(350 days)
No
The description focuses on digital signal processing techniques to extract features from EEG signals and does not mention AI or ML.
No
The device is a monitoring system that processes EEG signals to provide information about the patient's brain state and the effects of anesthetics. It does not exert a therapeutic effect on the patient.
Yes
The device monitors the state of the brain by acquiring EEG signals and uses the BIS™ Index to guide anesthetic administration, which involves assessing and monitoring the effect of drugs on the brain. This activity falls under the definition of diagnosing or assessing conditions in the body.
No
The device description explicitly lists multiple hardware components, including a monitor, docking station, adapter cable, mounting accessory, BISx/BISx4 module, and patient/monitor interface cables.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples outside the body. The description clearly states that the BIS™ Advance Monitoring System acquires and processes EEG signals directly from the patient's head using sensors placed on the skin. This is an in vivo measurement, not an in vitro analysis of a biological sample like blood, urine, or tissue.
- The intended use is monitoring brain activity and guiding anesthetic administration. This is a physiological monitoring function, not a diagnostic test performed on a sample.
Therefore, the BIS™ Advance Monitoring System falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The BISTM Advance Monitoring System is intended for monitoring the state of the brain by data acquisition of EEG signals under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISTM Advance Monitoring System, and all its associated parameters, is intended for use on adults and pediatric patients (4 years old and above) within a hospital or medical facility.
For Adult patients, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of desflurane, propofol and sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain.
The use of the BIS™ Index for monitoring may be associated with the following when used with propofol anesthesia: reduction in primary anesthetic use; reduction in emergence and recovery time; and reduction in incidence of awareness with recall.
For pediatric patients, ages 4 and above, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of sevoffurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain.
The use of the BIS™ Index in pediatric patients, when used with sevothurane anesthesia, has demonstrated a reduction in primary anesthetic use.
Product codes
OLW, OMC, OLT, ORT
Device Description
The BIS™ Advance Monitoring System is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on acquisition and processing of EEG signals. It processes raw EEG signals to produce a single number, called the Bispectral Index, or BIS value, which correlates with the patient's level of hypnosis.
The BIS™ Advance Monitoring system is comprised of the following components: BIS™ Advance Monitor, BIS™ Advance Docking Station, BIS™ Advance Adapter Cable, GCX Mounting Accessory, BISx/BISx4 Module, Patient Interface Cable (PIC) and Monitor Interface Cable (MIC).
The BIS™ Advance Monitor displays:
- The current BIS™ number .
- . Raw EEG waveforms in real time
- . Various signal quality indicators (EMG. SQI)
- 트 Trend graphs of processed EEG parameters (including various options)
- I Processed EEG variables:
- . Electromyography (EMG)
- Signal Quality Index (SQI)
- . Suppression Ratio (SR)
- . Burst Count (BURST) (for Extend Sensor and four-channel monitoring only)
- . Suppression Time (ST)
- I Spectral Edge Frequency (SEF)
- Median Frequency (MF)
- EEG Power Asymmetry Index (ASYM) (for four-channel monitoring only)
- I Alarm Indicator and Messages
The BIS™ Advance Monitor displays 2 channels of EEG when connected to the BISx module and a unilateral BIS sensor (BIS™ Extend Sensor, BIS™ Pediatric Sensor and BIS™ Quatro Sensor) and displays 4 channels of EEG, two from each side of the brain, when connected to the BISx4 module and BIS™ Bilateral Sensor.
For both the 2-channel and the 4-channel systems, BIS monitoring is implemented as follows:
A sensor placed on the patient's head transmits EEG signals to the BISx module. The BISx module filters the data, analyzes it for artifacts and processes it using digital signal processing techniques, then sends the data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal in order to provide easier pattern recognition of changes over time during the recording.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
EEG signals
Anatomical Site
patient's head
Indicated Patient Age Range
Adult and pediatric patients (4 years old and above)
Intended User / Care Setting
licensed healthcare practitioner or by personnel trained in its proper use / hospital or medical facility
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)
-
Oliver (MDT19053OLIVER): A multicenter, prospective study conducted across 3 sites in the United States, with 143 subjects. Healthy volunteers were randomized to one of five anesthetic regimen groups (sevoflurane, sevoflurane with remifentanil, sevoflurane with fentanyl, desflurane, or isoflurane). The study determined the BIS50 and BIS95 values at which 50% and 95% of patients were unresponsive, finding these values were similar across all treatment groups. BIS™ values were highly correlated with the level of sedation, and prediction probabilities for correctly predicting whether a subject would respond to a verbal command were very high, suggesting BIS™ is an excellent predictor for the level of consciousness.
