(114 days)
No
The document describes a multi-parameter patient monitor with standard physiological monitoring capabilities and enhanced software features like arrhythmia detection and NEWS calculation. While these features involve complex algorithms, there is no mention of AI or ML being used in their implementation or in any other aspect of the device's functionality. The description focuses on hardware, software updates, and standard signal processing techniques.
No
The device is described as a "multi-parameter unit to be used for monitoring, and to generate alarms for multiple physiological parameters". Its functions are to monitor, display, and alarm, not to treat or provide therapy.
Yes
The device monitors, displays, and generates alarms for multiple physiological parameters, including ECG with diagnostic analysis (e.g., arrhythmia detection, ST segment analysis), invasive and non-invasive blood pressure, SpO2, temperature, respiration rate, and airway gases, which are all used to assess a patient's health status. The ECG Diagnostic Analysis and Measurement, along with specific arrhythmia detection, indicates the device provides information for diagnostic interpretation.
No
The device description explicitly states it is a "multi-parameter patient monitor" and details hardware components like an LCD display, integrated keypad, measurement modules (Hemo module, E-MiniC module), and a wireless interface module. It also mentions hardware bench testing.
Based on the provided text, the device (Monitor B125/B105) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport." This describes a device that monitors physiological signals directly from the patient's body.
- Parameters Monitored: The list of parameters monitored (ECG, blood pressure, heart/pulse rate, SpO2, temperature, respiration rate, airway gases, cardiac output, Entropy) are all physiological measurements taken from the patient.
- Device Description: The description reinforces that it's a "multi-parameter patient monitor" that utilizes modules to measure these physiological parameters.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly monitor physiological functions within the body.
N/A
Intended Use / Indications for Use
The monitor B125/B105 is a portable multi-parameter unit to be used for monitoring, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport.
The monitor B125/B105 is intended for use under the direct supervision of a licensed health care practitioner.
The monitor B125/B105 is not intended for use during MRI.
The monitor B125/B105 can be a stand-alone monitor or interfaced to other devices via network.
The monitor B125/B105 monitors and displays: ECG (including ST segment, arrhythmia detection, ECG Diagnostic Analysis and Measurement), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/ Bladder/Axillary/Skin/Airway/Room/Myocardial/ Core/Surface temperature, impedance respiration rate, airway Gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate), Cardiac output (C.O.) and Entropy.
The monitor B125/B105 is able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.
Product codes
MHX, BZQ, CBR, CBS, CBQ, CCK, CCL, DXN, DQA, DRT, DSJ, DSK, GWQ, FLL, NHO, NHP, NHQ, DPZ, DQK, DSI, DSJ, KRB, MLD, OLT, OLW, OMC, ORT.
Device Description
The proposed Monitor B125/B105 is a multi-parameter patient monitor that was developed based on predicate Monitor B125/B105 (K171580) to provide additional monitored parameters: Airway gases, Entropy and Cardiac output, by supporting additional optional modules previously cleared by FDA: CARESCAPE Respiratory module (K171028), Airway Ga Option N-CAiO(K151063), E-Entropy Module (K150298) (E-ENTROPY-01) and E-COP module (K052976) with extension interface rack and/or second frame(B1X5-F2).
In addition to the added parameters, the proposed Monitor B125/B105 offers several enhanced software features:
- Enabled the Impedance Respiration measurement for Neonates (in addition to Ped/Adult);
- Option called "Full Disclosure" to allow the display of parameter waveforms for up to 36 hours;
- National Early Warning Score (NEWS) calculation provided ;
- Additional printing capabilities to a remote recorder/Laser printer connected to a central station;
- Adoption of EK-Pro V14 ECG algorithm (previously cleared K191323) to support enhanced arrhythmia detection performance;
- Added Irregular, SV Tachy and Supra Ventricular Contraction (SVC), three more arrhythmia alarms;
- Enhanced parameter alarm priority adjustment/ configuration options,
- Cybersecurity enhancements.
The proposed monitor B125 and B105 is based on the previous design, and therefore shares a common software and hardware platform with its primary predicate, the Monitor B125/B105 (K171580). The primary function and operation of the monitors remain unchanged from the predicate. The difference between the two models (B125 and B105) is the LCD screen size. B125 has a 12-inch display; B105 has a 10-inch display. There is no change from the predicate in the display size.
