(54 days)
VentView - a PC programm for displaying ventilation parameters and status messages in both graphical and numerical form for the Drager ventilators Savina, Evita 2 dura and Evita 4.
VentView - a PC programm for displaying ventilation parameters and status messages in both graphical and numerical form for the Drager ventilators Savina, Evita 2 dura and Evita 4.
I am sorry, but the provided text only contains an FDA 510(k) clearance letter for the "VentView" device. This letter indicates that the device has received marketing clearance but does not include information about acceptance criteria, specific studies, or performance data to answer your request.
To provide that information, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a detailed technical specification for the VentView device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 4 2001
Mr. James J. Brennan Dräger Medical AG & Co. KGaA c/o Dräger Medical, Inc. 3135 Quarry Road Telford, PA 18969
Re: K012177
VentView Regulation Number: 868.5895 Regulatory Class: II (two) Product Code: 73 CBK Dated: August 15, 2001 Received: August 21, 2001
Dear Mr. Brennan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use above and we no nove we) to legally marketed predicate devices marketed in interstate commerce buiced in also are, so 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). You may, therefore, market the device, subject to the general controls Cooniette 110 (110 ) - The general controls provisions of the Act include requirements for annual provisions of ation 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1) affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
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Page 2 - Mr. James J. Brennan
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will and it your ding of substantial equivalence of your device to a legally marketed nothloate 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 11 you as a surfall for in vitro diagnostic devices), please contact the Office of Compliance at additionally 0091100114, 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) 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,
Denk Telle
J. E. Dillard, III
James E. Dillard II Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): KO12177
VentView Device Name:
Indications For Use:
VentView - a PC programm for displaying ventilation parameters and status messages in both graphical and numerical form for the Drager ventilators Savina, Evita 2 dura and Evita 4.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) k) Number
(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)
§ 868.5895 Continuous ventilator.
(a)
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.(b)
Classification. Class II (performance standards).