(498 days)
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).
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.
This document specifies that the Masimo SedLine Sedation Monitor and Accessories (subject device) is substantially equivalent to the Masimo SedLine® Sedation Monitor (K172890) (predicate device). The key difference is the expansion of indications for use to include pediatric patients and the addition of pediatric sensors. The majority of the original acceptance criteria and performance data for the predicate device were maintained, with additional testing focusing on the new pediatric sensor and software verification for the expanded indications.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the specifications of the SedLine device and the pediatric sensor. These specifications effectively serve as acceptance criteria for the various features and functionalities of the device.
| Feature | Acceptance Criteria (Specification) | Reported Device Performance (Implied by substantial equivalence) |
|---|---|---|
| SedLine Specifications (General) | ||
| PSI Display Range | 0 to 100 | Meets specification |
| EMG Display Range | 0 to 100% | Meets specification |
| SR Display Range | 0 to 100% | Meets specification |
| ARTF Display Range | 0 to 100% | Meets specification |
| DSA Amplitude (Left & Right) | -60 to 40 dB | Meets specification |
| SEFL/SEFR | 0-30Hz | Meets specification |
| DSA Asymmetry | -100% to +100% | Meets specification |
| Electrode Impedance | 0 to 65 kohms | Meets specification |
| DSA Frequency Range | 0 to 30 Hz and 0 to 40 Hz | Meets specification |
| Resolution | ||
| PSI | 1 | Meets specification |
| EMG | 1% | Meets specification |
| SR | 2% | Meets specification |
| ARTF | 1% | Meets specification |
| DSA Amplitude (Left & Right) | ≤1dB | Meets specification |
| SEFL/SEFR | 1 Hz | Meets specification |
| DSA Asymmetry | 1% | Meets specification |
| Electrode Impedance | 1 kohms | Meets specification |
| General | ||
| Visual/Audible Alarm | Host/Backboard Device (Masimo Root Monitoring System) provides in compliance with IEC60601-1-8 | Meets standard |
| Storage/Recording | Host/Backboard Device (Masimo Root Monitoring System) provides trend/data storage | Meets specification |
| Electrical | ||
| DC Power | Host/Backboard Device (Masimo Root Monitoring System) provides DC power to SedLine Module | Meets specification |
| Interface | ||
| SedLine Module Connection | MOC-9 interface | Meets specification |
| Mechanical | ||
| Module Dimensions | 1 3/10 in (3.3 cm) x 4 in (10.2 cm) x .8 in (2.0 cm) | Meets specification |
| Environmental (Operating) | ||
| Temperature | +41°F to +104°F (+5°C to +40°C) | Meets specification |
| Humidity | 15% to 95%, non-condensing | Meets specification |
| Environmental (Storage) | ||
| Temperature | -40°F to +158°F (-40°C to +70°C) | Meets specification |
| Humidity | 15-95%, non-condensing | Meets specification |
| SedLine Pediatric Sensor Specifications | ||
| Application Site | Forehead | Meets specification |
| Intended patient population | 1 to 17 years | Meets specification (new indication) |
| Mechanical Dimensions | 7" by 5.5" | Meets specification |
| Biocompatibility | ISO 10993-1 | Meets standard |
| Operating Temperature | 10°C to 40°C | Meets specification |
| Storage Temperature | -40°C to +70°C | Meets specification |
| Humidity | 10% to 95% non-condensing | Meets specification |
The "Reported Device Performance" for most criteria is implied by the statement "The testing was found to support the substantial equivalence of the subject device" and "The non-clinical testing was conducted in accordance with Masimo requirements to ensure that the specifications of the subject device were met." For the pediatric sensor, specific dimensions and environmental specifications are provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for test sets for the performance of the device's main functionalities (EEG signal processing, PSi calculation, etc.). The non-clinical testing for the subject device focused on software verification/validation, mechanical, and environmental aspects related to the expansion of indications and pediatric sensor.
- Software Verification and Validation Testing: Conducted 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 was considered a "moderate" level of concern. No specific sample size or data provenance details are provided for this testing.
- Mechanical and Environmental Testing (Pediatric Sensor): Performed, but no specific sample size or data provenance details are provided.
