(77 days)
Not Found
No
The summary describes standard EEG signal processing and display features, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as an electroencephalograph (EEG) for monitoring brain activity, not for treating any condition. Its intended use is to acquire and display EEG signals, making it a diagnostic or monitoring device, not a therapeutic one.
Yes
The device is an electroencephalograph that measures and records brain activity to monitor the "state of the brain." This falls under diagnostic testing as it provides data used to assess a patient's condition.
No
The device description explicitly lists multiple hardware components including Skin Electrodes, Sensor Lead, Acquisition Unit, Isolation Unit, Serial and Power Cables, Monitor, and Roll-Pole.
Based on the provided text, the Brainz Instruments Ltd BRM2 Brain Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Intended Use: The BRM2 Brain Monitor is described as an Electroencephalograph used to "measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head." This involves directly interacting with the patient's body, not analyzing specimens taken from the body.
- Device Description: The components listed (Skin Electrodes, Sensor Lead, Acquisition Unit, etc.) are consistent with a device that measures physiological signals directly from the patient.
- Anatomical Site: The anatomical site is the "head," indicating direct application to the patient.
Therefore, the BRM2 Brain Monitor is a medical device used for in vivo measurement of brain activity, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BRM2 Brain Monitor is an Electroencephalograph as per 21 CFR 8882.1400. It is used to measure and record the electrical activity of a patient's brain, obtained by placing electrodes on the head. Refer to the Indications for Use Statement for further information.
The Brainz Instruments Ltd BRM2 Brain Monitor is an Electroencephalograph as per 21 CFR §882.1400 (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).
The BRM2 Brain Monitor is intended to monitor the state of the brain by acquisition of electroencephalogram (EEG) signals, in the intensive care unit, operating room, and for clinical research.
Product codes
OLI, ONR, OLT, OMC
Device Description
The BRM2 Brain Monitor is a two-channel BBG device, consisting of Skin Electrodes, Sensor Lead, Acquisition Unit, Isolation Unit, Serial and Power Cables, Monitor, and Roll-Pole.
The Acquisition Unit is an EBG head stage, providing filtering, amplification and digitization of EEG signals. The Acquisition and Lolation Units provide electrical isolation of the equipment from the patient and protection of the equipment from defibrillator discharges. The Monitor provides processing, display and storage of EEG signals.
User operation of the BRM2 Brain Monitor is via the Monitor graphical user interface (GUI) and touch-sensitive screen. The main display formats are Spectral Edge, Integrated Amplitude, and EEG Wavoform. Various time and amplitude display scale options, timeaveraged display traces and numeric values, and event marking features are available.
EEG signal processing includes data checking for environment, and electrode contact quality problems, with continuous signal quality monitoring for the user. Data file transfer to removable media, and printing of summary report data features are included.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's brain (obtained by placing electrodes on the head)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
intensive care unit, operating room, and for clinical research.
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
Non-clinical testing of the BRM2 Brain Monitor has been carried out covering mechanical, electrical and themal safety, exvironmental conditions and electromagnetic compatibility, functional verification, and performance.
The BRM2 Brain Monitor meets the requirements of the FEC 60601-1 general safety und IEC 60601-1-2 EMC international standards. It meets relevant USA deviations of the UL 2601-1 standard for general safety, and particular requirements of the IEC 60601-2-26 standard for electroencephalographs.
No clinical testing was necessary to demonstrate substantial equivalence for this product.
The testing carried out for the BRM2 Brain Monitor indicates that it meets design and performance functional requirements. The subject device meets the requirements of IEC and UL medical electrical equipment standards for safety, and the IEC particular standard for electroencephalographs.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
KO30489
Image /page/0/Picture/1 description: The image shows a logo for Brainz Instruments Limited. The logo features a black square with a white waveform inside, resembling an EEG reading. Below the square, the word "BRAINZ" is printed in large, bold, sans-serif letters. Underneath "BRAINZ", the words "INSTRUMENTS LIMITED" are printed in a smaller font size.
MAY = 2, 2003
Brainz Instrumenta Umlted
25 Carbine Road, MI Wellington PO Box 51-078, Pakuranga Aucklond, New Zealand
Telephone: +64-9 978 8896 Facsimile: +64-9 978 B889
30 April, 2003
510(k) Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is heing submitted in accordance with the requirements of 21 CFR $807.92.
(a){ }) Refer to information above and concluding this summary.
(a)(2) Name of the Device
BRM2 Brain Monitor Model No. / Name:
Classification Name: Electroencephalograph Neurology Devices, 21 CFR $882.1400, Class II, OLI, ONR
(a)(3) Identification of Legally Marketed Devices
| Aspect Medical Systems Inc | A2000 EEG Monitor | K974496 |
|---|---|---|
| Olympic Medical Corp | Lectromed CFM | K983229 |
| Fisher & Paykel Healthcare Ltd | PW810 Patient Warmer | K982630 |
(a)(4) Description of the Device
The BRM2 Brain Monitor is a two-channel BBG device, consisting of Skin Electrodes, Sensor Lead, Acquisition Unit, Isolation Unit, Serial and Power Cables, Monitor, and Roll-Pole.
