(115 days)
No
The summary explicitly states "The BWII system also allows for computer-assisted, usercontrolled quantitative analysis of EEG," and "The BWII does not make any judgment of normality of the displayed signals or the results of an analysis." There is no mention of AI, ML, or related terms, and the analysis is described as user-controlled.
No
The description states the device acquires, displays, and archives data for review and analysis, and explicitly mentions it "does not make any judgment of normality or abnormality 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 for research and clinical environments, indicating it's an assessment tool rather than a therapeutic one.
No
The document explicitly states multiple times that "The BWII system does not make any judgment of normality or abnormality 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."
No
The device description explicitly states that the BWII system consists of three major components: the Amplifier Unit, the Power Module, and the BWAnalysis Software. The Amplifier Unit and Power Module are described as plastic-made hardware components.
Based on the provided text, the BWII system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done in vitro (outside the body).
- BWII Function: The BWII system acquires, displays, and archives physiological signals (EEG and PSG) directly from the patient's body. This is an in vivo (within the body) measurement.
- Intended Use: The intended use clearly states it's for electroencephalography and sleep recordings, which are direct physiological measurements, not analysis of specimens.
- Device Description: The description details connections for electrodes and sensors applied to the patient, not for handling biological samples.
Therefore, the BWII system falls under the category of a physiological monitoring or recording device, not an IVD.
N/A
Intended Use / Indications for Use
The BWII system may be used for electroencephalography (EEG) and sleep recordings (polysomnography) in research and dinical environments. It acquires, displays, and archives EEG and PSG data for on screen review, annotation and event marking by the user. The BWII system also allows for computer-assisted, usercontrolled quantitative analysis of EEG.
The BWII system is not intended to replace conventional devices or methods used for EEG and PSG monitoring in critical care or intraoperative settings.
The BWII system requires competent user input, and its output must be reviewed and interpreted by a trained technicians or neurologists who will exercise professional judgment in using this information.
The BWII system does not make any judgment of normality or abnormality 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, OLT, OLV
Device Description
BWII is multi-channel (up to 25 channels) system designed for electroencephalograph (EEG) and polysomnography (PSG) recording application, in sleep lab, hospital or dinical environment under the supervision of a physician, using a lap top or a desk top computer.
The BWII system consists of three maior components: the Amplifier Unit, the Power Module (Both plastic made) and the BWAnalysis Software (a CD to be installed on a regular PC). The system provides connections for electrodes and sensors, and connects to the computer using an Ethernet cable.
The BWII works with any good quality patient leads / electrodes and sensors (snore, flow, effort belts and position) that have the safety touch connectors and are legally marketed in accordance with FDA requirements. As these accessories are already legally on the market from different manufactures, they are not part of this submission.
The BWII 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.
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
Not Found
Intended User / Care Setting
research and dinical environments.
trained technicians or neurologists
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)
Not Found
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.
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
[K062533]/A1
Image /page/0/Picture/1 description: The image shows the logo for Neurovirtual. The logo consists of a stylized "N" symbol on the left, followed by the word "NEUROVIRTUAL" in bold, sans-serif font. The logo is black and white.
