(306 days)
Not Found
No
The description details a rule-based algorithm for identifying burst suppression based on predefined thresholds and statistical calculations, not adaptive learning or pattern recognition characteristic of AI/ML.
No
The device is intended to collect, record, store, and analyze EEG data to identify burst suppression patterns and quantify inter-burst intervals. It does not provide any diagnostic conclusions or therapeutic interventions.
No
The "Intended Use / Indications for Use" explicitly states: "The Wavestate Neuromonitor System does not provide any diagnostic conclusion about the patient's condition to the user." It is intended to collect, record, and analyze EEG data, but the interpretation and diagnosis remain with a licensed medical practitioner.
No
The device description explicitly states that the software is an application for the TrackIt-2, an FDA-approved ambulatory EEG hardware unit. It also mentions that FDA-approved EEG electrodes will be bought separately. This indicates the device is a system that includes both software and hardware components, not a software-only medical device.
Based on the provided information, the Wavestate Neuromonitor System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Wavestate Neuromonitor System Function: The Wavestate Neuromonitor System collects, records, and analyzes electrical activity from the brain (EEG data) directly from the patient. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to collect, record, store, and analyze EEG data to identify burst suppression patterns and display statistical information about interburst intervals. It explicitly states that it "does not provide any diagnostic conclusion about the patient's condition to the user."
Therefore, the Wavestate Neuromonitor System falls under the category of a medical device that interacts directly with the patient to collect physiological data, rather than an IVD device that analyzes specimens.
N/A
Intended Use / Indications for Use
The Wavestate Neuromonitor System is intended to collect, record, and store up to 24 channels of adult EEG data for up to 24 hours. The System also can perform a post review of adult EEG data and identify burst suppression pattern in the stored EEG. The device displays the mean interburst interval reviewed up to that time point and the probability that the displayed value is within +/- 2 seconds of the mean of the interburst intervals for the entire dataset for that patient. The Wavestate Neuromonitor System does not provide any diagnostic conclusion about the patient's condition to the user. The Wavestate Neuromonitor is to be used under the guidance and interpretation of a licensed medical practitioner.
Product codes (comma separated list FDA assigned to the subject device)
ORT, GWO
Device Description
Wavestate, Inc. has created a new application for the TrackIt-2, an FDA-approved ambulatory EEG hardware unit manufactured by Lifelines, Ltd (UK). Our proprietary software analyzes EEG data files recorded with the TrackIt-2. Data are displayed on an Xplore touch-screen tablet computer using Microsoft Windows XP.
Our application is used to quantify the inter-burst interval with 95% statistical confidence the duration of the interval within +/- 2 seconds.
The Trackit-2 system is FDA approved.
FDA-approved EEG electrodes will be bought separately by the end user.
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
Adult
Intended User / Care Setting
Licensed medical practitioner
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)
Testing of the Wavestate Neuromonitor was performed. Testing included:
-
- Software verification and validation
-
- Electrical and EMC safety compliance to:
- IEC 60601-1 IEC 60601-1-2 IEC 60601-2-26
The validation testing demonstrates how each feature of the burst suppression algorithm is accurately implemented. The algorithm consists of five features: (1) burst detection, (2) channel logic, (3) suppression duration, (4) interburst interval, and (5) statistical confidence.
First, the accuracy of burst detection is tested in a single EEG channel. 40-ms-duration spikes of varving amplitude are inserted into digitized EEG files consisting of background activity (
§ 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
510(k) Summary K092625 807.92(c)
JUN 2 9 2010
SPONSOR
| Company Name: | Wavestate, Inc. |
|---|---|
| Company Address | 333 Washington Blvd. #15 |
| Marina del Ray, CA 90292 | |
| Telephone: | 310-591-8844 |
| Fax: | 310-591-8191 |
| Contact Person: | Michael J. Bier Ph.D., President and CEO |
807.92(a)(1)Summary Preparation Date: June 29, 2010
DEVICE NAME
Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class:
PREDICATE DEVICE
807.92(a)(2)
Wavestate Neuromonitor EEG Electroencephalograph 882.1400 ORT / GWQ I I
807.92(a)(3)
510(k) # K021185
| Legally Marketed Equivalent Device | |
|---|---|
| Company | Product |
| Taugagreining HF | Nervus Monitor |
| Viasys NeuroCare, Inc. | NicoletOne System V32 |
| Lifelines Ltd. | Lifelines Trackit |
DEVICE DESCRIPTION
Wavestate, Inc. has created a new application for the TrackIt-2, an FDA-approved ambulatory EEG hardware unit manufactured by Lifelines, Ltd (UK). Our proprietary software analyzes EEG data files recorded with the TrackIt-2. Data are displayed on an Xplore touch-screen tablet computer using Microsoft Windows XP.
