TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)

K962944 · Transtracheal Systems · NFB · Oct 23, 1996 · Anesthesiology

Device Facts

• Record ID: K962944
• Device Name: TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
• Applicant: Transtracheal Systems
• Product Code: NFB · Anesthesiology
• Decision Date: Oct 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1) Conserve the flow of oxygen 2) Deliver oxygen during the inspiration cycle 3) Maintain adequate oxygen saturation of a patient 4) Adjustable time for delayed inspiration alarm 5) Adjustable inspiration time

Device Story

DOC-2000 Demand Oxygen Controller; pneumatic device for oxygen delivery. Inputs: continuous oxygen source. Operation: senses patient inspiration cycle; delivers oxygen bolus during inspiration to conserve supply; maintains patient oxygen saturation. Features: adjustable inspiration time; adjustable delayed inspiration alarm. Used in clinical or home settings; operated by patients or caregivers. Benefits: extends oxygen supply duration; ensures oxygen delivery synchronized with breathing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pneumatic oxygen controller; non-electronic or mechanical flow regulation; adjustable timing mechanisms for inspiration and alarm functions. Class II device (Product Code 73 NFB).

Indications for Use

Indicated for patients requiring supplemental oxygen therapy to maintain adequate oxygen saturation. Used to conserve oxygen flow by delivering oxygen specifically during the inspiration cycle.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

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
FEB 26 2002

Mr. Lewis Ward
Transtracheal Systems, Inc.
c/o L.W. Ward and Associates, Inc.
4655 Kirkwood Court
Boulder, CO 80301

Re: K962944
Demand Oxygen Controller, DOC-2000
Regulation Number: 868.5905
Regulation Name: Noncontinuous Ventilator
Regulatory Class: II (two)
Product Code: 73 NFB

Dear Mr. Ward:

This letter corrects our substantially equivalent letter of October 23, 1996, regarding the Demand Oxygen Controller, DOC-2000. Our letter identified the product code as 73 BZD. This is in error; the correct product code is 73 NFB as indicated above.

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. Lewis Ward

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,


Bram D. Zuckerman, M.D.
Acting Director
Division of Cardiovascular and Respiratory Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Device name: Transtracheal Systems, Inc. DOC 2000 Demand Oxygen Controller

## Indications for Use:

1) Conserve the flow of oxygen
2) Deliver oxygen during the inspiration cycle
3) Maintain adequate oxygen saturation of a patient
4) Adjustable time for delayed inspiration alarm
5) Adjustable inspiration time

Prescription Use Per 21 CFR 801.109

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K962944

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