(324 days)
Not Found
No
The device is an electroconductive paste, a passive material used to improve signal recording. The description focuses on its physical and electrical properties, biocompatibility, and performance as a conductor, with no mention of data processing, analysis, or algorithmic functions that would involve AI/ML.
No.
This device is an electroconductive paste used as a conductor for EEG recordings and explicitly states its purpose is to "amplify the electrical signal and thereby improves the electrophysiological recording," rather than to treat or diagnose a disease or condition.
Yes
EEG-acp is intended for use in clinical and research EEG recordings, which contribute to the diagnosis by providing electrical signals from the brain. The device acts as a conductor to facilitate better recording of these signals, which are then used by professionals for diagnostic purposes.
No
The device is a physical substance (paste) intended for use as a conductor, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "clinical and research EEG recordings from humans." This involves measuring electrical activity from the body (in vivo), not analyzing samples taken from the body (in vitro).
- Mechanism of Action: The device acts as an "electroconductive paste" to "reduce impedance between the electrode surface and the skin" and "facilitates better recording of the signal." This is a physical function to improve the quality of an electrical measurement, not a diagnostic test performed on a sample.
- No Mention of Samples: The description focuses on application to the scalp and interaction with electrodes, not the analysis of blood, urine, tissue, or other biological samples typically associated with IVDs.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This EEG adhesive conductive paste does not fit that definition.
N/A
Intended Use / Indications for Use
EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp.
Product codes (comma separated list FDA assigned to the subject device)
GYB
Device Description
EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans (from the age of 2) under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp. It acts as a conductor between the scalp and the cup electrodes to reduce impedance between the electrode surface and the skin. The reduction in impedance facilitates better recording of the signal. It is intended to be used for up to 10 hours after application to healthy, intact skin. After drying, it is self-adhesive and can be washed off with water.
The cream is provided non-sterile and in a 100g aluminum tube. It is white and has no adverse smell. Its texture is smooth and creamy directly after withdrawal from the tube, and solid after drying.
EEG-acp is intended to be used as an electroconductive medium between the electrode and the patient's skin, i.e., it amplifies the electrical signal and thereby improves the electrophysiological recording. The high salt content of the cream is responsible for its conductive properties. Its impedance is -1.9 kΩ and its conductivity is 20 mS/cm.
The cream consists of the following substances: Allantoin, Bentonite, Glycerin, Lactate, Panthenol, PEG-40, Phenoxyethanol, Polyquaternium-10, Sodium Chloride, Sodium Hydroxide, Skin protection solution, Talcum, Water, Zinc oxide.
Ingredients such as Allantoin, Polyquaternium-10 and Panthenol are used in a large variety of pharmaceutical and cosmetical drugs for skin care/protection and healing. In the EEG-acp these ingredients are included to reduce the occurrence and severity of occasionally occurring adverse effects such as itching, skin irritation and hypersensitive skin reactions and thereby improve the cream's safety. The pH (6-7.5) is adjusted to a more skin-neutral pH, contributing to a less stressful application to the skin.
The shelf life of EEG-acp is two years if stored at a cool place (59 to 86 F) and protected from sunlight. During this period, it will not crystallize, flocculate, nor change its color or smell.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp
Indicated Patient Age Range
from the age of 2 (children older than 2 years and adults)
Intended User / Care Setting
clinical and research EEG recordings from humans under professional guidance.
Trained medical personnel
Electrophysiological
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)
- Biocompatibility:
- Study Type: Biocompatibility evaluation in accordance with ISO 10993-1:2018.
- Tests performed:
- ISO 10993-5: Cytotoxicity invitro Skin Irritation (Human Skin Model Test).
- ISO 10993-10: Acute Dermal Irritation/Corrosion, Irritation/Skin Sensitization, Guinea Pig Maximization Test.
- Key Results: The cream has contact with intact skin for
§ 882.1275 Electroconductive media.
(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
June 21, 2022
SOMNOmedics GmbH Timo Gehring Regulatory Affairs Manager Am Sonnenstuhl 63 Randersacker, 97236 Germany
Re: K212325
Trade/Device Name: EEG-acp Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive media Regulatory Class: Class II Product Code: GYB
Dear Timo Gehring:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 15, 2022. Specifically, FDA is updating this SE Letter to reflect an administrative error made in the 510(k) Summary.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Heather Dean, OHT5: Office of Neurological and Physical Medicine Devices, 240-402-9874, Heather.Dean@fda.hhs.gov.
Sincerelv.
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
1
Image /page/1/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, with the letters "FDA" in a blue box. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 15, 2022
SOMNOmedics GmbH Timo Gehring Regulatory Affairs Manager Am Sonnenstuhl 63 Randersacker, 97236 Germanv
Re: K212325
Trade/Device Name: EEG-acp Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive media Regulatory Class: Class II Product Code: GYB Dated: June 8, 2022 Received: June 13, 2022
Dear Timo Gehring:
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. 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 located 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.
