B40i Patient Monitor

K143676 · GE Healthcare Finland Oy · MHX · Jul 31, 2015 · Cardiovascular

Device Facts

• Record ID: K143676
• Device Name: B40i Patient Monitor
• Applicant: GE Healthcare Finland Oy
• Product Code: MHX · Cardiovascular
• Decision Date: Jul 31, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The B40i is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The B40i is intended for use under the direct supervision of a licensed health care practitioner. The B40i is not intended for use during MRI. The B40i can be a stand-alone monitor or interfaced to other devices via a network. The B40i monitors and displays: ECG (including ST segment, arrhythmia detection), 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/Nasopharvngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myo cardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.

Device Story

B40i is a portable multi-parameter patient monitor; inputs include ECG, invasive/non-invasive blood pressure, SpO2, temperature, impedance respiration, and airway gases. Device processes signals to display real-time physiological data, generate alarms, and trend information. Used in hospital settings and intra-hospital transport by clinicians. Features 12.1-inch LCD, integrated keypad, and network interface for central station connectivity. Expands impedance respiration monitoring to neonates using algorithms from predicate Aware Transport (K042642). Supports optional modules for Entropy and respiratory gas analysis. Provides clinicians with continuous patient status updates to facilitate timely clinical decision-making and patient safety monitoring.

Clinical Evidence

No clinical data was performed for the B40i. Substantial equivalence is supported by bench testing, including module verification, system integration testing, and performance/safety testing against recognized standards (e.g., IEC 60601 series, AAMI/ANSI EC13, ISO 21647, ISO 9919).

Technological Characteristics

Multi-parameter monitor with 12.1-inch TFT LCD, LED backlight, and 18-key interface. Powered by Lithium-Ion battery. Connectivity via LAN. Materials include standard medical-grade components. Sensing principles: electrical potential (ECG), oscillometric (NIBP), bridge-type transducers (IBP), thermally sensitive resistors (Temp), non-dispersive infrared/paramagnetic (Gas), and impedance variation (Respiration). Software runs on Linux OS. Sterilization not applicable (external device).

Indications for Use

Indicated for monitoring and recording physiological parameters of adult, pediatric, and neonatal patients in hospital environments and during intra-hospital transport. Not for use during MRI. Requires direct supervision of a licensed health care practitioner.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Monitor B40 (K133576)
• Patient Data Module (K071073)

Reference Devices

• E-Entropy module (K061907)
• CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195)
• CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195)
• Aware Transport (K042642)
• E-MiniC (K052582)
• SuperStat (DINAMAP) (K022834)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol, indicating the department's name and national affiliation.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 31, 2015

GE Healthcare Finland Oy % Joel Kent Regulatory Affairs Manager GE Healthcare 86 Pilgrim Road Needham, Massachusetts 02492

Re: K143676

Trade/Device Name: B40i Patient Monitor 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, BZO, CBO, CBR, CBS, CCK, CCL, DSK, DOA, DRT, DSB, DXN, FLL, GWQ, NHO, NHO, NHQ, NHP Dated: June 17, 2015 Received: June 23, 2015

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. 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

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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 devicerelated 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 at its toll-free number [phone] or [phone] 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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Bram D. Zuckerman -S

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE

510(k) Number (if known): K143676

Device Name: B40i

Indications for use:

The B40i is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The B40i is intended for use under the direct supervision of a licensed health care practitioner.

The B40i is not intended for use during MRI.

The B40i can be a stand-alone monitor or interfaced to other devices via a network. The B40i monitors and displays: ECG (including ST segment, arrhythmia detection), 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/Nasopharvngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myo cardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 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: | 19 December 2014 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Healthcare Finland Oy<br>Kuortaneenkatu 2,<br>00510 Helsinki<br>Finland<br>Phone: [phone] |
| Primary Contact Person: | Joel Kent<br>Manager, Quality and Regulatory Affairs<br>GE Medical Systems Information Technologies, Inc.<br>Telephone: [phone]<br>Fax at [phone]<br>E-mail: [e-mail] |
| Secondary Contact Person: | Anssi Ruokonen<br>Regulatory Affairs Leader<br>GE Healthcare Finland Oy<br>Kuortaneenkatu 2,<br>00510 Helsinki<br>Finland<br>Phone: [phone]<br>E-mail: [e-mail] |

