(60 days)
Not Found
Not Found
No
The description focuses on data acquisition, stimulus presentation, and archiving, with no mention of AI/ML for analysis or interpretation.
No
Explanation: The device is described as a "data acquisition tool" for fMRI procedures, presenting stimuli and collecting responses, and archiving data. There is no mention of it treating, mitigating, or preventing any disease or condition.
No
The device is described as a "data acquisition tool" that collects behavioral and fMRI data. It does not perform analysis or interpretation of this data to diagnose a condition.
No
The device description explicitly mentions collecting patient responses from a "button (response) device," indicating the inclusion of hardware beyond just software.
Based on the provided information, the MindState Functional Data Acquisition Device (fDAD) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- fDAD's Function: The fDAD's primary function is to acquire data during an fMRI procedure. It presents stimuli to a patient and collects their behavioral responses (button presses). It also archives fMRI image data received from an MR scanner.
- No Specimen Analysis: The fDAD does not analyze any biological specimens from the patient. It interacts directly with the patient and the MR scanner.
Therefore, the fDAD falls under the category of a medical device used in conjunction with an imaging modality (MRI) to collect data related to brain activity and behavior, rather than an IVD device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in the MRI environment to perform functional MRI (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast.
fDAD presents a stimulus to the patient and collects the patient’s responses from a button (response) device. Execution of specific cognitive or motor activation tasks by the patient in response to a set of stimuli creates the necessary behavioral data. The fMRI data comprised of the MR images (in DICOM format) sent from the MR scanner control station, and the behavioral response (binary) data are archived to a removable media by fDAD.
The fDAD-PT (fDAD Personal Trainer) is used to train the patient in the use of the four button response device and to ensure their understanding and ability to perform the specific task. A short activation task is presented on the fDAD-PT control station and the patient is allowed to become familiar with the nature of the activation task and the nature of the response to be provided.
Product codes
90 LNH
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
MR images (in DICOM format) through an MR scanner control station.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the circle is an abstract symbol that resembles a bird or a stylized human figure.
JAN 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hrishikesh Gadagkar, Ph.D. Director of Product Development and Manufacturing Neurognostics, Inc. 10437 Innovation Drive, Suite 309 MILWAUKEE WI 53226
Re: K043290 Trade/Device Name: MindState Functional Data Acquisition Device (fDAD) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: November 26, 2004 Received: December 10, 2004
Dear Dr. Gadagkar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have levice your becaller better by probation (for the indications for use stated in above and nave decemined the ad predicate devices marketed in interstate commerce prior to the cliciosure) to regarly manusical Device Amendments, or to devices that have been May 20, 1770, the citted in accordance of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accondation warmarket approval application (PMA). You may, therefore, market the do not require approval of a premance 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 (Premarket rryour de rice is classilled (000 as 11 additional controls. Existing major regulations affecting your Apployal), It inal 60 babyer to and Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA device ban of tound mouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that Ficast be advised that i 271 o total 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 I cacrat statues and regulaing, but not limited to registration and listing (21 CFR Part 807); labeling ACC S requirements, metading, bactive practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to ocgin marketing your antial equivalence of your device to a legally premarket notification. The FDA Inding of substantial organities and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleased If you desire specific advice for your device on our laceming regains. In ( the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation entitled, "Thisoration on your responsibilities under the Act from the 807.97). You may outler general meanal on on your Assistance at its toll-free number (800).
Division of Small Manufacturers, International and Consumer Assistance at and 1711sion of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmadsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows a logo for a company called "Neurognostics". The logo includes an image of a human head on the left side. Below the company name is the text "Functional MR imaging".
Section D - 1
SECTION D - STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MindState Functional Data Acquisition Device (fDAD)
Indications for Use:
The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in the MRI environment to perform functional MRI (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast.
fDAD presents a stimulus to the patient and collects the patient's responses from a button (response) device. Execution of specific cognitive or motor activation tasks by the patient in response to a set of stimuli creates the necessary behavioral data. The fMRI data comprised of the MR images (in DICOM format) sent from the MR scanner control station, and the behavioral response (binary) data are archived to a removable media by fDAD.
The fDAD-PT (fDAD Personal Trainer) is used to train the patient in the use of the four button response device and to ensure their understanding and ability to perform the specific task. A short activation task is presented on the fDAD-PT control station and the patient is allowed to become familiar with the nature of the activation task and the nature of the response to be provided.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
text
Nancy Brogdon
(Division Sign-Off)
sion of Reproductive, Abdominal,
Radological Devices
C Neurognostics, Inc. 2004
5 F(x) Number _
MindState fDAD 510(k)