VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA

K063813 · Ventlab Corp. · CCK · Mar 26, 2008 · Anesthesiology

Device Facts

• Record ID: K063813
• Device Name: VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA
• Applicant: Ventlab Corp.
• Product Code: CCK · Anesthesiology
• Decision Date: Mar 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended Use

The Ventlab End-Tidal CO2 Nasal Cannula is an accessory to a carbon dioxide analyzer used when there is a need to measure the percentage of exhaled carbon dioxide of a nonintubated patient while administering oxygen during inhalation.

Device Story

Ventlab End-Tidal CO2 Nasal Cannula functions as an accessory to carbon dioxide analyzers. Device delivers supplemental oxygen to nonintubated patients while simultaneously sampling exhaled breath for CO2 concentration measurement. Used in clinical settings by healthcare providers to monitor respiratory status. Output is a gas sample delivered to an external analyzer; clinical decision-making relies on the analyzer's CO2 readings to assess patient ventilation and gas exchange. Benefits include simultaneous oxygen therapy and continuous capnography monitoring without requiring intubation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nasal cannula interface for oxygen delivery and gas sampling. Connects to standard carbon dioxide analyzers. Materials are medical-grade plastics typical for respiratory accessories. Non-powered, passive device.

Indications for Use

Indicated for nonintubated patients requiring supplemental oxygen and monitoring of exhaled carbon dioxide levels.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines extending from its head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 2 6 2008

Mr. James A. Cochie Director, Regulatory Affairs Ventlab Corporation 155 Boyce Drive Mocksville, North Carolina 27028

Re: K063813

Trade/Device Name: Ventlab End-Tidal CO2 Nasal Cannula Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: March 13, 2008 Received: March 14, 2008

Dear Mr. Cochie:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Cochie

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): \$0638 3

Device Name: _Ventlab End-Tidal CO2 Nasal Cannula

Indications for Use:

The Ventlab End-Tidal CO2 Nasal Cannula is an accessory to a carbon dioxide analyzer used when there is a need to measure the percentage of exhaled carbon dioxide of a nonintubated patient while administering oxygen during inhalation.

Ques

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _K c638

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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