As with the predicate Monitor B125/B105 (K171580), the proposed Monitor B125/B105 is a multi-parameter patient monitor, utilizing an LCD display with an integrated keypad and an identical pre-configuration patient parameter measurement module (Hemo module) which provides basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2. The proposed Monitor B125/B105 uses the identical E-MiniC module (K052582) and equivalent optional thermal recorder module as the predicate B125/B105 (K171580).
As with the predicate Monitor B125/B105 (K171580), the proposed Monitor B125/B105 interfaces to a variety of existing central station systems via a cabled or wireless network interface. The wireless interface is implemented with the identical integrated WIFI module (WLAN module type: B1x5-01. FCC ID: OU5B1X501) as used in the predicate Monitor B125/B105 (K171580).
As with the predicate Monitor B125/B105 (K171580), proposed Monitor B105/B125 includes features and subsystems that are optional or configurable. It can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric, and neonatal patients
Intended User / Care Setting
licensed health care practitioner, hospital environment and during intrahospital transport.
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)
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the proposed Monitor B125/B105, demonstrating the design meets the specifications.
The hardware bench testing included electromagnetic compatibility, electrical safety, environmental, WLAN, and usability.
Software testing included software design, development, verification, validation and traceability. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered "Major" level of concern, the same as the predicate.
Patient safety, security, and privacy risks have been addressed in the design and development of the proposed B125/B105 including a Security Risk Assessment and Threat model. This includes system integrity controls, access controls, audit controls and network controls which map to the General Principles and Security Capabilities outlined in the FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on October 2, 2014.
Testing was completed to show the device can withstand network storm, i.e. continue to monitor patients without rebooting when connected by wire to GE Unity networks which suffer broadcast storm traffic.
The subject of this premarket submission, the proposed Monitor B125/B105 did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K171580, K151063, K191323, K143676, K162012, K122223
Reference Device(s)
K171028, K150298, K052976, K052582, K123195
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
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November 04, 2020
GE Medical Systems Information Technologies, Inc. Joel Kent Senior Regulatory Affairs Manager 8200 West Tower Avenue Milwaukee, Wisconsin 53223
Re: K201941
Trade/Device Name: Monitor B125/B105 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX Dated: October 2, 2020 Received: October 5, 2020
Dear Joel Kent:
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 (OS) 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/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,
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201941
Device Name Monitor B125/B105
Indications for Use (Describe)
The monitor B125/B105 is a portable multi-parameter unit to be used for monitoring, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport.
The monitor B125/B105 is intended for use under the direct supervision of a licensed health care practitioner.
The monitor B125/B105 is not intended for use during MRI.
The monitor B125/B105 can be a stand-alone monitor or interfaced to other devices via network.
The monitor B125/B105 monitors and displays: ECG (including ST segment, arrhythmia detection, ECG Diagnostic Analysis and Measurement), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/ Bladder/Axillary/Skin/Airway/Room/Myocardial/ Core/Surface temperature, impedance respiration rate, airway Gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate), Cardiac output (C.O.) and Entropy.
The monitor B125/B105 is able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.
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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3
Section 5: 510(k) Summary
Monitor B125/B105
4
510(k) Summary
In accordance with 21 CFR 807.92(c) the following summary of information is provided:
Owner/Contact/Date (807.92(a)(1): | |
---|---|
Date: | July 10th, 2020 |
Submitter: | GE Medical Systems Information Technologies, Inc. |
8200 West Tower Avenue | |
Milwaukee, Wisconsin 53223 | |
USA | |
Primary Contact Person: | Joel Kent |
Senior Regulatory Affairs Manager | |
GE Healthcare | |
Phone: 617-851-0943 | |
E-mail: joel.kent@ge.com | |
Secondary Contact Person: | Monica Morrison |
Sr. Regulatory Affairs Director | |
GE Healthcare | |
E-mail: monica.morrison@ge.com |
Sun Yanli
Regulatory Affairs Program Manager
GE Healthcare
E-mail: yanli.sun@ge.com |
| Device names (807.92(a)(2): | |
| Trade Name: | Monitor B125/B105 |
| Common/Usual Name: | Multiparameter patient monitor (monitor, physiological, patient
(with arrhythmia detection or alarms) |
5
| Classification Names: | 21 C.F.R. §868.1400 Carbon dioxide gas analyzer.