-
BTIGER (MDT20032BTIGER): A multicenter, prospective, randomized control study conducted across 8 sites in the United States, with 170 subjects. Pediatric subjects aged 4 - 18 years (ASA PS I - III) undergoing routine sevoflurane general anesthesia were included. The study determined the mean end-tidal sevoflurane (ETSevo) administration during the maintenance phase of anesthesia during pediatric surgery. ETSevo was statistically significantly lower in the BIS™ guided treatment group compared to the standard practice group. This study provides clinical evidence that the BIS™ index can be used to guide the anesthetic administration of sevoflurane in pediatric patients aged 4 - 18 years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Covidien LLC Moshe J Cohen Senior Regulatory Specialist 6135 Gunbarrel Ave Boulder, Colorado 80301
March 4, 2024
Re: K230693 Trade/Device Name: BISTM Advance Monitoring System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLW, OMC, OLT, ORT
Dear Moshe J Cohen:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 26, 2024. Specifically, FDA is updating this SE letter due to incomplete contact name, which was incorrectly stated as Moshe Cohen as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bradley Quinn, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-5575, bradley.quinn@fda.hhs.gov
Sincerely,
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthsia Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 26, 2024
Covidien LLC Moshe Cohen Senior Regulatory Specialist 6135 Gunbarrel Ave Boulder, Colorado 80301
Re: K230693
Trade/Device Name: BISTM Advance Monitoring System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLW, OMC, OLT, ORT Dated: February 18, 2024 Received: February 20, 2024
Dear Moshe Cohen:
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.
2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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.
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthsia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230693
Device Name BISTM Advance Monitoring System
Indications for Use (Describe)
The BISTM Advance Monitoring System is intended for monitoring the state of the brain by data acquisition of EEG signals under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISTM Advance Monitoring System, and all its associated parameters, is intended for use on adults and pediatric patients (4 years old and above) within a hospital or medical facility.
For Adult patients, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of desflurane, propofol and sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain.
The use of the BIS™ Index for monitoring may be associated with the following when used with propofol anesthesia: reduction in primary anesthetic use; reduction in emergence and recovery time; and reduction in incidence of awareness with recall.
For pediatric patients, ages 4 and above, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of sevoffurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain.
The use of the BIS™ Index in pediatric patients, when used with sevothurane anesthesia, has demonstrated a reduction in primary anesthetic use.
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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4
BIS™ Advance Monitoring System 510(k) Summary
This summary of 510(k) safety and effectiveness information for the BISTM Advance Monitoring System is submitted in accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with the requirements of 21 CFR §807.92.
SUBMITTER INFORMATION
Submitted Bv: Covidien, Ilc 6135 Gunbarrel Avenue Boulder. CO 80301 Date Prepared: 09 March 2023 Contact Person: Moshe J Cohen Senior Regulatory Affairs Specialist Phone: +972-507094475 Email: moshe.cohen2@medtronic.com
DEVICE
Trade Name: BIS™ Advance Monitoring System Common Name: BIS™ Advance Monitoring System Classification Requlation: 21 CFR 882.1400 Classification Name: Index-Generating Electroencephalograph Software Requlatory Class: Class II Primary Product Code: OLW Secondary Product Code: OMC, OLT, ORT Review Panel: Anesthesiology Devices
PREDICATE DEVICE
Predicate Manufacturer: Aspect Medical Systems, INC Predicate Trade Name: BIS EEG Vista Monitor System and BISX Predicate 510(k): K072286
PREVIOUS CORRESPONDENCE WITH FDA
Covidien held 2 Pre-Submission meetings with the FDA regarding this submission (Q200053 and Q200053 S001). Refer to VOL 020 Performance Testing Clinical for further details regarding previous correspondence with FDA.
