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.

Device Description

Not Found

AI/ML Overview

The provided FDA 510(k) summary (K130208) for the Bernoulli® Enterprise Software is a clearance letter and an "Indications for Use" statement. It affirms the device's substantial equivalence to a predicate device but does not contain the detailed study information or acceptance criteria requested.

Therefore, I cannot extract the specific details about the acceptance criteria or a study proving the device meets them from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on performance studies with specific statistical metrics.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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

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Indications for Use

510(k) Number (if known): K130208

Device Name: Bernoulli® Enterprise Software

Indications For Use:

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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510(k) Submission Page D-18

Regulation Number and Section

§ 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.