21 C.F.R. §868.1500 Enflurane gas analyzer.
21 C.F.R. §868.1620 Halothane gas analyzer.
21 C.F.R. §868.1700 Nitrous oxide gas analyzer.
21 C.F.R. §868.1720 Oxygen gas analyzer.
21 C.F.R. §868.2375 Breathing frequency monitor.
21 C.F.R. §870.1025 Arrhythmia detector and alarm (including
ST-segment measurement and alarm).
21 C.F.R. §870.1110 Blood pressure computer.
21 C.F.R. §870.1130 Noninvasive blood pressure measurement
system.
21 C.F.R. §870.1425 Programmable diagnostic computer.
21 C.F.R. §870.1915 Thermodilution probe.
21 C.F.R. §870.2300 Cardiac monitor (including
cardiotachometer and rate alarm).
21 C.F.R. §870.2700 Oximeter
21 C.F.R. §870.2710 Ear oximeter.
21 C.F.R. §880.2910 Clinical electronic thermometer.
21 C.F.R. §882.1400 Electroencephalograph
21 C.F.R. §870.1100 alarm, blood-pressure |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code: | MHX |
| Subsequent Product
Code: | BZQ, CBR, CBS, CBQ, CCK, CCL, DXN, DQA, DRT, DSJ,
DSK, GWQ, FLL, NHO, NHP, NHQ, DPZ, DQK, DSI, DSJ,
KRB, MLD, OLT, OLW, OMC, ORT. |
| Predicate Device(s)
(807.92(a)(3)): | Primary Predicate: K171580 Monitor B125/B105
Additional Predicate Devices:
K151063 Monitor B40
K191323 CARESCAPE B850
K143676 B40i Patient Monitor
K162012 CARESCAPE Central Station V2
K122223 IntelliVue MP5SC with IntelliVue Guardian Software |
| Device Description
(807.92(a)(4)): | The proposed Monitor B125/B105 is a multi-parameter patient
monitor that was developed based on predicate Monitor
B125/B105 (K171580) to provide additional monitored
parameters: Airway gases, Entropy and Cardiac output, by
supporting additional optional modules previously cleared by
FDA: CARESCAPE Respiratory module (K171028), Airway Ga
Option N-CAiO(K151063), E-Entropy Module (K150298) (E-
ENTROPY-01) and E-COP module (K052976) with extension
interface rack and/or second frame(B1X5-F2). |
In addition to the added parameters, the proposed Monitor
6
B125/B105 offers several enhanced software features:
- . Enabled the Impedance Respiration measurement for Neonates (in addition to Ped/Adult);
- Option called "Full Disclosure" to allow the display of . parameter waveforms for up to 36 hours;
- . National Early Warning Score (NEWS) calculation provided ;
- . Additional printing capabilities to a remote recorder/Laser printer connected to a central station;
- Adoption of EK-Pro V14 ECG algorithm (previously ● cleared K191323) to support enhanced arrhythmia detection performance;
- Added Irregular, SV Tachy and Supra Ventricular . Contraction (SVC), three more arrhythmia alarms;
- Enhanced parameter alarm priority adjustment/ . configuration options,
- . Cybersecurity enhancements.
The proposed monitor B125 and B105 is based on the previous design, and therefore shares a common software and hardware platform with its primary predicate, the Monitor B125/B105 (K171580). The primary function and operation of the monitors remain unchanged from the predicate. The difference between the two models (B125 and B105) is the LCD screen size. B125 has a 12-inch display; B105 has a 10-inch display. There is no change from the predicate in the display size.
As with the predicate Monitor B125/B105 (K171580), the proposed Monitor B125/B105 is a multi-parameter patient monitor, utilizing an LCD display with an integrated keypad and an identical pre-configuration patient parameter measurement module (Hemo module) which provides basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2. The proposed Monitor B125/B105 uses the identical E-MiniC module (K052582) and equivalent optional thermal recorder module as the predicate B125/B105 (K171580).
As with the predicate Monitor B125/B105 (K171580), the proposed Monitor B125/B105 interfaces to a variety of existing central station systems via a cabled or wireless network interface. The wireless interface is implemented with the identical integrated WIFI module (WLAN module type: B1x5-01. FCC ID: OU5B1X501) as used in the predicate Monitor B125/B105 (K171580).
