(151 days)
No
The summary describes a multi-parameter patient monitor with various physiological measurements and alarm capabilities. While it mentions algorithms for SpO2 and calculations for SPV/PPV, there is no explicit mention of AI or ML being used for these functions or any other part of the device's operation. The focus is on standard physiological monitoring and software enhancements.
No
The device is a patient monitor, explicitly stating its purpose as "monitoring, recording, and to generate alarms for multiple physiological parameters." It does not provide any form of therapy or treatment.
Yes
Explanation: The device is referred to as a "patient monitor" which is used for monitoring, recording, and generating alarms for physiological parameters, including "ECG diagnostic analysis and measurement." The ability to perform diagnostic analysis of ECG indicates a diagnostic function beyond mere monitoring.
No
The device is described as a multi-parameter patient monitor with hardware components (LCD screen, interface rack, second frame, battery, integrated WIFI module) and relies on physical connections to sensors and modules for data acquisition. While it includes software enhancements, it is not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential donors and recipients, or to monitor therapeutic measures.
- Device Function: The description clearly states that the monitor is a "portable multi-parameter patient monitor intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients". It lists parameters like ECG, blood pressure, heart/pulse rate, SpO2, temperature, respiration, airway gases, Cardiac Output, Entropy, and neuromuscular transmission. These are all measurements taken directly from the patient's body, not from specimens in vitro.
- Lack of Specimen Analysis: There is no mention of the device analyzing blood, tissue, or any other bodily fluid or sample outside of the body.
Therefore, the device described is a patient monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The monitor B105M, B125M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.
The monitor B105M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner.
The monitor B105M, B155M, B105P and B125P are not intended for use during MRI.
The monitor B105M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network.
The monitor B105M, B155M, B105P and B125P monitor and display: ECG (including ST segment, arrhythmia detection, ECG diagnostic analysis and measurement), invasive blood pressure, heart/pulse rate, oscillometric noninvasive blood pressure (systolic 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/ Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agent identification and respiratory rate), Cardiac Output (C.O.), Entropy and neuromuscular transmission (NMT).
The monitor B105M, B125M, B105P and B125P are 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, 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, KOI
Device Description
The proposed monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors that were developed based on predicate Monitor B125/B105(K201941) to provide additional monitored parameter: neuromuscular transmission (NMT), by supporting additional optional modules previously cleared by FDA: E-NMT module (K051635) with existing interface rack and/or second frame (B1X5-F2).
In addition to the added parameter, the proposed monitors B105M, B125M, B155M, B105P and B125P offer several software enhancements:
- Support 12-lead ECG measurement mode;
- Additional SPV (Systolic Pressure Variation) and PPV (Pulse Pressure Variation) values calculation;
- Enabled the Impedance Respiration measurement from lead RL-LL:
- Display Pulse Rate (PR) from NIBP when performing NIBP determination;
- Display real-time GE SpO2 Perfusion Index (PI) value;
- Adoption of TruSignal V3 SpO2 algorithm;
- Additional optimizing IBP waveform scale function;
- Additional connectivity capabilities within GE CARESCAPE network (K032582) including Bed-to-Bed View and Automatic View on Alarm (AVOA);
- Additional remote service function:
- Additional cybersecurity enhancements.
The proposed monitors B105M, B125M, B155M, B105P and B125P include improved Industrial Design (ID) to be more portable and more compact for clinicians than the primary predicate Monitor B125/B105(K201941) while maintaining the same primary function and operation.
The five models (B105M, B125M, B155M, B105P and B125P) share the same hardware platform and software platform to support the data acquisition and algorithm modules. The differences between them are the LCD screen size and configuration options.
As with the predicate Monitor B125/B105 (K201941), the proposed monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors, utilizing an LCD display and pre-configuration basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2, and optional parameters whic include CO2 and Gases parameters provided by the E-MiniC module (K052582), CARESCAPE Respiratory modules E-sCO and E-sCAiO (K171028), Airway Gas Option module N-CAiO (K151063), Entropy parameter provided by the E-ENTROPY module (K150298), Cardic Output parameter provided by the E-COP module (K052976), and thermal recorder B1X5-REC.