5
DEVICE DESCRIPTION
The BIS™ Advance Monitoring System is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on acquisition and processing of EEG signals. It processes raw EEG signals to produce a single number, called the Bispectral Index, or BIS value, which correlates with the patient's level of hypnosis.
The BIS™ Advance Monitoring system is comprised of the following components: BIS™ Advance Monitor, BIS™ Advance Docking Station, BIS™ Advance Adapter Cable, GCX Mounting Accessory, BISx/BISx4 Module, Patient Interface Cable (PIC) and Monitor Interface Cable (MIC).
The BIS™ Advance Monitor displays:
- The current BIS™ number .
- . Raw EEG waveforms in real time
- . Various signal quality indicators (EMG. SQI)
- 트 Trend graphs of processed EEG parameters (including various options)
- I Processed EEG variables:
- . Electromyography (EMG)
- Signal Quality Index (SQI)
- . Suppression Ratio (SR)
- . Burst Count (BURST) (for Extend Sensor and four-channel monitoring only)
- . Suppression Time (ST)
- I Spectral Edge Frequency (SEF)
- Median Frequency (MF)
- EEG Power Asymmetry Index (ASYM) (for four-channel monitoring only)
- I Alarm Indicator and Messages
The BIS™ Advance Monitor displays 2 channels of EEG when connected to the BISx module and a unilateral BIS sensor (BIS™ Extend Sensor, BIS™ Pediatric Sensor and BIS™ Quatro Sensor) and displays 4 channels of EEG, two from each side of the brain, when connected to the BISx4 module and BIS™ Bilateral Sensor.
For both the 2-channel and the 4-channel systems, BIS monitoring is implemented as follows:
A sensor placed on the patient's head transmits EEG signals to the BISx module. The BISx module filters the data, analyzes it for artifacts and processes it using digital signal processing techniques, then sends the data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal in order to provide easier pattern recognition of changes over time during the recording.
6
Image /page/6/Figure/2 description: This image shows a medical device with several labeled parts. The device includes a screen labeled as '1', a camera labeled as '2', and a cable labeled as '3'. The device is attached to a stand labeled as '4', and another cable labeled as '5' is connected to it.
Figure 1. BIS™ Advance Monitoring System Components
| Number | Component |
|---|---|
| 1 | BIS TM Advance Monitor |
| 2 | BIS TM Docking Station |
| 3 | BIS TM Adapter Cable |
| 4 | GCX mounting accessory |
| 5 | Monitor Interface Cable (MIC) |
| 6 | BIS TM Sensor |
| 7 | Patient Interface Cable (PIC) |
| 8 | BISx/BISx4 module |
7
INDICATIONS FOR USE
The BIS™ Advance Monitoring System is intended for monitoring the state of the brain by data acquisition of EEG signals under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS™ Advance Monitoring System, and all its associated parameters, is intended for use on adults and pediatric patients (4 years old and above) within a hospital or medical facility.
For Adult patients, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of desflurane, isoflurane, propofol and sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain.
The use of the BIS™ Index for monitoring may be associated with the followinq when used with propofol anesthesia: reduction in primary anesthetic use; reduction in emergence and recovery time; and reduction in incidence of awareness with recall.
For pediatric patients, ages 4 and above, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain.
The use of the BIS™ Index in pediatric patients, when used with sevoflurane anesthesia, has demonstrated a reduction in primary anesthetic use.
TECHNOLOGICAL CHARACTERISTICS COMPARISON
There are 2 proposed changes in this submission in regard to the predicate device. The first change is related to the indications for use, which will be narrowed down from the predicate device. The indications for use of the subject device now specify the minimum age of patients (4 years and above), as well as the specific anesthetic agents for which the BIS™ Advance Monitoring System may be utilized to guide administration of, and the clinical benefits that mav be associated with when utilizing the BIS™ Advance Monitoring System to quide administration of specified anesthetic agents. The revised indications for use do not introduce any new indications, claims or target populations. The indication for use changes are supported by clinical studies and detailed in this submission in VOL 020 Performance Testing Clinical.
