(63 days)
No
The summary describes a passive electrode device for recording EEG signals and does not mention any AI/ML processing or analysis of the data.
No
The device is used for recording EEG signals to define the location of epileptogenic foci, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is intended for "intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci," which directly implies its use in diagnosing or localizing a medical condition (epileptic foci).
No
The device description explicitly states it is a physical electrode designed to be placed on the cortical surface of the brain and connected to hospital EEG recording equipment. It also mentions physical testing like MRI compatibility and dimensional performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Auragen™ Cortical Surface Electrodes are designed for the intraoperative recording of EEG signals at the cortical surface of the brain. This involves placing the electrodes directly on or near the brain during surgery to measure electrical activity within the body.
The device is used for in vivo (within the living body) measurement, not in vitro (outside the living body) testing of samples.
N/A
Intended Use / Indications for Use
The cortical surface electrodes are intended for the intraoperative recording of EEG signals at the cortical surface of the brain.
Product codes
GYC
Device Description
The cortical surface electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical electrodes vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested. The Auragen Cortical Electrodes are available with platinum/iridium contacts, with 4 to 64 contacts. The electrodes are connected to Integra recording cables themselves connected to the hospital EEG recording equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cortical surface of the brain
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)
An array of cortical electrodes were subjected to MRI testing, which included radio frequency induced heating, magnetically induced displacement force and torque. MR imaging artifacts were assessed and the artifacts that appeared were shown as localized signal voids that were considered small in size in relation to the size and shape of the product. Results of the testing supports a "MR Conditional" labeling claim as defined in ASTM F 2503-05, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. The cortical electrodes are provided sterile and are non-pyrogenic. The cortical electrodes have been tested for dimensional, physical and electrical performance and meet the defined requirements of the products specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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KOT2STO
OCT 1 0 2008
Auragen™ Cortical Surface Electrodes 510(k) SUMMARY
Submitter's name and address:
Integra NeuroSciences Implants SA 2905 Route des Dolines 06921 Sophia Antipolis Cedex, France
Contact person and telephone number:
Anne Bigeard, Regulatory Affairs Manager Telephone: +33 (0)4 93 95 5667 Facsimile: +33 (0)4 93 65 4030
Date summary was prepared:
September 22, 2008
Name of the device:
| Proprietary Name: | Cortical Surface Epilepsy Electrode |
|---|---|
| Common Name: | Cortical Electrodes |
| Classification Name: | Cortical Electrodes, GYC |
Substantial Equivalence:
The modified cortical surface electrodes are substantially equivalent to the cortical surface electrodes cleared by the FDA under 510(k) (K926424). The design, intended use, materials of composition, functional/performance specifications, manufacturing process are equivalent to the previously cleared cortical surface electrodes.
Intended use:
The cortical surface electrodes are intended for the intraoperative recording of EEG signals at the cortical surface of the brain.
Device Description:
The cortical surface electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical electrodes vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested. The Auragen Cortical Electrodes are available with platinum/iridium contacts, with 4 to 64 contacts. The electrodes are connected to Integra recording cables themselves connected to the hospital EEG recording equipment.
Safety and Effectiveness:
An array of cortical electrodes were subjected to MRI testing, which included radio frequency induced heating, magnetically induced displacement force and torque. MR imaging artifacts were assessed and the artifacts that appeared were shown as localized signal voids that were considered small in size in relation to the size and shape of the product. Results of the testing supports a "MR
1
Conditional" labeling claim as defined in ASTM F 2503-05, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. The cortical electrodes are provided sterile and are non-pyrogenic. The cortical electrodes have been tested for dimensional, physical and electrical performance and meet the defined requirements of the products specification.
Conclusion :
The modified cortical electrodes defined in this submission are substantially equivalent to the unmodified cortical electrodes cleared by the FDA under 510(k) (K926424). The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is rendered in black and white, giving it a formal and official appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Integra Neurosciences % Integra Lifesciences Corporation Mr. Jon Caparotta Director, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536
OCT 1 0 2008
Re: K082250
Trade/Device Name: Auragen Cortical Surface Electrodes Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: September 22, 2008 Received: September 23, 2008
Dear Mr. Caparotta:
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
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Page 2 - Mr. Jon Caparotta
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.
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Survcillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Mark N Wilkinson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name: Auragen™ Strip and Grid Electrodes
Indications For Use:
The Auragen™ Cortical Surface Electrodes are intended for the intraoperative recording of EEG signals at the cortical surface of the brain.
AND/OR Over-The-Counter Use Prescription Use x (Part 21 CFR 801 Subpart D) (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)
ই
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number 1