In addition, the predicate Monitor B125/B105 (K201941) and the proposed monitors B105M, B125M, B155M, B105P and B125P consists of the same interface to a variety of existing central station systems via a cabled or wireless network interface which implemented with identical integrated WIFI module. (WIFI feature is disabled in B125P/B105P)
Moreover, both the predicate Monitor B125/B105(K201941) and the proposed monitors B105M, B125M, B155M, B105P and B125P 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, in a hospital environment and during intra-hospital 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)
Summary of Non-Clinical Tests:
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the proposed monitors B105M, B125M, B155M, B105P and B125P, demonstrating the design meets the specifications.
The hardware bench testing included electromagnetic compatibility, electrical safety, environmental, WLAN, and usability.
The proposed monitors B105M, B125M, B155M, B105P and B125P have been found to be equivalent to the predicate devices for the intended users, functionality, 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.
The proposed monitors B105M, B125M, B155M, B105P and B125P have introduced and verified one additional battery optional. The battery is equivalent to the predicate and tested to comply with UL 2054 2nd Edition, UL1642 5th Edition and IEC 62133-2:2017 standards. Integration of the battery management has been successfully verified the functionality of proposed monitors can respond to certain battery and power management conditions as specified And also tested as part of system EMC testing.
Patient safety, security, and privacy risks have been addressed in the design and development of the proposed B1x5M/B1x5P 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 issued on October 18, 2018. The proposed monitors B1x5M/B1x5P have been subjected to rigorous testing for cybersecurity vulnerability including penetration testing via an independent firm has been completed with acceptable conclusion, security controls verification testing including network port scan, vulnerability scan and virus scan were conducted, the results demonstrated that the potential cybersecurity risks are appropriately mitigated in the proposed devices and the cybersecurity protections are at least substantially equivalent to the predicate.
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.
Summary of Clinical Tests:
The subject of this premarket submission, the proposed monitors B105M, B125M, B155M, B105P and B125P did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K201941, K191249, K133810, K200494
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows 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.
April 1, 2022
GE Medical Systems Information Technologies, Inc. Joel Kent Director, Regulatory Affairs Strategy 9900 Innovation Drive Wauwatosa, Wisconsin 53226
Re: K213490
Trade/Device Name: Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P Regulation Number: 21 CFR 870.1025 Regulation Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: MHX, BZQ, CBR, CBS, CBQ, CCK, CCL, DXN, DQA, DRT, DSJ, DSK, GWQ, FLL, NHO, NHP, NHQ, DPZ, DQK, DSI, KRB, MLD, OLT, OLW, OMC, ORT, KOI Dated: February 28, 2022 Received: March 2, 2022
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.
1
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.
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213490
Device Name
Monitor B105M, Monitor B125M, Monitor B155M,Monitor B105P, Monitor B125P
Indications for Use (Describe)
The monitor B105M, B125M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.
The monitor B105M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner.
The monitor B105M, B155M, B105P and B125P are not intended for use during MRI.
The monitor B105M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network.
The monitor B105M, B155M, B105P and B125P monitor and display: ECG (including ST segment, arrhythmia detection, ECG diagnostic analysis and measurement), invasive blood pressure, heart/pulse rate, oscillometric noninvasive blood pressure (systolic 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/ Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agent identification and respiratory rate), Cardiac Output (C.O.), Entropy and neuromuscular transmission (NMT).
