(98 days)
No
The summary explicitly states the device does not make judgments of normality or abnormality and requires user interpretation, indicating a lack of AI/ML for automated analysis or diagnosis.
No
The device is described as an EEG and PSG recording application that acquires, displays, and archives data for review and interpretation by a physician. It does not make diagnostic judgments or provide therapy.
No
The text explicitly states: "The BWIII 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 an acquisition and display system for data that must be interpreted by a physician.
No
The device description explicitly states that the BWIII system consists of four major hardware components: the amplifier unit, head box unit, flash stimulator unit, and the power module. It also mentions connections for electrodes and sensors and connecting to a computer via an ethernet cable. This indicates it is a hardware system with accompanying software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BWIII system acquires, displays, and archives electroencephalography (EEG) and polysomnography (PSG) data. These are recordings of electrical activity in the brain and physiological parameters during sleep, respectively. This data is collected directly from the patient's body using electrodes and sensors, not from a sample taken from the body.
- Intended Use: The intended use describes the device for EEG and sleep recordings in research and clinical environments for on-screen review, annotation, and event-marking. This aligns with physiological monitoring, not in vitro testing.
- Lack of Sample Analysis: The description focuses on the acquisition and display of signals, not the analysis of biological samples.
Therefore, the BWIII system is a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BWIII system may be used for electroencephalography (EEG) and sleep recordings (Polysomnography) in research and clinical environments. It acquires displays and archives EEG and PSG data for on-screen review, annotation, and event-marking by the user.
The BWIII requires competent user input, and its output must be reviewed and interpreted by a trained physician who will exercise professional judgment in using this information.
The BWIII 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
GWQ, OLV
Device Description
BWIII is multi-channel (up to 50 channels) system designed for polysomnography (PSG) and electroencephalograph (EEG) recording application, in sleep lab, hospital or clinical environment under the supervision of a physician, using a laptop or a desktop computer.
The BWIII system consists of four major components: the amplifier unit, head box unit, flash stimulator unit and the power module (all plastic made). The system provides connections for electrodes and sensors, and connects to the computer using an ethernet cable.
The BWIII 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 in the market from different manufactures, they are not part of this submission.
The BWIII 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
The BWIII system may be used for electroencephalography (EEG) and sleep recordings (polysomnography) in research and clinical environments. The BWIII requires competent user input, and its output must be reviewed and interpreted by a trained physician who will exercise professional judgment in using this information.
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)
Reference Device(s)
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
OCT 2 8 2011
K 112107 p.1/4
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: | September 28, 2011 |
| F) Classification Name: | |
| Common / Usual Name: | Full-Montage Standard Electroencephalograph |
| Proprietary Name: | BWIII (Models: EEG, EEG Plus, PSG and PSG Plus) |
| Product Code: | GWQ |
| Additional Product Codes: | OLV |
| Class: | Class II |
| Regulation: | 882.1400 |
G) Substantial Equivalence:
The BWIII is equivalent with the following products:
| 510(k) Number | Model | Company |
|---|---|---|
| K932407 | Easy Write and Easy Reader | Cadwell Laboratories, Inc. |
| K991900 | XLTEC PSG-40 Polysomnography | Excel Tech Ltd. |
| K062533 | BWII Digital | Neurovirtual USA Inc. |
Technological Characteristics:
The predicate devices used to establish substantial equivalence for the BWIII are outlined below. This section of this submission will provide a comparison of functional features and technical specifications of the BWIII to each of the predicate devices stratified by functional modality.
