The Brainz Instruments Ltd BRM3 Brain Monitor is an electroencephalograph or EEG system, 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 BRM3 Brain Monitor is intended for use to monitor the state of the brain by acquisition of electroencephalogram (EEG) signals, in clinical environments such as the intensive care unit, and for clinical research.
The BRM3 Brain Monitor is intended for use only with neonatal patients, defined as from birth to 28 days post-delivery, and corresponding to a post-conceptual age of 24 to 46 weeks.
The BRM3 Brain Monitor does not provide any diagnostic conclusion about the patient's condition.

Device Description

The BRM3 Brain Monitor is a three-channel electroencephalograph (EEG) system, as per 21 CFR §882.1400: a device used to measure and record the electrical activity of the patient's brain by placing two or more electrodes on the head.

The BRM3 Brain Monitor system consists of a Neonatal Sensor Set (EEG skin electrodes) or Sensor Adaptor Set (electrode adaptor), Data Acquisition Unit (EEG head stage), Data Cable, Monitor, Power Supply Unit, and Roll-Pole. These components have equivalent configuration and functions to those described in 510(k) K030489 and K033010 for the BRM2 Brain Monitor.

Changes to the BRM3 Brain Monitor consist of a new touch-screen panel PC (Monitor), new EEG head stage (Data Acquisition Unit) and new mobile mounting hardware (Roll-Pole). New software features include display of a further EEG channel, display of an aEEG parameter, and improved signal quality indication and file reviewing capacity. User instructions have been updated accordingly.

AI/ML Overview

The provided text is a 510(k) summary for the BRM3 Brain Monitor, and it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria in terms of analytical performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technological characteristic summaries, non-clinical testing, and a declaration that clinical testing was not required for the modifications.

Here's an analysis based on the document, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission does not specify quantitative acceptance criteria for device performance (e.g., signal-to-noise ratio limits, frequency response ranges, accuracy of aEEG parameter against a gold standard) for the BRM3, nor does it report specific performance values against such criteria.

Instead, the document states:

"Non-clinical testing of the BRM3 Brain Monitor has been carried out to cover the changes to the system. These include performance testing of the new EEG head stage electronics module, full software verification procedures for updated device functionality, comparative results of the aEEG parameter implementation, and third-party testing of the entire system for compliance to IEC 60601 standards for electromagnetic compatibility, electrical safety, particular requirements for electroencephalographs, and US national requirements."
"This established correct functionality of the BRM3 Brain Monitor system according to requirements, and is equivalent to the predicate devices."
"The testing carried out for the BRM3 Brain Monitor indicates that it meets design and performance functional requirements."
"The software verification demonstrates that the modified device features are effective, and the hardware / electronics configuration functions equivalently to the predicate devices."

This indicates that the "acceptance criteria" were primarily related to meeting functional requirements, regulatory standards (IEC 60601), and demonstrating equivalence to predicate devices, rather than specific performance metrics.

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

This information is not applicable/not provided in the context of typical clinical performance studies. The "test set" in this case refers to hardware components and software functionalities during non-clinical testing. The document does not describe a clinical test set of patient data, nor its provenance.

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

This information is not applicable/not provided. The document details non-clinical testing focused on hardware, software, and regulatory compliance, not on evaluating diagnostic accuracy against expert-established ground truth from medical images or signals.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data to establish a ground truth. The testing described here is non-clinical.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed or described. The device is an electroencephalograph, not an AI-assisted diagnostic tool that would typically involve human reader performance comparison with and without AI assistance. The submission explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the modifications involved in the BRM3 Brain Monitor."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of an algorithm is not described. The BRM3 Brain Monitor is described as an EEG system that acquires and displays signals, with an aEEG parameter implementation. While the "aEEG parameter implementation" was subject to "comparative results" during non-clinical testing, the details of this comparison (e.g., against a known gold standard or simulated data) are not provided, nor is it presented as an "algorithm only" performance study in the typical sense of AI.

7. Type of Ground Truth Used

For the described non-clinical testing, the "ground truth" would likely be engineering specifications, regulatory standards (e.g., IEC 60601), and the performance characteristics of the predicate devices. The document states that "technical equivalence has been established to ensure accuracy of the aEEG parameter implementation" and "the hardware / electronics configuration functions equivalently to the predicate devices." Implied ground truth for the aEEG parameter would be its accurate calculation according to established methods, possibly verified against simulated signals or the known performance of the predicate device's aEEG.

8. Sample Size for the Training Set

This information is not applicable/not provided. The BRM3 Brain Monitor is a medical device, not an AI algorithm that undergoes machine learning training on a "training set" of data in the common sense. The "software verification procedures" mentioned would involve testing the implemented code, not training a model.

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

This information is not applicable/not provided for the same reasons as point 8.

Summary of the Study (as described in the document):

The "study" to prove the BRM3 Brain Monitor meets acceptance criteria was primarily a non-clinical engineering and regulatory compliance assessment.

Objective: To demonstrate substantial equivalence of the BRM3 Brain Monitor to predicate devices (K030489, K033010, K983229) after modifications to the touch-screen panel PC, EEG head stage, mobile mounting hardware, and software (new EEG channel display, aEEG parameter display, improved signal quality indication, file reviewing).
Methods:
- Performance testing of the new EEG head stage electronics module.
- Full software verification procedures for updated device functionality.
- Comparative results of the aEEG parameter implementation (details of this comparison are not provided, but it likely involved comparison against established methods or predicate device output).
- Third-party testing for compliance to IEC 60601 standards (electromagnetic compatibility, electrical safety, particular requirements for electroencephalographs) and US national requirements.
Results/Conclusion:
- "Established correct functionality of the BRM3 Brain Monitor system according to requirements, and is equivalent to the predicate devices."
- "Testing carried out... indicates that it meets design and performance functional requirements."
- "Software verification demonstrates that the modified device features are effective, and the hardware / electronics configuration functions equivalently to the predicate devices."
- "Clinical testing was not required."