The monitor B105M, B125M, B105P and B125P are 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, 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) |
|__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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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: | February 28, 2022 |
| Submitter: | GE Medical Systems Information Technologies, Inc. |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| USA | |
| Primary Contact Person: | Joel Kent |
| Director, Regulatory Affairs Strategy | |
| GE Healthcare | |
| Phone: 617-851-0943 | |
| E-mail: joel.kent@ge.com | |
| Secondary Contact Person: | William Jung |
| Regulatory Affairs Director | |
| GE Healthcare | |
| Phone: 571-396-1558 | |
| E-mail: William.Jung@ge.com |
Sun Yanli
Regulatory Affairs Program Manager
GE Healthcare
Phone: +86-18051597363
E-mail: yanli.sun@ge.com |
| Device names (807.92(a)(2): | |
| Trade Name: | Monitor B105M, Monitor B125M, Monitor B155M,
Monitor B105P, Monitor B125P |
| 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
21 C.F.R. §868.2775 Electrical peripheral nerve stimulator |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code:
Subsequent Product
Code: | 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, KOI |
| Predicate Device(s)
(807.92(a)(3)): | Primary Predicate: K201941 Monitor B125/B105
Additional Predicate Devices:
K191249 CARESCAPE B450
K133810 CARESCAPE VC150
K200494 CARESCAPE ONE |
| Device Description
(807.92(a)(4)): | The proposed monitors B105M, B125M, B155M, B105P and
B125P are multi-parameter patient monitors that were developed
based on predicate Monitor B125/B105(K201941) to provide
additional monitored parameter: neuromuscular transmission
(NMT), by supporting additional optional modules previously
cleared by FDA: E-NMT module (K051635) with existing
interface rack and/or second frame (B1X5-F2). |
6
In addition to the added parameter, the proposed monitors B105M, B125M, B155M, B105P and B125P offer several software enhancements:
- Support 12-lead ECG measurement mode; ●
- Additional SPV (Systolic Pressure Variation) and PPV (Pulse Pressure Variation) values calculation;
- Enabled the Impedance Respiration measurement from lead RL-LL:
- Display Pulse Rate (PR) from NIBP when performing NIBP determination;
- Display real-time GE SpO2 Perfusion Index (PI) value; .
- Adoption of TruSignal V3 SpO2 algorithm; ●
- Additional optimizing IBP waveform scale function; ●
- Additional connectivity capabilities within GE ● CARESCAPE network (K032582) including Bed-to-Bed View and Automatic View on Alarm (AVOA);
- Additional remote service function: ●
- Additional cybersecurity enhancements. ●
The proposed monitors B105M, B125M, B155M, B105P and B125P include improved Industrial Design (ID) to be more portable and more compact for clinicians than the primary predicate Monitor B125/B105(K201941) while maintaining the same primary function and operation.
The five models (B105M, B125M, B155M, B105P and B125P) share the same hardware platform and software platform to support the data acquisition and algorithm modules. The differences between them are the LCD screen size and configuration options.
As with the predicate Monitor B125/B105 (K201941), the proposed monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors, utilizing an LCD display and pre-configuration basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2, and optional parameters whic include CO2 and Gases parameters provided by the E-MiniC module (K052582), CARESCAPE Respiratory modules E-sCO and E-sCAiO (K171028), Airway Gas Option module N-CAiO (K151063), Entropy parameter provided by the E-Entropy module (K150298), Cardic Output parameter provided by the E-COP module (K052976), and thermal recorder B1X5-REC.
7
| Indications for Use
(807.92(a)(5)): | In addition, the predicate Monitor B125/B105 (K201941) and the proposed monitors B105M, B125M, B155M, B105P and B125P consists of the same interface to a variety of existing central station systems via a cabled or wireless network interface which implemented with identical integrated WIFI module. (WIFI feature is disabled in B125P/B105P)
Moreover, both the predicate Monitor B125/B105(K201941) and the proposed monitors B105M, B125M, B155M, B105P and B125P can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories. |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The monitor B105M, B125M, B155M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. |
| | The monitor B105M, B125M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner. |
| | The monitor B105M, B125M, B155M, B105P and B125P are not intended for use during MRI. |
| | The monitor B105M, B125M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network. |
| | The monitor B105M, B125M, B155M, B105P and B125P 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/Skin/Airway/Room/Myocardial/ Core/Surface temperature, impedance respiration, respiration rate, airway Gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and |
8
respiratory rate), Cardiac output (C.O.) and Entropy and neuromuscular transmission (NMT).
