BERNOULLI VENTILATOR MANAGEMENT SYSTEM

K011861 · Cardiopulmonary Corp. · MOD · Nov 6, 2001 · Anesthesiology

Device Facts

• Record ID: K011861
• Device Name: BERNOULLI VENTILATOR MANAGEMENT SYSTEM
• Applicant: Cardiopulmonary Corp.
• Product Code: MOD · Anesthesiology
• Decision Date: Nov 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• 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 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 system for central monitoring stations; inputs ventilator data from bedside mechanical ventilators; transforms data into secondary displays for remote monitoring and alarm surveillance; used in hospital environments by clinicians; supplements existing monitoring procedures; provides remote visibility of patient ventilation status; enhances clinical oversight by centralizing alarm and data monitoring; benefits patients by facilitating timely response to ventilator status changes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based system for central monitoring stations; functions as a secondary display and remote alarm surveillance tool; operates within hospital network environments; designed to interface with existing mechanical ventilators.

Indications for Use

Indicated for mechanically ventilated patients in hospital or hospital-type environments. Used for secondary display of ventilator data, remote monitoring, and alarm surveillance. Intended to supplement, not replace, existing monitoring procedures.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 6 2001

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

Re: K011861

Bernoulli™ Ventilator Management System Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II (two) Product Code: 73 MOD Dated: October 9, 2001 Received: October 9, 2001

Dear Mr. Laviola:

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.

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.

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. John Laviola

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,

K. Dea Telle

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K011861
CONFIDENTIAL

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NOV 0 6 2001

## APPENDIX B:

| | Indications for Use Statement |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K011861 |
| 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 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 K011861

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________