(13 days)
The Venturi® ventilator is intended to mechanically control or assist the breathing of adult and pediatric patients. The Venturi® is designed for use in hospital intensive care units (ICU).
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria, study details, or performance data for the Venturi® Ventilator. The document is an FDA 510(k) clearance letter from 1999, which primarily states that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.
Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1999
Mr. John LaViola Cardiopulmonary Corp. 200 Cascade Boulevard Milford, CT 06460
Re: K990429 Venturi® Ventilator Requlatory Class: II (two) Product Code: 73 CBK February 9, 1999 Dated: Received: February 11, 1999
Dear Mr. LaViola:
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 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. 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 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.
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Page 2 - Mr. John LaViola
This letter will allow you to begin marketing your device as described inis recei will arrow you co iceation. The FDA finding of substantial In your 510(x) premained noto a legally marketed predicate device equivalence or 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 809.10 for in vitro regulacion (21 orrelate ase contact the Office of Compliance at Graghobers actroomally, for questions on the promotion and (301) 354 4040. haarenene please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (301) 33 4009. Tiroo, passo premarket notification" (21 CFR 807.97). Hrobranding by Formation on your responsibilities under the Act may other general Information of Small Manufacturers Assistance at its be obtained trom eno bra8-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX E
Indications for Use Statement
| 510(k)Number | K990429 |
|---|---|
| Device Name | Venturi® Ventilator |
| Indications forUse | The Venturi® ventilator is intended to mechanically control or assist thebreathing of adult and pediatric patients. The Venturi® is designed for use inhospital intensive care units (ICU). |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
z kramer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 990429 510(k) Number
§ 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).