(140 days)
No
The device description focuses solely on the physical components and materials of surface electrodes for EEG/EP recording, with no mention of data processing, analysis, or algorithms that would typically involve AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as an electrode system for recording and monitoring electroencephalography (EEG) and evoked potential (EP), which are diagnostic processes, not therapeutic treatments.
Yes
Explanation: The device is intended for "recording and monitoring of the electroencephalography (EEG), evoked potential (EP)". EEG and EP recordings are used to diagnose neurological conditions.
No
The device description explicitly details physical components such as electrodes made of various materials (gold, silver, conductive plastic, Ag-Ag/Cl), lead wires, heat-shrink tubes, and connectors. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a surface electrode system applied to the patient's skin to record electrical activity (EEG and EP). It is used on the patient, not to analyze a sample from the patient.
The description clearly states the device is applied to the "surface of the patient's skin" and is used for "recording and monitoring" of electrical signals. This aligns with the definition of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The cutaneous, surface electrode system is intended for use for the recording and monitoring of the electroencephalography (EEG), evoked potential (EP) and the ground and reference associated with these recordings.
Product codes
GXY
Device Description
The cutaneous surface electrode (GCE, SCE, SCE, SCE' and CPES) are electrodes that are all applied to the surface of the patient's skin, they are non-invasive. These electrodes are used for the recording of electroencephalography (EEG), evoked potential (EP) as well as the ground and reference associated with the recording. They consist of a disc or cup made from a variety of materials, which include, gold, silver, conductive plastic, Ag-Ag/Cl, that have long been used for this intended purpose throughout the industry. The recording disc is permanently connected to a lead wire. This joint is then covered in a heat-shrink tube so as not to allow exposed lead wires and also to provide a strain relief. The lead wires are insulated with a Teflon insulation or equivalent. The lead wires are short and terminate in a small mass connector than conforms to DIN 42-802 for electrical safety. This small mass connector mates with a harness system as per K062880 (an Ives EEG Solutions 510K describing a Subdermal Wire Electrode System) which connects to the EEG recording instrument using molded "touch-proof" connectors which also conform to DIN 42-802.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surface of the patient's skin
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)
marketed before 1974, K032278, K022197
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
5. 510(k) Summary
EEG Surface Electrode System
| SEP - 7 2007 | ||||
|---|---|---|---|---|
| Company Name: | Ives EEG Solutions, Inc. | |||
| Contact: | ||||
| Phone: | ||||
| Fax: | ||||
| Email: | Mr. John Ives | |||
| 613-692-1567 | ||||
| 613-692-1567 | ||||
| jives@uwo.ca | ||||
| Summary Date: | April 12, 2007 | |||
| Trade Name: | EEG Surface Electrode System | |||
| Model Number: | GCE, SCES, SCES and CPES | |||
| Common Name: | Surface Electrode, Cutaneous electrode | |||
| Classification Name: 21 CFR 882.1350, Cutaneous Electrode GXY | ||||
| Main Predicate | ||||
| Device: | 510(k) Number: | |||
| Manufacture: | ||||
| Trade Name: | ||||
| Product Code: | marketed before 1974 (see note below) | |||
| Grass Instruments, Inc, Quincy, MA | ||||
| Surface EEG Electrode | ||||
| GXY | ||||
| Other Predicate | ||||
| Devices: | 510(k) Number: | |||
| Manufacture: | ||||
| Trade Name: | ||||
| Product Code: | K032278 | |||
| AMBU, Inc. | ||||
| EEG/EP Cup Electrode | ||||
| GXY | ||||
| 510(k) Number: | ||||
| Manufacture: | ||||
| Trade Name: | ||||
| Product Code: | K022197 | |||
| The Electrode Store | ||||
| Cutaneous Electrode | ||||
| GXY |
Description of Electrodes
The cutaneous surface electrode (GCE, SCE, SCE, SCE' and CPES) are electrodes that are all applied to the surface of the patient's skin, they are non-invasive. These electrodes are used for the recording of electroencephalography (EEG), evoked potential (EP) as well as the ground and reference associated with the recording. They consist of a disc or cup made from a variety of materials, which include, gold, silver, conductive plastic, Ag-Ag/Cl, that have long been used for this intended purpose throughout the industry. The recording disc is permanently connected to a lead wire. This joint is then covered in a heat-shrink tube so as not to allow exposed lead wires and also to provide a strain relief. The lead wires are insulated with a Teflon insulation or equivalent. The lead wires are
1
short and terminate in a small mass connector than conforms to DIN 42-802 for electrical safety. This small mass connector mates with a harness system as per K062880 (an Ives EEG Solutions 510K describing a Subdermal Wire Electrode System) which connects to the EEG recording instrument using molded "touch-proof" connectors which also conform to DIN 42-802.
Intended Use of Electrodes
The cutaneous, surface electrode system is intended for use for the recording and monitoring of the electroencephalography (EEG), evoked potential (EP) and the ground and reference associated with these recordings.
NOTE: Mr. Albert Grass began marketing EEG electrodes for general use when he established his company (Grass Instruments, Inc. Quincy, MA) in 1935. These cutaneous, surface cup electrodes have been continuously marketed under the Grass name by Astro-Med, Inc., West Warwick, RI. Advertising for these electrodes can be seen in copies of the Journal of Clinical Neurophysiology from 1949 to 1974 as well as in the early publications of the American Journal of Electroneurodiagnostic Technology.
2
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ives EEG Solutions, Inc % Mr. John Ives President 6325 Rideau Valley Drive Manotick, Ontario Canada, K4M 1B3
SEP - 7 2007
Re: K071118
Trade/Device Name: EEG Surface Electrode System Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: August 28, 2007 Received: September 4, 2007
Dear Mr. Ives:
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
3
Page 2 – Mr. John Ives
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 Surveillance at 240-276-3474. For questions regarding the reporting 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 you
sincerely yours,
for Pete D. Rumm
OEP
8/7/07
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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4. Indications for Use
510(k) Number:
Device Name:
EEG Surface Electrode System
The cutaneous, surface cup electrode system is intended Indications for Use: for use in the general recording and monitoring of the electroencephalography (EEG), evoked potential (EP) as well as ground and reference related to the EEG and EP recording.
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
Pedro Lumino mo
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number 4071118