- The document mentions that biocompatibility, wireless and cybersecurity, and human factors usability testing were not required for this submission as there were no changes to the materials, wireless capabilities, communication capabilities, or critical user-related tasks from the previously cleared predicate device (K172890). Therefore, the test data for these aspects would pertain to the predicate device and are not detailed here.
Overall, specific sample sizes and data provenance for the tests conducted for this submission are not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide information about the number or qualifications of experts used to establish ground truth for any test sets. The tests mentioned are primarily engineering/software verification and validation, and mechanical/environmental testing, which typically do not involve expert-established ground truth in the same way clinical studies might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication methods for the test sets.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study is mentioned in the provided text. The device is a monitor that provides processed EEG data (including PSi), not an AI assisting human readers in interpretation like in diagnostic imaging.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device as a "SedLine Sedation Monitor" that processes EEG signals to compute values like the Patient State Index (PSi). The PSi is "computed continuously from monitored changes in the QEEG when the sensor is applied." This indicates that the algorithm for generating PSi operates in a standalone manner, deriving its output directly from the EEG signals. The performance specifications for PSi (display range, resolution) are listed, and the overall non-clinical performance testing was conducted to ensure the device met its specifications. Therefore, the device's core algorithms operate in a "standalone" fashion on the incoming EEG data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the device's core functionality (PSi calculation related to anesthetic effect), the "ground truth" implicitly relates to the physiological changes in brain activity due to anesthetic agents. The PSi is described as "a proprietary computed EEG variable that is related to the effect of anesthetic agents" and "intended to provide information on the changes in sedation with the lower values reflecting lower levels of brain activity and deeper levels of sedation." The underlying validation of this relationship to actual anesthetic depth would have been established during the development and clearance of the predicate device. This document does not detail the specific ground truth used for that relationship.
For the current submission, the ground truth for the verification and validation (V&V) testing would be the predefined functional requirements, design specifications, and relevant standards (e.g., ISO 10993 for biocompatibility, IEC 60601-1 for electrical safety).
8. The sample size for the training set
The document does not mention a training set or its sample size. The focus is on the verification and validation of the device's performance, not on the training of a machine learning model for a new diagnostic task. The PSi algorithm is described as "proprietary" and "computed continuously," suggesting a fixed algorithm rather than one that undergoes continuous training with new data.
9. How the ground truth for the training set was established
Not applicable, as no training set is discussed in the document.
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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 (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
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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) | |
|---|---|
| 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 ofManufacturing Facility: | Masimo Corporation52 DiscoveryIrvine, CA 92618Phone: (949) 297-7982FAX: (949) 297-7199 |
|---|---|
| Date: | 10/13/2020 |
| Contact: | Sindura PenubarthiRegulatory Affairs Senior ManagerMasimo CorporationPhone: (949) 396-4041spenubarthi@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 RegistrationNumber: | 3011353843 |
| Reason for PremarketNotification: | 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 promulgatedpursuant to Section 514 of the Food and Drug AdministrationModernization 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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| 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) | |
| GeneralInformation | |||