The second change is related to a new monitor design, the BIS™ Advance Monitor, which will replace the predicate monitor, the BIS VISTA Monitor. The BISx/BISx4 modules and the BIS™ Sensors are not modified as part of this submission and rely on the previously cleared 510k submissions, K072286 and K143506, respectively.
The BIS™ Advance Monitor is a customized off the shelf durable tablet designed for the same functionality as the predicate device, BIS VISTA Monitor: it displays EEG data and processed parameters computed by the BISx/BISx4 module either numerically and/or graphically, via user interface, and presents alarms when alarm thresholds are crossed. The new monitor is equipped with a larger display, additional user interface options and up-todate operating system.
8
The BIS™ Advance Monitor is provided with a newly-developed software which integrates all key features of the predicate, while incorporating a user interface that closely mirrors it, along with minor changes and improvements, as summarized below:
- Display and user-interface modifications, to implement minor . improvements and increased number of user-selection options
- New low-priority alarms and additional battery life alert ●
- Removal of two processed parameters, sEMG and sBIS, which have ● no clinical significance
- New electromagnetic interference artifact detection .
The software change does not impact diagnosis and treatment, as no software changes were performed to the BISx/BISx4 module (the unit that performs the computation for EEG acquisition), the BIS algorithm nor to the algorithm database structure.
The change is mainly focused on the display of data while the principle of operation, main displayed parameters as well as the technology utilized for acquisition and processing of EEG waves are all unaffected by the change. The verification and validation tests enable the use of the BIS™ Advance Monitor for use with the existing BISx/BISx4 module and the BIS™ sensors. Based on the results of the verification and validation studies (including system verification), the subject device, the BIS™ Advance Monitor, is substantially equivalent to the predicate device.
The following technological characteristics comparison was performed on the BIS™ Advance Monitor of the subject device vs. the BIS Vista Monitor of the predicate device. The other components of both the subject and predicate devices are identical and will therefore be excluded from this comparison.
| Device
Characteristic | Subject Device
BIS™ Advance
Monitoring System | Predicate Device
BIS EEG VISTA Monitor
System and BISX
(K072286) | Similarities
and
Differences |
|----------------------------------|-------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------|
| Classification | II | II | Similar |
| Device
Classification
Name | Index-Generating
Electroencephalograph
Software | Index-Generating
Electroencephalograph
Software | Similar |
| Primary Product
Code | OLW | OLW | Similar |
| Secondary
Product Code(s) | OMC, OLT, ORT | OMC, OLT, ORT | Similar |
9
| Fundamental
Technology | Acquisition, processing
and display of real-
time EEG waveforms
and processed EEG
parameters | Acquisition, processing and
display of real-time EEG
waveforms and processed
EEG parameters | Similar |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of
Operation | EEG signals are
transmitted from
sensors placed on
patient's head to the
BISx/BISx4 Module.
