(86 days)
Not Found
No
The description focuses on standard signal processing techniques (amplification, filtering, A/D conversion, CSA, topographic/tomographic maps) and does not mention AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an EEG amplifier intended for measuring, recording, and analyzing the electrical activity of a patient's brain to aid in monitoring and diagnosis, and for research. It does not perform any therapeutic function.
Yes
The device is intended for "monitoring and diagnosis" of the brain's electrical activity, and it aids in the analysis of EEG signals and complete data sets for clinical use.
No
The device description explicitly states it is a 40-channel EEG amplifier capable of signal amplification, analog-to-digital conversion, and filtering, which are hardware functions. While it includes software for control, display, storage, and analysis, it is a system that includes both hardware and software components.
Based on the provided information, the Neuroscan Nuamps® system is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the system is for "measuring, recording and analysis of the electrical activity of a patient's brain" and "for the EEG and long/middle-latency EP registration". This involves directly measuring physiological signals from the patient's body.
- Device Description: The description details an EEG amplifier that acquires and processes electrical signals from electrodes attached to the patient.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Neuroscan Nuamps® system does not perform this function. It measures electrical activity in vivo (within the body).
Therefore, the Neuroscan Nuamps® system falls under the category of a medical device that measures physiological signals directly from the patient, not an IVD.
N/A
Intended Use / Indications for Use
The Neuroscan Nuamps® system is intended for the measuring, recording and analysis 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-latency EP registration in the research environment
Product codes (comma separated list FDA assigned to the subject device)
OLT, GWQ
Device Description
The Neuroscan Nuamps® is a 40-channel EEG amplifier capable of direct current (DC) recording, including signal amplification, analog-to-digital conversion, and filtering. Nuamps® permits high-speed simultaneous sampling, acquisition and transfer of data host computer that controls, displays, and stores the acquired data. Nuamps®'s software routines separately control each channel and perform real-time digital filtering. Nuamps® software measures and analyzes EEG signals and performs analysis of complete data sets, calculates compressed spectrum arrays (CSA), and presents results as annotated signal plots or topographic/tomographic maps in real-time two or threedimensional (2/3-D) context. Nuamps® is optically isolated and transformers are available for line voltages of 100, 120, 230, VAC.
The Neuroscan Nuamps® systems works in the same manner as the approved and predicate device, and:
- permits 1 to 40 channels configuration, and .
- simplifies the acquisition, recording and analysis of the data generated in . high-resolution
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
Adults, children and infants
Intended User / Care Setting
routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle-latency EP registration in the research environment
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)
The Neuroscan Nuamps® system was designed and is manufactured to comply with:
- IEC-60601-1 ●
- IEC-60601-1-1 ●
- IEC-60601-1-1-2
- IEC-60601-1-1-4 .
- IEC-60601-1-2-26 .
- EN46001 ●
- EN ISO9001:2000 ●
- MDD 93/42/EEC .
- AAMI EC53-1995 ●
- CDRH Guidance Document on the "Performance Standard for Electrode ● Lead Wire and Patient Cables," March 9, 1998
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SCAN LT, 510(k) # K001564
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
V. 510(k) Summary
Safety and effectiveness 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: | Neuroscan
7850 Paseo Del Norte, Suite 101
El Paso, TX 79912
Phone: 915-845-5600 ext 217
Fax: 915-845-2965 | JAN 1 5 2003 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Elvira Garcia | |
| Date Prepared: | October 9, 2002 | |
| Proprietary Name: | Nuamps® | |
| Common Name: | Electroencephalograph (EEG) | |
| Classification Name: | Electroencephalograph (GWQ), OLT | |
| Device Classification
Class II: | 21 CFR § 882.1400 Electroencephalograph | |
| Predicate Device: | SCAN LT
510(k) # K001564 | |
Description of the Device: The Neuroscan Nuamps® is a 40-channel EEG amplifier capable of direct current (DC) recording, including signal amplification, analog-to-digital conversion, and filtering. Nuamps® permits high-speed simultaneous sampling, acquisition and transfer of data host computer that controls, displays, and stores the acquired data. Nuamps®'s software routines separately control each channel and perform real-time digital filtering. Nuamps® software measures and analyzes EEG signals and performs analysis of complete data sets, calculates compressed spectrum arrays (CSA), and presents results as annotated signal plots or topographic/tomographic maps in real-time two or threedimensional (2/3-D) context. Nuamps® is optically isolated and transformers are available for line voltages of 100, 120, 230, VAC.
The Neuroscan Nuamps® systems works in the same manner as the approved and predicate device, and:
- permits 1 to 40 channels configuration, and .
- simplifies the acquisition, recording and analysis of the data generated in . high-resolution
1
The Neuroscan SCAN LT was slightly modified to make the Neuroscan Nuamps. The modification does not affect the safety or effectiveness of the device. The modification consisted of a hardware change. We added a 12-bit trigger board that adds timing information on stimulus presentation to the EEG data collected by the amplifier.
Statement of Indications For Use:
The Neuroscan Nuamps® system is intended for the measuring, recording and analysis 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 setting for EEG.
Patient Population: Adults, children and infants
510(k) Summary of Non-Clinical Testing
The following is a list of test performed on the Neuroscan Nuamps® system. These tests demonstrate that the performance of the system is equivalent to that of the predicate devices in the terms of safety and effectiveness, and that the additional features provide utility and product performance which exceed that of the predicate devices. All tests were completed satisfactorily without adverse report.
The Neuroscan Nuamps® system was designed and is manufactured to comply with:
- IEC-60601-1 ●
- IEC-60601-1-1 ●
- IEC-60601-1-1-2
- IEC-60601-1-1-4 .
- IEC-60601-1-2-26 .
- EN46001 ●
- EN ISO9001:2000 ●
- MDD 93/42/EEC .
- AAMI EC53-1995 ●
- CDRH Guidance Document on the "Performance Standard for Electrode ● Lead Wire and Patient Cables," March 9, 1998
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Neuroscan Elvira Garcia Quality Assurance Manager 7850 Paseo del Norte, Suite 101 El Paso, Texas 79912
Re: K023536
Trade/Device Name: NuAmps Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLT, GWQ Dated (Date on orig SE ltr): October 9, 2002 Received (Date on orig SE ltr): October 21, 2002
APR - 9 2012
Dear Ms. Garcia:
This letter corrects our substantially equivalent letter of January 15, 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.
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/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
4
Statement of Indications for Use IV.
| Applicant: | Neuroscan
7850 Paseo Del Norte, Suite 101
El Paso, TX 79912
Phone: 915-845-5600 ext. 217
Fax: 915-845-2965 |
| ------------ | ------------------------------------------------------------------------------------------------------------------------ |
|---|
51(k) Number: Ko23536
Neuroscan Nuamps® Device Name:
Indications For Use: The Neuroscan Nuamps® system is intended for the measuring recording and analysis 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-latency EP registration in the research environment
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of device Evaluation (ODE)
R. Mark N. Melkman
(Division Sign-Off) Division of Coneral, Res rative and Neurological Devices
:10(k) Number K 023536
K023536 mnr
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Nuamps 510(k) Application