(155 days)
Not Found
No
The description focuses on the physical components and intended use of an EEG electrode set, with no mention of AI or ML capabilities.
No.
The device is an EEG electrode set, which is used for diagnostic purposes (recording brain activity), not for therapy or treatment.
No
The device is described as an "EEG electrode set" for routine clinical settings, which is used to record brain activity. While this recorded data can be used for diagnosis, the device itself is a tool for data acquisition, not for processing that data into a diagnosis.
No
The device description explicitly details physical components like "Cap fabric," "Electrodes," "Chin-strap," and "Cable bundle(s) with connector(s)," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to record EEG signals in routine clinical settings. This involves measuring electrical activity from the brain, which is a physiological process within the body.
- Device Description: The device is an EEG electrode set, which is a tool used to acquire physiological signals.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. This device does not perform any analysis on specimens outside the body. It directly measures electrical signals from the scalp.
Therefore, this device falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This is an EEG electrode set intended for routine clinical settings where rapid placement of large number or EEG electrodes is desired.
Product codes
GXY
Device Description
WaveGuard caps consist of Cap fabric Electrodes arranged in a certain layout Chin-strap (placed under the chin) Cable bundle(s) with connector(s) The layout of the electrodes depends on the number of electrodes placed in the cap, and may be placed according to the international 10/20, 10/10 or 10/5 percent system, or according an equidistant "Duke" layout. Caps can have different sizes, ranging from neonatal size (23-weeks old) to large adult head-size, spanning a total of 11 different cap sizes.
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
Neonatal size (23-weeks old) to large adult head-size
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)
We performed electrical safety (IEC 60601-1) and biocompatibility testing: Test Report Cytotoxicity, -Proliferation EN ISO 10993-5, -12, Test Report Chemical analysis (characterization of organic leachables) EN ISO 10993-12, -18 and Evaluation Biological safety - toxicology (ISO 10993-1). Usability and risk analysis was also conducted. Electrical specifications were examined and found to be comparable to the predicate. Patient contact materials (silver/silver chloride electrodes) are identical to the predicate. Physical examination demonstrates the connectors comply with the FDA performance standard. A clinical investigation "High-fidelity recording of brain activity in the extremely preterm babies: Feasibility study in the incubator" concluded that all recordings were successful beginning from the very first baby recorded with this cap design.
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
§ 882.1320 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).
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510(k) Summary 510(k) Number K110223
1. Submitter:
eemagine Medical Imaging Solutions GmbH Gubener Strasse 47 10243 Berlin, Germany Phone +49 (0)30 2904 8404 Fax +49 (0)30 2904 8405 Date Prepared: May 24, 2011 Contact: Maarten van de Velde, PhD, Quality Assurance Manager
JUN 2 9 2011
11,2
2. Identification of the Device: Proprietary-Trade Name: WaveGuard™ EEG cap Classification Name: Product Code GXY Common/Usual Name: EEG Electrode Cap
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- Description of the Device: WaveGuard caps consist of Cap fabric Electrodes arranged in a certain layout Chin-strap (placed under the chin) Cable bundle(s) with connector(s) The layout of the electrodes depends on the number of electrodes placed in the cap, and may be placed according to the international 10/20, 10/10 or 10/5 percent system, or according an equidistant "Duke" layout. Caps can have different sizes, ranging from neonatal size (23-weeks old) to large adult head-size, spanning a total of 11 different cap sizes. Here is a list:
| Cap size
indication | Minimum-Maximum
head circumference (cm) | Minimum-Maximum
(inches, approx. values) |
|------------------------|--------------------------------------------|---------------------------------------------|
| Large | 56 - 61 | 22.0" - 24.0" |
| Medium | 51 - 56 | 20.1" - 22.0" |
| Small | 47 - 51 | 18.5" - 20.1" |
| Child | 43 - 47 | 16.9" - 18.5" |
| Infant | 39 - 43 | 15.4" - 16.9" |
| Baby | 36 - 39 | 14.2" - 15.4" |
| Neonatal | 5: 33 - 36 | 13.0" - 14.2" |
| | 4: 31 - 33 | 12.2" - 13.0" |
| | 3: 29 - 31 | 11.4" - 12.2" |
| | 2: 27 - 29 | 10.6" - 11.4" |
| | 1: 25 - 27 | 9.8" - 10.6" |
Available cap sizes
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- Indications for Use (intended use) This is an EEG electrode set intended for routine clinical settings where rapid placement of large number or EEG electrodes is desired.
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- Technological Characteristics: This device has the same technological characteristics (i.e., design, material, chemical composition) as the predicate device. Specifications are nearly identical. The electrodes are made from sintered silver chloride, identical to multiple similar devices used for EEG recording
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- Discussion of the clinical and nonclinical tests in the premarket notification submission for a determination of substantial equivalence: We performed electrical safety (IEC 60601-1) and biocompatibility testing: Test Report Cytotoxicity, -Proliferation EN ISO 10993-5, -12, Test Report Chemical analysis (characterization of organic leachables) EN ISO 10993-12, -18 and Evaluation Biological safety - toxicology (ISO 10993-1). Usability and risk analysis was also conducted. Electrical specifications were examined and found to be comparable to the predicate. Patient contact materials (silver/silver chloride electrodes) are identical to the predicate. Physical examination demonstrates the connectors comply with the FDA performance standard. A clinical investigation "High-fidelity recording of brain activity in the extremely preterm babies: Feasibility study in the incubator" concluded that all recordings were successful beginning from the very first baby recorded with this cap design.
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- Conclusion. Based on the results of the nonclinical tests (that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed devices) we conclude that this device is safe and effective as the predicate identified in paragraph (3). Furthermore, the materials and construction methods are nearly identical to the predicate.
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Image /page/2/Picture/13 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its head turned to the right. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Eemagine Medical Imaging Solutions, GmbH c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates 8870 Ravello Ct Naples, FL 34114
JUN 2 9 2011
Re: K110223
Trade/Device Name: WaveGuard™ EEG Cap Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: June 21, 2011 Received: June 27, 2011
Dear Mr. Kamm:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/Aboutf-DA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Kesia Alexander
Image /page/3/Picture/7 description: The image contains a stylized, cursive signature or symbol. It features a flowing line that begins with a loop at the top left, descends in a curved stroke, and then transitions into a smaller, connected element at the upper right. The overall impression is that of a calligraphic mark, possibly representing initials or a unique design.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K110223
Device Name: WaveGuard™ EEG cap
Indications For Use:
This is an EEG electrode set intended for routine clinical settings where rapid placement of large number or EEG electrodes is desired.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-vitro Diagnostics (OIVD)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110223