optionalnetwork printer connectivity | Same. Display and Analysissoftware operates onstandard computerhardware. | |
| 2.4 PATIENT INPUTS | Up to 22 channels EEG and 2channels ECG | Up to 32 channels EEG/EMG | Same. Both systems allowcomplete 10-20 positioningof scalp electrodes.Different. Additionalelectrodes for other electro-physiological inputs - ECGinputs for the Seer Homeand EMG for ElectroTek.The additional inputs do notaffect safety or performancefor product code GWQ orimpact the indications foruse. | |
| 2.5 SIGNALACQUISITION | Analog to digital conversion atfixed sample rate | Analog to digital conversion atvariable sample rate | Different. Maximumsampling rates are thesame: 500Hz. Predicateallows for selection of otherlower frequency fixed rates.The sampling rate of 500 Hzis a requirement forcompliance to theinternational EEG standard,so the difference does notaffect safety or performance. | |
| 2.6 TRIGGER INPUT | Yes | Yes | Same. Trigger input forpatient event recording. |
| 001_510(k) Summary | 510(k) Summary |
|---|---|
| © Seer Medical Pty Ltd | Page 4 of 8 |
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| Document No. | Heading | Rev | |
|---|---|---|---|
| Image: Seer logo | 001_510(k) Summary | Traditional 510(k) Premarket SubmissionSeer Medical Pty. Ltd.Device: Seer Home | 1 |
| Characteristics | Subject Device:Seer MedicalSeer Home™ (K212788) | Predicate DeviceMobileMedTekElectroTek (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 OFSTANDARDSOFTWAREPLATFORM(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 CUSTOMIZATIONOF 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 APPLICATIONFLEXIBILITY /EXPANDABILITY | Via SEER CLOUD software update | Via RENDR software update | Same. Display and analysis software updated via cloud platform |
| 2.11 SAFETYSTANDARDS | IEC 60601-1 ed3.1,IEC 60601-1-2 ed4.0,IEC 60601-1-11 ed2.0IEC 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 PATIENTCIRCUITRYISOLATION | 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 SYSTEMCOMPONENTS | 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 -COMPUTERINTERFACE | Ethernet | USB | Same. Wired digital communication link.Ethernet being faster and having transformer isolation. |
| 2.15 SYSTEM POWERSUPPLY2.16 AMPLIFIERPOWER SUPPLY | Mains (100-240 VAC) thru an isolated power supply3.7 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 Amplifier84 x 36 x 23 cm (Hub unit - unit) | 14 x 9.5 x 3 cm Amplifier53.10 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 |
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| Image: Seer logo | Document No. | Heading | Rev |
|---|---|---|---|
| 001_510(k) Summary | Traditional 510(k) Premarket SubmissionSeer Medical Pty. Ltd.Device: Seer Home | 1 |
| Characteristics | Subject Device:Seer MedicalSeer Home™ (K212788) | Predicate DeviceMobileMedTekElectroTek (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 OFCHANNELS | 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 CommonMode 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 INPUTIMPEDANCE | > 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 |
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| Image: seer logo | Document No. | Heading | Rev |
|---|---|---|---|
| 001_510(k) Summary | Traditional 510(k) Premarket SubmissionSeer Medical Pty. Ltd.Device: Seer Home | 1 | |
| Characteristics | Subject Device: | Predicate Device | Similarities, differences, |
| Characteristics | Subject Device:Seer MedicalSeer Home ™ (K212788) | Predicate DeviceMobileMedTekElectroTek (K170441) | Similarities, differences,impact |
| 3.9 SAMPLING RATE | 500 Hz (EEG) | 500 Hz (EEG) | Same. Sampling rate thesame as determined by IECstandard. |
| 3.10 TRIGGER MODE | Manual event marker | Manual event marker | Same. Manual eventmarker. |
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.
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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.
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§ 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).