7
As with the predicate Monitor B125/B105 (K171580), proposed Monitor B105/B125 includes features and subsystems that are optional or configurable. It can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.
Indications for Use The monitor B125/B105 is a portable multi-parameter unit to be used for monitoring, recording, and to generate alarms for (807.92(a)(5)): multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport.
The monitor B125/B105 is intended for use under the direct supervision of a licensed health care practitioner.
The monitor B125/B105 is not intended for use during MRI.
The monitor B125/B105 can be a stand-alone monitor or interfaced to other devices via network.
The monitor B125/B105 monitors and displays: ECG (including ST segment, arrhythmia detection, ECG Diagnostic Analysis and Measurement), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring during conditions of clinical patient motion or low perfusion). temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/S kin/Airway/Room/Myocardial/ Core/Surface temperature. impedance respiration, respiration rate, airway Gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate), Cardiac output (C.O.) and Entropy.
The monitor B125/B105 is able to detect and generate alarms for ECG arrhythmias: Asystole. Ventricular tachycardia. VT>2. Ventricular Bradycardia, Accelerated Ventricular Rhythm, Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs. Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.
Contraindications for using the monitor
8
The monitor B125/B105 is not intended for use during MRI
The Monitor B125/B105 is a multi-parameter patient monitor. Technology (807.92(a)(6)): The hardware functionality is unchanged compared to the predicate Monitor B125/B105 (K171580), however this 510(k) introduces monitoring of additional (previously cleared) parameters through existing cleared and marketed measurement modules, enhancements of several software features and additional cybersecurity enhancements.
The fundamental technology of the proposed Monitor B125/B105 is the same as the predicate devices.
The proposed Monitors B125/B105 is substantially equivalent to the predicate devices.
A summary of the main changes compared to the predicate are listed below in the comparison table.
| Specification | Predicate monitor
B125/B105 (K171580) | Proposed monitor
B125/B105 | Differences |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient type | Adult, pediatric & neonatal | Adult, pediatric & neonatal | Identical |
| Use environments | The Patient Monitor is
intended for use in multiple
areas within a professional
healthcare facility | The Patient Monitor is
intended for use in multiple
areas within a professional
healthcare facility | Identical |
| Intrahospital
transport within a
professional
healthcare facility | Yes | Yes | Identical |
| Size (H x W x D) | Physical size without
extension rack and modules:
B105: 270 mm x 290 mm x
150 mm
B125: 280 mm x 317 mm x
150 mm
Horizontal space projection
size without extension rack
and modules:
B105: 265 mm x 290 mm x
165 mm
B125: 280 mm x 320 mm x
165 mm | Physical size without
extension rack and modules:
B105: 270 mm x 290 mm x
150 mm
B125: 280 mm x 317 mm x
150 mm
Horizontal space projection
size without extension rack
and modules:
B105: 265 mm x 290 mm x
165 mm
B125: 280 mm x 320 mm x
165 mm | Identical |
| Weight | Weight with battery, without
extension rack and modules:
B105: $[le]$ 3.9 kg
B125: $[le]$ 4.3 kg | Weight with battery, without
extension rack and modules:
B105: $[le]$ 3.9 kg
B125: $[le]$ 4.3 kg | Identical |
| Module Housing | Optional rack which provides
one slot for E-Modules | Optional rack which provides
one slot for E-Modules.
Optional Second Frame
B1x5-F2 which provides two
slots for E-Modules. | Equivalent to predicate.
The Proposed monitor supports the
optional Second Frame to provide
more slots for E-Modules to improve
parameter acquisition capability.
One monitor can connect to one rack
and one Second Frame at a time. |
| Display/screen | TFT LCD with Touch screen
B105: 10.1-inch
B125: 12.1-inch | TFT LCD with Touch screen
B105: 10.1-inch
B125: 12.1-inch | Equivalent to predicate
12.1inch LCD qualified a new
supplier.
The display from new supplier meets
the same specifications and
functionality. |
| Battery Type | Rechargeable Lithium-Ion
batteries | Rechargeable Lithium-Ion
batteries | Identical |
| Waveforms and
parameter windows | Up to 6 waveforms
Up to 10 parameter windows | Up to 6 waveforms
Up to 10 parameter windows | Identical |
| Operating System | Linux
(Rev 3.18) | Linux
(Rev 4.4) | Equivalent to predicate.
