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 Description

The BRM2 Brain Monitor is a two-channel EEG device, consisting of skin electrodes, Sensor Lead, Acquisition Unit, Isolation Unit, Serial and Power Cables, Monitor, and Roll-Pole. All components other than the skin electrodes and Sensor Lead are the same as described in 510(k) K030489 for the BRM2 Brain Monitor.

Changes to the BRM2 Brain Monitor consist of using the Neonatal Sensor Set for the EEG skin electrodes, which has two signal electrode pairs and a reference electrode all pre-wired to a single connector. The Sensor Lead has been modified to add a compatible connector for the Neonatal Sensor Set. Products used for skin preparation at the EEG electrode application sites have been made available in a convenience kit.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that indicates the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (BRM2 Brain Monitor) seeking substantial equivalence. As such, the level of detail regarding acceptance criteria, study methodologies, and exact performance metrics is often less comprehensive than what would be found in a full scientific publication or clinical trial report. The information is focused on demonstrating equivalence to predicate devices, rather than establishing de novo performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Standards Met	Reported Device Performance/Conclusion
Electrical Safety	IEC 60601-1 (general safety international standard)	Device (BRM2 Brain Monitor and Neonatal Sensor Set) meets the requirements.
	UL 2601-1 (relevant USA deviations for general safety)	Device meets the requirements.
	IEC 60601-2-26 (particular requirements for electroencephalographs)	Device meets the requirements.
Biocompatibility	(Not explicitly named, but implied for device components)	Non-clinical testing to cover biocompatibility was carried out. (Conclusion: meets design and performance requirements)
Product Shelf Life	(Not explicitly named)	Non-clinical testing to cover product shelf life was carried out. (Conclusion: meets design and performance requirements)
Electrode Performance	AAMI EC12 (standard for disposable ECG electrodes)	Neonatal Sensor Set meets the requirements.
	FDA / IEC requirements for safety of electrode lead wires	Neonatal Sensor Set meets the requirements.
Clinical Effectiveness	Acceptable performance of electrodes in general use and over the 24-hour maximum recommended usage period for the Neonatal Sensor Set.	"Clinical testing was carried out to demonstrate the effective duration of use for the Neonatal Sensor Set. This established acceptable performance in general use of the electrodes and in particular over the 24-hour maximum recommended usage period."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the sample size used for the clinical testing of the Neonatal Sensor Set.
Data Provenance: The document does not specify the country of origin for the clinical testing data. It mentions "Clinical testing was carried out," implying it was a prospective study, but doesn't explicitly state "retrospective" or "prospective."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The clinical test was to demonstrate the effective duration of use for the Neonatal Sensor Set, implying observation of electrode function and patency rather than a diagnostic accuracy study requiring expert adjudication of ground truth for EEG interpretation.

4. Adjudication Method for the Test Set

This information is not provided as the nature of the clinical test described (electrode duration of use) does not typically involve an adjudication method in the way a diagnostic accuracy study would.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical and clinical testing focused on the device's technical performance and electrode efficacy, not a comparison of human reader performance with and without AI assistance. The device itself is an electroencephalograph, a signal acquisition device, not an AI-powered diagnostic interpretation tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable / No. This device is an electroencephalograph, which is a hardware device for measuring and recording brain activity. It does not contain an AI algorithm for standalone performance evaluation that would be distinct from human interpretation. The "performance" being evaluated relates to the quality of the signal acquisition and the durability of the electrodes.

7. The Type of Ground Truth Used

For the electrical safety, biocompatibility, and shelf-life testing, the "ground truth" is adherence to established international and national standards (e.g., IEC 60601-1, UL 2601-1, AAMI EC12).
For the clinical testing of the Neonatal Sensor Set's effective duration of use, the "ground truth" would likely be direct observation of electrode integrity, signal quality over time, and possibly absence of adverse skin reactions (though not explicitly detailed beyond "acceptable performance"). It relies on objective measurements and clinical assessment, not expert consensus on diagnostic interpretation.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware system for signal acquisition. It does not use a "training set" in the context of machine learning or AI algorithms. The design and validation are based on engineering principles and regulatory standards.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the reasons stated in point 8.

