(90 days)
Not Found
No
The summary describes a passive electrode for recording biopotential signals and does not mention any computational processing or analysis of these signals using AI/ML.
No
Explanation: The device is intended for recording, monitoring, and stimulation to acquire biopotential signals (e.g., EEG, nerve potentials) for diagnostic or monitoring purposes, not for treating a condition.
No
The device is an electrode used to record biopotential signals (EEG, nerve potentials) for monitoring and recording purposes, but it does not perform the diagnostic interpretation itself. It is an accessory to diagnostic equipment.
No
The device description explicitly details physical components (Ag/AgCl plated ABS disc, lead wire, touch proof connector) and mentions material analysis and biocompatibility testing, 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 biopotential signals (like EEG and nerve potentials) directly from the patient's skin. This is a direct measurement from the body, not an analysis of a sample taken from the body (which is the core of an IVD).
- Device Description: The device is a cutaneous electrode applied to the skin. It's designed to acquire electrical signals from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
In summary, this device is a medical device used for physiological monitoring by directly interacting with the patient's body, not an IVD which analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The single patient EEG Cup Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals, for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.
Product codes
GXY
Device Description
A cutaneous electrode is an electrode that is applied directly to a patient's skin to record physiological (biopotential) signals. Cutaneous electrodes are used in the acquisition of signals for the purpose of monitoring and recording electroencephalograph (EEG), electromyograph (EMG), and evoked potentials (EP).
The CONMED BRAINSTREAM™ Disposable Deep Cup EEG Electrodes are disposable electrodes for single patient use. The electrodes are provided non-sterile. The device consists of 10 electrode assemblies, each consisting of the following: passive Ag/AgCl plated ABS disc permanently adhered to a lead wire, with the leadwire terminated in a touch proof connector (DIN 42 802) for electrical safety.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient scalp
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
Non-clinical bench and simulated use testing demonstrate that the CONMED BRAINSTREAM™ Disposable Deep Cup EEG Electrodes are substantially equivalent to the predicate device with regard to intended use/ indication for use, materials, technology, and performance. Design verification demonstrates devices comply with design specifications and applicable sections of ANSI AAMI EC 12, ANSI AAMI ES60601-1, and ANSI AAMI IEC 60601-1-2. Material analysis and testing demonstrate the patient contacting materials are biocompatible and comply with the requirements of ISO 10993-1. Performance testing demonstrates that the performance of the CONMED BRAINSTREAM™ Disposable Deep Cup EEG Electrodes is substantially equivalent to the predicate device.
Key Metrics
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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 1, 2020
CONMED Corporation Tessa Hopsicker Senior Specialist, Regulatory Affairs 525 French Road Utica, New York 13502
Re: K200540
Trade/Device Name: BRAINSTREAM Disposable Deep Cup EEG Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 2, 2020 Received: March 3, 2020
Dear Tessa Hopsicker:
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
1
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 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 (OS) 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 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-regulatoryassistance/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,
Amber T. Ballard -S
For Vivek Pinto, PhD Director 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
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Indications for Use
510(k) Number (if known) K200540
Device Name
BRAINSTREAM Disposable Deep Cup EEG Electrodes
Indications for Use (Describe)
The single patient EEG Cup Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals, for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.
| 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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510(k) Summary of Safety and Effectiveness
BRAINSTREAM™ Disposable Deep Cup EEG Electrodes by CONMED
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502
Establishment Reqistration: 1320894
B. Company Contact
Tessa Hopsicker Senior Specialist, Regulatory Affairs Telephone: (315) 624-3345 Fax: (315) 624-3225
C. Device Name
| Proprietary Name: | BRAINSTREAM™ Disposable Deep Cup EEG Electrodes |
|---|---|
| Common Name: | Electrode, Cutaneous |
| Panel: | Neurology |
| Product Code: | GXY |
| Device Class: | II |
| Regulation Number: | 21 CFR 882.1320 |
D. Predicate Device
Primary Device Name:
Company Name: 510(k):
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE AMBU, INC. K032278
E. Device Description
A cutaneous electrode is an electrode that is applied directly to a patient's skin to record physiological (biopotential) signals. Cutaneous electrodes are used in the acquisition of signals for the purpose of monitoring and recording electroencephalograph (EEG), electromyograph (EMG), and evoked potentials (EP).
