MODIFICATION OF VENTURI VENTILATOR

K990429 · Cardiopulmonary Corp. · CBK · Feb 24, 1999 · Anesthesiology

Device Facts

• Record ID: K990429
• Device Name: MODIFICATION OF VENTURI VENTILATOR
• Applicant: Cardiopulmonary Corp.
• Product Code: CBK · Anesthesiology
• Decision Date: Feb 24, 1999
• Decision: ST
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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).

Device Story

Venturi® Ventilator provides mechanical ventilation support to adult and pediatric patients within hospital intensive care units (ICU). Device functions to control or assist patient breathing. Operated by clinical staff in ICU settings. Output consists of mechanical respiratory support to maintain patient ventilation. Benefits include stabilization of respiratory function in critically ill patients.

Technological Characteristics

Mechanical ventilator for ICU use; intended for adult and pediatric patient populations.

Indications for Use

Indicated for adult and pediatric patients requiring mechanical ventilation assistance or control in hospital intensive care units (ICU).

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. haarenene please contact the Office of Compliance at [phone]. 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 [phone], 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)<br>Number | k990429 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Venturi® Ventilator |
| Indications for<br>Use | The Venturi® ventilator is intended to mechanically control or assist the<br>breathing of adult and pediatric patients. The Venturi® is designed for use in<br>hospital 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