The monitors B105M, B125M, B155M, B105P and B125P are 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
The monitors B105M, B125M, B155M, B105P and B125P are not intended for use during MRI.
Technology (807.92(a)(6)): The monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors. The hardware functionality is unchanged compared to the predicate Monitor B125/B105(K201941), however this 510(k) introduces monitoring of additional (previously cleared) parameter through an existing cleared and marketed measurement module, enhancements of several software features and additional cybersecurity enhancements.
The fundamental technology of the proposed monitors B105M, B125M, B155M, B105P and B125P are the same as the predicate devices.
The proposed monitors B105M, B125M, B155M, B105P and B125P are substantially equivalent to the predicate devices.
A summary of the main changes compared to the predicate are listed below in the comparison table.
Product Comparison versus Predicate Main Features:
The proposed monitors B105M, B155M, B105P and B125P share identical indications for use, intended use patient populations, and functional features as the predicate devices. The monitors B105M, B125M, B155M, B105P and B125P consist of improvements and optional features outlined below that are substantially equivalent to the primary predicate device B125/B105 (K201941).
9
| Specification | Predicate monitors
B125/B105 (K201941) | Proposed monitors
B105M/B125M/B155M/B
105P | Differences |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | Physical size without
extension rack and
modules:
B105P/B105M: 275 mm x
265 mm x 175 mm
B125P/B125M: 280 mm x
312 mm x 175 mm
B155M: 305 mm x 405
mm x 175 mm | Equivalent to predicate.
Slight change in physical size for 10 inch and
12-inch devices as the proposed device
improved Industrial Design for more portable
and compact design than the predicate devices.
The proposed device also introduced a 15-inch
screen version to meet customer requests.
Regardless of the display size, all monitors
have the same functionality and options. The
change doesn't impact the safety or
effectiveness. |
| Weight | Weight with battery,
without extension rack and
modules:
B105: $≤$ 3.9 kg
B125: $≤$ 4.3 kg | Weight with battery,
without extension rack and
modules:
B105P/B105M: $≤$ 3.8 kg
B125P/B125M: $≤$ 4.2 kg
B155M: $≤$ 5.2 kg | Equivalent to predicate.
Decrease in display size for B105 and B125
have resulted in decreased weight. B155M is a
larger monitor with higher weight.
B155M has the same functionality and options
as B125M and B105M except different display
size.
The change doesn't impact the safety or
effectiveness. |
| Hard keys | three functional hard keys
on front panel: Alarm
Audio Pause, Take
Snapshot and Manual
NIBP | No functional hard keys
on front panel | Equivalent to predicate
The proposed device removed the three
functional hard keys for better cleaning.
Instead, the proposed device provides three
soft keys with same functionality.
The change doesn't impact the safety or
effectiveness. |
| Battery Type | Rechargeable Lithium-Ion
battery | Rechargeable Lithium-Ion battery | Equivalent to predicate
The predicate monitor supports one standard
Lithium-Ion battery. The proposed device
provides two different capacity Lithium-Ion
battery options to meet different customer
needs, however only one battery can be
selected/installed in each device.
The change doesn't impact the safety or
effectiveness. |
| Waveforms and
parameter windows | Up to 6 waveforms
Up to 10 parameter
windows | Up to 12 waveforms
Up to 10 parameter
windows | Equivalent to predicate
The proposed device can display more
waveforms on the screen simultaneously to let
the clinician to view more information on one
screen.
The change doesn't impact the safety or
effectiveness. |
| E-Modules | E-MiniC
E-sCO
E-sCAiO
N-CAiO
E-ENTROPY
E-COP | E-MiniC
E-sCO
E-sCAiO
N-CAiO
E-ENTROPY
E-COP
E-NMT | Equivalent to predicate.