The BISx module
filters the data,
analyzes it for artifact
and processes it using
digital signal
processing techniques,
then sends the data to
the monitor for display. | EEG signals are transmitted
from sensors placed on
patient's head to the
BISx/BISx4 Module. The
BISx module filters the data,
analyzes it for artifact and
processes it using digital
signal processing
techniques, then sends the
data to the monitor for
display. | Similar |
| Regulation
Number | 882.1400 | 882.1400 | Similar |
| Prescription/over
the counter use | Prescription | Prescription | Similar |
| Intended
Population | Adult and pediatric,
from age 4 years and
up | Adult and pediatric, without
age limitation | Different:
pediatric
patients age
is now limited |
| Intended Users | Professionally trained
health care providers | Professionally trained
health care providers | Similar |
| Environment of
Use | hospitals or medical
facilities providing
patient care | hospitals or medical
facilities providing patient
care | Similar |
| Monitor | BISTM Advance
Monitor | BIS VISTA Monitor | Similar: Same
functionality
Different:
minor
software
changes,
mostly UI-
related,
SOUP and
OS changes,
updated
hardware
design |
10
| | | | different
dimensions
and weight,
new docking
station,
mounting
accessories
and adapter
cable to
connect to the
BISx/BISx4 |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Monitor –
Primary External
materials | Glass, TPR
(Thermoplastic
rubber), ABS
(Acrylonitrile butadiene
styrene), PC
(Polycarbonate),
Acrylic, Zinc alloy,
Lexan 8B35 film | Glass, ABS (Acrylonitrile
butadiene styrene), PC
(Polycarbonate), Polyester,
Polyutherane | Different
(note - the
monitor does
not come in
contact with
the patient) |
| User interface | Default display options
along with user-
selection options for
display of EEG and
processed parameters
and graphs; Display of
alert messages; User-
selection options for
setting and configuring
alarms | Default display options
along with user-selection
options for display of EEG
and processed parameters
and graphs; Display of alert
messages; User-selection
options for setting and
configuring alarms | Similar: main
features
remain
unchanged
Different:
More user-
selection
options
compared to
predicate,
change to
default
settings for
specific
parameters,
additional
export-to-file
support, new
low-priority
configurable
alarms,
additional
battery life |
11
| | | | display
improvements |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electromagnetic
interference
artifact detection | Supported, system
adjusts the Signal
Quality Indicator
accordingly | Not supported | Different:
allows for a
more
accurate
Signal Quality
Indicator |
| Monitor
Operating
System | Windows 10 Enterprise | Windows CE | Different |
| Display size | Height: 5.3"
Width: 8.5" | Height: 4"
Width: 5.25" | Different |
| Module | BISX/BISX4 | BISX/BISX4 | Similar |
| Monitor
accessories | Docking Station;
GCX Clamp Mount /
GCX Desktop Mount;
Adapter Cable | Pole Clamp | Different:
different
monitor
mounting
accessories
to
accommodate
the different
monitor
designs; New
Adapter
Cable to allow
connection of
the new
monitor to the
existing
Monitor
Interface
Cable which
connects to
the
BISx/BISx4
module |
| Sensors | BISTM sensors (cleared
under K143506):
Quatro / Pediatric /
Extend / Bilateral | BISTM sensors (cleared
under K143506): Quatro /
Pediatric / Extend / Bilateral | Similar |
| Displayed data | EEG, BIS index, SR,
ST, SQI, EMG, Burst
Count, DSA ASYM | EEG, BIS index, SR, ST,
SQI, EMG, Burst Count,
DSA ASYM SEMG sBIS | Different:
sEMG and
sBIS removed |
12
| | artifact detection,
alarm indicators and
messages, trend
graphs of processed
EEG Parameters | artifact detection alarm
indicators and messages,
trend graphs of processed
EEG Parameters | from subject
device display
due to not
being
supported by
scientifically-
proven
clinical
significance
and device
claims |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Energy Source | AC-power source;
Internal lithium-ion
battery | AC-power source;
Internal lithium-ion battery | Similar |
| Software level of
concern | Moderate | Moderate | Similar |
| Sterility | Non-sterile | Non-sterile | Similar |
| Main Safety and
Performance
Standards | 1. IEC 60601-
1:2005+A1:2012 /
ANSI/AAMI
ES60601-
1:2005/(R)2012 and
A1:2012,
C1:2009/(R)2012
and
A2:2010/(R)2012
2. IEC 60601-1-2:2014
3. IEC 60601-1-6:
2010 +A1:2013
4. IEC 60601-1-8:
2006 + A1:2012
5. IEC 62366-1:2015
6. IEC 80601-2-
26:2019
7. IEC 62133-2:2017 | 1.IEC 60601-
1:2005+A1:2012+A2:2020
2.IEC 60601-1-
2:2014+A1:2020
3.IEC 60601-1-6:2010 +
A1:2013 +A2:2020
4.IEC 60601-1-8:2006 +
A1:2012+A2:2020
5.IEC 62366-1:2015 +
A1:2020
6.IEC 80601-2-26:2019
7.IEC 62133-2:2017 | Similar, with
the exception
of 2020
amendments
of several
standards,
which are still
under
transition
period - the
predicate
device
already
complies with
such
amendments,
while the
subject
device is
scheduled to
comply with
the
amendments
before the
end of the
transition
period |
13
PERFORMANCE DATA
The following performance data is provided to support the substantial equivalence determination with the predicate device:
Electrical Safety and EMC
Electrical safety and EMC testing were performed per ANSI/AAMI ES 60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012, IEC 60601-1-2:2014. Additionally, testing was performed in accordance with the deviceparticular safety and performance standard, IEC 80601-2-26:2019. Electrical Safety and EMC Test reports are provided in sections VOL 017 Electromagnetic Compatibility and Electrical Safety and VOL 018 Performance Testing Bench.