23 15NW 107th Avenue - B.133 - WH. 1A16
Doral, FL - USA - 33172 Phone: (786) 693-8200 - Fax (305) 393-8429
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Page ① of 4
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1 Z
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Section S 510(k) Summary
A) Submitter's Name: | Neurovirtual USA, Inc. | DEC 2 2 2006 |
---|---|---|
Owner / Operator Registration Number: | ||
Manufacture Registration Number: | ||
B) Address: | 2315NW 107th Ave - B.133 - WH. 1A16 | |
Doral, FL - 33172 | ||
C) Phone and Fax Numbers | ||
Phone: | (786) 693-8200 | |
Fax: | (305) 393-8429 | |
D) Contact Person: | Eduardo J.M. Faria | |
E) Preparation Date: | August 14, 2006 | |
November 28, 2006 (Reviewed) | ||
F) Classification Name: | ||
Common / Usual Name: | Electroencephalograph | |
Proprietary Name: | BWII Digital (Amplifier and Power Module) | |
Product Code: | GWQ | |
Class: | Class II | |
Regulation: | 882.1400 | |
Common / Usual Name: | Analyzer, spectrum, electroencephalogram signal | |
Proprietary Name: | BWAnalysis (Software) | |
Product Code: | OLT, GWQ, OLV | |
Class: | Class I | |
Regulation: | 882.1420 |
FDA# G) Substantial Equivalence:
510(k) Number | Model | Manufacture |
---|---|---|
K932407 | Easy Write and Easy Reader | Cadwell |
Laboratories, Inc. | ||
K991900 | XLTEC PSG-40 | |
Polysomnography | Excel Tech Ltd. |
1
Image /page/1/Picture/0 description: The image shows the logo for Neurovirtual. The logo consists of a stylized waveform symbol on the left, followed by the word "NEUROVIRTUAL" in bold, sans-serif font. The "O" in "NEUROVIRTUAL" contains a circular design with a pattern inside.
2315NW 107th Avenue - B.133 - WH. 1A16 Doral, FL - USA - 33172 Phone: (786) 693-8200 - Fax (305) 393-8429
Page ② of 4
And the BWAnalysis software is equivalent with the following:
510(k) Number | Model | Manufacture |
---|---|---|
K980214 | Excel Neuro Works | Excel Tech Ltd. |
K932407 | Easy Write and Easy Reader | Cadwell |
Laboratories, Inc. | ||
K974718 | Persyst Prism | Persyst |
Development Corp. |
F) Description:
BWII is multi-channel (up to 25 channels) system designed for electroencephalograph (EEG) and polysomnography (PSG) recording application, in sleep lab, hospital or dinical environment under the supervision of a physician, using a lap top or a desk top computer.
The BWII system consists of three maior components: the Amplifier Unit, the Power Module (Both plastic made) and the BWAnalysis Software (a CD to be installed on a regular PC). The system provides connections for electrodes and sensors, and connects to the computer using an Ethernet cable.
The BWII works with any good quality patient leads / electrodes and sensors (snore, flow, effort belts and position) that have the safety touch connectors and are legally marketed in accordance with FDA requirements. As these accessories are already legally on the market from different manufactures, they are not part of this submission.
The BWII 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.
I) Intended Used:
The BWII system may be used for electroencephalography (EEG) and sleep recordings (polysomnography) in research and dinical environments. It acquires, displays, and archives EEG and PSG data for on screen review, annotation and event marking by the user. The BWII system also allows for computer-assisted, usercontrolled quantitative analysis of EEG.
The BWII system is not intended to replace conventional devices or methods used for EEG and PSG monitoring in critical care or intraoperative settings.
The BWII system requires competent user input, and its output must be reviewed and interpreted by a trained technicians or neurologists who will exercise professional judgment in using this information.
2
Image /page/2/Picture/0 description: The image shows the logo for Neurovirtual. The logo consists of a stylized waveform symbol on the left, followed by the word "NEUROVIRTUAL" in bold, sans-serif font. The waveform symbol is a simple, angular line that resembles a brainwave pattern.
2315NW 107th Avenue - B.133 - WH. 1A16 Doral, FL - USA - 33172 Phone: (786) 693-8200 - Fax (305) 393-8429
page 3 of 4
The BWII system does not make any judgment of normality or abnormality 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.
