MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE

K020018 · Cardiopulmonary Corp. · MSX · Feb 21, 2002 · Cardiovascular

Device Facts

• Record ID: K020018
• Device Name: MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
• Applicant: Cardiopulmonary Corp.
• Product Code: MSX · Cardiovascular
• Decision Date: Feb 21, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Bernoulli VMS software is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator and blood gas monitor data to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli VMS is intended to supplement and not replace any part of the current device monitoring procedures.

Device Story

Bernoulli VMS is a software-based system for central monitoring of mechanically ventilated patients. It ingests data from bedside ventilators and blood gas monitors; transforms these inputs into a secondary, centralized display for remote monitoring and alarm surveillance. Used in hospital environments by clinicians; supplements existing monitoring procedures without replacing them. Provides real-time visibility into patient status; facilitates remote oversight; enhances alarm awareness; supports clinical decision-making by consolidating data from disparate bedside devices into a single central station interface.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based system; operates on a central monitoring station; integrates with existing bedside ventilators and blood gas monitors for data display and alarm surveillance.

Indications for Use

Indicated for mechanically ventilated patients in hospital or hospital-type environments. Used for secondary display of ventilator and blood gas monitor data, remote monitoring, and alarm surveillance. Not intended to replace current monitoring procedures.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle, indicating the organization represented by the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2002

Mr. John LaViola Cardiopulmonary Corp. 200 Cascade Boulevard Milford, CT 06460

Re: K020018

Bernoulli™ Ventilator Management System Regulation Number: 870.2300 / 868.5895 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (two) Product Code: 74 MSX / 73 MOD Dated: January 2, 2002 Received: January 3, 2002

Dear Mr. LaViola:

We have reviewed your Section 510(k) premarket notification of intent to market the device we neve and have 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 10 as cance in 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. John LaViola

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Obertelli

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

Enclosure

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## APPENDIX B:

## Indications for Use Statement

510(k) Number

:

(KO20018)

Device Name

Bernoulli™ Ventilator Management System

Indications for Use

The Bernoulli VMS software is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator and blood gas monitor data to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli VMS is intended to supplement and not replace any part of the current device monitoring procedures.

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Division of Cardiovascular & Respiratory Devices**
510(k) Number K020018

Prescription Use
(Per 21 CFR 801.109) √

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________