Support added for additional parameter
measurement module E-NMT (K051635).
The E-NMT module is cleared and available
on the market. This change solely adds the
capability to display these additional
parameters on the proposed device's display,
similar to the other displayed parameters.
The change doesn't impact the safety or |
| Maximum E-Modules Maximum three E-
Support | Modules can be supported Maximum three E-
at the same time:
One through module rack,
two through external
Second Frame B1X5-F2. | B1x5M:
Modules can be supported
at the same time:
One through module rack,
two through external
Second Frame B1X5-F2.
B1x5P:
Maximum one E-Module
can be support through
the module rack. | effectiveness.
Equivalent to predicate
Identical for the proposed monitors B1x5M.
The Second Frame B1X5-F2 is not available
for the proposed monitors B1x5P per different
customer needs so only one E-module may be
connected for those devices.
The change doesn't impact the safety or
effectiveness. |
| Available parameters | ECG, ST segment,
arrhythmia detection, ECG
diagnostic analysis and
measurement, invasive
pressure, heart/pulse rate,
non-invasive blood
pressure, pulse oximetry,
temperature, impedance
respiration, airway gases
(CO2, O2, N2O, and
anesthetic agents),
Entropy,
cardiac output. | ECG, ST segment,
arrhythmia detection, ECG
diagnostic analysis and
measurement, invasive
pressure, heart/pulse rate,
non-invasive blood
pressure, pulse oximetry,
temperature, impedance
respiration, airway gases
(CO2, O2, N2O, and
anesthetic agents),
Entropy,
cardiac output,
neuromuscular
transmission (NMT). | Equivalent to predicate.
The NMT parameter has been added and can
be displayed on the screen through the
compatibility/support for the E-NMT module
(K051635).
This change solely adds the capability to
display these additional parameters on the
proposed device's display, similar to the other
displayed parameters.
The change doesn't impact the safety or
effectiveness. |
| ECG Measurement
Mode | 3-lead and 5-lead | 3-lead, 5-lead and 12-lead | Equivalent to predicate.
The proposed monitor adds the additional
option for a 12-lead ECG mode measurement
and display. This is equivalent to the 12-lead
ECG measurement and display already
implemented in the predicate device B450 V3
(K191249). |
| | | | |
| SPV and PPV values
calculation | Not supported | Support SPV (Systolic
Pressure Variation) and
PPV (Pulse Pressure
Variation) values calculation
from arterial Invasive Blood
Pressure (IBP) monitoring | The change doesn't impact the safety or
effectiveness.
Equivalent to predicate.
SPV (Systolic Pressure Variation) and PPV
(Pulse Pressure Variation) values are
calculated based on existing arterial Invasive
Blood Pressure (IBP) monitoring already in the
predicate. SPV and PPV values can support an
assessment of the patient's arterial pressure
variation and reflect patient's respiratory
changes in arterial pressure during positive
pressure ventilation. This feature is alreadypredicate monitor CARESCAPE Monitor
B450 V3 (K191249).
The change doesn't impact the safety or
effectiveness. |
| Impedance
respiration source
lead | I, II and III | I, II and RL-LL | Equivalent to predicate.
The proposed device no longer provides
Impedance respiration measurement from ECG
lead III, but provide additional Impedance
respiration source from ECG lead RL-LL.
The Impedance respiration from ECG lead RL
LL is equivalent to ECG lead I and II.
Impedance respiration measurement from lead
RL-LL is already implemented in the
equivalent way in the predicate device
CARESCAPE Monitor B450 V3 (K191249).
The change doesn't impact the safety or
effectiveness. |
| NIBP measurement | Systolic pressure,
Diastolic pressure and
Mean pressure | Systolic pressure, Diastolic
pressure, Mean pressure
and Pulse Rate | Equivalent to predicate.
