(218 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on signal acquisition, transmission, display, and storage, without mentioning any analytical or interpretive functions that would typically involve AI/ML.
No.
The device is intended to acquire, transmit, display, and store EEG and auxiliary signals for diagnostic purposes. It is not designed to provide therapy or treatment.
Yes
This device is a diagnostic device because its "Intended Use / Indications for Use" states that it "acquires, transmits, displays and stores primarily EEG and optional auxiliary signals," which are then used by healthcare professionals to interpret and diagnose conditions. The device facilitates the collection of physiological data (EEG, ECG) for diagnostic purposes.
No
The device description explicitly lists hardware components such as a headset, electrodes, charger, and charging cable, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The WR19 System acquires, transmits, displays, and stores physiological signals (EEG, ECG, accelerometer, etc.) directly from the patient's body. It does not process or analyze specimens taken from the body.
- Intended Use: The intended use is to acquire and display these signals for diagnostic purposes, but the signals are obtained in vivo (from the living body), not in vitro (outside the body).
Therefore, the WR19 System falls under the category of a medical device that performs physiological monitoring and recording, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The WR19 System is intended for prescription use in a health care facility or clinical research environment to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns.
The WR19 System requires operation by a healthcare professional familiar with EEG.
The WR19 System acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), accelerometer, photic sensor, external trigger signals and video.
Product codes
GWO, GXY
Device Description
The WR19 System is primarily intended to acquire, transmit, display and store EEG and optionally do so for auxiliary signals. WR19 headset is designed to perform Routine or Outpatient EEG using 19 dry signal electrodes and 1 dedicated dry ground/driven-right-leg (DRL) electrode, adjusted and placed to comply with the 10-20 EEG system.
The device consists of the following components:
- . Headset
- Electrodes (affixed to the underside of the headset) ●
- Charger
- Charging cable .
- Software ●
- Headset firmware -
- Client application -
- Data center application
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and children, not including newborns.
Intended User / Care Setting
health care facility or clinical research environment.
The WR19 System requires operation by a healthcare professional familiar with EEG.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing was performed at a United States hospital to demonstrate that the WR19 System's electrode variations provide EEG signal quality that is comparable to a common EEG device cleared in K163163 - XLTEK EMU40EX. 7 subjects in 2 study cohorts (EEG patients and healthy volunteers) for 15-30 minutes of recording (2 cohorts, of EEG patients and healthy volunteers, 2 subjects each) and 2 hours (1 sub-cohort of healthy volunteers. 3 subjects). Healthy volunteers in both recording durations were asked to generate sources of artifact and/ or error. The results of time to setup, qualitative waveform comparisons, Likert scoring, and spectral correlation and SNR comparisons were analyzed to assess device performance. The subject device was found to perform at least as well as the comparator device based on predefined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health and Human Services logo. The logo on the right is the Food and Drug Administration logo. The FDA logo is in blue and contains the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
April 17, 2018
Zeto, Inc. % Donna-Bea Tillman, PhD Team Leader and Senior Consultant, Medical Devices Biologics Consulting Group 1555 King Street, Suite 300 Alexandria, Virginia 22314
Re: K172735
Trade/Device Name: WR19 System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO. GXY Dated: March 16, 2018 Received: March 19, 2018
Dear Dr. Tillman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Michael J. Hoffmann -S
Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172735
Device Name WR19 System
Indications for Use (Describe)
The WR19 System is intended for prescription use in a health care facility or clinical research environment to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns.
The WR19 System requires operation by a healthcare professional familiar with EEG.
