(90 days)
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.
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.
This document describes the CONMED BRAINSTREAM™ Disposable Deep Cup EEG Electrodes. The information provided is for regulatory clearance based on substantial equivalence to a predicate device, not an AI/ML device, therefore, many requested criteria are not applicable.
Here's the breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate device standards) | Reported Device Performance (BRAINSTREAM™) |
|---|---|
| Compliance with ANSI AAMI EC 12 (Electrode performance) | Demonstrated compliance with design specifications and applicable sections of ANSI AAMI EC 12. |
| Compliance with ANSI AAMI ES60601-1 (General requirements for basic safety and essential performance) | Demonstrated compliance with design specifications and applicable sections of ANSI AAMI ES60601-1. |
| Compliance with ANSI AAMI IEC 60601-1-2 (Electromagnetic compatibility) | Demonstrated compliance with design specifications and applicable sections of ANSI AAMI IEC 60601-1-2. |
| Biocompatibility (Irritation, Sensitization, Cytotoxicity) | Verified with Irritation, Sensitization, and Cytotoxicity testing per ISO 10993-5:2009 and ISO 10993-10:2010. |
| Performance equivalent to predicate device | Performance testing demonstrates substantial equivalence to the predicate device. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a medical device clearance based on engineering and biocompatibility testing against standards and comparison to a predicate device, not an AI/ML study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert consensus on medical images) is not relevant for this device clearance. The "truth" is established through adherence to recognized international standards and engineering performance metrics.
4. Adjudication method for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this device clearance is established by:
- Adherence to recognized international standards for medical devices, specifically:
- ANSI AAMI EC 12 (for electrode performance)
- ANSI AAMI ES60601-1 (for basic safety and essential performance)
- ANSI AAMI IEC 60601-1-2 (for electromagnetic compatibility)
- ISO 10993-1, ISO 10993-5:2009, and ISO 10993-10:2010 (for biocompatibility)
- Substantial equivalence to a legally marketed predicate device (AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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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
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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
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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 DeviceCONMED BRAINSTREAMTMDisposable Deep Cup EEGElectrodes | Predicate DeviceAMBU NEUROLINE SINGLEPATIENT EEG/EP CUP |
|---|---|---|
| IntendedUse/Indicationsfor Use | The single patient EEG CupElectrode is intended for usewith recording, monitoring andstimulation equipment for thepurpose of recording ofbiopotential signals, forexample:Electroencephalograph (EEG)and Nerve potentials signals. | The single patient EEG CupElectrode is intended for use withrecording, monitoring andstimulation equipment for thepurpose of recording ofbiopotential signals, for example:Electroencephalograph (EEG)and Nerve potentials signals. Theelectrodes are for single patient |
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| Attribute | Subject DeviceCONMED BRAINSTREAM™Disposable Deep Cup EEGElectrodes | Predicate DeviceAMBU NEUROLINE SINGLEPATIENT EEG/EP CUP |
|---|---|---|
| The electrodes are for singlepatient use only. | use only. | |
| ClassificationRegulation | Class II per 21CFR882.1320,cutaneous electrode | Class II per 21CFR882.1320,cutaneous electrode |
| Product Code | GXY, Electrode, cutaneous | GXY, Electrode, cutaneous |
| Type of PatientContact | 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 CupDimensions | 10 mm | 10 mm |
| Leadwire | PVC insulated tin plated copper | PVC insulated tin plated copper |
| LeadwireLength | 100 cm, 150 cm, 200 cm | 100 cm, 150 cm, 200 cm |
| Connector | DIN 42802 1.5 mm and Touchproof connector | DIN 42802 1.5 mm and Touchproof connector |
| Compatibility | Can connect to various EEGdevices utilizing a DIN socket | Can connect to various EEGdevices utilizing a DIN socket |
| Sterilization | Non-Sterile | Non-Sterile |
| Biocompatibility | Biocompatibility of patientcontacting components verifiedwith Irritation, Sensitization,and Cytotoxicity testing per ISO10993-5:2009 and ISO 10993-10:2010 | Biocompatibility of patientcontacting components verifiedwith Irritation, Sensitization, andCytotoxicity testing per ISO10993-5:2009 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.
§ 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).