PRO-FLOW MULTIPURPOSE CANNULA

K053063 · Pro-Tech Services, Inc. · CCK · Dec 13, 2005 · Anesthesiology

Device Facts

• Record ID: K053063
• Device Name: PRO-FLOW MULTIPURPOSE CANNULA
• Applicant: Pro-Tech Services, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Dec 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pro-Flow MultiPurpose Cannula may be intended for use for simultaneous detection of respiratory airflow and sampling, or delivery, of gases, such as EtC02 or oxygen.

Device Story

Pro-Flow MultiPurpose Cannula functions as a nasal interface for respiratory monitoring and gas delivery. Device facilitates simultaneous detection of respiratory airflow and sampling or delivery of gases (e.g., EtCO2, oxygen). Used in clinical settings to assist healthcare providers in monitoring patient respiratory status and administering supplemental gases. Output consists of sampled gases routed to an analyzer or delivered gases provided to the patient. Benefits include integrated monitoring and delivery capabilities in a single cannula interface.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nasal cannula interface for gas sampling and delivery. Mechanical device; no electronic components, software, or energy source.

Indications for Use

Indicated for patients requiring simultaneous respiratory airflow detection and gas sampling or delivery (e.g., EtCO2 or oxygen).

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

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Public Health Service

DEC 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Neil Sheller Pro-Tech Services, Incorporated 4338 Harbour Pointe Boulevard, S.W. Mukilteo, Washington 98275

Re: K053063

Trade/Device Name: Pro-Flow MultiPurpose Cannula Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: October 20, 2005 Received: November 3, 2005

Dear Mr. Sheller:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the received above and have and have a molosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device merslate commerce prior to way to was reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket the I cuclar I vou, Drag, and Osbu may, therefore, market the device, subject to the general approval uppreadion (The Act. The general controls provisions of the Act include controls providens of an 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 If your device is classified (oos assile) in a controls. Existing major regulations affecting (1 Mr), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear of toundsh further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Sheller

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. or the rice of any a with all the Act's requirements, including, but not limited to: registration 1 od into compry 7 11 CFR Part 801); labeling (21 CFR Part 801); good manufacturing practice and ifsing (s 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) rrent reter 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), n from and 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 maj obtain 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,

Cluts

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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510(k) Number (if known): K053063

## Device Name: Pro-Flow MultiPurpose Cannula

Indication for Use:

indocuses not of the may be intended for use for simultaneous detection of respiratory airflow
MultiPurpose of the county as a such as EfC02 or oxygen Pro-Flow MultiPurpose - Cannalde are International and sampling, or oxygen.
and sampling, or delivery, of gases, such as EtC02 or oxygen.

Prescription Use ____________ Over-The-Counter Use_________________________________________________________________________

(Per 21 CFR 801.109)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

(Posted July 1, 1998)

Arny Safram

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental B 510(k) Number: