(204 days)
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No
The provided 510(k) summary does not contain any keywords or descriptions that explicitly mention or strongly suggest the use of AI or ML technology. The focus is on "navigated brain stimulation" and "mapping," which are typically associated with image-guided or spatial localization techniques, not necessarily AI/ML for analysis or decision-making.
No.
The device is indicated for mapping the primary motor cortex for assessment and pre-procedural planning, not for treating any condition or disease.
Yes
The device is indicated for "non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus" and "provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning." These activities fall under the definition of diagnosis, which involves distinguishing or identifying diseases or conditions through evaluation of signs and symptoms.
No
The description refers to a "System" and "Navigated Brain Stimulation System," implying hardware components are involved in the navigation and stimulation process, even if not explicitly detailed in this summary. The term "System" typically encompasses both hardware and software.
Based on the provided information, the Nexstim eXimia Navigated Brain Stimulation System (NBS System) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- NBS System Function: The provided description states the NBS System is used for "non-invasive mapping of the primary motor cortex of the brain." This is a procedure performed on the patient's body, not on a specimen taken from the body.
- Intended Use: The intended use is for "mapping" and "assessment of the primary motor cortex for pre-procedural planning." This is a diagnostic imaging or mapping procedure, not a laboratory test on a biological sample.
Therefore, the NBS System falls under the category of a medical device used for diagnostic or mapping purposes in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nexstim eXimia Navigated Brain Stimulation System (NBS System) is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
Product codes
GWF, HAW, IKN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
primary motor cortex of the brain
Indicated Patient Age Range
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Intended User / Care Setting
trained clinical professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and features an abstract design of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Nexstim OY c/o Cynthia J.M. Nolte, Ph.D., RAC Senior Regulatory Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
DEC - 8 2009
Re: K091457
Trade/Device Name: Nexstim eXimia Navigated Brain Stimulation System Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: II Product Code: GWF, HAW, and IKN Dated: November 23, 2009 Received: November 23, 2009
Dear Dr. Nolte:
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.
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.
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. .
1
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Eula Fir, m f
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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Indications for Use Statement
510(k) Number:
Device Name:
Nexstim eXimia Navigated Brain Stimulation System
Indications for Use:
The Nexstim eXimia Navigated Brain Stimulation System (NBS System) is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Kristen Bowsher | |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic, Neurological and Ear, | |
| Nose and Throat Devices |
| 510(k) Number | K091457 |
|---|---|
| --------------- | --------- |
| Prescription Use | (Per 21 CFR 801.109) |
|---|---|
| ------------------ | --------------------------------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |