(49 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 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.
Not Found
I'm sorry, but without the actual study or a detailed summary of its contents, I cannot provide the requested information about acceptance criteria and device performance. The provided text is a letter from the FDA regarding a 510(k) premarket notification for the Bernoulli™ Ventilator Management System, which acknowledges receipt and substantial equivalence to legally marketed predicate devices. It does not contain details about specific acceptance criteria, study methodologies, results, or the other specific points you've requested.
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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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 _________________________________________________________________________________________________________________________________________________________
§ 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).