(231 days)
Not Found
No
The description focuses solely on the sensor hardware for collecting EEG signals and mentions it is used in conjunction with a separate monitoring system and software. There is no mention of AI/ML being used within the sensor itself or in the processing of the signals it collects.
No.
The device is described as a sensor that records electrophysiological signals (e.g., EEG) for monitoring purposes, and there is no mention of it providing therapy or treatment.
No
The device is described as a sensor that records electrophysiological signals, such as EEG, which are inputs for a monitoring system. It does not perform analysis or provide diagnostic output on its own.
No
The device description explicitly details a physical sensor with electrodes, hydrogel, and packaging, indicating it is a hardware component, not software only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to record electrophysiological signals (like EEG) directly from the patient's skin. This is a direct measurement from the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device is an electrode sensor applied to the skin. It collects electrical signals from the body.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological sample taken from the patient.
IVDs are devices used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The CAIs Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
Product codes
GXY
Device Description
The CAIs Sensor, generally speaking with regard to the four variations of the sensor, is a circle shaped, pre-gelled array of four electrodes that is applied to the patient's skin to record electrophysiological signals, such as EEG signals. It is a low impedance, single patient use, disposable electrode sensor designed for application to the frontal/temporal area. The sensor is designed to provide ease of use and electrode placement accuracy. It is in conjunction with CAIx and CAI software of CAI Monitoring System. The CAIs sensor is attached to the forehead, and the four electrodes placed on the sensor collect EEG signals and transmit them to the CAI monitoring system through the CAI cable. Each sensor is packed in individual heat-sealed pouches are packed into a cardboard box. The hydrogel used in the sensors is designed for single use by one patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin, frontal/temporal area, forehead
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
Biocompatibility testing was performed according to the following standard: 10993-1: 2018, 10993-5:2009/(R)2014, 10993-10:2021, 10993-23:2021.
Usability engineering, Risk Analysis was performed. (Performed within the CAI Monitoring System).
Bench testing reaarding Electrical. Adhesive Performance, and Shelf Life was performed according to the following: FDA Guidance "Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway" ANSI/AAMI EC12:2000/(R)2015, IEC 60601-2-2 (2016).
Clinical studies were not performed.
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
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: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
December 13, 2024
BrainU Co., Ltd. Yeonwoo Lee Senior Staff CTI Co., Ltd. A-1712, 43, Ilji-ro Gwangmyeong-si, Gyeonggi-do 14353 Korea, South
Re: K241160
Trade/Device Name: CAIs Sensor (CAIs-001) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: November 22, 2024 Received: November 22, 2024
Dear Yeonwoo Lee:
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.
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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
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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
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Indications for Use
Submission Number (if known)
Device Name
CAls Sensor (CAls-001)
Indications for Use (Describe)
The CAIs Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
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) #: K241160
510(k) Summary
Prepared on: 2024-11-22
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | BrainU Co.,Ltd. |
|---|---|
| Applicant Address | 3F, 7, Yatap-ro 105beon-gil, Bundang-gu Seongnam-si Gyeonggi-do 13506 Korea, South |
| Applicant Contact Telephone | +82 31 707 1788 |
| Applicant Contact | Mr. Sangwoo Choi |
| Applicant Contact Email | choisw@brainu.co.kr |
| Correspondent Name | CTI Co.,Ltd. |
| Correspondent Address | A-1712, 43, Ilji-ro Gwangmyeong-si Gyeonggi-do 14353 Korea, South |
| Correspondent Contact Telephone | +82 2 6914 5602 |
| Correspondent Contact | Ms. Yeonwoo Lee |
| Correspondent Contact Email | ywlee@cticert.co.kr |
Device Name 21 CFR 807.92(a)(2)
| Device Trade Name | CAls Sensor (CAls-001) |
|---|---|
| Common Name | Cutaneous electrode |
| Classification Name | Electrode, Cutaneous |
| Regulation Number | 882.1320 |
| Product Code(s) | GXY |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) Product Code |
|---|---|
| K143506 | Covidien BIS Sensors(BIS Quatro Sensor, BIS Extend, BIS Pedia GXY |
Device Description Summary 21 CFR 807.92(a)(4)
The CAls Sensor, generally speaking with regard to the four variations of the sensor, is a circle shaped, pre-gelled array of four electrodes that is applied to the patient's skin to record electrophysiological signals, such as EEG signals.
It is a low impedance, single patient use, disposable electrode sensor designed for application to the frontal/temporal area. The sensor is designed to provide ease of use and electrode placement accuracy. It is in conjunction with CAlx and CAI software of CAI Monitoring System.
The CAls sensor is attached to the forehead, and the four electrodes placed on the sensor collect EEG signals and transmit them to the CAI monitoring system through the CAI cable.
5
Each sensor is packed in individual heat-sealed pouches are packed into a cardboard box.
The hydrogel used in the sensors is designed for single use by one patient.
Intended Use/Indications for Use
The CAIs Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
Indications for Use Comparison
Both devices are applied directly to the patient's skin to enable the recording of electrophysiological (such as EEG) signals. The CAls Sensor has substantially the same indications for use as the predicate device (BIS Sensor is equivalent to the predicate device (BIS Sensor) in terms of the applied site, method of use, material, etc.
Technological Comparison
Through the above comparison, it was confirmed that the CAls Sensor has the same major characteristics that affect safety and performance as the preceding device (BIS Sensor). Therefore, we conclude that the CAIs Sensor is as safe and effective as its predecessor (BIS Sensor).
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Biocompatibility testing was performed according to the following standard: 10993-1: 2018, 10993-5:2009/(R)2014, 10993-10:2021, 10993-23:2021
Usability engineering, Risk Analysis was performed. (Performed within the CAI Monitoring System)
Bench testing reaarding Electrical. Adhesive Performance, and Shelf Life was performed according to the following: FDA Guidance "Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway" ANSI/AAMI EC12:2000/(R)2015, IEC 60601-2-2 (2016)
Clinical studies were not performed.
CONCLUSIONS
Based on the results of the non-clinical tests conducted, they demonstrate that the CAIs Sensor (CAIs-001) device is as safe and effective as the current legally marketed predicate device.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)