| Intended Use/Indications for Use(IFU) | The SedLine® Sedation Monitor isintended to monitor the state of the brainby real-time data acquisition andprocessing of EEG signals. The systemincludes the Patient State Index (PSi), aproprietary computed EEG variable thatis related to the effect of anestheticagents. The SedLine® Sedation Monitoris indicated for adult and pediatricpatients (1 year of age and older) in theoperating room (OR), intensive care unit(ICU), and clinical research laboratory.The PSi is indicated for use on adultssedated with the following agents:Alfentanil, Desflurane, Fentanyl,Isoflurane, Nitrous Oxide, Propofol,Remifentanil, and Sevoflurane.The SedLine® is only to be used withMasimo SedLine® sensors and cables.The use of any other sensor or cable isneither supported nor recommended byMasimo, and could give erroneousresults. | The SedLine Sedation Monitor isindicated for use in the operating room(OR), intensive care unit (ICU), andclinical research laboratory. It is intendedto monitor the state of the brain by real-timedata acquisition and processing ofEEG signals for adult patients (18 yearsof age and older). The system includesthe Patient State Index (PSI), aproprietary computed EEG variable thatis related to the effect of anestheticagents.The agents include: Alfentanil,Desflurane, Fentanyl, Isoflurane, NitrousOxide, Propofol, Remifentanil, andSevoflurane. | Added the indication for pediatrics and thespecific use of SedLine with MasimoSedLine sensors and cables. |
| TABLE 5 SUBSTANTIAL EQUIVALENCE | |||
| FEATURE | Masimo SedLine® Sedation MonitorSubject device | Masimo SedLine® Sedation MonitorPredicate device(K172890) | Comparison |
| 510(k) Number | SedLine SensorThe RD SedLine Pediatric Sensorelectrodes are applied directly to thepatient's skin to enable the recording ofelectrophysiological signals (e.g., EEG).The RD SedLine Pediatric Sensors areindicated for pediatric patients (1 to 17years). | ||
| MonitoringParameters | Electrode Status, EEG Waveforms,Patient State Index (PSi), DensitySpectral Array (DSA),Electromyography (EMG), Artifacts(ARTF), Suppression Ratio (SR), andSpectral Edge Frequency (SEFL/SEFR) | Electrode Status, EEG Waveforms,Patient State Index (PSi), DensitySpectral Array (DSA),Electromyography (EMG), Artifacts(ARTF), Suppression Ratio (SR), andSpectral Edge Frequency (SEFL/SEFR) | Same |
| ClassificationRegulation/ ProductCode | 21 CFR 882.1400,Class II/OLW | 21 CFR 882.1400,Class II/OLW | Same |
| Additional ProductCodes | OLT, OMC, ORT, GXT | OLT, OMC, ORT, GXT | Same |
| Principle ofOperation | The SedLine is based upon the principlethat brain activity results in electricalactivity that can be create detectablepotential difference activity at the skinsurface of the forehead that increase withincreased brain activity and decreasewith reduced brain activity. The PatientState Index (PSi) utilizes this relationship | The SedLine is based upon the principlethat brain activity results in electricalactivity that can be create detectablepotential difference activity at the skinsurface of the forehead that increase withincreased brain activity and decreasewith reduced brain activity. The PatientState Index (PSi) utilizes this relationship | Same |
| TABLE 5 SUBSTANTIAL EQUIVALENCE | |||
| FEATURE510(k) Number | Masimo SedLine® Sedation MonitorSubject device | Masimo SedLine® Sedation MonitorPredicate device(K172890) | Comparison |
| to establish characteristics of the EEGthat can be quantified to establishmultivariate combinations of quantitativeelectroencephalogram (QEEG) variablesthat are sensitive to the brain activityunder changing levels of anesthesia. ThePSi is the result of a proprietarycomputation that combines weightedquantitative values reflecting manydimensions of brain electrical activity,such as: (1) changes in power in variousEEG frequency bands, (2) changes insymmetry and synchronization betweencritical brain regions, and (3) theinhibition of regions of the frontal cortex.The PSi is computed continuously frommonitored changes in the QEEG whenthe sensor is applied. The PSi values areintended to provide information on thechanges in sedation with the lower valuesreflecting lower levels of brain activityand deeper levels of sedation. | to establish characteristics of the EEGthat can be quantified to establishmultivariate combinations of quantitativeelectroencephalogram (QEEG) variablesthat are sensitive to the brain activityunder changing levels of anesthesia. ThePSi is the result of a proprietarycomputation that combines weightedquantitative values reflecting manydimensions of brain electrical activity,such as: (1) changes in power in variousEEG frequency bands, (2) changes insymmetry and synchronization betweencritical brain regions, and (3) theinhibition of regions of the frontal cortex.The PSi is computed continuously frommonitored changes in the QEEG whenthe sensor is applied. The PSi values areintended to provide information on thechanges in sedation with the lower valuesreflecting lower levels of brain activityand 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 | |||
| FEATURE510(k) Number | Masimo SedLine® Sedation MonitorSubject device | Masimo SedLine® Sedation MonitorPredicate 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 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 | Same |
| Input/OutputInterface | |||
| Type of Interface | MOC-9 | MOC-9 | Same |
| CommunicationType | 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 | |||
| OperatingTemperature | 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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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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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.
§ 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).