MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE

K051283 · Cardiopulmonary Corp. · MSX · Jun 23, 2005 · Cardiovascular

Device Facts

• Record ID: K051283
• Device Name: MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
• Applicant: Cardiopulmonary Corp.
• Product Code: MSX · Cardiovascular
• Decision Date: Jun 23, 2005
• Decision: SESE
• Submission Type: Special
• 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 respiratory 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 respiratory gas monitors; transforms these inputs into a secondary, centralized display for remote monitoring and alarm surveillance. Used in hospital environments by clinical staff; provides real-time visibility into patient respiratory status. Supplements existing bedside monitoring procedures; does not replace them. Benefits include enhanced clinical oversight and centralized alarm management, allowing healthcare providers to monitor multiple patients from a single station, potentially improving response times to ventilator-related events.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based system for data aggregation and display. Operates as a secondary monitoring station. Integrates with existing bedside ventilators and respiratory gas monitors. Connectivity via network interface to central station. No specific hardware materials or sterilization requirements as it is a software-only system.

Indications for Use

Indicated for mechanically ventilated patients in hospital or hospital-type environments. Used for secondary display of ventilator and respiratory gas monitor data, remote monitoring, and alarm surveillance. Not intended to replace existing 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2005

Mr. Jordan Schreck Quality Manager Cardiopulmonary Corporation 200 Cascade Boulevard Milford, Connecticut 06460

Re: K051283

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Trade/Device Name: Bernoulli™ Ventilator Management System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II Product Code: MOD, MSX Dated: June 13, 2005 Received: June 16, 2005 :

Dear Mr. Schreck:

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 intersule conmisers prices 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 approvisions 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 (1 111 ), it noy obe are your 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. Schreck

Please be advised that FDA's issuance of a substantial equivalence determination does not Frease be auvrsod that I Dr. o termination that your device complies with other requirements Incall that I D7 mas made statutes and regulations administered by other Federal agencies. of the Act of ally I outhal the Act's requirements, including, but not limited to: registration 1 ou must continery with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF RT Fact 807), labality systems (QS) regulation (21 CFR Part 820); and if requirences as set for in are quardion 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) This letter will anow you to began finding of substantial equivalence of your device to a premarket notification - I - I - 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), If you desire specific at no compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may other butter generalional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Senette y. Michui Om-D

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental 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 | (K051283) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 respiratory 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)

Am
Sign Off

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology General Hospital,
Division of Anesthesiology, General Devices Division of Anesthesion of Anesther 83

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510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Prescription Use
(Per 21 CFR 801.109)

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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________