(138 days)
No
The summary describes a standard EEG/ERP/EP amplifier and data acquisition system with no mention of AI or ML capabilities for data analysis or interpretation. The interpretation is explicitly stated to be performed by a qualified physician.
No
The device is described as measuring and recording electrical activity for monitoring and diagnosis, not providing therapy.
Yes
The device is described as aiding in "monitoring and diagnosis" of the electrical activity of a patient's brain, and the data acquired "must be interpreted by a qualified physician," indicating its use in diagnosing medical conditions.
No
The device description explicitly mentions hardware components like the "Neuvo Amplifier System," "Headbox," and "System Unit," which are physical devices used for data acquisition and interfacing. This indicates it is a system with both hardware and software, not a software-only medical device.
Based on the provided text, the Compumedics Neuvo System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The text explicitly states the system is for "measuring recording of the electrical activity of a patient's brain" and involves "attachment of multiple electrodes at various locations." This is a direct measurement of physiological activity from the patient's body, not the analysis of a specimen taken from the body (like blood, urine, tissue, etc.).
- The intended use and device description focus on EEG and EP registration. These are techniques for measuring electrical signals from the brain and nervous system, which are in vivo measurements.
Therefore, the Compumedics Neuvo System falls under the category of a medical device used for physiological monitoring and diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Compumedics Neuvo System is intended for measuring recording of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short- latency EP registration in the research environment. The system is intended to be used by qualified/trained EEG technologists and/or physicians. The data acquired must be interpreted by a qualified physician.
Product codes
GWQ, GWF, GWJ, GWE
Device Description
The Compumedics Neuvo System is intended for measuring of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP registration in the research environment. The system is intended to be used by qualified/traincd EEG technologists and/or physicians. The data acquired must be interpreted by a qualified physician.
The Neuvo Amplifier System is an EEG/ERP/EP amplifier and data acquisition system. The amplifier and data acquisition clectronics are housed in a small enclosure (Headbox) placed near the patient, and into which individual clectrodes, collections of electrodes, may be connected. Additionally a high density electrode cap connector is provided on the Headbox. The Headbox also contains a connector for the interconnect cable to the System Unit.
The System Unit is slightly larger than the Headbox and serves as an interface between up to four Headboxes and the host computer.
The system operates under the software control of a host computer over an Ethernet 100BaseT interface. Data flows from the Neuvo amplifier over this interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The system is intended to be used by qualified/traincd EEG technologists and/or physicians. The data acquired must be interpreted by a qualified physician.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SynAmps2 510(k) # K023771
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
(K08115)
Page ① of 2
510(k) Summary
SEP - 8 2008
Safety and offectiveness information concerning this device is summarized below. Because this is not a Class III device, the special certification defined in this section is not required.
Submitted by:
David Graves Quality Engineer Compumedics USA Ltd 6605 West WT Harris Blvd, Suitc F Charlotte, NC, USA 28269 Ph : 704 749 3221 Fx : 704 749 3298 dgraves@compumedicsusa.com www.compumedics.com
Contact Person:
| David Graves |
|---|
| Quality Engineer |
| Compumedics USA Ltd |
| 6605 West WT Harris Blvd. Suite F |
| Charlotte, NC, USA 28269 |
| Ph : 704 749 3221 |
| Fx : 704 749 3298 |
| dgraves@compumedicsusa.com |
| www.compumcdics.com |
Date Prepared: 25 Feb 2008
Proprietary Namc: Neuvo
Common Name: Electroencephalograph (EEG)
Classification Name: GWQ, GWP, GWF, GWE, GWJ
Device Classification: Class II: 21 CFR § 882.1400 Electroencephalograph
Predicate Device: SynAmps2 510(k) # K023771
Description of the Device:
The Compumedics Neuvo System is intended for measuring of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP registration in the research environment. The system is intended to be used by qualified/traincd EEG technologists and/or physicians. The data acquired must be interpreted by a qualified physician.
1
Page (2) of 2
The Neuvo Amplifier System is an EEG/ERP/EP amplifier and data acquisition system. The amplifier and data acquisition clectronics are housed in a small enclosure (Headbox) placed near the patient, and into which individual clectrodes, collections of electrodes, may be connected. Additionally a high density electrode cap connector is provided on the Headbox. The Headbox also contains a connector for the interconnect cable to the System Unit.
The System Unit is slightly larger than the Headbox and serves as an interface between up to four Headboxes and the host computer.
The system operates under the software control of a host computer over an Ethernet 100BaseT interface. Data flows from the Neuvo amplifier over this interface.
Image /page/1/Figure/4 description: This image shows a diagram of a medical device system. The system includes a display, a system unit, a network connection, a power connection, an external DC input module, a headbox, an LTM headbox, and an event button. The headbox is labeled as "up to 4 off."
NEUVO SYSTEM COMPONENTS
Figure 1-1 Illustration of the various Neuvo components.
Figure 1-1 illustrates the various components that can be used in a Neuvo system. Note that the cable management system is not shown.
2
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 depiction of an eagle or bird-like figure with three distinct lines forming its body and wings. The bird is positioned diagonally within the frame. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Compumedics USA, Limited c/o Intertek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road, Unit B Twinsburg, Ohio 44087
Re: K081151
Trade/Device Name: Compumedics Neuvo Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ, GWF, GWJ, GWE Dated (Date on orig SE ltr): August 22, 2008 Received (Date on orig SE ltr): August 25, 2008
Dear Mr. Lehtonen:
This letter corrects our substantially equivalent letter of September 8, 2008.
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.
APP - 9 2012
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/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
Image /page/3/Picture/7 description: The image shows a stylized signature. The signature appears to be handwritten in cursive. The letters are connected and flow together in a fluid manner.
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
4
Attachment 2 - Statement of Indications for use
| Applicant: | Compumedics USA, Ltd |
|---|---|
| 510(K) Number: | K081151 |
| Device Name: | Compumedics Neuvo |
| Indications For Use: | The Compumedics Neuvo System is intended for measuring recording of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short- latency EP registration in the research environment. The system is intended to be used by qualified/trained EEG technologists and/or physicians. The data acquired must be interpreted by a qualified physician. |
| Prescription Use
(Per 21 CFR 801 SubpartD) | ✓ | AND/OR | Over the Counter Use
(21 CFR 801 Subpart C) |
| ----------------------------------------------- | ----------------------------------------------------------------- | -------- | ------------------------------------------------ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of device Evaluation (ODE)
Mark A. Miller
K081151
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K08 115