(635 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a standard electroencephalograph for recording electrical activity, without mentioning any analytical or interpretive functions that would typically involve AI/ML.
No
The device is an electroencephalograph (EEG) used to measure and record brain activity, which is a diagnostic function, not a therapeutic one. The description explicitly states that it "does not make any judgment of normality of the displayed signals or the results of an analysis" and is "in no way...diagnostic," reinforcing its role as a measurement tool rather than a treatment device.
No
The device description explicitly states: "The BWMini does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic." It is an electroencephalograph used for measuring and recording electrical activity.
No
The device description explicitly states it is a "multi-channel system" with hardware components like electrodes, a memory card, hard plastic external material, batteries, and specific electrical specifications (AD Resolution, filters, DC Inputs). While it uses software (Windows) for the user interface and potentially data processing, it is not solely software.
Based on the provided information, the BWMini is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- BWMini's Function: The BWMini measures and records electrical activity directly from the patient's brain by placing electrodes on the head. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for measuring and recording brain electrical activity (EEG, PSG, HST) in various settings. It explicitly states it does not make judgments of normality or provide diagnoses.
Therefore, the BWMini falls under the category of a medical device used for physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
BWMini is an electroencephalograph, which 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.
BWMini is multi-channel (up to 32 channels) system designed for Electroencephalograph (EEG), Polysomnography (PSG) and Home Sleep Testing (HST) recording application, in research, home sleep studies, ambulatory and clinical environments.
The BWMini does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Product codes (comma separated list FDA assigned to the subject device)
GWQ, OLV
Device Description
The BWMini is an electroencephalograph, which 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. It is a multi-channel system (up to 32 channels) designed for Electroencephalograph (EEG), Polysomnography (PSG) and Home Sleep Testing (HST) recording applications. It is software-based (Windows), utilizes a memory card for data storage, is powered by batteries, and its external material is hard plastic. Key specifications include 16-bit AD resolution, 50-60Hz notch filter, configurable sensitivity (1-500 uv/mm), configurable low frequency filters (0.16-15Hz), and configurable high frequency filters (15-100Hz). It also includes 2 auxiliary DC inputs and uses an IBM PC for the user interface. The associated software is BWAnalysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
research, home sleep studies, ambulatory and clinical environments.
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
The produced units were tested for performance on the following frequencies: 0.5Hz, 1Hz, 2Hz, 3Hz, 4Hz, 5Hz, 10Hz, 15Hz, 20Hz, 25Hz, 30Hz, 40Hz, 50Hz, 70Hz, 80Hz, 90Hz, and 100Hz, comparing the results with a known and calibrated external source. A deviation of +/- 5% in the injected value in each frequency is acceptable.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: The BWMini meets the performance standards for perform EEG and PSG exams based on testing frequencies between 0.5Hz to 100Hz against a known and calibrated external source, with a deviation of +/- 5% being acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or clothing. The profiles are arranged in a way that creates a sense of depth and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2015
Neurovirtual USA. Inc. Eduardo Faria, CEO 2315 NW 107th Avenue Suite 1M27 Doral, FL 33172
Re: K131335
Trade/Device Name: BWMini EEG (Model PV 2310), BWMini HST (Model PV 2312), BWMini PSG (Model PV 2311) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Codes: GWQ, OLV Dated: December 29, 2014 Received: December 31, 2014
Dear Mr. Faria
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K131335
Device Name BWMini (EEG, HST and PSG)
Indications for Use (Describe)
BWMini is an electroencephalograph, which 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.
BWMini is multi-channel (up to 32 channels) system designed for Electroencephalograph (EEG). Polysomnography (PSG) and Home Sleep Testing (HST) recording application, in research, home sleep studies, ambulatory and clinical environments.
The BWMini does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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3
Section 5 510(k) SUMMARY
A) Submitter's Name: Neurovirtual USA, Inc.
Owner / Operator Registration Number: 9091724 Manufacture Registration Number: 3006136239
- B) Address: 2315 NW 107th Ave Suite 1M27 Doral, FL – 33172
- C) Phone and Fax Numbers Phone: (786) 693-8200 Fax: (305) 393-8429
- D) Contact Person: Eduardo J. Faria
- E) Preparation Date: January 26, 2015
F) Classification Name:
Common / Usual Name: Full-Montage Standard Electroencephalograph Proprietary Name: BWMini (EEG, HST, PSG) Product Code: GWQ Additional Product Codes: OLV Classification: Class II Regulation Number: 21 CFR 882.1400
G) Substantial Equivalence:
The BWMini is equivalent with the following products:
| 510(k) Number | Model | Company |
|---|---|---|
| K042150 | XLTEK Trex | EXCEL TECH. LTD. |
| K946094 | CADWELL EASY AMBULATORY | |
| EEG | CADWELL LABORATORIES, | |
| INC. |
4
Technological Characteristics Comparison:
The predicate devices used to establish substantial equivalence for the BWMini are outlined below. This section of this submission will provide a comparison of design, materials, energy source, functional features and technical specifications of the BWMini to each of the predicate devices stratified by functional modality.
