(498 days)
No
The summary describes a processed EEG monitor that uses a "proprietary computed EEG variable" (PSi). While this involves signal processing and computation, there is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with such technologies. The focus is on traditional signal processing and a proprietary algorithm.
No.
The device is a monitor that measures and displays EEG signals to assess the effect of anesthetic agents, rather than directly treating a condition.
Yes
The device is intended to monitor the state of data acquisition and processing of EEG signals, and provides a Patient State Index (PSi) related to the effect of anesthetic agents. This monitoring and assessment of physiological states is a diagnostic function.
No
The device description explicitly states that the system includes hardware components: the SedLine Module, SedLine EEG Sensor, and SedLine Patient Cable.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SedLine Sedation Monitor and Sensor work by directly measuring electrical activity from the patient's brain (EEG signals) through electrodes placed on the skin. This is a direct physiological measurement, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to monitor the state of data acquisition and processing of EEG signals and provide information related to the effect of anesthetic agents. This is a monitoring function, not a diagnostic test performed on a sample.
Therefore, the SedLine Sedation Monitor falls under the category of a patient-connected physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
OLW, OLT, GXY, OMC, ORT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
Adult and pediatric patients (1 year of age and older).
For PSi: Adults
For RD SedLine Pediatric Sensors: pediatric patients (1 to 17 years).
Intended User / Care Setting
Operating Room (OR), Intensive Care Unit (ICU), and clinical research laboratory.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing was performed for SedLine monitoring system. The non-clinical testing was conducted in accordance with Masimo requirements to ensure that the specifications of the subject device were met. The following non-clinical testing was performed:
- Software verification and validation testing per FDA Software Guidance
- Mechanical and Environmental Testing
The testing was found to support the expansion to the indications for use and do not raise different questions of safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K172890 - Masimo SedLine® Sedation Monitor
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K072286 - Aspect Medical System, Inc, BISx
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1400 Electroencephalograph.
(a)
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.(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). 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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | 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
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7982
FAX: (949) 297-7199 |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 10/13/2020 |
| Contact: | Sindura Penubarthi
Regulatory Affairs Senior Manager
Masimo Corporation
Phone: (949) 396-4041
spenubarthi@masimo.com |
| Trade Name: | Masimo SedLine Sedation Monitor and Accessories |
| Common Name: | Brain Function Monitor |
| Classification Regulation/
Product Code: | 21 CFR 882.1400, Class II/OLW |
| Additional Product Code: | OLT, OMC, ORT, GXY |
| Establishment Registration
Number: | 3011353843 |
| Reason for Premarket
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
pursuant to Section 514 of the Food and Drug Administration
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 | |
| (K172890) | |||
| General | |||
| Information | |||
| Intended Use | |||
| /Indications for Use | |||
| (IFU) | The SedLine® Sedation Monitor is | ||
| intended to monitor the state of the brain | |||
| by real-time data acquisition and | |||
| processing of EEG signals. The system | |||
| includes the Patient State Index (PSi), a | |||
| proprietary computed EEG variable that | |||
| is related to the effect of anesthetic | |||
| agents. 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 PSi is indicated for use on adults
sedated with the following agents:
Alfentanil, Desflurane, Fentanyl,
Isoflurane, Nitrous Oxide, Propofol,
Remifentanil, and Sevoflurane.
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. | The SedLine Sedation Monitor is
indicated for use in the operating room
(OR), intensive care unit (ICU), and
clinical research laboratory. It is intended
to monitor the state of the brain by real-time
data acquisition and processing of
EEG signals for adult patients (18 years
of age and older). The system includes
the Patient State Index (PSI), a
proprietary computed EEG variable that
is related to the effect of anesthetic
agents.