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
2
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
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
510(k) Number (if known) K212325
Device Name EEG-acp
Indications for Use (Describe)
EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp.
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
EEG-acp Electrode Cream (K212325)
Image /page/4/Picture/1 description: The image contains the logo for SOMNOmedics. The logo consists of a stylized waveform graphic on the left, followed by the word "SOMNO" in a bold, sans-serif font. Below "SOMNO", the word "medics" is written in a smaller, italicized font. A horizontal line extends from the waveform graphic to underline the word "SOMNO".
510(K) SUMMARY
| Manufacturer's Name: | SOMNOmedics GmbH |
|---|---|
| Am Sonnenstuhl 63 | |
| 97236 Randersacker, Germany | |
| Official Correspondent: | Dr. Marc Paul |
| Regulatory Affairs | |
| Telephone Number: | +49 931 359094-0 |
| Fax Number: | +49 931 359094-49 |
| Date of preparation: | July 23, 2021 |
| Proprietary Name: | EEG-acp |
| Common Name | Electrode cream |
| Classification Name: | Electroconductive Media (21 CFR 882.1275, Product Code GYB) |
| Device Class: | Class II |
| Product Code: | GYB |
| Classification Regulation: | 21 CFR 882.1275 Electroconductive Media |
| Predicate Device: | SAC2 – Electrode cream (K192606) |
Device description
EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans (from the age of 2) under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp. It acts as a conductor between the scalp and the cup electrodes to reduce impedance between the electrode surface and the skin. The reduction in impedance facilitates better recording of the signal. It is intended to be used for up to 10 hours after application to healthy, intact skin. After drying, it is self-adhesive and can be washed off with water.
The cream is provided non-sterile and in a 100g aluminum tube. It is white and has no adverse smell. Its texture is smooth and creamy directly after withdrawal from the tube, and solid after drying.
EEG-acp is intended to be used as an electroconductive medium between the electrode and the patient's skin, i.e., it amplifies the electrical signal and thereby improves the electrophysiological recording. The high salt content of the cream is responsible for its conductive properties. Its impedance is -1.9 kΩ and its conductivity is 20 mS/cm.
The cream consists of the following substances:
5
EEG-acp Electrode Cream (K212325)
Image /page/5/Picture/1 description: The image shows the logo for SOMNOmedics. The logo consists of a stylized waveform on the left, followed by the word "SOMNO" in a larger, bolder font. Below "SOMNO" is the word "medics" in a smaller, lighter font. A horizontal line extends from the waveform to underline the word "SOMNO."
Allantoin, Bentonite, Glycerin, Lactate, Panthenol, PEG-40, Phenoxyethanol, Polyquaternium-10, Sodium Chloride, Sodium Hydroxide, Skin protection solution, Talcum, Water, Zinc oxide
Ingredients such as Allantoin, Polyquaternium-10 and Panthenol are used in a large variety of pharmaceutical and cosmetical drugs for skin care/protection and healing. In the EEG-acp these ingredients are included to reduce the occurrence and severity of occasionally occurring adverse effects such as itching, skin irritation and hypersensitive skin reactions and thereby improve the cream's safety. The pH (6-7.5) is adjusted to a more skin-neutral pH, contributing to a less stressful application to the skin.
The shelf life of EEG-acp is two years if stored at a cool place (59 to 86 F) and protected from sunlight. During this period, it will not crystallize, flocculate, nor change its color or smell.
Indications for use
EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans under professional quidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp.
Technological characteristics
Technical properties are substantially equivalent between the subject and predicate device. Both creams are provided non-sterile and are salt-based, non-irritating and non-toxic. They become adhesive and form a solid connection between the electrode and the skin after drying.
EEG-acp and SAC2 are conductive creams provided in 100g aluminum tubes.
Both devices are water-based, use salts as conductive material (SAC2 contains additionally KCI), contain preservatives and thickening agents. There is no permissible exposure limit (PEL) for either of the devices.
The subject device contains additional ingredients such as Allantoin and Dexpanthenol. All of these substances are employed in a large variety of pharmaceutical drugs and cosmetical products for skin care, skin protection and healing. In the subject device, these ingredients are included to reduce the frequency and severity of occasionally occurring adverse effects such as itching, skin irritation and hypersensitive skin reactions and thereby improve the cream's safety.
Impedance and conductivity as the most relevant performance characteristics of the proposed intended use of EEG-acp are equivalent for SAC2 and EEG-acp. The pH of the predicate device is alkaline, whereas the subject device's pH is acidic to neutral. Acidic skin care products are considered to be preferable for patients with skin diseases because of their favorable tolerability profile and bacteria regulating properties (Schmid-Wendner and Korting, 2006)'. The pH difference has therefore no impact on the safety and the effectiveness of the subject device and does not raise any new concerns.
6
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Image /page/6/Figure/1 description: The image shows the word "SOMNO" vertically stacked on top of the word "medics". The two words are separated by a thin vertical line. Below the words is a line graph that has a few horizontal and vertical lines.