| | Neurovirtual
BWMini | CADWELL
EASY
AMBULATORY
EEG | XLTEK Trex | Analysis of
Differences |
|---------------------------|-----------------------------|-----------------------------------------------|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K131335 | K946094 | K042150 | NA |
| Classification | GWQ | GWQ | GWQ | NA |
| Indication of Use | EEG, PSG and
HST | EEG, PSG and
HST | EEG, PSG and
HST | NA |
| Number of
Channels | Up to 32 | Up to 32 | Up to 32 | NA |
| Data Storage | Memory Card | Memory Card | Memory Card | NA |
| Software Based | Windows | Windows | Windows | NA |
| Material (External) | Hard Plastic | Hard Plastic | Hard Plastic | NA |
| Power Source | Batteries | Batteries | Batteries | NA |
| AD Resolution | 16 Bits | 16 Bits | 12 Bits | Our product uses the most
current processors that exceed
the minimum resolution
requirement for recording EEG
according to the ACNS
(American Clinical
Neurophysiology Society)
Guideline. |
| Notch Filter | 50-60Hz | 50-60Hz | 50-60Hz | NA |
| Sensitivity
Selection | 1-500uv/mm
Configurable | 1-100uv/mm
Configurable | 1-200uv/mm
Configurable | Our product exceeds the
sensitive range reguirement
for recording EEG according to
the ACNS (American Clinical
Neurophysiology Society)
Guideline. |
| Low Frequency
filters | 0.16 - 15Hz
Configurable | 0.02-15 Hz
Configurable | 0.25 - 15Hz
Configurable | Our product exceeds the Low
Frequency Filters requirement
for recording EEG according to
the ACNS (American Clinical
Neurophysiology Society)
Guideline. |
| High Frequency
filters | 15 - 100 Hz
Configurable | 15 - 100 Hz
Configurable | 15 - 100Hz
Configurable | NA |
| Auxiliary DC
Inputs | 2 DC Inputs | 1 DC Input | 4 DC Inputs | DC Channels are not a
requirement by the ACNS
Guideline for recording EEG. |
| User Interface | IBM PC | IBM PC | IBM PC | NA |
| Software | BWAnalysis
510(k)K062533 | EasyWrite and
Easy Reader
510(k)K932507 | Excel Neuroworks
510(k)K980214 | This is only a Commercial
Name for each manufacturer
Software |
Conclusion: As showed above the comparison shows that BWMini was developed to be substantial equivalent to the predicates, not raising any safety or effectiveness concerns.
5
H) Intended Use:
BWMini is an electroencephalograph, which 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.
BWMini is multi-channel (up to 32 channels) system designed for Electroencephalograph (EEG), Polysomnography (PSG) and Home Sleep Testing (HST) recording application, in research, home sleep studies, ambulatory and clinical environments.
The BWMini does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
| Neurovirtual
BWMini | CADWELL EASY
AMBULATORY EEG | XLTEK Trex |
|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| BWMini is inteded to be used
as: | Easy Ambulatory EEG is inteded
to be used as: | XLTEK Trex is inteded to be
used as: |
| -Electroencephalograph(EEG) | -Electroencephalograph(EEG) | -Electroencephalograph(EEG) |
| -Polysomnography (PSG) | -Polysomnography (PSG) | -Polysomnography (PSG) |
| -Home Sleep Testing (HST) | -Home Sleep Testing (HST) | -Home Sleep Testing (HST) |
| BWMini can be used in research,
home sleep studies, ambulatory
and clinical environments. | Easy Ambulatory EEG can be
used in research, home sleep
studies, ambulatory and clinical
environments. | XLTEK Trex can be used in
research, home sleep studies,
ambulatory and clinical
environments. |
6
I) Safety and Effectiveness:
The BWMini is in compliance with the applicable clauses of the following standards:
- IEC 60601-1:2005, "Medical Device Equipment: General Requirements for -Safety"
- -IEC 60601-1-1:2009, Medical electrical equipment - Part 1: General requirements for safety - Section 1: Collateral standard: Safety requirements for medical electrical systems
- -IEC 60601-1-2:2008, "Medical Device Equipment – General Requirements for Safety, Collateral Standard: Electromagnetic Compatibility, Requirements and Test"
- -IEC 60601-2-26:2002, "Medical Device Equipment – Particular requirements for the safety of electroencephalographs"
- -IEC 60601-1-4:2009, "Medical Device Equipment – General Requirement for Safety, Collateral Standard: Programmable Electrical Medical Systems"
- -EN ISO 14971:2007, "Medical Devices: Application of Risk Management to Medical Devices"
- -EN ISO 13485:2003, "Medical Devices, Quality Management Systems: Requirements for Regulatory Purposes"
- -General Principles of Software Validation: FDA Guidance software validation version 1.1 (June 09, 1997)
Conclusion:
The BWMini is an EEG, PSG and HST recording device that is safe, effective and equivalent to the predicates above.
7
J) Non-clinical Testing:
The principal EEG authors speak about an acceptable frequency between 0.5Hz to 100Hz.
We test the produced units for performance of the device on the following frequencies: 0.5Hz, 1Hz, 2Hz, 3Hz, 4Hz, 5Hz, 10Hz, 15Hz, 20Hz, 25Hz, 30Hz, 40Hz, 50Hz, 70Hz, 80Hz, 90Hz, and 100Hz, comparing the results with a known and calibrated external source. A deviation of +/- 5% in the injected value in each frequency is acceptable.
The complete test report as ATTACHMENT 7.
Conclusion
The BWMini meets the performance standards for perform EEG and PSG exams.