K 171580
K 171580
K 171580
Re: K171580
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, BZQ, CBR, CBS, CBQ, CCK, CCL, DXN, DQA, DRT, DSB, DSK, GWQ, FLL,
NHO, NHP, NHQ
Dated: May 30, 2017
Received: May 31, 2017
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. 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
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the
Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-
7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's
Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of
Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its
Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
y,
or
for
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2020
Indications for Use See PRA Statement below.
Device Name
Monitor B125/B105
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, Multifocal PVCs, Missing Beat, Premature Ventricular
Contraction (PVC) and Ventricular fibrillation.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
K171580
Page 1 of 7
510k Summary
K171580
I. SUBMITTER
GE MEDICAL SYSTEMS (CHINA) CO., LTD.
No. 19 Changjiang road National Hi-Tech Dev. Zone
Wuxi, Jiangsu, China 214028
Sun YanLi
Regulatory Affairs Leader
II. DEVICE
Name of Device: Monitor B125/B105
Common or Usual Name: Multi-parameter Patient Monitor
Classification Name:
21 CFR 870.1025 monitor, physiological, patient (with arrhythmia detection or alarms)
21 CFR 868.2375 monitor, breathing frequency
21 CFR 868.1700 analyzers, gas, nitrous-oxide, gaseous phase (anesthetic conc.)
21 CFR 868.1620 analyzers, gas, halothane, gaseous-phase (anesthetic conc.)
21 CFR 868.1500 analyzers, gas, enflurane, gaseous-phase (anesthetic concentration)
21 CFR 868.1400 analyzers, gas, carbon-dioxide, gaseous-phase
21 CFR 868.1720 analyzers, gas, oxygen, gaseous-phase
21 CFR 870.1130 system, measurement, blood-pressure, non-invasive
21 CFR 870.2700 oximeters
21 CFR 870.2300 monitor, cardiac (incl. cardiotachometer & rate alarm)
K171580
Page 2 of 7
Regulatory Class: II
Product Code:
MHX, BZQ, CBR, CBS, CBQ, CCK, CCL, DXN, DQA, DRT, DSB, DSK, GWQ, FLL,
NHO, NHP, NHQ
The Monitor B125/B105 is a multi-parameter patient monitor that is developed based on the
predicate Monitor B40 (K151063) platform. The Monitor B125/B105 provides additional
support for ECG full arrhythmia (has been claimed in CARESCAPE Monitor
B650(K102239)), WLAN (FCC ID: OU5B1X501) and touch screen.
As with the predicate Monitor B40(K151063), the proposed Monitor B125/B105 is a multi-
parameter patient monitor, utilizes 12inches /10inches LCD display with an integrated
keypad and a pre-configuration (hemodynamic module (Hemo module) which provide basic
parameters: ECG, RESP, NIBP, IBP, TEMP, SPO2.
As with the predicate Monitor B40(K151063), the proposed Monitor B125/B105 has optional
CO2 parameter provided by the identical E-MiniC module (K052582).
As with the predicate Monitor B40(K151063), the proposed Monitor B125/B105 has a
mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of
ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting
accessories.
K171580
Page 3 of 7
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, Multifocal PVCs, Missing Beat, Premature
Ventricular Contraction (PVC) and Ventricular fibrillation.
The proposed Monitor B125/B105 is a multi-parameter patient monitor that is developed based
on the predicate Monitor B40 (K151063) platform. The proposed Monitor B125/B105 provides
additional support for ECG full arrhythmia (has been claimed in CARESCAPE Monitor B650
(K102239)), WLAN (FCC ID: OU5B1X501) and touch screen
The proposed Monitor B125/B105 uses the identical hemodynamic module (Hemo module) as
the predicate Monitor B40 (K151063) in the monitoring of ECG, Resp, NIBP, IBP, SpO2 and
Temp parameters data.
The proposed Monitor B125/B105 uses identical E-MiniC module (K052582) as the predicate
Monitor B40 (K151063).
The fundamental technology of the proposed Monitor B125/B105 is the same as the predicate
devices.
The proposed Monitors B125/B105 is as safe and effective as the predicate devices.
Environmental Testing:
Perform Rapid Change of Temperature, Change of Temperature, Dry heat for non-heat-
dissipating specimen with gradual change of temperature, Damp heat, Cold for non-heat
dissipating specimen with gradual change of temperature, Cold for heat-dissipating specimen
with gradual change of temperature and steady state testing to ensure the unit preference
meet the environmental requirements.
Mechanical stress Testing:
Perform sinusoidal vibration, shock, free fall, altitude test and broadband random vibration
testing to ensure the unit meet the Mechanical stress requirements.
Package Testing
Perform package transport testing to ensure the packaged product withstand the distribution
environment and to show the serviceability of the transport packages.
Animal Study
No animal studies have been performed on the Monitor B125/B105.
Clinical Studies
No clinical studies have been performed on the Monitor B125/B105.
VIII. CONCLUSIONS