The Acquisition Unit is an EBG head stage, providing filtering, amplification and digitization of EEG signals. The Acquisition and Lolation Units provide electrical isolation of the equipment from the patient and protection of the equipment from defibrillator discharges. The Monitor provides processing, display and storage of EEG signals.
User operation of the BRM2 Brain Monitor is via the Monitor graphical user interface (GUI) and touch-sensitive screen. The main display formats are Spectral Edge, Integrated Amplitude, and EEG Wavoform. Various time and amplitude display scale options, timeaveraged display traces and numeric values, and event marking features are available.
EEG signal processing includes data checking for environment, and electrode contact quality problems, with continuous signal quality monitoring for the user. Data file transfer to removable media, and printing of summary report data features are included.
1
510(k) Summary continued - BRM2 Brain Monitor
KC 30489
A telescoping-pole mounting system supports the Monitor, providing tilt- and heightadjustment options. The lower pole section is mounted into a stabilizer weight attached to a five-arm base unit, with casters that include foot-operated brake levers.
(a)(5) Statement of the Intended Use
The BRM2 Brain Monitor is an Electroencephalograph as per 21 CFR 8882.1400. It is used to measure and record the electrical activity of a patient's brain, obtained by placing electrodes on the head. Refer to the Indications for Use Statement for further information.
(a)(6) Technological Characteristics Summary
The technological characteristics of the BRM2 Brain Monitor are equivalent to the predicate devices listed above. The systems have equivalent components and hardware, self-test and impedance checking capabilities, electrical safety design, and similar displayed data formats.
(b)(1) Discussion of the Non-Clinical Tests
Non-clinical testing of the BRM2 Brain Monitor has been carried out covering mechanical, electrical and themal safety, exvironmental conditions and electromagnetic compatibility, functional verification, and performance.
The BRM2 Brain Monitor meets the requirements of the FEC 60601-1 general safety und IEC 60601-1-2 EMC international standards. It meets relevant USA deviations of the UL 2601-1 standard for general safety, and particular requirements of the IEC 60601-2-26 standard for electroencephalographs.
(b)(2) Discussion of the Clinical Tests
No clinical testing was necessary to demonstrate substantial equivalence for this product.
(b)(3) Conclusions Demonstrating Safety. Effectiveness and Performance
The testing carried out for the BRM2 Brain Monitor indicates that it meets design and performance functional requirements. The subject device meets the requirements of IEC and UL medical electrical equipment standards for safety, and the IEC particular standard for electroencephalographs.
This information indicates that the BRM2 Brain Monitor is equivalent to the predicate devices In terms of safety, effectiveness and performance.
signed:
e
Chris Mander Regulatory & Quality Manager Brainz Instruments Ltd
te: 30 April 2003
page 2-5 TOTAL P.03
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Brainz Instruments Ltd. c/o Mr. Charles Mack Underwriters Laboratories, Inc. Laboratory and Testing 2600 NW Lake Road Camas, Washington 98607-9526
APR - 9 2012
Re: K030489
Trade/Device Name: BRM2 Brain Monitor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLT, OMC Dated (Date on orig SE Itr): April 23, 2003 Received (Date on orig SE ltr): April 24, 2003
Dear Mr. Mack:
This letter corrects our substantially equivalent letter of May 2, 2003.
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.
3
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/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
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Image /page/4/Picture/3 description: The image shows a logo with a black square at the top and the word "BRAINZ" in large, bold letters below it. Inside the black square, there is a white waveform pattern, resembling a sound wave or brainwave. The waveform is centered within the square and consists of multiple peaks and valleys. The word "BRAINZ" is in a sans-serif font and appears to be the name of the company or brand.
Brginz Instruments Limited
25 Carbine Road, M1 Wellington PO Box 51-078, Pakuranga Auckland, New Zealand .
Telephone: +64-9 978 8896 Facsimile: +64-9 978 8889
15 April, 2003
[510(k)] Number:
Brainz Instruments Ltd - BRM2 Brain Monitor
PREMARKET NOTIFICATION 510(k) INDICATIONS FOR USE STATEMENT
The Brainz Instruments Ltd BRM2 Brain Monitor is an Electroencephalograph as per 21 CFR $882.1400 (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).
The BRM2 Brain Monitor is intended to monitor the state of the brain by acquisition of electroencephalogram (EEG) signals, in the intensive care unit, operating room, and for clinical research.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030489
Prescription Use (Per 21 CFR §801.109)