CRITERION, CRITERION I.V., MODIFIED

K952267 · Nova-Ventrx · BZE · Dec 2, 1997 · Anesthesiology

Device Facts

• Record ID: K952267
• Device Name: CRITERION, CRITERION I.V., MODIFIED
• Applicant: Nova-Ventrx
• Product Code: BZE · Anesthesiology
• Decision Date: Dec 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5270
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

The HYDRO-HEAT® Condensate Control System is a device designed to manage condensate in respiratory therapy circuits. It functions by controlling moisture accumulation within the breathing circuit to prevent patient airway obstruction or aspiration of fluid. Used in clinical settings, it is operated by respiratory therapists or nursing staff. The device integrates into the respiratory circuit, managing fluid output to ensure consistent delivery of humidified gases. By maintaining circuit patency, it supports patient safety during mechanical ventilation or respiratory support, reducing the risk of complications associated with condensate buildup.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) notification.

Technological Characteristics

Condensate management system for respiratory circuits. Class II device (Product Code 73 BZE).

Regulatory Classification

Identification

A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

DEC - 2 1997

Mr. Bernard R. Paluch
Nova-Ventrx, Inc.
1974 Raymond Drive
Northbrook, Illinois 60062

Re: K952267
HYDRO-HEAT® Condensate Control System
Regulatory Class: II (two)
Product Code: 73 BZE
Dated: May 1, 1997
Received: May 6, 1997

Dear Mr. Paluch:

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 to 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 requirement, 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. Bernard R. Paluch

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health