(142 days)
Not Found
No
The summary describes a standard multi-parameter patient monitor and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a monitor that measures and displays physiological parameters. It does not provide any treatment or therapy.
No
Explanation: A diagnostic device identifies a disease or condition. This device monitors and records physiological parameters and generates alarms, but it does not claim to diagnose any condition.
No
The device description explicitly states it is a "multi-parameter patient monitor including both new and existing subsystems" and mentions hardware components like a "12 inch display with integrated keypad and a fixed pre-configuration patient parameter measurement module (Hemo module)." This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the PROCARE Monitor B40 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 recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients." These parameters are measured directly from the patient's body (e.g., blood pressure, heart rate, temperature, SpO2).
- Device Description: The device description details a patient monitor that measures physiological signals.
- Lack of Mention of In Vitro Testing: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body. IVD devices are specifically designed for testing these types of samples to diagnose diseases or conditions.
The PROCARE Monitor B40 is a patient monitoring device used for real-time physiological measurements on living patients. This falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The PROCARE Monitor B40 is a portable multiparameter 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 PROCARE Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner.
The PROCARE Monitor B40 is not intended for use during MRI.
The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring.
Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.
Product codes
MHX
Device Description
The PROCARE Monitor B40 is a multi-parameter patient monitor including both new and existing subsystems. The PROCARE Monitor B40 has a12 inch display with integrated keypad and a fixed pre-configuration patient parameter measurement module (Hemo module). The PROCARE Monitor B40 also supports a thermal recorder and Airway gas module (E-MiniC, K052582) with an extension rack.
The PROCARE Monitor B40 includes features and subsystems that are optional or configurable. The PROCARE Monitor B40 interfaces to a variety of existing central station systems via a cabled network interface.
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 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:
The PROCARE Monitor B40 and its applications comply with voluntary standards as detailed in this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Final acceptance testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification)
Summary of Clinical Tests:
The subject of this premarket submission, The PROCARE Monitor B40 did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043276, K062576, K073203, K102239
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
JUL 1 9 2012
8 11 3
8200 West Tower Avenue Milwaukee, Wisconsin, 53223
Information Technologies
GE Medical Systems
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: Date: February 27, 2012
Submitter: Sun YanLi
Regulatory Affairs Manager GE MEDICAL SYSTEMS CHINA CO., LTD. No. 19 Changjiang road National Hi-Tech Dev. Zone Wuxi, Jiangsu, China 214028
Primary Contact Person:
Robert Casarsa Regulatory Affairs Leader GE Medical Systems Information Technologies, Inc. Telephone: 414-362-3063 8200 West Tower Avenue Milwaukee, Wisconsin 53223 Fax at 414-362-2585 E-mail: Robert.casarsa@ge.com
Secondary Contact Person:
Kentz, Douglas Regulatory Affairs Director GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, Wisconsin 53223 Phone: 414 362-2038 Fax: 414-262-2585 E-mail: Douglas.kentz@ge.com
PROCARETM Monitor B40 Device: Trade Name: Common/Usual Name: Multi-parameter patient monitor Classification Names: 21 CFR 870.1025 Arrhythmia detector and alarm (including STsegment measurement and alarm)
Product Code: MHX
1
p2/3
Predicate Device(s): K043276 Datex-Ohmeda S/5TM FM Monitor K062576 Datex-Ohmeda S/5 E-PSM Module K073203 CARESCAPE V100 Vital Signs Monitor K102239 CARESCAPE Monitor B650
Device Description: The PROCARE Monitor B40 is a multi-parameter patient monitor including both new and existing subsystems. The PROCARE Monitor B40 has a12 inch display with integrated keypad and a fixed pre-configuration patient parameter measurement module (Hemo module). The PROCARE Monitor B40 also supports a thermal recorder and Airway gas module (E-MiniC, K052582) with an extension rack.
The PROCARE Monitor B40 includes features and subsystems that are optional or configurable. The PROCARE Monitor B40 interfaces to a variety of existing central station systems via a cabled network interface.
Intended Use: The PROCARE Monitor B40 is a portable multiparameter 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 intrahospital transport.
The PROCARE Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner.
The PROCARE Monitor B40 is not intended for use during MRI.
The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), 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, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.
The PROCARE Monitor B40 is a new monitor that essentially is Technology: a combination of the features and parameters of three existing predicate monitor platforms. The predicate devices are the S/5TM FM Monitor (K043276) with E-PSM (K062576), the
2
CARESCAPE V100 Vital Signs Monitor (K073203) and CARESCAPE Monitor B650 (K102239).
The PROCARE Monitor B40 has the identical arrhythmia algorithm, EK-Pro V12, as the CARESCAPE Monitor B650 (K102239).
The PROCARE Monitor B40 has identical NIBP hardware and SuperStat algorithm with CARESCAPE V100 Vital Signs Monitor (K073203) with only one exception being an equivalent processor.
Refer to the Comparison Matrix in Section 12.1 for additional information
The fundamental technology of the PROCARE Monitor B40 is the same as the predicate devices.
The PROCARE Monitor B40 is as safe and effective as the predicate devices.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The PROCARE Monitor B40 and its applications comply with voluntary standards as detailed in this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Final acceptance testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification)
Summary of Clinical Tests:
The subject of this premarket submission, The PROCARE Monitor B40 did not require clinical studies to support substantial equivalence.
Conclusion: GE Healthcare considers the PROCARE Monitor B40 to be as safe, as effective, and performance is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 19 2012
GE Medical Systems Information Technologies, Inc. c/o Mr. Robert Casarsa Regulatory Affairs Leader 8200 West Tower Avenue Milwaukee, WI 53223
Re: K120598
Trade/Device Name: PROCARE™ Monitor B40 Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: MHX Dated: July 10, 2012 Received: July 13, 2012
Dear Mr. Casarsa:
We have reviewed your Section 510(k) premarket notification of intent to maiket 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
4
Page 2 - Mr. Robert Casarsa
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: PROCARETM Monitor B40
Indications for use:
The PROCARE Monitor B40 is a portable multiparameter 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 PROCARE Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner.
The PROCARE Monitor B40 is not intended for use during MRI.
The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring.
Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myo cardial/Core/Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.
Over-The-Counter Use Prescription Use X 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)
C
Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K120558
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