(326 days)
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No
The provided text describes a software system for central monitoring and alarm surveillance of various medical devices, but it does not mention or imply the use of AI or ML technologies.
No
The Bernoulli Management System (MS) Software is a monitoring and alarm surveillance application, not a device that directly treats or prevents disease. It provides a secondary display of patient data and alarm surveillance, supplementing rather than replacing existing monitoring procedures.
No
This device is a software application for secondary display and remote monitoring/alarm surveillance of existing multi-parameter monitor data and other medical devices. It supplements and does not replace current device monitoring procedures, meaning it doesn't independently diagnose.
Yes
The device is described as "Bernoulli Management System (MS) Software" and its intended use is as a "software application". The description focuses solely on its software functionalities for displaying and monitoring data from various medical devices. There is no mention of any accompanying hardware component being part of the device itself.
Based on the provided information, the Bernoulli Management System (MS) Software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Bernoulli MS Software clearly states its purpose is to display and monitor data from various medical devices connected to a patient in vivo (within the living body).
- The intended use focuses on real-time patient monitoring and alarm surveillance based on data from connected medical devices. This is distinct from analyzing biological samples.
The Bernoulli Management System is a medical device, but it falls under a different category than IVDs. It's a system for managing and displaying patient data from other medical devices.
N/A
Intended Use / Indications for Use
The Bernoulli Management System (MS) Software is a software application intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital-type environment. It is used to provide a secondary display of multi parameter monitor data (ECG, respiratory rate, pulse oximetry, ETCO2, blood pressure, cardiac output, temperature and associated derived outputs), lung ventilator, respiratory gas monitor, IV infusion.(including PCA) pump, feeding pump and related ancillary devices, and to provide remote monitoring and alarm surveillance. This application is also intended to provide primary alarm surveillance for devices where no alarm notification capability is enabled or available in low acuity MedSurg, Cardiac, General ward care areas to monitor patients who are currently not monitored. The Bernoulli MS is intended to supplement and not replace any part of the current device monitoring procedures.
The Bernoulli Management System (MS) Software is to be used under license by or on the order of a physician or licensed healthcare professional in the course of his/her professional practice.
Product codes
PFY, MHX, MSX
Device Description
The Bernoulli Management System (MS) Software is a software application intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital-type environment.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Used by or on the order of a physician or licensed healthcare professional in the course of his/her professional practice, in a hospital or hospital-type environment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 20, 2013
Cardiopulmonary Corp. Urey Kang 200 Cascade Blvd. Milford, CT 06460 US
Re: K130208
Trade/Device Name: Bernoulli Enterprise Software Regulation Number: 21 CFR 870.2300 Regulation Name: Central Monitoring Station Software Regulatory Class: Class II Product Code: PFY, MHX, MSX Dated: November 20, 2013 Received: November 21, 2013
Dear Urey Kang:
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
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Page 2 - Mr. Urey Kang
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K130208
Device Name: Bernoulli® Enterprise Software
Indications For Use:
The Bernoulli Management System (MS) Software is a software application intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital-type environment. It is used to provide a secondary display of multi parameter monitor data (ECG, respiratory rate, pulse oximetry, ETCO2, blood pressure, cardiac output, temperature and associated derived outputs), lung ventilator, respiratory gas monitor, IV infusion.(including PCA) pump, feeding pump and related ancillary devices, and to provide remote monitoring and alarm surveillance. This application is also intended to provide primary alarm surveillance for devices where no alarm notification capability is enabled or available in low acuity MedSurg, Cardiac, General ward care areas to monitor patients who are currently not monitored. The Bernoulli MS is intended to supplement and not replace any part of the current device monitoring procedures.
The Bernoulli Management System (MS) Software is to be used under license by or on the order of a physician or licensed healthcare professional in the course of his/her professional practice.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally
Owen F
Date: 20
14:31:5
Digitally signed by Owen P. Faris -5 Date: 2013.12.20 14:31:50 -05'00'
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