The WR19 System acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), accelerometer, photic sensor, external trigger signals and video.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
K172735
| Submitter Name | Zeto, Inc. |
|---|---|
| Submitter Address | 2336 Park Ave |
| Santa Clara, CA 95050 | |
| Submitter Tel. Number | (408) 658-0737 |
| Contact Person | Donna-Bea Tillman, Ph.D. |
| Senior Consultant | |
| Biologics Consulting Group | |
| dtillman@biologicsconsulting.com | |
| Phone: (410) 531-6542 | |
| Fax: (703) 548-745 | |
| Date Prepared | April 16th, 2018 |
| Trade Name | WR19 System |
| Common Name | Full-montage standard electroencephalograph |
| Classification Name | Electroencephalograph 21 CFR 882.1400 |
| Product Codes | GWQ, GXY |
| Primary Predicate | K131383 X10 Headset with X-series Basic Software, X24 Headset |
| with X-series Basic Software | |
| Reference Predicate | K171669 g.Nautilus PRO |
DEVICE DESCRIPTION 1.
The WR19 System is primarily intended to acquire, transmit, display and store EEG and optionally do so for auxiliary signals. WR19 headset is designed to perform Routine or Outpatient EEG using 19 dry signal electrodes and 1 dedicated dry ground/driven-right-leg (DRL) electrode, adjusted and placed to comply with the 10-20 EEG system.
The device consists of the following components:
- . Headset
- Electrodes (affixed to the underside of the headset) ●
- Charger
- Charging cable .
- Software ●
- Headset firmware -
- Client application -
- Data center application
4
2. INTENDED USE
The WR19 System is intended for prescription use in a health care facility or clinical research environment to acquire, transmit, display and store primarily EEG and optionally auxiliary signals for adults and children, not including newborns.
The WR19 System requires operation by a healthcare professional familiar with EEG.
The WR19 System acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), accelerometer, photic sensor, external trigger signals and video.
SUBSTANTIAL EQUIVALENCE DISCUSSION 3.
The primary predicate device is the X-Series System (models X10 and X24) (cleared in K131383). The reference device for dry electrodes is the g.Nautilus PRO (cleared in K171669).
3.1. Technological Comparison to Predicate Device
The following tables provide comparisons of technological characteristics between the WR19 System and the X-Series System.
3.1.1. Comparison - Overview
The following tables provide a comparison of the technological characteristics between the WR19 System and the X-Series System:
| | Subject Device
WR19 System
K172735 | Predicate Device X-
Series System
K131383 | Remarks |
|-----------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User
Interface | Operator control, visual
indicators | Operator control,
visual indicators | Same |
| System
Components | • Headset
• Electrodes
• Charger
• Charging cable
• Software | • Headset
(Electronics box)
• Electrode strip
• Electrodes
• Neoprene Strap
• Charger
• Charging cable
• Software | No significant difference.
Since WR19 works via the
cloud, it uses a data center
application, as opposed to
just using client software |
| | Subject Device
WR19 System
K172735 | Predicate Device X-
Series System
K131383 | Remarks |
| Signals
Acquired | • Scalp EEG
• Accelerometer
• Optional non-EEG
signals: | • Scalp EEG
• 3-D
actigraphy
(acceleromet
er based)
• Optional non-
EEG signals: | Same in measuring EEG
signals, but the subject
device offers a different
subset of optional auxiliary
features. |
| Power
Supply | 1 x 2050mAh 3.7V
Lithium Ion battery | 2 to 4 x 240mAh 3.7
Li- Ion batteries | No significant difference.
WR19 uses a bigger battery
because a higher sampling
rate generates more data and
requires more power. |
| Battery
Charging | Via USB connector
connected to USB wall
charger. | Via JED Connector
connected to USB port
or USB wall charger | Same |
| Typical
Charging
Time | 0.5-6.0 hours | 0.5-5.0 hours | Same |
| Operating
Time | 6-7 hours | Monitoring Days
after Charge/Hours
of Use
• 0-4 Days: 16 to
17 hours
• 5-10 Days: 14 to
15 hours | No significant
difference |
| Typical use
duration | 20 - 60 minutes | Not specified | Comparison not available;
however, the typical use
duration of the subject
device is standard for
outpatient / routine EEG
recording |
| | Subject Device
WR19 System
K172735 | Predicate Device X-
Series System
K131383 | Remarks |
| Dimensions | 8.5 x 10.8 x 5.7" or
214 x 274 x 144 mm
(Complete headset with
electrodes) | 5.0" long, 2.25" wide,
1.0" deep
(Electronics box) | No significant difference.