The proposed device uses the identical NIBP
design as the predicate monitor B125/B105
(K201941). The only difference is the
predicate Monitor B125/B105 (K201941) does
not offer Pulse Rate (PR) display on the
screen, although PR is already calculated by
the algorithm when performing NIBP
measurement. The proposed device now
displays the PR value on screen. There is no
change to the NIBP measurement algorithm or
calculations.
The PR monitoring from NIBP measurement
has been implemented in an equivalent way in
the CARESCAPE VC150 (K133810).
The change doesn't impact the safety or
effectiveness. |
| Perfusion Index (PI) for GE TruSignal SpO2 | Monitors PI and saves PI in trend as "Pleth" | Monitors PI and saves PI in trend as “PI” and displays real-time PI value in digit field. | Equivalent to predicate. |
| TruSignal SpO2 algorithm | TruSignal V2 | TruSignal V3 | Equivalent to predicate.
The TruSignal V3 algorithm was cleared with CARESCAPE ONE in K200494. This cleared algorithm provides equivalent functionality.
The change doesn't impact the safety or effectiveness. |
| IBP waveform scale adjustment | Manual adjustment | Manual adjustment and automatic optimizing scale. | Equivalent to predicate.
The proposed device provides an automatic optimizing scale feature.
Optimizing IBP waveform scale is the function of adjusting the "Scale" menu selection automatically to let the current IBP waveform fully utilize the IBP waveform area, to avoid waveform too small or too large.
It is an option the user can select and is not required. It does not change the data displayed only the scaling and use of the space on the screen. This is a workflow enhancement.
Optimizing IBP waveform scale has been implemented in an equivalent way in the predicate device CARESCAPE Monitor B450 V3 (K191249). |
| Bed-to-Bed View and Automatic View on Alarm (AVOA) | Not supported | Bed-to-Bed View and AVOA is supported | Bed-to-Bed View and AVOA share a feature to allow the monitor to display a view of another patient monitor (for another bed) that is on the same GE CARESCAPE network.
The AVOA allows configurable prioritization of displaying highest to lowest risk alarms.
Bed-to-Bed view and AVOA functionality has been implemented in an equivalent way in the predicate device CARESCAPE Monitor B450 V3 (K191249).
The change doesn't impact the safety or effectiveness. |
| Remote Service | Not supported | Remote Service is supported | With this feature, when the proposed device is connected to network, authorized service personnel can transfer the service log from the proposed device to GE Healthcare server via HTTPS for remote trouble shooting and support. The service log does not include patient information and the log files are encrypted before transmitting. |
| | | | The remote service feature is password protected and for service-use only. |
| | | | The service log does not include any patient information and the log files are encrypted before transmitting. |
| | | | This remote service functionality has been implemented in an equivalent way in the predicate device CARESCAPE Monitor B450 V3 (K191249). |
| | | | The change doesn't impact the safety or effectiveness. |
| Operating System | Linux
(Rev 4.4) | Linux
(Rev 4.19) | Equivalent to predicate. |
| | | | The two versions of the Operation System use the same technology. Since the 4.4 version Linux is going end of life, the updated version of Linux allows better technical support and cybersecurity while maintaining the same functionality, operation and performance. The change doesn't impact the safety or effectiveness. |
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11
12
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The proposed monitors B105M, B155M, B155M, B105P and B125P consist of improvements and optional features outlined below that are substantially equivalent to the additional predicate device CARESCAPE B450(K191249).
| Specification | Predicate monitor
CARESCAPE B450
(K191249) | Proposed monitors
B105M/B125M/B155M/B
105P | Differences |
|---------------------------|--------------------------------------------------|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NMT measurement
module | E-NMT module
(K051635) | E-NMT module
(K051635) | Identical |
| ECG Measurement
Mode | 3-lead, 5-lead, 12-lead,
6-lead and 12RL | 3-lead, 5-lead and 12-lead | Equivalent to predicate.
Although the proposed device only supports 3-lead, 5-lead and 12-lead ECG mode those
modes are identical to those used in
CARESCAPE B450 (K191249).
