(269 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 for data analysis or interpretation.
No
The device is described as an EEG electrode set intended for routine clinical settings for rapid placement of EEG electrodes, and its function is to acquire EEG signals, not to treat a condition.
Yes
Explanation: The device is an EEG electrode set, and EEG (electroencephalography) is a diagnostic procedure used to record brain activity to diagnose neurological conditions.
No
The device description clearly outlines physical components like electrodes, a chin-strap, cable bundles, and caps of different sizes, 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 for "routine clinical settings where rapid placement of a large number of EEG electrodes is desired." This describes a device used to acquire physiological signals (brain activity) from a patient.
- Device Description: The description details an "EEG electrode set" and "EEG cap" designed to be placed on the head to pick up electrical signals.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze such specimens. It is a medical device used for signal acquisition.
Therefore, the WaveGuard™ Net EEG cap is a medical device used for electroencephalography (EEG), which is a method of recording electrical activity of the brain. It is 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. Patient population from infants up to any age.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
WaveGuard™ Net EEG cap consists of Saline-based EEG electrolyte- soaked sponge electrodes made of PU substrate plated with Ag and arranged in 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 10/10, 10/20 or 10/5 percent system, or according an equidistant "Duke" layout. Caps can have different sizes, ranging from baby to large adult head-size, spanning a total of 6 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
Patient population from infants up to any age.
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)
Non-clinical testing was performed based on 21 CFR PART 898—Performance Standard for Electrode Lead wires and Patient Cables and FDA recognized standards for Biocompatibility (ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-12:2012, ISO 10993-17:2023, ISO 10993-18: 2020, ISO 10993-23:2021). The results demonstrate that the device is as safe, effective, and performs as well as the current legally marketed device.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 25, 2024
eemagine Medical Imaging Solutions GmbH Dana Coggin Consultant Quality and Regulatory Help, LLC. 115 Reeder St Tillamook, Oregon 97141
Re: K240575
Trade/Device Name: WaveGuard Net EEG Cap (NA-245, NA-261, NA-261, NA-265, NA-271, NA-281) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: October 11, 2024 Received: October 11, 2024
Dear Dana Coggin:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
WaveGuard Net EEG Cap (NA-245, NA-261, NA-261, NA-265, NA-271, NA-281)
Indications for Use (Describe)
This is an EEG electrode set intended for routine clinical settings where rapid placement of a large number of EEG electrodes is desired.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K240575
WaveGuard™ Net EEG cap - 510(K) Summary
prepared in accordance with 21 CFR 807.92
- I. SUBMITTER:
| Submitter name and address: | eemagine Medical Imaging Solutions GmbH
Gubener Strasse 47
10243 Berlin, Germany
Phone +49 (0)30 2904 8404
Fax +49 (0)30 2904 8405 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact information: | Maarten van de Velde, PhD, Quality Assurance Manager
Email: mvelde@ant-neuro.com
Phone +49 (0)30 2904 8404 |
II. DEVICE INFORMATION:
| Common name: | EEG Electrode cap |
|---|---|
| Proprietary-Trade Name(s): | WaveGuard™ Net EEG cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) |
| Classification: | Class II |
| Product Code: | GXY |
| Common / Usual Name: | EEG Electrode Cap |
| 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. Patient population from infants up to any | |
| age. | |
| III. PREDICATE DEVICE: | |
| Predicate Device: | WaveGuard™ EEG cap K110223 |
| Class II | |
| Product code: | GXY |
June 29, 2011
IV. DEVICE DESCRIPTION:
Clearance date:
WaveGuard™ Net EEG cap consists of Saline-based EEG electrolyte- soaked sponge electrodes made of PU substrate plated with Ag and arranged in 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 10/10, 10/20 or 10/5 percent system, or according an equidistant "Duke" layout. Caps can have different sizes, ranging from baby to large adult head-size, spanning a total of 6 different cap sizes.
V. INDICATIONS FOR USE
5
This is an EEG electrode set intended for routine clinical settings where rapid placement of large number or EEG electrodes is desired. Patient population is intended to be used from infants up to any age .
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following table is a comparison of the technological characteristics between the Modified and Predicate Device:
| Characteristic | WaveGuard™ EEG Cap
K110223 (predicate) | WaveGuard™ Net EEG Cap
K240575 (modified) |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GXY | GXY |
| Regulation Number | 882.1320 | 882.1320 |
| Classification Name | Electrode, Cutaneous | Electrode, Cutaneous |
| Manufacturer | eemagine Medical Imaging
Solutions GmbH | eemagine Medical Imaging
Solutions GmbH |
| Intended use and indications for
use | The WaveGuard™ EEG Cap is an
EEG Electrode set intended for
routine clinical settings where
rapid placement of a large
number of EEG electrodes is
desired.
Patient population from 23
weeks (gestational age) to old-
age (no limit). | The WaveGuard™ EEG Cap is an
EEG Electrode set intended for
routine clinical settings where
rapid placement of a large
number of EEG electrodes is
desired.
Patient population from infant
(29 days) up to any age. |
| Electrode Material and Housing | Sintered Ag/AgCl on
Polyurethane (PU) | Coated Ag on Polyurethane (PU) |
| Cap material | Lycra | Silicone Mesh |
| Cap Sizes | Adult Large 56-62 cm
Adult Medium 52-57 cm
Adult Small 47-53 cm
Child 42-48 cm
Infant 38-44 cm
Baby 35-39 cm
Neonate 5: 33-36 cm
Neonate 4: 31-33 cm
Neonate 3: 29-31 cm
Neonate 2: 27-29 cm
Neonate 1: 25-27 cm | Adult Large 56-61 cm
Adult Medium 51-56 cm
Adult Small 47-51 cm
Child 43-47 cm
Infant 39-43 cm
Baby* 36-39 cm
- not an indication of the patient
age. |
| Performance standard | 21 CFR PART 898— Performance
Standard for Electrode Lead
wires and Patient Cables. | 21 CFR PART 898— Performance
Standard for Electrode Lead
wires and Patient Cables. |
6
| Electrode Placement | 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. | 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. |
|---|---|---|
| Magnetic Resonance | ||
| Connector | MR safe, WaveGuard MRI cap | |
| Hirose high-density connector, DC37 or DB25 connector, or other standard connectors as available on EEG amplifiers | MR unsafe | |
| Additional standard EEG adapters compatible with the eego EE-2xx and EE-5xx range of amplifiers. No significant difference with existing adapter(s). | ||
| Accessory | Conductive Electrode Gel | Saline soaked |
| Re-use | Reusable after cleaning | Reusable after cleaning |
VII. PERFORMANCE DATA / SUMMARY OF NON-CLINICAL TESTING
21 CFR PART 898—Performance Standard for Electrode Lead wires and Patient Cables. Biocompatibility testing was completed to the FDA recognized standards:
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: valuation within a risk management process
- ISO 10993-5:2009, In vitro cytotoxicity
- ISO 10993-10:2021, Sensitization
- ISO 10993-12:2012, Sample preparation and reference materials
- ISO 10993-17:2023, Allowable limits for leachable substances
- ISO 10993-18: 2020, Chemical characterization
- ISO 10993-23:2021, Irritation
VIII. CONCLUSIONS
Based on the results of the non-clinical tests conducted which demonstrate that the device is as safe, effective, and performs as well as the current legally marketed device, we conclude that this device is safe and as effective as the predicate.