The agents include: Alfentanil,
Desflurane, Fentanyl, Isoflurane, Nitrous
Oxide, Propofol, Remifentanil, and
Sevoflurane. | Added the indication for pediatrics and the
specific use of SedLine with Masimo
SedLine sensors and cables. |
| TABLE 5 SUBSTANTIAL EQUIVALENCE | | | |
| FEATURE | Masimo SedLine® Sedation Monitor
Subject device | Masimo SedLine® Sedation Monitor
Predicate device
(K172890) | Comparison |
| 510(k) Number | 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). | | |
| Monitoring
Parameters | Electrode Status, EEG Waveforms,
Patient State Index (PSi), Density
Spectral Array (DSA),
Electromyography (EMG), Artifacts
(ARTF), Suppression Ratio (SR), and
Spectral Edge Frequency (SEFL/SEFR) | Electrode Status, EEG Waveforms,
Patient State Index (PSi), Density
Spectral Array (DSA),
Electromyography (EMG), Artifacts
(ARTF), Suppression Ratio (SR), and
Spectral Edge Frequency (SEFL/SEFR) | Same |
| Classification
Regulation/ Product
Code | 21 CFR 882.1400,Class II/OLW | 21 CFR 882.1400,Class II/OLW | Same |
| Additional Product
Codes | OLT, OMC, ORT, GXT | OLT, OMC, ORT, GXT | Same |
| Principle of
Operation | The SedLine is based upon the principle
that brain activity results in electrical
activity that can be create detectable
potential difference activity at the skin
surface of the forehead that increase with
increased brain activity and decrease
with reduced brain activity. The Patient
State Index (PSi) utilizes this relationship | The SedLine is based upon the principle
that brain activity results in electrical
activity that can be create detectable
potential difference activity at the skin
surface of the forehead that increase with
increased brain activity and decrease
with reduced brain activity. The Patient
State Index (PSi) utilizes this relationship | Same |
| TABLE 5 SUBSTANTIAL EQUIVALENCE | | | |
| FEATURE
510(k) Number | Masimo SedLine® Sedation Monitor
Subject device | Masimo SedLine® Sedation Monitor
Predicate device
(K172890) | Comparison |
| | 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. | 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. | |
| Function | | | |
| EEG Data Display | EEG Waveform, DSA | EEG Waveform, DSA | Same |
| PSi Algorithm | Adult | Adult | Same |
| Electrical | | | |
| TABLE 5 SUBSTANTIAL EQUIVALENCE | | | |
| FEATURE
510(k) Number | Masimo SedLine® Sedation Monitor
Subject device | Masimo SedLine® Sedation Monitor
Predicate device
(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/
EMC | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 | Same |
| Input/Output
Interface | | | |
| Type of Interface | MOC-9 | MOC-9 | Same |
| Communication
Type | Masimo Proprietary Protocol | Masimo Proprietary Protocol | Same |
| Mechanical | | | |
| Overall Dimensions | 4 by 1.3 by 0.8 in (10.2 by 3.3 by 2 cm) | 4 by 1.3 by 0.8 in (10.2 by 3.3 by 2 cm) | Same |
| Environmental | | | |
| Operating
Temperature | 5°C to 40°C | 5°C to 40°C | Same |
| Storage Temperature | -40°C to 70°C | -40°C to 70°C | Same |
| Humidity | 15-95% non-condensing | 15-95% non-condensing | Same |
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Image /page/9/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 logo is the text "MASIMO CORPORATION" in gray letters, followed by the address "52 Discovery, Irvine, CA 92618" also in gray letters.
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Image /page/10/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red symbol on the left, followed by 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.
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Image /page/11/Picture/0 description: The image shows the Masimo Corporation logo and address. The logo is a red circle with a white checkmark inside, followed by the word "Masimo" in black. The address is "52 Discovery, Irvine, CA 92618" and is located to the right of the logo.
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Image /page/12/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".
2. Performance Data
Biocompatibility Testing
Biocompatibility testing was not required for this submission as there was no change to the materials from the previously cleared adult SedLine sensor (K172890). The patient contacting materials were previously evaluated and found to be biocompatible in accordance with ISO 10993. Since there was no change to the patient contacting parts, additional biocompatibility testing was not conducted.
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
Electrical Safety, Environmental and Mechanical testing for the pediatric sensor was included in this submission.
Additional Electrical, Electromagnetic, Environmental, Mechanical and cleaning for this submission was not required as there was no change to the components from the previously cleared SedLine module (K172890).
Software Verification and Validation Testing
As part of this submission, additional Software verification and validation testing was conducted and documented as recommended by FDA's Guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005. The software for this device was still considered a "moderate" level of concern. The testing was found to support the substantial equivalence of the subject device.
Wireless and Cybersecurity Testing
Additional Wireless and Cybersecurity testing was not required as part of this submission as there were no changes to the wireless capabilities or communication capabilities of the subject device from the previously cleared SedLine sedation monitor (K172890). As a result, the acceptability of the wireless and cybersecurity risks for the subject device were determined based on the testing previously conducted as part of the predicate device clearance.
Human Factors Usability Testing
Additional Human Factors and Usability was not required as part of this submission as there was no change to the critical user related tasks or need for additional usability risk mitigations for the subject device from the previously cleared predicate device SedLine Sedation monitor (K172890). The human factor and usability consideration are the same as the previously cleared. As a result, the acceptability of the Human factors/ Usability risk for the subject device was determined based upon the testing conducted as part of the predicate device. The cleared predicate Sedation monitor had previously been tested in accordance with the FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016.
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Image /page/13/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 word "Masimo" is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
3. Non-clinical Performance Testing
Non-clinical performance testing was performed for SedLine monitoring system. The non-clinical testing was conducted in accordance with Masimo requirements to ensure that the specifications of the subject device were met. The following non-clinical testing was performed:
- Software verification and validation testing per FDA Software Guidance
- Mechanical and Environmental Testing
The testing was found to support the expansion to the indications for use and do not raise different questions of safety and effectiveness of the device.
4. Conclusion
The data provided as part of this submission supports the substantial equivalence of the subject device.