Substantial Equivalenc
EEG-acp is equivalent to the predicate device as presented in table
EC-acp equivalent to the as presented in tale 6-1.
has ben shown in the firences belven EE-scranit is prolisel device SAC2 do not rais
onems regarding the sfecivenes of EE-a
| Trade name | Manufacturer | 510(k) number | Product code | Regulation name | Regulation number | Indications for use | Use
environment | Intended user | Intended patient population | Discussion of differences |
|-------------------------------------|--------------------|---------------|--------------|-------------------------|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|---------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EEG-acp
(new device) | SOMNOmedics GmbH | K212325 | GYB | Electroconductive Media | 882.1275 | EEG adhesive conductive paste
(hereafter EEG-acp) is intended for use
in clinical and research EEG recordings
under professional guidance. EEG-acp
is an electroconductive paste which
should be used in combination with EEG
cup electrodes on scalp. | Electrophysiological | Trained medical personnel | Adults and children older than 2 years | |
| SAC2 Electrode Cream
(predicate) | Spes Medica S.r.l. | K192606 | GYB | Electroconductive Media | 882.1275 | SAC2 is intended for use in clinical
and research EEG/EP recordings
from humans. It is used with external
electrodes as the conductor between
the scalp and recessed electrodes to
reduce impedance between the
electrode surface and the skin. | Electrophysiological | Neurologists | Adults and children | |
| | | | | | | | | | | Same as predicate device |
| | | | | | | | | | | Same as predicate device |
| | | | | | | | | | | The indications for use are in principle the
same as for the predicate device.
EEG-acp specifies the exact type of
electrodes ("cup electrodes" instead of more
generally "recessed electrodes") and the
predicate allows also its use for EP recordings. |
| | | | | | | | | | | Same as predicate device |
| | | | | | | | | | | Intended users of EEG-acp are stated in more
general terms than the predicate device. This
is acceptable because electrodes are typically
not only applied by the neurologist, but also
their medical staff, if they are trained
accordingly. No new questions of safety or
effectiveness are raised. |
| | | | | | | | | | | The device is intended for children older than
2 years as a precaution to protect the sensitive |
7
EEG-acp Electrode Cream (K212325
Image /page/7/Picture/1 description: The image shows the word "SOMNO" stacked vertically on top of the word "medics". A vertical line separates the two words. Below the words is a line graph that shows a series of peaks and valleys.
| | | | | skin of neonates and infants. No negative
impact on the safety or effectiveness of the
subject device. |
|------------------------|----------------------------------------------|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Intended use
time | 24h, 15 min | > Not Publicly Available | No new questions regarding safety or effectiveness are raised. |
| pH range | 6-7.5 | 8-10 | The subject device's pH is neutral whereas the predicate device's is more basic. pH is adjusted with lactate to be closer to the natural skin pH (4.7-5.75). No new questions of safety or effectiveness are raised. |
| Weight | 100g per tube | 100 g per tube | Same as predicate device |
| Packaging | Aluminum tube | Aluminum tube | Same as predicate device |
| Characteristics | Salt base
Non-irritating
Non toxic
White color adhesive | Salt base
Non-irritating
Non toxic
Light-Grey color adhesive | Same as predicate device |
9
EEG-acp Electrode Cream (K212325)
Image /page/9/Picture/1 description: The image contains the logo for SOMNOmedics. The logo consists of a stylized waveform graphic on the left, followed by a horizontal line. To the right of the line is the text "SOMNO" in a larger, bolder font, with the word "medics" underneath in a smaller, italicized font. The color scheme appears to be a shade of blue.
Summary of Performance Testing - Biocompatibility
Biocompatibility has been evaluated for the EEG-acp in accordance with ISO 10993-1:2018.
The cream has contact with intact skin for in vitro Skin Irritation (Human Skin Model Test) |
|-----------------|------------------------------------------------------------------------------------------------------|
| • ISO 10993-10: | Acute Dermal Irritation/ Corrosion
Irritation/ Skin Sensitization
Guinea Pig Maximization Test |
Chemical characterization of the cream was not performed, as the exact chemical composition and chemical properties of all ingredients is known.
Performance Testing - Bench Testing
Performance characteristics of EEG-acp were verified for:
● Impedance
Impedance and conductivity of the device was measured to confirm that it is equivalent to the predicate device. It is an effective electroconductive medium to reduce the impedance of EEG cup electrodes.
● Qualitative characteristics
Color, odor, adhesiveness and time to dry are as specified and equivalent to the predicate device.
Shelf-life o
The indicated shelf life of 2 years was validated by accelerated aging testing in accordance with ASTM F1980-16.
Pass/fail criteria were defined at the beginning of the test (color, consistency, impedance). The cream was found to meet these criteria and to confirm the shelf life.
Conclusion
Results of performance testing demonstrate that EEG-acp meets the specified performance and design characteristics. It is safe for use and effective. The performance data demonstrate and support the substantial equivalence of EEG-acp with its predicate, SAC2 Electrode cream, with regards to safety, effectiveness and performance.