(405 days)
Not Found
No
The description focuses on the physical components and function of an electrode cap for EEG, with no mention of AI or ML for data analysis or interpretation.
No
The device is described as an "Electrode Array Cap" intended for "routine clinical settings where rapid placement of large number or EEG electrodes is desired." It's used for positioning electrodes for EEG (Electroencephalography), which is a diagnostic tool to measure brain activity, not to treat a condition. The predicate devices listed are also EEG caps, which are diagnostic devices.
Yes
The device is described as an "electrode placement system for positioning electrodes" compatible with "standard AC/DC EEG amplifiers," intended for "routine clinical settings where rapid placement of large number or EEG electrodes is desired." EEG (electroencephalography) is a diagnostic procedure used to measure electrical activity in the brain, thus the device, by facilitating EEG, is used for diagnostic purposes.
No
The device description explicitly lists hardware components such as an elastic cap, electrode holders, sintered Ag/AgCl electrodes, shielded wires, and a passive memory chip.
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.
- Device Function: The Electrode Arrays Cap is a device used to place electrodes on the head for EEG (Electroencephalography). EEG measures electrical activity in the brain.
- Intended Use: The intended use is for "rapid placement of large number or EEG electrodes." This is a measurement device, not a diagnostic test performed on a sample.
- No Sample Analysis: The description does not mention any analysis of biological samples. The device facilitates the collection of electrical signals from the brain.
Therefore, the Electrode Arrays Cap is a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Electrode Array Cap has the same intended use as the predicate device and is intended for routine clinical settings where rapid placement of large numbers of EEG electrodes is desired.
Indications For Use; The Electrode Arrays Cap is intended for routine clinical settings where rapid placement of large number or EEG electrodes is desired.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The Electrode Array Cap comprises an electrode placement system for positioning electrodes. The density of electrodes will vary, but in general will conform to the 10-20 to 5-5 positioning system (Oostenveld & Praamstra, 2005). The electrode will be compatible with all standard AC/DC EEG amplifiers The Electrode Array Cap will consist of an elastic can, electrode holders, sintered Ag/AgCl electrodes, and shielded wires. The Electrode Array Cap will fit all head shapes and will be comfortable to wear. Shielded wires will terminate into a standardized connector designed. Separate shielded cables, tailored to each amplifier system, will mate with the standardized cap connector. Located in each connector will be a passive memory chip that will read out the serial number and other device information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
routine clinical settings
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
§ 882.1320 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
JUL - 2 2008
510(k) SUMMARY
| Submitted by: | Electrode Arrays
612 N. Resler
El Paso, TX 79912
(915) 760-5253 |
|----------------------|--------------------------------------------------------------------------|
| Contact Person: | Elvira Garcia |
| Date Prepared: | May 22, 2007 |
| Proprietary Name: | Electrode Array Cap |
| Common Name: | Electrode Positioning Cap |
| Classification Name: | Electrode, Metallic with Soft Pad Covering |
| Predicate Device: | Electro-Cap 510(k) K780045
Quik-Cap 510(k) K000865 |
Description of the Device: The Electrode Array Cap comprises an electrode placement system for positioning electrodes. The density of electrodes will vary, but in general will conform to the 10-20 to 5-5 positioning system (Oostenveld & Praamstra, 2005). The electrode will be compatible with all standard AC/DC EEG amplifiers The Electrode Array Cap will consist of an elastic can, electrode holders, sintered Ag/AgCl electrodes, and shielded wires. The Electrode Array Cap will fit all head shapes and will be comfortable to wear. Shielded wires will terminate into a standardized connector designed. Separate shielded cables, tailored to each amplifier system, will mate with the standardized cap connector. Located in each connector will be a passive memory chip that will read out the serial number and other device information.
Intended Use of the Device: The Electrode Array Cap has the same intended use as the predicate device and is intended for routine clinical settings where rapid placement of large numbers of EEG electrodes is desired.
Technological Characteristics: The Electrode Array Cap has the same technological characteristics as the predicate device. The design of the Electrode Array Cap is in conformance with AAMI Standard Specifications for ECG Cables and Leadwires and Other Devices that use Patient Cables. EC53-1995, and the IEC Standard 60601-1 subclause 56.3, (c). The Electrode Array Cap, like the predicate device, consists of a stretchable elastic fabric cap, sintered Ag/AgCl electrodes, in electrode holders and shielded lead wires. The perforations on the cap help in reducing heat on the subject's head. The electrode holder is a 2 part component made of a PVC material. The purpose for the PVC material is to allow the 2 parts to snap together between the fabric. Another characteristic of the Electrode Array Cap is the placement of the electrode lead wires are on the inside of the cap. This allows the cap to slip more casily on the subject' head and gives the technician easy access to the electrodes without the interference of the lead wires.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. (USA)" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The seal is simple and conveys a sense of official authority.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Electrode Arrays % Ms. Elvira Garcia QA/RA Manager 612 North Resler Drive, Suite C El Paso, Texas 79902
JUL - 2 2008
Re: K071446 Trade/Device Name: Electrode Arrays Cap Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: April 4, 2008 Received: April 7, 2008
Dear Ms. Garcia:
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.
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Page 2 - Ms. Elvira Garcia
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 yours,
Mark N. Millison
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name:
Electrode Arrays Cap
Indications For Use; The Electrode Arrays Cap is intended for routine clinical settings where rapid placement of large number or EEG electrodes is desired.
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number
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