TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000

K982943 · Transtracheal Systems · NFB · Jul 12, 1999 · Anesthesiology

Device Facts

• Record ID: K982943
• Device Name: TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
• Applicant: Transtracheal Systems
• Product Code: NFB · Anesthesiology
• