Masimo SedLine Sedation Monitor and Accessories

K203113 · Masimo Corporation · OLW · Feb 25, 2022 · Neurology

Device Facts

• Record ID: K203113
• Device Name: Masimo SedLine Sedation Monitor and Accessories
• Applicant: Masimo Corporation
• Product Code: OLW · Neurology
• Decision Date: Feb 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SedLine® Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The SedLine® Sedation Monitor is indicated for adult and pediatric patients (1 year of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. The system includes the Patient State Index (PSi), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The PSi is indicated for use on adults sedated with the following agents: Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The PSi is not indicated for use in the pediatric population and is not displayed when using the pediatric sensors. The SedLine® is only to be used with Masimo SedLine® sensors and cables. The use of any other sensor or cable is neither supported nor recommended by Masimo and could give erroneous results.

Device Story

SedLine Sedation Monitor is a 4-channel processed EEG monitor; acquires/processes EEG signals via forehead sensors; computes Patient State Index (PSi) to reflect anesthetic effect; displays EEG waveforms, Density Spectral Array (DSA), EMG Index, Suppression Ratio (SR), and Artifact (ARTF) on host device (Masimo Root Monitoring System). Used in OR, ICU, and clinical research labs by clinicians. Pediatric expansion introduces smaller form-factor sensors for patients 1-17 years. PSi calculation is disabled for pediatric sensors. Device provides real-time brain state monitoring to assist clinicians in managing sedation levels.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical performance testing, including software verification and validation, and mechanical/environmental testing of the pediatric sensor.

Technological Characteristics

4-channel processed EEG monitor; MOC-9 interface; low voltage DC power from host. Sensors applied to forehead. Biocompatibility per ISO 10993-1. Electrical safety/EMC per IEC 60601-1 and IEC 60601-1-2. Software level of concern: moderate.

Indications for Use

Indicated for adult and pediatric patients (1 year and older) in OR, ICU, and clinical research labs for monitoring brain state via EEG. PSi parameter indicated for adults sedated with Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol, Remifentanil, or Sevoflurane. PSi not indicated for pediatric patients.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

• Masimo SedLine® Sedation Monitor (K172890)

Reference Devices

• Aspect Medical System, Inc, BISx (K072286)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 25, 2022

Masimo Corporation Sindura Penubarthi Regulatory Affairs Manager 52 Discovery Irvine, California 92618

Re: K203113

Trade/Device Name: Masimo SedLine Sedation Monitor and Accessories Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLW, OLT, GXY, OMC, ORT Dated: December 15, 2021 Received: December 17, 2021

Dear Sindura Penubarthi:

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 (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/cdrl-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K203113

### Device Name

Masimo SedLine® Sedation Monitor and Accessories

Indications for Use (Describe) SedLine Sedation Monitor

The SedLine® Sedation Monitor is intended to monitor the state of the data acquisition and processing of EEG signals. The SedLine® Sedation Monitor is indicated for adult and pediatric patients (1 year of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.

The system includes the Patient State Index (PSi), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The PSi is indicated for use on adults sedated with the following agents: Alfentanil, Desflurane, Fentany], Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The PSi is not indicated for use in the pediatric population and is not displayed when using the pediatric sensors.

The SedLine® is only to be used with Masimo SedLine® sensors and cables. The use of any other sensor or cable is neither supported nor recommended by Masimo and could give erroneous results.

### SedLine Sensor

The RD SedLine Pediatric Sensor electrodes are applied directly to the patient's skin to enable the recording of electrophysiological signals (e.g., EEG). The RD SedLine Pediatric Sensors are indicated for pediatric patients (1 to 17 years).

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/1 description: The image shows the Masimo Corporation logo. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in bold, black letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

| Submitter and Address of<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 10/13/2020 |
| Contact: | Sindura Penubarthi<br>Regulatory Affairs Senior Manager<br>Masimo Corporation<br>Phone: [phone]<br>[e-mail] |
| Trade Name: | Masimo SedLine Sedation Monitor and Accessories |
| Common Name: | Brain Function Monitor |
| Classification Regulation/<br>Product Code: | 21 CFR 882.1400, Class II/OLW |
| Additional Product Code: | OLT, OMC, ORT, GXY |
| Establishment Registration<br>Number: | 3011353843 |
| Reason for Premarket<br>Notification: | Expansion to the indications for use and introduction of Pediatric Sensor |
| Predicate Device: | K172890 - Masimo SedLine® Sedation Monitor |
| Reference Predicate: | K072286 - Aspect Medical System, Inc, BISx |
| Performance Standards | No performance standards for the above device have been promulgated<br>pursuant to Section 514 of the Food and Drug Administration<br>Modernization Act of 1997 (FDAMA) |

# 1. Device Description

The Masimo SedLine® Sedation Monitor is a patient-connected, 4-channel processed Electroencephalograph (EEG) monitor. It displays electrode status, EEG waveforms, Density Spectral Array (DSA), and Patient State Index (PSi), EMG Index, Suppression Ratio (SR) and Artifact (ARTF).

The Masimo SedLine® Sedation Monitor includes the SedLine Module, SedLine EEG Sensor, and SedLine Patient Cable. The SedLine Module includes Masimo technology that processes the signal data collected from the SedLine sensor on the Host/Backboard device which provides the user interface.

The performance specifications for SedLine are included in Table 1.1 below:

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Image /page/4/Picture/1 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".

| TABLE 1.1 SedLine Specifications | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| FEATURE | SPECIFICATION |
| Display Range | |
| PSI | 0 to 100 |
| EMG | 0 to 100% |
| SR | 0 to 100% |
| ARTF | 0 to 100% |
| DSA Amplitude (Left and Right) | -60 to 40 dB |
| SEFL/SEFR | 0-30Hz |
| DSA Asymmetry | -100% to +100% |
| Electrode Impedance | 0 to 65 kohms |
| DSA frequency Range | 0 to 30 Hz and 0 to 40 Hz |
| Resolution | |
| PSI | 1 |
| EMG | 1% |
| SR | 2% |
| ARTF | 1% |
| DSA Amplitude (Left and Right) | ≤1db |
| SEFL/SEFR | 1 Hz |
| DSA Asymmetry | 1% |
| Electrode Impedance | 1 kohms |
| General | |
| Visual/Audible Alarm | Host/Backboard Device (Masimo Root Monitoring System) provides the audible/visual alarm in compliance with IEC60601-1-8 |
| Storage/Recording | Host/Backboard Device (Masimo Root Monitoring System) provides trend/data storage |
| Electrical | |
| DC Power | Host/Backboard Device (Masimo Root Monitoring System) provides DC power to SedLine Module |
| Interface | |
| SedLine Module Connection | MOC-9 interface with Host/Backboard device (Masimo Root Monitoring System) |
| Mechanical | |
| Module: Dimensions | 1 3/10 in (3.3 cm) x 4 in (10.2 cm) x .8 in (2.0 cm) |
| Environmental | |
| Operating Conditions | |
| Temperature | +41°F to +104°F (+5°C to +40°C) |
| Humidity | 15% to 95%, non-condensing |
| Storage Conditions | |
| Temperature | -40°F to +158°F (-40°C to +70°C) |
| Humidity | 15-95%, non-condensing |

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Image /page/5/Picture/1 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

| Table 1.2 SedLine Pediatric Sensor Specifications | |
|---------------------------------------------------|---------------------------|
| Application site | Forehead |
| Intended patient population | 1 to 17 years |
| Mechanical | |
| Dimensions | 7" by 5.5" |
| Biocompatibility | ISO 10993-1 |
| Environmental specifications | |
| Operating Temperature | 10°C to 40°C |
| Storage Temperature | -40°C to +70°C |
| Humidity | 10% to 95% non-condensing |

#### 1.1 Intended Use

#### 1.1.1 Intended Use

The SedLine® Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The computed values are displayed on a Host/Backboard monitor such as the Masimo Root Monitoring System.

#### 1.1.2 Indications for Use

### SedLine Sedation Monitor

The SedLine® Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The SedLine® Sedation Monitor is indicated for adult and pediatric patients (1 year of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.

The system includes the Patient State Index (PSi), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The PSi is indicated for use on adults sedated with the following agents: Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The PSi is not indicated for use in the pediatric population and is not displayed when using the pediatric sensors.

The SedLine® is only to be used with Masimo SedLine® sensors and cables. The use of any other sensor or cable is neither supported nor recommended by Masimo and could give erroneous results.

### SedLine Sensor

The RD SedLine Pediatric Sensor electrodes are applied directly to the patient's skin to enable the recording of electrophysiological signals (e.g., EEG). The RD SedLine Pediatric Sensor is indicated for pediatric patients (1 to 17 years).

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Image /page/6/Picture/1 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in bold, black letters. To the right of the logo, the text "MASIMO CORPORATION" is displayed above the address "52 Discovery, Irvine, CA 92618".

#### 1.2 Technological Characteristics

#### 1.2.1 Principle of Operation

The SedLine is based upon the principle that brain activity results in electrical activity that can create detectable potential difference at the skin surface of the forehead that increased brain activity and decrease with reduced brain activity. The Patient State Index (PSi) utilizes this relationship to establish characteristics of the EEG that can be quantified to establish multivariate combinations of quantitative electroencephalogram (QEEG) variables that are sensitive to the brain activity under changing levels of anesthesia. The PSi is the result of a proprietary computation that combines weighted quantitative values reflecting many dimensions of brain electrical activity, such as: (1) changes in power in various EEG frequency bands, (2) changes in symmetry and synchronization between critical brain regions, and (3) the inhibition of regions of the frontal cortex.

The PSi is computed continuously from monitored changes in the QEEG when the sensor is applied. The PSi values are intended to provide information on the changes in sedation with the lower values reflecting lower levels of brain activity and deeper levels of sedation.

#### 1.2.2 Mechanism of Action for Achieving the Intended Effect

The SedLine EEG Sensor is noninvasively applied to the patient's forehead and is connected to the SedLine Module using a SedLine patient cable. The SedLine Module connects to a Host/Backboard device through an electrical connection. The SedLine EEG Sensor detects the potential differences at the forehead which are transmitted to the SedLine Module, which processes those potential differences as the EEG waveform and the analysis of the signal characteristics to be displayed on the Host/Backboard device.

To accommodate the smaller foreheads of the pediatric patient population, the SedLine is provided with a smaller form factor sensor more tailored to pediatric patients.

#### 1.2.3 Summary of Technological Characteristics of Subject Device Compared to Predicate Device

The subject device, SedLine® Sedation Monitor, and the predicate device, SedLine® Sedation Monitor (K172890), have the following key similarities:

- . Both devices have the same intended use to monitor the state of the brain by real-time data acquisition and processing of EEG signals;
- Both devices rely on the same principles of operations;
- Both devices have the same environmental specifications; ●
- Both devices utilize the same sensor materials; ●
- Both devices provide similar displays of EEG features. ●

The subject device and the predicate device. SedLine® Sedation Monitor (K172890), have the following key differences:

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Image /page/7/Picture/1 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold font. To the right of the company name is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

- . Subject device includes the indication for pediatric patients 1 to 17 years of age;
- . Subject device includes pediatric sensors that have a smaller sensor form factor.

The main difference between the subject device and the predicate device (K172890) is the expansion of the indications to support the pediation and the addition of pediatric sensors that have a smaller form factor compared to the adult sensor and a pediatric sensor that is sized equivalent to the adult sensor. To support the substantial equivalence of the subject device non-clinical testing was performed.

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Image /page/8/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red symbol on the left and the word "Masimo" in black letters. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in gray letters, followed by the address "52 Discovery, Irvine, CA 92618" also in gray letters.

| TABLE 5 SUBSTANTIAL EQUIVALENCE | | | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| FEATURE | Masimo SedLine® Sedation Monitor | Masimo SedLine® Sedation Monitor | Comparison |
| 510(k) Number | Subject device | Predicate device<br>(K172890) | |
| General<br>Information | | | |
| Intended Use<br>/Indications for Use<br>(IFU) | The SedLine® Sedation Monitor is<br>intended to monitor the state of the brain<br>by real-time data acquisition and<br>processing of EEG signals. The system<br>includes the Patient State Index (PSi), a<br>proprietary computed EEG variable that<br>is related to the effect of anesthetic<br>agents. The SedLine® Sedation Monitor<br>is indicated for adult and pediatric<br>patients (1 year of age and older) in the<br>operating room (OR), intensive care unit<br>(ICU), and clinical research laboratory.<br><br>The PSi is indicated for use on adults<br>sedated with the following agents:<br>Alfentanil, Desflurane, Fentanyl,<br>Isoflurane, Nitrous Oxide, Propofol,<br>Remifentanil, and Sevoflurane.<br><br>The SedLine® is only to be used with<br>Masimo SedLine® sensors and cables.<br>The use of any other sensor or cable is<br>neither supported nor recommended by<br>Masimo, and could give erroneous<br>results. | The SedLine Sedation Monitor is<br>indicated for use in the operating room<br>(OR), intensive care unit (ICU), and<br>clinical research laboratory. It is intended<br>to monitor the state of the brain by real-time<br>data acquisition and processing of<br>EEG signals for adult patients (18 years<br>of age and older). The system includes<br>the Patient State Index (PSI), a<br>proprietary computed EEG variable that<br>is related to the effect of anesthetic<br>agents.<br><br>The agents include: Alfentanil,<br>Desflurane, Fentanyl, Isoflurane, Nitrous<br>Oxide, Propofol, Remifentanil, and<br>Sevoflurane. | Added the indication for pediatrics and the<br>specific use of SedLine with Masimo<br>SedLine sensors and cables. |
| TABLE 5 SUBSTANTIAL EQUIVALENCE | | | |
| FEATURE | Masimo SedLine® Sedation Monitor<br>Subject device | Masimo SedLine® Sedation Monitor<br>Predicate device<br>(K172890) | Comparison |
| 510(k) Number | SedLine Sensor<br><br>The RD SedLine Pediatric Sensor<br>electrodes are applied directly to the<br>patient's skin to enable the recording of<br>electrophysiological signals (e.g., EEG).<br>The RD SedLine Pediatric Sensors are<br>indicated for pediatric patients (1 to 17<br>years). | | |
| Monitoring<br>Parameters | Electrode Status, EEG Waveforms,<br>Patient State Index (PSi), Density<br>Spectral Array (DSA),<br>Electromyography (EMG), Artifacts<br>(ARTF), Suppression Ratio (SR), and<br>Spectral Edge Frequency (SEFL/SEFR) | Electrode Status, EEG Waveforms,<br>Patient State Index (PSi), Density<br>Spectral Array (DSA),<br>Electromyography (EMG), Artifacts<br>(ARTF), Suppression Ratio (SR), and<br>Spectral Edge Frequency (SEFL/SEFR) | Same |
| Classification<br>Regulation/ Product<br>Code | 21 CFR 882.1400,Class II/OLW | 21 CFR 882.1400,Class II/OLW | Same |
| Additional Product<br>Codes | OLT, OMC, ORT, GXT | OLT, OMC, ORT, GXT | Same |
| Principle of<br>Operation | The SedLine is based upon the principle<br>that brain activity results in electrical<br>activity that can be create detectable<br>potential difference activity at the skin<br>surface of the forehead that increase with<br>increased brain activity and decrease<br>with reduced brain activity. The Patient<br>State Index (PSi) utilizes this relationship | The SedLine is based upon the principle<br>that brain activity results in electrical<br>activity that can be create detectable<br>potential difference activity at the skin<br>surface of the forehead that increase with<br>increased brain activity and decrease<br>with reduced brain activity. The Patient<br>State Index (PSi) utilizes this relationship | Same |
| TABLE 5 SUBSTANTIAL EQUIVALENCE | | | |
| FEATURE<br>510(k) Number | Masimo SedLine® Sedation Monitor<br>Subject device | Masimo SedLine® Sedation Monitor<br>Predicate device<br>(K172890) | Comparison |
| | to establish characteristics of the EEG<br>that can be quantified to establish<br>multivariate combinations of quantitative<br>electroencephalogram (QEEG) variables<br>that are sensitive to the brain activity<br>under changing levels of anesthesia. The<br>PSi is the result of a proprietary<br>computation that combines weighted<br>quantitative values reflecting many<br>dimensions of brain electrical activity,<br>such as: (1) changes in power in various<br>EEG frequency bands, (2) changes in<br>symmetry and synchronization between<br>critical brain regions, and (3) the<br>inhibition of regions of the frontal cortex.<br>The PSi is computed continuously from<br>monitored changes in the QEEG when<br>the sensor is applied. The PSi values are<br>intended to provide information on the<br>changes in sedation with the lower values<br>reflecting lower levels of brain activity<br>and deeper levels of sedation. | to establish characteristics of the EEG<br>that can be quantified to establish<br>multivariate combinations of quantitative<br>electroencephalogram (QEEG) variables<br>that are sensitive to the brain activity<br>under changing levels of anesthesia. The<br>PSi is the result of a proprietary<br>computation that combines weighted<br>quantitative values reflecting many<br>dimensions of brain electrical activity,<br>such as: (1) changes in power in various<br>EEG frequency bands, (2) changes in<br>symmetry and synchronization between<br>critical brain regions, and (3) the<br>inhibition of regions of the frontal cortex.<br>The PSi is computed continuously from<br>monitored changes in the QEEG when<br>the sensor is applied. The PSi values are<br>intended to provide information on the<br>changes in sedation with the lower values<br>reflecting lower levels of brain activity<br>and deeper levels of sedation. | |
| Function | | | |
| EEG Data Display | EEG Waveform, DSA | EEG Waveform, DSA | Same |
| PSi Algorithm | Adult | Adult | Same |
| Electrical | | | |
| TABLE 5 SUBSTANTIAL EQUIVALENCE | | | |
| FEATURE<br>510(k) Number | Masimo SedLine® Sedation Monitor<br>Subject device | Masimo SedLine® Sedation Monitor<br>Predicate device<br>(K172890) | Comparison |
| Type of power | Operates on low voltage DC provided through connection to host device. | Operates on low voltage DC provided through connection to host device. | Same |
| Electrical Safety/<br>EMC | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 | Same |
| Input/Output<br>Interface | | | |
| Type of Interface | MOC-9 | MOC-9 | Same |
| Communication<br>Type | Masimo Proprietary Protocol | Masimo Proprietary Protocol | Same |
| Mechanical |…