(7 days)
The Venturi Ventilator is intended to mechanically control and assist the breathing of adult and pediatric patients under the direction of a physician.
Not Found
I am able to extract the requested information about the device and its indications for use. However, the provided document is a 510(k) clearance letter from the FDA, which confirms the substantial equivalence of the "Venturi Ventilator" to a legally marketed predicate device.
This document does not contain the detailed study information (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test/training sets, or training set size and ground truth establishment) that you are requesting.
Regulatory clearance letters like this one often refer to studies and data submitted by the manufacturer, but they do not typically reproduce those study details in the letter itself. The FDA's determination of substantial equivalence is based on the applicant demonstrating that their device is as safe and effective as a predicate device, often by showing that it has the same technological characteristics and indications for use, or that any differences do not raise new questions of safety or effectiveness.
Therefore, I cannot fulfill your request using only the provided text. You would need access to the actual 510(k) submission or supporting documentation from Cardiopulmonary Corp. to find the information you're looking for.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1998
Mr. John LaViola Cardiopulmonary Corp. 200 Cascade Boulevard Milford, CT 06460
K982174 Re: Venturi Ventilator Regulatory Class: II (two) Product Code: 73 CBK Dated: June 16, 1998 Received: June 17, 1998
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 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 requlation (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.
{1}------------------------------------------------
Page 2 - Mr. John LaViola
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
{2}------------------------------------------------
510(k) Number (if known): K982174
Venturi Ventilator Device Name: _
Indications For Use:
The Venturi Ventilator is intended to mechanically control and assist the breathing of adult and The Venturi Ventilator is intended to inechalican'y control and and and and and a many of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Krame
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. __
Prescription Use ✓
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
§ 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).