WR19 System contains a
headset worn like a bike
helmet. The electronics are
integrated into the headset.
Predicate has flexible
electrode strips that attach
to Velcro bands that hold an
electronics housing. Hence
dimensions vary. |
| Weight | 120dB (typical)
Input Impedance: 1000 GOhm
Noise: 1µV RMS
A/D Conversion: 24 Bit | Sampling rate: 256 Hz
Dynamic range: +/- 1000μV
Resolution: 0.03μV
Peak to peak noise: 3.7 µV (typical)
Common Mode Rejection Ratio: 110dB (typical)
Input Impedance: 100 GOhm
Noise: RMS not specified | No significant difference |
| Headset material | Semi-rigid and
flexible polymer
material (e.g.,
Polyamide PA12,
ABS, Polyurethane
and Polycarbonate) | Neoprene strap,
flexible plastic type
strips that hold foam
electrodes filled with
gel, rear electronics
casing (material not
specified) | No significant difference.
Both devices passed
applicable
Biocompatibility tests
outlined in relevant
standards. |
| Electrode type | Active, dry | Passive, wet | No significant difference |
| Contact
quality/Impedance
measurement | Contact quality
monitoring
performed real time
throughout the
recording/ test | Impedance
measurement
performed by operator
before the start of
EEG test during 'Test
Impedance' mode | No significant difference |
| | Subject Device
WR19 System
K172735 | Predicate Device
X-Series System
K131383 | Remarks |
| Channels | Single Differential ECG
using non-active (passive),
electrodes (optional)
(ECG lead wire and
electrodes not included) | Single Differential ECG
(optional)
(ECG cable included) | No significant
difference |
| Accuracy,
performance | Sampling rate: 500 Hz
Dynamic range: +/- 3900 mV
Resolution: 0.536 µV
Peak to peak noise: 4 µV
Common Mode Rejection
Ratio: > 110dB (typical)
Input Impedance: 500 MOhm
A/D Conversion: 24 Bit
Noise: 1 µV RMS | Sampling rate: 256 Hz
Dynamic range: +/- 2000 µV
Resolution: 0.06 µV
Peak to peak noise: 4.2 µV
Common Mode Rejection
Ratio: > 110dB (typical)
Input Impedance: 100 GOhm
A/D Conversion: 16 Bit
Noise: not specified | No significant
differences.
The amplitudes
of heartbeat
electrical
signals are of
the order of
millivolts. |
8
3.1.3. Comparison – EEG Measurements
The following table provides a comparison of EEG measurement characteristics between the WR19 System and the X-Series System:
9
10
3.1.4. Comparison – ECG Measurements
The following table provides a comparison of ECG measurement characteristics between the WR19 System and the X-Series System.
3.1.5. Comparison – Accelerometer
The following table provides a comparison of accelerometer characteristics between the WR19 System and the X-Series System.
| | Subject Device
WR19 System
K172735 | Predicate Device
X-Series System
K131383 | Remarks |
|-----------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Scope of
use | Used primarily as an aid
for motion detection and
hence finding EEG
artifacts | Used primarily as part of
a 3-D actigraphy for
monitoring rest/ non-
specific activity cycles | No significant
difference. WR19
intended scope is a subset
of the predicate. |
11
| Channels | Dynamic Range: -180° to 180° | Same as predicate device |
|---|---|---|
| Three channels (X, Y, Z) used by software to measure movement and position | Three channels (X, Y, Z) used by software to measure movement and position |
3.1.6. Comparison - Software Characteristics
The following table provides a comparison of software technological characteristics between the WR19 System and the X-Series System:
| | Subject Device
WR19 System
K172735 | Predicate
Device
X-Series System
K131383 | Remarks |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Firmware | WR19 headset is controlled by a
firmware. | X-series
headset is
controlled by a
firmware (No
more details
specified) | Same as predicate
device |
| Data center
application | WR19 sends data to the data center
application in the cloud. | Not applicable. | No significant
difference.