The two versions of the Operation
System use the same fundamental
technology.
The newer version of Linux includes
equivalent clinical user functionality
with improved operating system
security. |
| Modules | E-MiniC | E-MiniC
E-sCO, E-sCAiO
N-CAiO
E-ENTROPY-01
E-COP | Equivalent to predicate.
Support added for additional
parameter measurement modules
including: CARESCAPE Respiration
Module (K123195) (E-sCO, E-sCAiO)
Airway Gas Module N-CAiO (Cleared
with B40(K151063))
E-Entropy Module E-ENTROPY-
01(K150298)
And COP module (K052976).
The measurement modules are cleared
and available on the market. This
change solely adds the capability to
display these additional parameters on |
| | | | |
| Available parameters | ECG, ST segment, arrhythmia
detection, ECG diagnostic
analysis and measurement,
invasive pressure, non-
invasive blood pressure, pulse
oximetry, temperature,
impedance respiration, airway
gases (CO2) | ECG, ST segment, arrhythmia
detection, ECG diagnostic
analysis and measurement,
invasive pressure, non-
invasive blood pressure, pulse
oximetry, temperature,
impedance respiration, airway
gases (CO2, O2, N2O, and
anesthetic agents), Entropy,
cardiac output. | Equivalent to predicate.
Additional airway gases parameters
(O2, N2O, Anesthetic Agents) are
added and can be displayed on the
screen, through the
compatibility/support for
CARESCAPE Respiration module
(K123195) and Airway Gas Module
N-CAIO (cleared with B40(K151063)
Additional Entropy monitoring
capability is added through the
compatibility/support for additional
supporting for E-Entropy Module
E-ENTROPY-01(K150298)
Additional Cardiac Output monitoring
is added through the
compatibility/support for additional
supporting for E-COP module
(K052976)
This change solely adds the capability
to display these additional parameters
on the B105/B125 display, similar to
the other displayed parameters. |
| EK-Pro arrhythmia
detection algorithm | EK-Pro V12 | EK-Pro V14 | Equivalent to predicate.
The Ek-Pro V14 algorithm was
cleared with CARESCAPE B850 in
K191323.
This cleared algorithm provides
equivalent functionality and was
updated to further enhance the
analysis. |
| Printing | Local thermal recorder for
printings waveforms, alarms
waveforms, numeric trends | Local thermal recorder for
printing waveforms, alarms
waveforms, numeric trends
Remote printer via central
station for printing waveforms,
alarms waveforms, numeric
trends | Equivalent to predicate. Equivalent
functionality with an additional
supported printer option.
Proposed device supports additional
remote printing via central station to
address customer requests. |
| Thermal Recorder
Module | B1X5-REC thermal recorder
module with "off the shelf"
printer core XE-50 | B1X5-REC thermal recorder
module with "off the shelf"
printer core GPR212-M0 | Equivalent to predicate.
Both XE-50 and GPR212-M0 are
Industry's standard 50mm thermal
printer.
XE-50 and GPR212-M0 have the
same specifications except GPR212-
M0 (APS) has lower power
consumption. |
| Alarm Classification
(IEC) | Four levels — High, Medium,
Low and Informational | Four levels — High, Medium,
Low and Informational | Identical |
| Alarm Notification | Audible and visual | Audible and visual | Identical |
| Alarm Priority
adjustment | Support to adjust ECG (only
Arrhythmia) alarm priority | Support to adjust ECG, IBP,
SpO2, NIBP, Respiration,
CO2, Gas and Temperature
technical alarm and
physiological alarms priority | Equivalent to predicate.
The predicate already included the
option to adjust and configure some
alarm settings and priorities. In the
proposed monitor, more flexibility was
added for the user to adjust alarm
priorities for additional parameter
alarms to meet the user requirements
of different hospitals and departments
within each hospital.
This alarm priority configuration
option and mechanism has already
been implemented in the identical way
in the predicate CARESCAPE B850
(K191323).
The default settings are according to
IEC 60601-1-8 |
| Full Disclosure | Not supported | Acquires ECG and mixed
parameters waveforms data
from monitor and displays
for review and storage for up
to 36 hours. | Equivalent to predicate.
