(76 days)
Not Found
No
The device description explicitly states that the electrodes do not contain active electronics or software, and there are no mentions of AI, DNN, or ML in the provided text.
No.
The device is used for stimulating and recording brain activity, which are diagnostic/monitoring functions, not therapeutic.
Yes
The device is described as supporting "recording the brain's electrical activity," which implies gathering information to aid in diagnosis.
No
The device description explicitly states "These electrodes do not contain active electronics or software." and describes a physical electrode device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Nicolet Subdural Strip Electrodes are used to directly stimulate or record electrical activity on the surface of the brain or in the subdural space. This is an in vivo (within the living body) procedure, not an in vitro test on a sample.
- Intended Use: The intended use clearly states the device is placed on the surface of the brain or subdural space for stimulation and recording of electrical activity. This is a direct interaction with the patient's body.
Therefore, the function and intended use of this device fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Nicolet Subdural Strip Electrodes can be temporally placed on the surface of the brain or subdural space in support of stimulating the brain or recording the brain's electrical activity.
Product codes (comma separated list FDA assigned to the subject device)
GYC
Device Description
Subdural Strip Electrodes are used by licensed medical professionals to support stimulation and recording of biopotentials from the surface of the brain or the subdural space above the surface of the brain. The electrodes connect to medical equipment in support of stimulation and recording.
The electrodes are provided to the user sterile. The electrodes are single patient use, disposable devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surface of the brain or the subdural space above the surface of the brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed medical professionals
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): 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.
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
§ 882.1310 Cortical electrode.
(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).
0
JUN 2 4 2002
Image /page/0/Picture/1 description: The image shows the logo for Nicolet Biomedical. The word "Nicolet" is in a large, bold, serif font. Below the word "Nicolet" is a thick, black line. Below the line, the word "BIOMEDICAL" is in a smaller, sans-serif font, with a large space between each letter.
Image /page/0/Picture/2 description: The image contains a handwritten string of characters. The string appears to be "Ko21144". The characters are written in a simple, slightly slanted style, with varying stroke thicknesses. The writing is clear and legible against the plain background.
Summary of Safety and Effectiveness
| Company Name: | Nicolet Biomedical
5225 Verona Road
Madison, WI 53711 | |
|----------------------------|-------------------------------------------------------------------------------------------|--|
| Contact:
Phone:
Fax: | Glen Hermanson, Manager of Standards and Compliance
608 441-2065
608 441-2007 | |
| Summary Date: | April 3, 2002 | |
| Trade Name: | Subdural Strip Electrodes | |
| Common Name: | Cortical Electrode | |
| Classification Name: | 21 CFR 882.1310; Product Code: GYC | |
| Predicate Device: | 510(k) Number: K970587, K923803, K850342
Manufacture: Ad-Tech Medical Instrument Corp. | |
Trade Name:
1.0 Description of Device
Subdural Strip Electrodes are used by licensed medical professionals to support stimulation and recording of biopotentials from the surface of the brain or the subdural space above the surface of the brain. The electrodes connect to medical equipment in support of stimulation and recording.
Subdural Electrode
The electrodes are provided to the user sterile. The electrodes are single patient use, disposable devices.
1
2.0 Intended Use
The intended use of the Nicolet Subdural Strip Electrodes is the same as the predicate electrodes. The Nicolet Subdural Strip Electrodes can be temporally placed on the surface of the brain or subdural space in support of stimulating the brain or recording the brain's electrical activity.
3.0 Technological
The Subdural Strip Electrodes are made from the same materials as the predicate devices. The electrode lead wires terminate in a safety connector, complying with the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898.
These electrodes do not contain active electronics or software. The electrodes connect to the user's medical equipment.
4.0 Conclusions
The intended use and technology of the Nicolet Subdural Strip Electrodes is substantially equivalent to the predicate electrodes. No new questions of safety or effectiveness are raised.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol composed of three parallel, curved lines that resemble a stylized caduceus without the snake.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2002
Nicolet Biomedical, Inc. c/o Mr. Gary Syring Ouality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589
Re: K021144
Trade/Device Name: Nicolet Biomedical/Subdural Strip Electrode Regulation Number: 882.1310 Regulation Name: Cortical Electrode Regulatory Class: II Product Code: GYC Dated: April 5, 2002 Received: April 9, 2002
Dear Mr. Syring:
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 such 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); 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.
3
Page 2 - Mr. Gary Syring
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Sincerely yours,
Mark A. Mikkelson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
The Nicolet Subdural Strip Electrodes can be temporarily placed on the surface of the brain or subdural space in support of stimulating the brain or recording the brain's electrical activity.
(PLEASE: DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K021144
(Optional Format 3-10-98)