(14 days)
No
The summary describes a standard EEG device and its components, with no mention of AI or ML for signal processing or analysis.
No.
The device is described as an Electroencephalograph used to measure and record the electrical activity of the patient's brain, and it is intended to "monitor the state of the brain". Monitoring and measuring are diagnostic functions, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section states that the device is an "Electroencephalograph as per 21 CFR §882.1400 (a device used to measure and record the electrical activity of the patient's brain...)". Measuring and recording the electrical activity of the brain is a diagnostic function.
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 information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: 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 BRM2 Brain Monitor is an electroencephalograph (EEG). It measures and records the electrical activity of the brain by placing electrodes on the patient's head. This is a direct measurement of physiological activity within the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to monitor the state of the brain by acquiring EEG signals. This aligns with the function of an EEG device, not an IVD.
- Input Imaging Modality: The input is Electroencephalogram (EEG) signals, which are electrical signals from the brain, not images or data derived from in vitro testing.
Therefore, the BRM2 Brain Monitor falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
OLT, OMC, GXY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's brain (accessed by placing electrodes on the head)
Indicated Patient Age Range
The change to the device includes the "Neonatal Sensor Set", suggesting use on neonates, but an explicit age range is not given.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing:
- Verification of electrical safety and performance, biocompatibility, and product shelf life.
- Meets the requirements of IEC 60601-1, UL 2601-1, IEC 60601-2-26, AAMI EC12, and FDA/IEC requirements for safety of electrode lead wires.
Clinical testing:
- Performed to demonstrate the effective duration of use for the Neonatal Sensor Set.
- Established acceptable performance in general use of the electrodes and in particular over the 24-hour maximum recommended usage period.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K030489, K960732, K911529, K000206
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).
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Image /page/0/Picture/0 description: The image is a logo for Brainz Instruments Limited. The logo consists of a black square with a white waveform inside, above the word "BRAINZ" in large, bold, sans-serif font. Below the word "BRAINZ" is the text "INSTRUMENTS LIMITED" in a smaller, sans-serif font.
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:
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
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.
(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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1
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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The eagle is stylized and drawn in black and white.
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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Image /page/4/Picture/0 description: The image is a logo for Brainz Instruments Limited. The logo features a black square with a white waveform inside, resembling brainwaves. Below the square, the word "BRAINZ" is printed in large, bold, sans-serif font, followed by "INSTRUMENTS LIMITED" in a smaller font size.
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
[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 of General, Restorative and Neurological Devices
510(k) Number K033010
Prescription Use (Per 21 CFR §801.109)