J) Technological Characteristics:
| | Neurovirtual
BWII | Cadwell
Easy Write | Excel Tech
PSG-40 | Excel Tech
Neuro Works |
|--------------------------------------------------|-----------------------|-----------------------|-----------------------|---------------------------|
| HARWARE | | | | |
| 510(k) Number | K062533 | K932407 | K991900 | K980214 |
| Classification | Electroencephalograph | Electroencephalograph | Electroencephalograph | Electroencephalograph |
| Application | EEG and PSG | EEG and PSG | EEG and PSG | EEG |
| Number of
Channels | Up to 25 | 32 | 40 | 40 |
| Data
Communication | Ethernet | Ethernet | Ethernet | Ethernet |
| Material
(External) | Hard Plastic | Hard Plastic | Hard Plastic | Hard Plastic |
| Power Source | External Power Module | External Power Module | Internal Power Module | Internal Power Module |
| SOFTWARE | | | | |
| Platform | Windows XP | Windows XP | Windows XP | Windows NT |
| Impedance | YES | YES | YES | YES |
| Calibration | YES | YES | YES | YES |
| Spectrum
Analyzer
(Frequency and
Power) | YES | YES | YES | YES |
| Montage Editor | YES | YES | YES | YES |
K) Safety and Effectiveness:
The BWII is in compliance with the applicable clauses of the following standards:
- EN 60601-1:1990, "Medical Device Equipment: General Requirements for Safety"
- EN 60601-1-1:2000, Medical electrical equipment Part 1: General requirements for safety - Section 1: Collateral standard: Safety requirements for medical electrical systems
- EN 60601-2: 2001, "Medical Device Equipment General Requirements l for Safety, Collateral Standard: Electromagnetic Compatibility, Requirements and Test"
- -EN 60601-2-26:1994, "Medical Device Equipment - Particular requirements for the safety of electroencephalographs"
- -EN 60601-1-4: 1996, "Medical Device Equipment - General Requirement for Safety, Collateral Standard: Programmable Electrical Medical Systems"
- -EN ISO 14971:2000, "Medical Devices: Application of Risk Management to Medical Devices"
3
Page (4) of 4
Image /page/3/Picture/1 description: The image shows the logo for Neurovirtual. The logo consists of a stylized waveform symbol on the left, followed by the word "NEUROVIRTUAL" in bold, sans-serif font. The waveform symbol is a series of sharp, angular lines resembling a brainwave pattern.
2315NW 107th Avenue – B.133 – WH. 1A16
Doral, FL – USA – 33172
Phone: (786) 693-8200 – Fax (305) 393-8429
- EN 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) -
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, positioned to the right of a circular emblem. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Neurovirtual c/o Mr. Eduardo J.M. Faria President 2315 NW 107th Avenue Box #133 Warehouse 1A16 Doral, Florida 33172
APR - 9 2012
Re: K062533
Trade/Device Name: BWII Digital EEG and BWII Digital PSG with BWAnalysis Software Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLT, GWQ, OLV Dated (Date on orig SE 1tr): December 8, 2006 Received (Date on orig SE ltr): December 19, 2006
Dear Mr. Faria:
This letter corrects our substantially equivalent letter of January 16, 2007.
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 (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.
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.
5
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Image /page/6/Picture/0 description: The image shows the logo for Neurovirtual. The logo consists of a stylized waveform graphic to the left of the word "NEUROVIRTUAL". The word is in all caps and in a bold sans-serif font. The letter "O" in "NEUROVIRTUAL" contains a circular design inside it.
2315NW 107th Avenue - B.133 - WH. 1A16 Doral, FL - USA - 33172 Phone: (786) 693-8200 - Fax (305) 393-8429
Section 4 Indications for Use
510(k) Number (if known): K062533
Device Name: BWII Digital EEG and BWII Digital PSG with BWAnalysis Software
Indications for Use:
The BWII system may be used for electroencephalography (EEG) and sleep recordings (polysomnography) in research and dinical environments. It acquires, displays, and archives EEG and PSG data for on screen review, annotation and event marking by the user. The BWII system also allows for computer-assisted, usercontrolled quantitative analysis of EEG.
The BWII system is not intended to replace conventional devices or methods used for EEG and PSG monitoring in critical care or intraoperative settings.
The BWII system requires competent user input, and its output must be reviewed and interpreted by a trained technicians or neurologists who will exercise professional judgment in using this information.
The BWII system does not make any judgment of normality or abnormality 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.
AND/OR
Prescription Use X
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Plo
and Neurologics
510(k) Number L06253