The CONMED BRAINSTREAM™ Disposable Deep Cup EEG Electrodes are disposable electrodes for single patient use. The electrodes are provided non-sterile. The device
4
consists of 10 electrode assemblies, each consisting of the following: passive Ag/AgCl plated ABS disc permanently adhered to a lead wire, with the leadwire terminated in a touch proof connector (DIN 42 802) for electrical safety.
F. Intended Use / Indications for Use
The single patient EEG Cup Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals, for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.
G. Non-clinical Performance Testing
Non-clinical bench and simulated use testing demonstrate that the CONMED BRAINSTREAM™ Disposable Deep Cup EEG Electrodes are substantially equivalent to the predicate device with regard to intended use/ indication for use, materials, technology, and performance. Design verification demonstrates devices comply with design specifications and applicable sections of ANSI AAMI EC 12, ANSI AAMI ES60601-1, and ANSI AAMI IEC 60601-1-2. Material analysis and testing demonstrate the patient contacting materials are biocompatible and comply with the requirements of ISO 10993-1. Performance testing demonstrates that the performance of the CONMED BRAINSTREAM™ Disposable Deep Cup EEG Electrodes is substantially equivalent to the predicate device.
H. Substantial Equivalence
Comparison of the Intended use and Technological Characteristics with the Predicate Device:
The subject and predicate device share the same intended use: for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. The characteristics of the subject device and the predicate device are summarized in the table below. The subject device is found to be similar to the predicate device with reqard to design, function, and technical characteristics.
| Attribute | Subject Device
CONMED BRAINSTREAMTM
Disposable Deep Cup EEG
Electrodes | Predicate Device
AMBU NEUROLINE SINGLE
PATIENT EEG/EP CUP |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications
for Use | The single patient EEG Cup
Electrode is intended for use
with recording, monitoring and
stimulation equipment for the
purpose of recording of
biopotential signals, for
example:
Electroencephalograph (EEG)
and Nerve potentials signals. | The single patient EEG Cup
Electrode is intended for use with
recording, monitoring and
stimulation equipment for the
purpose of recording of
biopotential signals, for example:
Electroencephalograph (EEG)
and Nerve potentials signals. The
electrodes are for single patient |
5
| Attribute | Subject Device
CONMED BRAINSTREAM™
Disposable Deep Cup EEG
Electrodes | Predicate Device
AMBU NEUROLINE SINGLE
PATIENT EEG/EP CUP |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The electrodes are for single
patient use only. | use only. |
| Classification
Regulation | Class II per 21CFR882.1320,
cutaneous electrode | Class II per 21CFR882.1320,
cutaneous electrode |
| Product Code | GXY, Electrode, cutaneous | GXY, Electrode, cutaneous |
| Type of Patient
Contact | Contacts patient scalp | Contacts patient scalp |
| Type of Use | Single use, non-sterile,
disposable | Single use, non-sterile,
disposable |
| Electrode Cup | Ag/AgCl plated ABS | Ag/AgCl plated ABS |
| Electrode Cup
Dimensions | 10 mm | 10 mm |
| Leadwire | PVC insulated tin plated copper | PVC insulated tin plated copper |
| Leadwire
Length | 100 cm, 150 cm, 200 cm | 100 cm, 150 cm, 200 cm |
| Connector | DIN 42802 1.5 mm and Touch
proof connector | DIN 42802 1.5 mm and Touch
proof connector |
| Compatibility | Can connect to various EEG
devices utilizing a DIN socket | Can connect to various EEG
devices utilizing a DIN socket |
| Sterilization | Non-Sterile | Non-Sterile |
| Biocompatibility | Biocompatibility of patient
contacting components verified
with Irritation, Sensitization,
and Cytotoxicity testing per ISO
10993-5:2009 and ISO 10993-
10:2010 | Biocompatibility of patient
contacting components verified
with Irritation, Sensitization, and
Cytotoxicity testing per ISO
10993-5:2009 and ISO 10993-
10:2010 |
Conclusion -
The CONMED BRAINSTREAM™ Disposable Deep Cup EEG Electrodes are as safe and effective as the predicate device. The CONMED BRAINSTREAM™ Disposable Deep Cup EEG Electrodes have the same intended use and indications, and similar technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between the BRAINSTREAM™ Disposable Deep Cup EEG Electrodes and its predicate raise no new issues of safety or effectiveness. Performance data demonstrate that the CONMED BRAINSTREAM™ Disposable Deep Cup EEG Electrodes are as safe and effective as the predicate device. Thus, the CONMED BRAINSTREAM™ Disposable Deep Cup EEG Electrodes are substantially equivalent.