Essentially, the device approval was based on demonstrating that the changes made did not negatively impact the device's fundamental function, safety, and effectiveness, and that it continued to perform equivalently to previously cleared devices while complying with relevant safety standards.

Summary

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K071449

Page ① of 2

Image /page/0/Picture/2 description: The image shows the word "BRAINZ" in a bold, sans-serif font. Above the word is a graphic that resembles an electroencephalogram (EEG) reading, with jagged lines representing brain activity. The graphic is positioned directly above the word, creating a visual association between the word "BRAINZ" and the concept of brain activity or intelligence.

7 September 2007

SEP 1 4 2007

510(k) SUMMARY

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

Model Number / Name: BRM3 Brain Monitor Classification Name: Electroencephalograph Neurology Devices, 21 CFR §882.1400, Class II, OMA, OMC, OLT

(a)(3) Identification of Legally Marketed Devices

K030489	BRM2 Brain Monitor	Bra
K033010	BRM2 Brain Monitor	Bra
K983229	Lectromed Cerebral Function Monitor	Oly

inz Instruments Ltd inz Instruments Ltd mpic Medical Corp

(a)(4) Description of the Device

(a)(5) Statement of the Intended Use

The BRM3 Brain Monitor is intended for use to monitor the state of the brain by acquisition of . electroencephalogram (EEG) signals, in clinical environments such as the intensive care unt, and for clinical research.
The BRM3 Brain Monitor is intended for use only with neonatal patients, defined as from birth to 28 days post-delivery, and corresponding to a post-conceptual age of 24 to 46 weeks.
The BRM3 Brain Monitor does not provide any diagnostic conclusion about the patient's condition.

Image /page/0/Picture/22 description: The image shows contact information for Brainz Instruments Ltd. The address is 25 Carbine Rd, Mt Welling, Auckland 1060, New Zealand. The PO box is 51078, Pakura, Manukau 2140, New Zealand, and the phone number is +64 9 978 8896. The website is www.brainz.com.

Brainz Instruments USA la
Suite 1700
8850 Stanford Blvd.
Columbia MD 21045
United States
Tel +1-410-312-0324
TOLL FREE 1-877-312-03-
Fax +1-410-312-0328

The image doesn't contain any discernible text.

Brainz Instruments UK Ltd

Fountain Court
2 Victoria Square
Victoria Street
St Albans
Hertfordshire AL1 3TF
United Kingdom
Tel +44 1727 884 784

Image /page/0/Picture/26 description: The image is a square with a grainy texture. The center of the image is a lighter shade of gray, and the words "see inside" are written in a simple, sans-serif font. The text is also a lighter shade of gray, blending in with the background.

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(a)(6) Technological Characteristics Summary

The technological characteristics of the BRM3 Brain Monitor are equivalent to the predicate devices listed above. The system uses similar components for the touch-screen panel PC display unit, EEG head stage electronics module mounting hardware. Technical equivalence has been established to ensure accuracy of the aEEG parameter implementation. Software is updated for compatibility with those changes, and the same skin electrodes are used as previously notified in 510(k) K033010.

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

Non-clinical testing of the BRM3 Brain Monitor has been carried out to cover the changes to the system. These include performance testing of the new EEG head stage electronics module, full software verification procedures for updated device functionality, comparative results of the aEEG parameter implementation, and third-party testing of the entire system for compliance to IEC 60601 standards for electromagnetic compatibility, electrical safety, particular requirements for electroencephalographs, and US national requirements. This established correct functionality of the BRM3 Brain Monitor system according to requirements, and is equivalent to the predicate devices.

{b)(2)_Discussion of the Clinical Tests

Clinical testing was not required to demonstrate the safety and effectiveness of the modifications involved in the BRM3 Brain Monitor. The changes to hardware, electronics, and software have been adequately assessed by establishing technical equivalence and bench testing as above.

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

The testing carried out for the BRM3 Brain Monitor indicates that it meets design and performance functional requirements. The software verification demonstrates that the modified device features are effective, and the hardware / electronics configuration functions equivalently to the predicate devices.

This information indicates that the BRM3 Brain Monitor is equivalent to the predicate devices in terms of device safety, effectiveness and performance.

signed:

Chris Mander

cerations Manager rainz Instruments Ltd

te: 7 Sept 2007

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Brainz Instruments Ltd. c/o Mr. Morten Simon Christensen Underwriters Laboratories, Inc. Staff Engineer & FDA Office Coordinator 455 East Trimble Road San Jose, California 95131-1230

APR - 9 2012

Re: K071449

Trade/Device Name: BRM3 Brain Monitor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMA, OMC, OLT Dated (Date on orig SE ltr): August 13, 2007 Received (Date on orig SE ltr): August 14, 2007

Dear Mr. Christensen:

This letter corrects our substantially equivalent letter of September 14, 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.

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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 (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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11 June 2007

510(k) Number:	K071449
Device Name:	BRM3 Brain Monitor
Indications for Use:

The BRM3 Brain Monitor is intended for use to monitor the state of the brain by acquisition of electroencephalogram (EEG) signals, in clinical environments such as the intensive care unit, and for clinical research.
The BRM3 Brain Monitor is intended for use only with neonatal patients, defined as from birth to 28 days post-delivery, and corresponding to a post-conceptual age of 24 to 46 weeks.
The BRM3 Brain Monitor does not provide any diagnostic conclusion about the patient's condition.

Prescription Use (21 CFR 801 Subpart D)	✓	AND/OR	Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	K071449
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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).