(90 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functionality of a template for electrode placement, with no mention of AI or ML.
No
The device is described as an accessory to support the placement of EEG electrodes, providing a workflow solution, not actively diagnosing, treating, or preventing a disease or condition. Its function is to aid in electrode placement for EEG, which is a diagnostic tool, but the template itself is not performing the therapeutic action.
No
The device is an accessory to support the placement of EEG electrodes, which are used to measure brain activity. It does not perform any diagnostic function itself; it merely guides the placement of other devices that might be part of a diagnostic process.
No
The device description explicitly states the device is made from "elastic webbing" and has "holes," indicating it is a physical, hardware-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an accessory to support the placement of electroencephalograph (EEG) electrodes." This describes a physical tool used for positioning, not a test performed on a sample taken from the body.
- Device Description: The description details a physical template made of elastic webbing with holes for electrode placement. It does not mention any reagents, samples (like blood, urine, or tissue), or analysis of biological material.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample from the human body.
- Providing information about a physiological state, disease, or condition.
- Using reagents or analytical methods.
The device is clearly a physical accessory used externally on the patient's head to facilitate a medical procedure (EEG electrode placement).
N/A
Intended Use / Indications for Use
The EEG Electrode Template is intended for use as an accessory to support the placement of electroencephalograph (EEG) electrodes.
Product codes
GXY
Device Description
The EEG Electrode Template is intended to be used in medical environments where EEG electrode placement is required. The device provides a workflow solution to support application of EEG electrodes.
The EEG Electrode Template is made from elastic webbing to conform to various head shapes and sizes. The device has between 16 to 21 holes in predetermined locations that are arranged by generally referencing the 10-20 Positioning System. The EEG Electrode Template is placed on the patient's head and is oriented with its nasion marker and secured with its chinstrap to support positioning of EEG electrodes. The elasticity of the device enables flexibility to account for various head shapes and sizes and to avoid interference with intracranial pressure monitoring, ventricular drainage, or other separate devices. Identical to the predicate (K043009), the subject device is non-invasive, non-sterile, and for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital
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
Functional performance equivalency was determined by dimensional characterization of the EEG Electrode Template, which demonstrated that all hole-to-hole spacing was within 5 mm of specifications. In conclusion, all non-clinical performance testing passed predetermined acceptance criteria, demonstrating the EEG Electrode Template is equivalent to the predicate device in functionality, safety, and effectiveness. No Clinical Tests were conducted.
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).
0
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August 5, 2019
Rhythmlink International, LLC Gabriel Orsinger Director of Engineering 1140 First Street South Columbia, South Carolina 29209
Re: K191225
Trade/Device Name: EEG Electrode Template Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: May 6, 2019 Received: May 7, 2019
Dear Gabriel Orsinger:
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
1
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 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,
for
Vivek Pinto. 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
2
Indications for Use
510(k) Number (if known) K191225
Device Name EEG Electrode Template
Indications for Use (Describe)
The EEG Electrode Template is intended for use as an accessory to support the placement of electroencephalograph (EEG) electrodes.
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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3
510(k) Summary
| 807.92(a)(1)
Submitter
Information | Rhythmlink International, LLC
1140 First Street South
Columbia, SC 29209
Phone: 803-252-1222
FDA Registration #: 1067162 | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Official
Correspondent | Gabriel Orsinger, PhD
Director of Engineering
Email: gorsinger@rhythmlink.com
Phone: 803-365-9664 | |
| Summary Date | August 5, 2019 | |
| 807.92(a)(2)
Device
Identification | Device Trade Name: | EEG Electrode Template |
| | Common/Classification Name: | Cutaneous Electrode |
| | Product Code: | GXY |
| | Classification: | 21 CFR 882.1320 Class II |
| | Classification Panel: | Neurology |
| 807.92(a)(3)
Predicate
Device | K043009 – Brainet Kit | |
| 807.92(a)(4)
Device
Description | The EEG Electrode Template is intended to be used in medical environments
where EEG electrode placement is required. The device provides a workflow
solution to support application of EEG electrodes. | |
| | The EEG Electrode Template is made from elastic webbing to conform to various
head shapes and sizes. The device has between 16 to 21 holes in predetermined
locations that are arranged by generally referencing the 10-20 Positioning System.
The EEG Electrode Template is placed on the patient's head and is oriented with
its nasion marker and secured with its chinstrap to support positioning of EEG
electrodes. The elasticity of the device enables flexibility to account for various
head shapes and sizes and to avoid interference with intracranial pressure
monitoring, ventricular drainage, or other separate devices. Identical to the
predicate (K043009), the subject device is non-invasive, non-sterile, and for single
patient use. | |
| 807.92(a)(5)
Intended Use | The EEG Electrode Template is intended for use as an accessory to support the
placement of electroencephalograph (EEG) electrodes. | |
4
807.92(a)(6) Technological Characteristics
The technological characteristics of the EEG Electrode Template are identical to the predicate device (K043009), with several minor dimensional and material modifications which have been assessed to be substantially equivalent to the predicate and therefore do not affect the safety or effectiveness of the device (reference Technological Characteristics table, below).
| Characteristic | Subject Device: | Predicate Device: |
|---|---|---|
| 510(k) Number | EEG Electrode Template | Brainet Kit |
| Manufacturer | K191225 | K043009 |
| Device Class | Rhythmlink International, LLC | Jordan Neuroscience, Inc. |
| Product Code | Class II | Class II |
| GXY | GXY | GXZ (different model) |
| Regulatory Name | Cutaneous electrode | |
| Regulation # | 21 CFR 882.1320 | 21 CFR 882.1320 |
| Intended Use | The EEG Electrode Template is | |
| intended for use as an accessory | ||
| to support placement of | ||
| electroencephalograph (EEG) | ||
| electrodes. | The Brainet® template is | |
| placed on the scalp to support | ||
| electroencephalograph | ||
| (EEG) electrode placement. | ||
| Single Patient Use | YES – disposable | YES - disposable |
| Sterilization Method | Non-sterile | Non-sterile |
| Shelf Life | 2 years | N/A – not listed on device |
| Anatomical Site(s) | Head | Head |
| Environment usage | Hospital | Hospital |
| Targeted Procedures | EEG | EEG |
| Number of Electrode | ||
| Positions | 16 to 21 | Up to 21 |
| Electrode Position | ||
| Identifier | Number and text | Color |
| Template Materials | Elastic, polyester thread, screen- | |
| printed ink, Velcro/Veltex | Elastic, Velcro (other | |
| materials unknown) | ||
| Duration of Use | Short term | Short term |
| Biocompatible | Yes | Yes |