Our application is used to quantify the inter-burst interval with 95% statistical confidence the duration of the interval within +/- 2 seconds.
The Trackit-2 system is FDA approved.
FDA-approved EEG electrodes will be bought separately by the end user.
807.92(a)(4)
1
DEVICE INTENDED USE
The Wavestate Neuromonitor System is intended to collect, record, and store up to 24 channels of adult EEG data for up to 24 hours. The System also can perform a post review of adult EEG data and identify burst suppression pattern in the stored EEG. The device displays the mean interburst interval reviewed up to that time point and the probability that the displayed value is within +/- 2 seconds of the mean of the interburst intervals for the entire dataset for that patient. The Wavestate Neuromonitor System does not provide any diagnostic conclusion about the patient's condition to the user. The Wavestate Neuromonitor is to be used under the guidance and interpretation of a licensed medical practitioner.
Caution: (USA law) Restricts this device to sale by or on the order of a physician.
Predicate Product Comparison
NONCLINICAL AND CLINICAL TEST 807.92(b) SAFETY and EFFECTIVENESS
Testing of the Wavestate Neuromonitor was performed. Testing included:
-
- Software verification and validation
-
- Electrical and EMC safety compliance to:
- IEC 60601-1 IEC 60601-1-2 IEC 60601-2-26
Software Verification and Validation Summary
V&V SUMMARY
The validation testing demonstrates how each feature of the burst suppression algorithm is accurately implemented. The algorithm consists of five features: (1) burst detection, (2) channel logic, (3) suppression duration, (4) interburst interval, and (5) statistical confidence.
First, the accuracy of burst detection is tested in a single EEG channel. 40-ms-duration spikes of varving amplitude are inserted into digitized EEG files consisting of background activity (20 Mohms | >20 Mohms | | >20 Mohms |
| Common mode
input impedance | >100 Mohms | >100 Mohms | >100 Mohms | >100 Mohms |
| Common mode
rejection ratio | >110d @ 0.16Hz to
70Hz w/ active ground
connected | >110d @ 0.16Hz to 70Hz
w/ active ground
connected | >110d @ 50/60 Hz | >110d @ 0.16Hz to
70Hz w/ active ground
connected |
| Channel hardware
gain | 1000 ± 2% | 1000 ± 2% | | 500 |
| Max. differential
AC input before
clipping | 10 mV pk-pk | 10 mV pk-pk | | 10 mV pk-pk |
| DC Input
tolerance | ±500mV | ±500mV | ±350mV | |
| Burst Suppression | yes | no | yes | yes |
Predicate Product Comparison
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wavestate, Inc. c/o Ned Devine Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, IL 60062
JUN 2 9 2010
Re: K092625
Trade/Device Name: Wavestate Neuromonitor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: ORT, GWO Dated: April 28, 2010 Received: April 30, 2010
Dear Mr. Devine:
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 (reporting of medical
5
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources.forYou/Industry/default.htm.
Sincerely yours,
Eithim im to
Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K092625
Device Name: Wavestate Neuromonitor
Indications for Use:
The Wavestate Neuromonitor System is intended to collect, record, and store up to 24 channels of adult EEG data for up to 24 hours. The System also can perform a post review of adult EEG data and identify burst suppression pattern in the stored EEG. The device displays the mean interburst interval reviewed up to that time point and the probability that the displayed value is within +/- 2 seconds of the mean of the interburst intervals for the entire dataset for that patient. The Wavestate Neuromonitor System does not provide any diagnostic conclusion about the patient's condition to the user. The Wavestate Neuromonitor is to be used under the guidance and interpretation of a licensed medical practitioner.
Caution: (USA law) Restricts this device to sale by or on the order of a physician.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rick Rahn
Page 1 of 1
(Division Sign-Off). Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K092628