Device names (807.92(a)(2)):

Trade Name: B40i Common/Usual Name: Multi-parameter patient monitor

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| Classification Names: | 21 CFR 870.1025 Arrhythmia detector and alarm (including<br>ST-segment measurement and alarm) |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Product<br>Code: | MHX |
| Subsequent Product Codes | BZQ CBQ CBR CBS CCK<br>CCL DQA DRT DSB DSK DXN<br>FLL GWQ NHO NHP NHQ |
| Predicate Device(s)<br>(807.92(a)(3): | K133576 Monitor B40<br>K071073 Patient Data Module |
| Device Description<br>(807.92(a)(4)): | The proposed monitor B40i is a multi-parameter patient monitor<br>that is developed based on the predicate Monitor B40 (K133576)<br>platform. The proposed monitor B40i provides support for<br>optional modules (E-Entropy module (K061907) and<br>CARESCAPE Respiratory modules (E-sCO and E-sCAiO)<br>(K123195). The proposed monitor B40i is also compatible with<br>CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV)<br>(K123195) but with disabled spirometry function. The proposed<br>monitor B40i supports Airway Gas Option (N-CAiO). The<br>proposed monitor B40i expands the impedance respiration<br>parameter feature to cover the neonatal patient population<br>compared to the predicate Monitor B40 (K133576). This<br>parameter feature patient population extension to cover neonatal<br>patient population uses Patient Data Module as predicate<br>(K071073), which impedance respiration implementation<br>especially concerning the algorithm used is based on the predicate<br>Aware Transport (K042642). The proposed monitor B40i utilizes<br>12 inch LCD display panel and LED backlight with an integrated<br>keypad and a pre-configuration patient parameter measurement<br>module. The proposed monitor B40i interfaces with the optional<br>E-MiniC (K052582) and Thermal Recorder with an extension<br>rack. As with the predicate Monitor B40, the proposed monitor<br>B40i includes features and subsystems that are optional or<br>configurable. The proposed monitor B40i interfaces to a variety<br>of existing central station systems via a cabled network interface.<br>As with the predicate Monitor B40, the proposed monitor B40i<br>has a mounting plate on the bottom of the monitor. The monitor<br>can be mounted in a variety of ways (e.g. shelf, countertop, table,<br>wall, pole, or head/foot board) using existing mounting<br>accessories. |

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| Intended Use (807.92(a)(5)): | The B40i is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The B40i is intended for use under the direct supervision of a licensed health care practitioner. |
| | The B40i is not intended for use during MRI. |
| | The B40i can be a stand-alone monitor or interfaced to other devices via a network. |
| | The B40i monitors and displays: |
| | ECG (including ST segment, arrhythmia detection), 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 respiratory rate) and Entropy. |
| Technology (807.92(a)(6)): | The proposed monitor B40i is a modified system based on the predicate Monitor B40 (K133576). In addition to the labeling differences with the predicate Monitor B40 (K133576), the proposed monitor B40i also expands the impedance respiration parameter feature to cover the neonatal patient population compared to the predicate Monitor B40 (K133576). Patient Data Module (K071073) is the predicate, which impedance respiration implementation especially concerning the algorithm used is based on the predicate Aware Transport (K042642). The fundamental technology of the proposed monitor B40i is the same as the predicate devices. The proposed monitor B40i is as safe and effective as the predicate devices as summarized in the comparison table below. |

