BRM2 BRAIN MONITOR

K030489 · Brainz Instruments , Ltd. · OLT · May 2, 2003 · Neurology

Device Facts

• Record ID: K030489
• Device Name: BRM2 BRAIN MONITOR
• Applicant: Brainz Instruments , Ltd.
• Product Code: OLT · Neurology
• Decision Date: May 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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.

Device Story

BRM2 Brain Monitor is a two-channel EEG device; acquires, filters, amplifies, and digitizes EEG signals via skin electrodes and head stage acquisition unit. System includes isolation unit for patient protection; monitor with GUI and touch-screen for processing, display, and storage. Used in ICU, OR, and research settings. Displays include Spectral Edge, Integrated Amplitude, and EEG waveform. Features include event marking, data file transfer, and summary report printing. Provides continuous signal quality monitoring and electrode contact checks. Assists clinicians in monitoring brain state; supports clinical decision-making through visual and numeric EEG data.

Clinical Evidence

No clinical testing was performed. Substantial equivalence was demonstrated through bench testing, including mechanical, electrical, and thermal safety, environmental conditions, electromagnetic compatibility (EMC), and functional verification against international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26) and UL 2601-1.

Technological Characteristics

Two-channel EEG monitor; includes skin electrodes, sensor lead, acquisition unit, isolation unit, and display monitor. Features include signal filtering, amplification, and digitization. Connectivity includes serial ports and removable media for data transfer. Safety design includes electrical isolation and defibrillator protection. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, and UL 2601-1 standards.

Indications for Use

Indicated for monitoring brain state via EEG signal acquisition in intensive care units, operating rooms, and clinical research settings. No specific age or gender restrictions provided.

Regulatory Classification

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.

Predicate Devices

• A2000 EEG Monitor (K974496)
• Lectromed CFM (K983229)
• PW810 Patient Warmer (K982630)

Submission Summary (Full Text)

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# 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: [phone] Facsimile: +64-9 978 B889

www.brainzinstruments.com

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.

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#### 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.

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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 [phone] or [phone] 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: [phone] Facsimile: [phone]

www.brainzinstruments.com

15 April, 2003

[510(k)] Number:

K030489

## 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)