General Performance
VOL 018 Performance Testing Bench contains a summary of all the performance bench testing performed on the subject device. The results of the bench performance testing demonstrate that the performance of the subject device, BIS™ Advance Monitor, complies with the requirements of testing standards applied.
Hazard/Risk Analysis
A hazard analysis was carried out on the BIS™ Advance Monitor's software in compliance with ISO 14971:2019. This hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of. The hazard analysis is detailed further in this submission in MISC FILES: 001 Extract of the monitor software-related items from BIS Advance Risk Management File.
Software
The software description and documentation, including test report, are provided in VOL 016 Software. The test report indicates that the BIS™ Advance Monitor software complies with all software requirements and design specifications.
Biocompatibility
The BIS™ Advance Monitor does not come into direct or in-direct contact with the patient. Therefore, no biocompatibility assessment is required.
Performance Testing - Animal
No animal performance testing was required to demonstrate subject device safety and effectiveness.
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Performance Testing - Clinical
Clinical studies were performed and outlined in section VOL 020 Performance Testing Clinical of this submission. The proposed changes to the indications for use are supported via performance of the following clinical studies:
1. Oliver (MDT19053OLIVER)
This multicenter, prospective study was conducted to investigate the relationship between BIS™ and inhaled anesthetics across a wide range of anesthetic concentration and hypnotic states.
This study was conducted across 3 sites in the United States, in 143 subjects. Healthy volunteers were randomized to one of five anesthetic regimen groups: sevoflurane, sevoflurane with remifentanil, sevoflurane with fentanyl, desflurane, or isoflurane. The OLIVER trial determined the BIS50 and BIS95 values at which 50% and 95% of patients were unresponsive and found that these values were similar across all treatment groups BIS™ values were highly correlated with level of sedation and the prediction probabilities for correctly predicting whether a subject would respond to a verbal command were very high, suggesting that BIS™ is an excellent predictor for the level of consciousness.
2. BTIGER (MDT20032BTIGER)
This multicenter, prospective, randomized control study was conducted to investigate the relationship between BIS™ values including EEG profile and anesthetic agents in the pediatric population.
This study was conducted across 8 sites in the United States, in 170 subjects. Pediatric subjects aged 4 - 18 years (ASA PS I - III) undergoing routine sevoflurane general anesthesia were included in the trial. The BTIGER study determined the mean end-tidal sevoflurane (ETSevo) administration during the maintenance phase of anesthesia during pediatric surgery. ETSevo was statistically significantly lower in the BIS™ guided treatment group compared to the standard practice group. This study provides clinical evidence that the BIS™ index can be used to quide the anesthetic administration of sevoflurane in pediatric patients aged 4 - 18 years.
Previous Correspondence With FDA
Covidien held 2 Pre-Submission meeting with the FDA regarding this submission (Q200053 BIS and Q200053 S001 BIS). Refer to VOL 020 Performance Testing Clinical for further details regarding previous correspondence with FDA.
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CONCLUSIONS
The subject device, BIS™ Advance Monitor is equivalent in intended use, technological characteristics and performance to the existing legally marketed predicate device. The subject device was tested to verify and validate the safety and performance of the new monitor and its substantial equivalence to the predicate device. From the evidence presented in this Premarket Notification, the subject device can be considered substantially equivalent to the predicate device.