CAIs Sensor (CAIs-001)

K241160 · Brainu Co., Ltd. · GXY · Dec 13, 2024 · Neurology

Device Facts

• Record ID: K241160
• Device Name: CAIs Sensor (CAIs-001)
• Applicant: Brainu Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Dec 13, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The CAIs Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

Device Story

CAIs Sensor (CAIs-001) is a disposable, pre-gelled, four-electrode array; applied to patient's forehead (frontal/temporal area) to collect EEG signals. Device functions as a passive interface; transmits raw electrophysiological signals via cable to CAI Monitoring System for processing. Used in clinical settings; operated by healthcare professionals. Provides signal acquisition for monitoring; facilitates clinical assessment of brain activity. Benefits include ease of use and accurate electrode placement for EEG monitoring.

Clinical Evidence

No clinical data. Evidence is based on non-clinical bench testing, including biocompatibility (ISO 10993-1, -5, -10, -23), electrical performance, adhesive performance, and shelf-life testing per FDA guidance and ANSI/AAMI EC12:2000/(R)2015 and IEC 60601-2-2 (2016).

Technological Characteristics

Disposable, single-patient use, four-electrode array. Features pre-gelled hydrogel interface. Designed for low impedance. Dimensions/form factor: circle-shaped array for frontal/temporal application. Connectivity: wired transmission via CAI cable to monitoring system. Sterilization: not specified. Biocompatibility compliant with ISO 10993 series.

Indications for Use

Indicated for patients requiring electrophysiological signal recording, specifically EEG, via cutaneous electrode application to the frontal/temporal area.

Regulatory Classification

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.

Predicate Devices

• Covidien BIS Sensors (BIS Quatro Sensor, BIS Extend, BIS Pedia) (K143506)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K241160

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 | [phone] |
| Applicant Contact | Mr. Sangwoo Choi |
| Applicant Contact Email | [e-mail] |
| Correspondent Name | CTI Co.,Ltd. |
| Correspondent Address | A-1712, 43, Ilji-ro Gwangmyeong-si Gyeonggi-do 14353 Korea, South |
| Correspondent Contact Telephone | [phone] |
| Correspondent Contact | Ms. Yeonwoo Lee |
| Correspondent Contact Email | [e-mail] |

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.

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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)