(37 days)
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.
Not Found
This document is a 510(k) premarket notification FDA clearance letter for the Bernoulli™ Ventilator Management System. It does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria.
The letter confirms that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices. This means that the device is considered as safe and effective as a legally marketed device, but the letter does not include details of performance studies or acceptance criteria themselves.
Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need a different document, such as the full 510(k) submission or a detailed performance study report for the Bernoulli™ Ventilator Management System.
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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
.
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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)
OR
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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
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.(b)
Classification. Class II (performance standards).