Predicate is not a
cloud solution. |
| Client
application | Client application presents
waveforms, controls EEG session,
and offers standard EEG
transformations such as low-pass,
high-pass and notch filters and
montage transformations. | Client application
presents
waveforms (No
more details
specified) | No significant
difference |
| Client
application | Client application records and
retrieves EEG waveforms. | Client application
presents
waveforms (No
more details
specified) | No significant
difference.
Predicate uses 3rd
party software to
retrieve and display
waveforms. |
12
3.2. Technological Comparison to Reference Device
The following table provides a comparison of electrode technological characteristics between the WR19 System and the g.Nautilus PRO:
| | Subject Device
WR19 System
K172735 | Reference Device
g.Nautilus PRO
K171669 | Remarks |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Electrode
material | Ag/AgCl coated | Gold or Ag/AgCl coated | Same as
reference
predicate |
| Type of
electrodes | Active, dry | Active, wet or dry | Same as
reference
predicate |
| Electrode
mounting
mechanism | Semi-rigid wearable headset
with certain electrode
positions. Electrode positions
can be adjusted to a limited
extent | Elastic EEG cap with chin
strap with certain
electrode positions | No significant
difference |
| Typical usage
setting | Intended for use for Routine
clinical EEG where rapid
placement of EEG electrodes
as per the 10-20 EEG system
is required | Intended for use in routine
clinical settings where
rapid placement of a
number of EEG electrodes
is desired | Same as
reference
predicate |
4. PERFORMANCE DATA
The following performance testing was provided to support the substantial equivalence of the subject device:
- EEG performance testing, as per IEC 60601-2-26:2012 ●
- Testing of dry electrode input buffers (modified IEC 60601-2-26 testing)
- Testing to verify functionality of optional auxiliary signals: .
- -Infrared receiver
- Infrared transmitter -
- External optical input -
- Photic trigger detector -
- ECG input -
- -Accelerometer
- Video capture —
- Contact quality detection feature -
13
5. STANDARDS
The table below provides the complete list of standards that are used in the 510(k) to establish device performance and support substantial equivalence:
| Standard | Title |
|---|---|
| ANSI / AAMI 60601- | |
| 1:2005 + A1:2012 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety |
| and Essential Performance | |
| IEC 60601-1-6:2010 + | |
| A1:2013 | Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety |
| and Essential Performance - Collateral Standard: Usability | |
| IEC 60601-1-2:2014 | Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety |
| and Essential Performance - Collateral Standard: Electromagnetic Disturbances - | |
| Requirements and Tests | |
| IEC 60601-2-26:2012 | Medical electrical equipment - Part 2-26: Particular requirements for the basic |
| safety and essential performance of electroencephalographs | |
| ISO 14971:2007 | Medical Devices - Application of Risk Management to Medical Devices |
| ANSI/AAMI | |
| 62304:2006 + A1:2015 | Medical Device Software - Software Life Cycle Processes |
| ISO 10993-1:2009 + | |
| TC:2010 | Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing |
| Within a Risk Management Process | |
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro |
| Cytotoxicity | |
| ISO 10993-10:2010 | Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin |
| Sensitization | |
| ANSI / AAMI | |
| 62366:2007 + A1:2014 | Consolidated Version Medical Devices - Application Of Usability Engineering |
| To Medical Devices |
STERILIZATION, SHELF LIFE, CLEANING, REUSE 6.
The WR19 System is neither shipped nor intended to be used sterile. The device is reusable, is intended for multi-patient use, and is intended to be cleaned and disinfected between uses.
7. BIOCOMPATIBILITY
The patient-contacting materials of the WR19 System are all either limited duration (