Summary

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8 September, 2003

OCT 1 0 2003

Brainz Instruments Limited

25 Carbine Road, Mt Wellington PO Box 51-078, Pakuranga Auckland, New Zealand

KO33010

Telephone: +64-9 978 8888 +64-9 978 8889 Facsimile:

www.brainzinstruments.com

510(k) Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92:

(a)(1) Refer to information above and concluding this summary.

(a)(2) Name of the Device

BRM2 Brain Monitor Model No. / Name:

Electroencephalograph Classification Name: Electrochecphanigraphi
Neurology Devices, 21 CFR §882.1400, Class II, OLT, ONACTLY

(a)(3) Identification of Legally Marketed Devices

K030489	BRM2 Brain Monitor	Brainz Instruments Ltd
K960732	HydroSpot EEG Electrode Model 1501	Physiometrix Inc
K911529	Bunny Electrode / Stealth Electrode	Lead-Lok Inc
K000206	PALS Neonatal Pediatric ECG Electrode	Axelgaard Manufacturing Co Ltd

(a)(4) Description of the Device

(a)(5) Statement of the Intended Use

The BRM2 Brain Monitor is an Electroencephalograph as per 21 CFR §882.1400. 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.

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K033010 2/2

510(k) Summary continued - BRM2 Brain Monitor

(a)(6) Technological Characteristics Summary

The technological characteristics of the BRM2 Brain Monitor are equivalent to the predicate devices listed above. The EEG monitor system is the same as described in 510(k) K030489 for the BRM2 Brain Monitor. The Neonatal Sensor Set is equivalent in terms of materials and construction to the electrode predicate devices.

(b)(1) Discussion of the Non-Clinical Tests

Non-clinical testing of the BRM2 Brain Monitor has been carried out to cover the changes to the system, including verification of electrical safety and performance, biocompatibility, and product shelf life.

The BRM2 Brain Monitor and Neonatal Sensor Set meet the requirements of IEC 60601-1 general safety international standard. They meet relevant USA deviations of the UL 2601-1 standard for general safety, and particular requirements of the IEC 60601-2-26 standard for electroencephalographs.

The Neonatal Sensor Set meets the requirements of the AAMI EC12 standard for disposable ECG electrodes, and FDA / IEC requirements for safety of electrode lead wires.

(b)(2) Discussion of the Clinical Tests

Clinical testing was carried out to demonstrate the effective duration of use for the Neonatal Sensor Set. This established acceptable performance in general use of the electrodes and in particular over the 24-hour maximum recommended usage period.

(b)(3) Conclusions Demonstrating Safety, Effectiveness and Performance

The testing carried out for the BRM2 Brain Monitor and Neonatal Sensor Set indicates that they meet design and performance requirements. The subject device continues to meet the requirements of IEC and UL medical electrical equipment standards for safety, and the IEC particular standard for electroencephalographs. The Neonatal Sensor Set meets appropriate performance requirements for ECG electrodes, and effectiveness was demonstrated in a clinical evaluation.

This information indicates that the BRM2 Brain Monitor and Neonatal Sensor Set are equivalent to the predicate devices in terms of safety, effectiveness and performance.

te: 8 Sept 2003

signed:

Chris Mander Regulatory & Quality Manager Brainz Instruments Ltd

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Brainz Instruments Ltd. c/o Ms. Denise L. Klinker Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050-4169

APR - 9 2012

Re: K033010

Trade/Device Name: Model BRM2 Brain Monitor with Neonatal Sensor Set Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLT, OMC, GXY Dated (Date on orig SE ltr): September 25, 2003 Received (Date on orig SE ltr): September 26, 2003

Dear Ms. Klinker:

This letter corrects our substantially equivalent letter of October 10, 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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Page 2 - Ms. Denise L. Klinker

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 vours.

Kesia Alexander

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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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8 September, 2003

Brainz Instruments Limited

25 Carbine Road, Mt Wellington PO Box 51-078, Pakuranga Auckland, New Zealand

Telephone: +64-9 978 8888 Facsimile: +64-9 978 8889

www.brainzinstruments.com

[510(k)] Number:

Brainz Instruments Ltd - BRM2 Brain Monitor

PREMARKET NOTIFICATION 510(k) INDICATIONS FOR USE STATEMENT

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 of General, Restorative and Neurological Devices

510(k) Number K033010

Prescription Use (Per 21 CFR §801.109)

Regulation Number and Section

§ 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).