The change has been verified and validated
and does not affect safety or effectiveness. |
14
| SPV and PPV values
calculation | Support SPV (Systolic
Pressure Variation) and
PPV (Pulse Pressure
Variation) values
calculation from arterial
Invasive Blood Pressure
(IBP) monitoring | Support SPV (Systolic
Pressure Variation) and
PPV (Pulse Pressure
Variation) values
calculation from arterial
Invasive Blood Pressure
(IBP) monitoring | Identical |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Impedance
respiration source
lead | I, II and RL-LL | I, II and RL-LL | Identical |
| IBP waveform scale
adjustment | Manual adjustment and
automatic optimizing
scale. | Manual adjustment and
automatic optimizing
scale. | Identical |
| Bed-to-Bed View and
Automatic View on
Alarm (AVOA) | Bed-to-Bed View and
AVOA are supported | Bed-to-Bed View and
AVOA are supported | Identical |
| Remote Service
functionalities | Transfer service log
Configure the device
Update device software | Transfer service log | Equivalent to predicate.
The proposed device limits the supported
remote service functionality to transferring the
service log only. That functionality is
equivalent to the predicate and has been
implemented with the equivalent security
controls and verification, including encryption.
The change doesn't impact the safety or
effectiveness. |
The proposed monitors B105M, B155M, B155M, B105P and B125P consist of improvements and optional features outlined below that are substantially equivalent to the additional predicate device CARESCAPE VC150 (K133810).
| Specification | Predicate monitor
CARESCAPE VC150
(K133810) | Proposed monitors
B105M/B125M/B155M/B
105P | Differences |
|------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|-------------|
| NIBP measurement | Systolic pressure,
Diastolic pressure, Mean
pressure and Pulse Rate | Systolic pressure, Diastolic
pressure, Mean pressure
and Pulse Rate | Identical |
The proposed monitors B105M, B155M, B155M, B105P and B125P consist of improvements and optional features outlined below that are substantially equivalent to the additional predicate device CARESCAPE ONE (K200494).
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| Specification | Predicate monitor
CARESCAPE ONE
(K200494) | Proposed monitors
B105M/B125M/B155M/B
105P | Differences |
|-----------------------------|-------------------------------------------------|--------------------------------------------------|-------------|
| TruSignal SpO2
algorithm | TruSignal V3 | TruSignal V3 | Identical |
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 monitors B105M, B125M, B155M, B105P and B125P, demonstrating the design meets the specifications.
The hardware bench testing included electromagnetic compatibility, electrical safety, environmental, WLAN, and usability.
The proposed monitors B105M, B125M, B155M, B105P and B125P have been found to be equivalent to the predicate devices for the intended users, functionality, 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.
The proposed monitors B105M, B125M, B155M, B105P and B125P have introduced and verified one additional battery optional. The battery is equivalent to the predicate and tested to comply with UL 2054 2nd Edition, UL1642 5th Edition and IEC 62133-2:2017 standards. Integration of the battery management has been successfully verified the functionality of proposed monitors can respond to certain battery and power management conditions as specified And also tested as part of system EMC testing.
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Patient safety, security, and privacy risks have been addressed in the design and development of the proposed B1x5M/B1x5P 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 issued on October 18, 2018. The proposed monitors B1x5M/B1x5P have been subjected to rigorous testing for cybersecurity vulnerability including penetration testing via an independent firm has been completed with acceptable conclusion, security controls verification testing including network port scan, vulnerability scan and virus scan were conducted, the results demonstrated that the potential cybersecurity risks are appropriately mitigated in the proposed devices and the cybersecurity protections are at least substantially equivalent to the predicate.
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.
| Clinical (807.92(b)(2)): | Summary of Clinical Tests: |
|---|---|
| -------------------------- | ---------------------------- |
The subject of this premarket submission, the proposed monitors B105M, B125M, B155M, B105P and B125P did not require clinical studies to support substantial equivalence.