(288 days)
Not Found
No
The summary describes a system for acquiring, displaying, and storing EEG/ECG and video data for physician interpretation. It explicitly states the device "does not draw any diagnostic conclusions" and relies on qualified operators for interpretation. There are no mentions of AI, ML, or related concepts in the device description, performance studies, or key metrics.
No.
The device is used to acquire, display, and store electro-physiological signals for aid in diagnosis, not for treatment or therapy.
Yes
The device aids in the diagnosis of neurological disorders by recording and displaying electro-physiological signals, which are then interpreted by qualified operators or physicians to assist in making a diagnosis.
No
The device description clearly outlines multiple hardware components: an ambulatory EEG recorder ("Wearable"), a "Seer Sight Video Monitoring Hub," disposable electrodes, cables, a power adapter, and rechargeable batteries. While software is a critical part of the system (Seer Cloud Platform), it is integrated with and relies on these physical components for data acquisition and video recording.
Based on the provided information, the Seer Home device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health.
- Seer Home Function: The Seer Home system acquires, displays, and stores electro-physiological signals (EEG and ECG) directly from the patient's body by placing electrodes on the scalp and chest. It also records video of the patient.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It measures electrical activity of the body.
- Intended Use: The intended use is to aid in the diagnosis of neurological disorders by providing physiological data and video for interpretation by a qualified professional. It explicitly states that it "does not draw any diagnostic conclusions."
Therefore, the Seer Home falls under the category of a medical device that measures physiological signals in vivo (within the living body), rather than an In Vitro Diagnostic device that analyzes samples in vitro (outside the living body).
N/A
Intended Use / 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 or EEG technologist or clinician.
Product codes
GWQ
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Seer Home is only to be used under the direction and supervision of a physician or EEG technologist or clinician.
For use in either a home or hospital/clinic environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
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) |
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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 | 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 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 |
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| 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 |