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| Feature/Function | Current Device/System<br>the legally marketed<br>predicate Monitor B40V2.1<br>(K133576) | Proposed Device/System<br>Name<br>proposed Monitor B40i | Change<br>Explanation/Notes |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Intended Use description to include: | | | |
| Claims/ features | The Monitor B40 is a portable<br>multi-parameter unit to be used<br>for monitoring and recording of,<br>and to generate alarms for,<br>multiple physiological<br>parameters of adult, pediatric,<br>and neonatal patients in a<br>hospital environment and during<br>intra-hospital transport.<br>The Monitor B40 is intended for<br>use under the direct supervision<br>of a licensed health care<br>practitioner.<br>The Monitor B40 is not intended<br>for use during MRI.<br>The Monitor B40 can be a<br>stand-alone monitor or<br>interfaced to other devices via a<br>network.<br>The Monitor B40 monitors and<br>displays: ECG (including ST<br>segment, arrhythmia detection),<br>invasive blood pressure,<br>heart/pulse rate, oscillometric<br>non-invasive blood pressure<br>(systolic, diastolic and mean<br>arterial pressure), functional<br>oxygen saturation (SpO2) and<br>pulse rate via continuous<br>monitoring (including monitoring<br>during conditions of clinical<br>patient motion or low perfusion),<br>temperature with a reusable or<br>disposable electronic<br>thermometer for continual<br>monitoring.<br>Esophageal/Nasopharyngeal/Ty<br>mpanic/Rectal/B ladder/Axi<br>llary/Skin/Airway/Room/Myocard<br>ial/Core/Surface temperature,<br>impedance respiration,<br>respiration rate, airway gases<br>(C02, 02, N20, anesthetic<br>agents, anesthetic agent<br>identification and respiratory<br>rate) and Entropy. | The B40i is a portable multi-<br>parameter unit to be used for<br>monitoring and recording of, and<br>to generate alarms for, multiple<br>physiological parameters of<br>adult, pediatric, and neonatal<br>patients in a hospital<br>environment and during intra-<br>hospital transport.<br>The B40i is intended for use<br>under the direct supervision of a<br>licensed health care practitioner.<br>The B40i is not intended for use<br>during MRI.<br>The B40i can be a stand-alone<br>monitor or interfaced to other<br>devices via a network.<br>The B40i monitors and displays:<br>ECG (including ST segment,<br>arrhythmia detection), invasive<br>blood pressure, heart/pulse rate,<br>oscillometric non-invasive blood<br>pressure (systolic, diastolic and<br>mean arterial pressure),<br>functional oxygen saturation<br>(SpO2) and pulse rate via<br>continuous monitoring (including<br>monitoring during conditions of<br>clinical patient motion or low<br>perfusion), temperature with a<br>reusable or disposable<br>electronic thermometer for<br>continual monitoring<br>Esophageal/Nasopharyngeal/Ty<br>mpanic/Rectal/Bladder/Axillary/S<br>kin/Airway/Room/Myocardial/Cor<br>e/Surface temperature,<br>impedance respiration,<br>respiration rate, airway gases<br>(CO2, O2, N2O, anesthetic<br>agents, anesthetic agent<br>identification and respiratory<br>rate) and Entropy. | Identical (only the<br>name of the monitor is<br>different) |
| Patient<br>Population | Adult, pediatric and neonate | Adult, pediatric and neonate | Identical |
| Environment of<br>Use | hospital environment and during<br>intra-hospital transport | hospital environment and during<br>intra-hospital transport | Identical |
| Hardware: | | | |
| Software Media | Embedded | Embedded | Identical |
| Battery Type | Lithium-Ion | Lithium-Ion | Identical |
| Battery run in time | >=2:15<br>typical monitor configuration:<br>- ECG, NIBP cycle time 5min,<br>SpO2, 2x INVP, 2x Temp<br>and continuous CO2 use<br>- Ambient temperature 25 °C<br>- Display brightness 70% | >=2:15<br>typical monitor configuration:<br>- ECG, NIBP cycle time 5min,<br>SpO2, 2x INVP, 2x Temp and<br>continuous CO2 use<br>- Ambient temperature 25 °C<br>- Display brightness 70% | Identical |
| Operating Systems Infrastructure Software: | | | |
| Operating System | Linux | Linux | Identical |
| Networking | | | |
| Networking<br>Interface | LAN | LAN | Identical |
| User Interface | | | |
| Front Key Pad | 18 hard keys with Trim Knob,<br>and 1 power On/Standby | 18 hard keys with Trim Knob,<br>and 1 power On/Standby | Identical |
| Display: | | | |
| Size | 12.1-inch | 12.1-inch | Identical |
| Types | TFT LCD | TFT LCD…