1
| Model | Neurovirtual BWIII | Neurovirtual BWII | Cadwell Easy Write | Excel Tech PSG-40 |
|---|---|---|---|---|
| 510(k) Number | K062533 | K932407 | K991900 | |
| Classification | GWQ | GWQ | GWQ | GWQ |
| Application | EEG | EEG | Easy II EEG | EEG and PSG |
| EEG Plus PSG | PSG Plus | |||
| Number of Channels | 31 | 47 | 25 | Up to 50 |
| EEG | PSG | EEG and PSG | ||
| 29 | 32 | |||
| Oximeter | Built-in | Built-in | Built-in | |
| Flash Stimulator | 1-30 Hz | 1-25 Hz | 1-30 Hz | |
| Data Communication | Ethernet / RJ-45 | Ethernet / RJ-45 | Ethernet / RJ-45 | |
| Software Based | MS Windows | MS Windows | MS Windows | |
| Material (External) | Hard Plastic | Hard Plastic | Hard Plastic | |
| Power Source | External | External | Internal | |
| Line Power | 100-240VAC | 120/250VAC | 130/215VAC | |
| AD Resolution | 16 Bits | 16 Bits | 12 Bits | |
| Common Mode Rejection Ratio | 50-60Hz | 50-60Hz | 60Hz | |
| Sensitivity Selection | 1-500uv/mm | 1-100uv/mm | 1-200uv/mm | |
| Low Frequency filters | 0.16 - 10Hz | 0.02-10 Hz | 0.25 - 20Hz | |
| High Frequency filters | 15 - 100 Hz | 15 - 100 Hz | 15 - 120Hz | |
| Auxiliary DC Inputs | 4 | 8 | 1-6 DC Inputs | 1-6 DC Inputs |
| User Interface | IBM PC | IBM PC | IBM PC | |
| Software | BWAnalysis | |||
| 510(k)K062533 | EasyWrite and Easy Reader | |||
| 510(k)K932507 | Excel Neuroworks | |||
| 510(k)K980214 |
:
.
2
K 112107 p.3/4
H) Description:
BWIII is multi-channel (up to 50 channels) system designed for polysomnography (PSG) and electroencephalograph (EEG) recording application, in sleep lab, hospital or clinical environment under the supervision of a physician, using a laptop or a desktop computer.
The BWIII system consists of four major components: the amplifier unit, head box unit, flash stimulator unit and the power module (all plastic made). The system provides connections for electrodes and sensors, and connects to the computer using an ethernet cable.
The BWIII 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 in the market from different manufactures, they are not part of this submission.
The BWIII 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 BWIII system may be used for electroencephalography (EEG) and sleep recordings (polysomnography) in research and clinical environments. It acquires displays and archives EEG and PSG data for on-screen review, annotation, and event-marking by the user.
The BWIII requires competent user input, and its output must be reviewed and interpreted by a trained physician who will exercise professional judgment in using this information.
The BWIII 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.
3
K112107 p.4/4
J) Safety and Effectiveness:
The BWIII 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: ﻨﻪ Requirements for Requlatory Purposes"
- -General Principles of Software Validation: FDA Guidance software validation version 1.1 (June 09, 1997)
K) Non-clinical Testing:
In order to demonstrate that the use of EEG / PSG equipment is safe and effective, we have compiled one article from the Journal of Epilepsy and Clinical Neurophysiology (J Epilepsy Clin Neurophysiol 2004; 10(4):191-200) that demonstrates the safety and effectiveness regarding the equipment.
The full article "Nonconvulsive Status Epilepticus: Clinical and Electrographic Aspects" is attached on the ATTACHMENT 05.
L) Conclusion
The BWIII system is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.
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 or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 8 2011
Neurovirtual USA, Inc. c/o Mr. Eduardo Faria President 2315 NW 107th Avenue, Ste. 1M27 Doral, FL 33172
Re: K112107
Trade/Device Name: BWIII EEG, BWIII EEG Plus, BWIII PSG, BWIII PSG Plus Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO, OLV Dated: September 28, 2011 Received: October 4, 2011
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.
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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Peter m.f.
Malvina B. Evdelman, 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
Indications for Use
510(k) Number (if known): _ K112107
Device Name: BWIII
Indications for Use:
The BWIII system may be used for electroencephalography (EEG) and sleep recordings (Polysomnography) in research and clinical environments. It acquires displays and archives EEG and PSG data for on-screen review, annotation, and event-marking by the user.
The BWIII requires competent user input, and its output must be reviewed and interpreted by a trained physician who will exercise professional judgment in using this information.
The BWIII 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.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
John Grimes
Division Sion-Off Division of Ophthalmic, Neurological and Ear. Nose and Throat Devices
510(k) Number K112107