Full disclosure is an optional license-
based feature to display parameter
waveforms up to 36 hours. It provides
the clinician the flexibility to view
historical waveforms on bedside
monitors, rather than solely relying on
an additional central station. It is
equivalent to the full disclosure
functionality within the predicate
CARESCAPE Central Station V2
(K162012). |
| Early Warning Score | Not supported | NEWS (National Early Warning Score)
NEWS is an optional license-based feature which allows the display of the NEWS Early Warning Score on the monitor. The monitor calculates the score based on the measured parameters following the exact formula for NEWS published from the Royal College of Physicians (a published/well-established clinical score). | Equivalent to Predicate.
The proposed Monitor B125/B105 V1.5 supports display/calculation of the National Early Warning Score (NEWS). NEWS is an optional license-based feature which allows for the display of a calculated/ well-established "Early Warning Score" that clinicians often use as one part of patient assessments/ clinical decision support looking for early signs of deterioration. The Early Warning Score concept is used in many monitors and even EMRs to provide standardized calculations. This is equivalent to the early warning score implemented in the legally marketed predicate Monitor IntelliVue MP5SC with IntelliVue Guardian Software (K122223). |
| ECG Alarms | ECG arrhythmias alarms:
Asystole, Ventricular tachycardia, VT>2,
Ventricular Bradycardia,
Accelerated Ventricular Rhythm, Ventricular Couplet,
Bigeminy, Trigeminy, “R on T”, Tachycardia, Bradycardia,
Pause, Atrial Fibrillation,
Multifocal PVCs, Missing Beat, Premature Ventricular Contraction (PVC), and Ventricular fibrillation. | Three additional alarm types added (highlighted in bold ).
ECG arrhythmias alarms:
Asystole, Ventricular tachycardia, VT>2,
Ventricular Bradycardia,
Accelerated Ventricular Rhythm, Ventricular Couplet,
Bigeminy, Trigeminy, “R on T”, Tachycardia, Bradycardia,
Pause, Atrial Fibrillation, Irregular , Multifocal PVCs, Missing Beat, SV Tachy , Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation. | Equivalent to predicate.
Added additional ECG arrhythmia alarms types based on the implemented algorithm. The additions are: Irregular, SV Tachy and Supra Ventricular Contraction (SVC). Provides additional options within the same monitored parameter as the predicate. |
| Neonatal respiration | Adult, Pediatric | Adult, Pediatric, Neonatal | Equivalent to predicate
The proposed device uses the identical Impedance Respiration design and algorithm as both the predicate Monitor B125/B105 V1(K171580) and B40i (K143676). It is now being implemented for neonates in the equivalent way to the Monitor B40i (K143676). |
| Networking Interface | LAN
WLAN (Optional) | LAN
WLAN (Optional) | Identical |
| Networking Protocol | CARESCAPE Network HL7 | CARESCAPE Network HL7 | Identical |
Product Comparison versus Predicate Main Features:
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Determination of Substantial Equivalence (807.92(b)(1):
Summary of Non-Clinical Tests:
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the proposed Monitor B125/B105, demonstrating the design meets the specifications.
The hardware bench testing included electromagnetic compatibility, electrical safety, environmental, WLAN, and usability.
The proposed Monitor B125/B105 has been found to be equivalent to the predicate device(s) for the intended users, uses and use environments. Usability evaluation has been completed for the proposed monitor and the predicate devices including critical task identification through use-based hazard analysis, multiple rounds of formative usability testing and summative testing, among other activities.
Software testing included software design, development, verification, validation and traceability. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered "Major" level of concern, the same as the predicate.
Patient safety, security, and privacy risks have been addressed in the design and development of the proposed B125/B105 including a Security Risk Assessment and Threat model. This includes system integrity controls, access controls, audit controls and network controls which map to the General Principles and Security Capabilities outlined in the FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on October 2, 2014.
Testing was completed to show the device can withstand network storm, i.e. continue to monitor patients without rebooting when connected by wire to GE Unity networks which suffer broadcast storm traffic.
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Clinical (807.92(b)(2)): Summary of Clinical Tests:
The subject of this premarket submission, the proposed Monitor B125/B105 did not require clinical studies to support substantial equivalence.
Conclusion (807.92(b)(3)): GE Healthcare considers the proposed Monitor B125/B105 to be substantially equivalent to the predicate device(s).