(455 days)
No
The summary describes electrodes for recording electrical signals, which are passive devices, and there is no mention of AI/ML in the text, including the specific "Mentions AI, DNN, or ML" field.
No
The device is indicated for intraoperative recording of electrical signals for epilepsy monitoring, which is a diagnostic function, not a therapeutic one.
Yes
The device is indicated for "intraoperative recording of electrical signals for epilepsy monitoring," which is a diagnostic activity to assess and understand a patient's electrical brain activity related to epilepsy.
No
The device description explicitly states it is an electrode, which is a hardware component used for recording electrical signals.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intraoperative recording of electrical signals for epilepsy monitoring at the surface levels of the brain." This describes a device used in vivo (within the body) to measure electrical activity directly from the brain.
- Device Description: The description reinforces this by stating the electrodes are used for "intraoperative recording of electrical signals for epilepsy monitoring at the surface and subsurface levels of the brain."
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve the examination of specimens in vitro.
The device is clearly designed for direct measurement of physiological signals within the patient's body during surgery.
N/A
Intended Use / Indications for Use
Radionics Epidural Peg, Sphenoidal and Foramen Ovale Depth Electrodes are intended for intraoperative recording of electrical signals for epilepsy monitoring at the surface and subsurface levels of the brain.
Product codes
84GYC, 84GZL
Device Description
The Epidural Peg, Sphenoidal, and Foramen Ovale Depth Electrodes addressed in this PMN have similar intended uses, materials, technological characteristics, sterilization procedures, and packaging as the commercially available Radionics Cortical Surface and Depth Electrodes (K926424). These electrodes are used for intraoperative recording of electrical signals for epilepsy monitoring at the surface and subsurface levels of the brain.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain (surface and subsurface levels)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
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).
0
Appendix A:
AUG 1 8 1007 Summary of Safety and Effectiveness General Information I. Cortical Surface and Depth Electrodes Common Name: Epidural Peg Electrode (EP), Sphenoidal Device Trade Name: Electrode (EDS) and Foramen Ovale Depth Electrode (ED-FO) for Epilepsy Monitoring Classification: Class II 882.1310 Cortical Electrode 882.1330 Depth Electrode Radionics Epidural Peg. Sphenoidal and Intended Use: Foramen Ovale Depth Electrodes are intended for intraoperative recording of electrical signals for epilepsy monitoring at the surface and subsurface levels of the brain. Predicate Device: Radionics Cortical Surface & Depth Electrodes (K926424). Radionics, Inc. Manufacturing Facility Address: 76 Cambridge St. Burlington, MA 01803 No applicable performance standards have Performance Standard: been issued under section 514 of the Food, Drug, and Cosmetic Act. Establishment Registration Number: 1219140 84GYC & 84GZL/Neurology Product Code/Classification Panel: Amy J. LaForte, Ph.D., (617) 272-1233 Contact Name and Address: Radionics, Inc. 22 Terry Ave. Burlington, MA 01803
II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
A summary of the information contined in this PMN that addresses safety and effectivness follows.
General Safety and Effectiveness Concerns
Radionics Epidural Peg, Sphenoidal, and Foarmen Ovale Depth Electrodes labeling contains instructions for the proper use of this product. It includes a description of the product, directions for use, and applicable safety information. These instructions ensure
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safe and effective use of the device when followed by the physician.
Description of the Device and Basis for Substantial Equivalence
The Epidural Peg, Sphenoidal, and Foramen Ovale Depth Electrodes addressed in this PMN have similar intended uses, materials, technological characteristics, sterilization procedures, and packaging as the commercially available Radionics Cortical Surface and Depth Electrodes (K926424). These electrodes are used for intraoperative recording of electrical signals for epilepsy monitoring at the surface and subsurface levels of the brain.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1997
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Amy J. LaForte, Ph.D. Manager Regulatory Submissions ... ... Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803-2516
Re: K961942 Trade Name: Radionics Epidural Peq, Sphenoidal, and Foramen Ovale Electrodes Regulatory Class: İI Product Code: 84GYC and 84GZL Dated: June 30, 1997 Received: July 2, 1997
Dear Dr. LaForte:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR fart 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Amy J. LaForte, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "dsmo@fdadr.cdrh.fda.gov".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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electrode
Indications for Use
Radionics Epidural Peg, Sphenoidal and Foramen Ovale Depth Electrodes are indicated for
intraoperative recording of electrical signals for epilepsy monitoring at the surface levels of the brain.
Prescription Use (Per 21 CFR 801.109)
(Division Sign-OM) Division of Cardiov and Neurological D 510(k) Numb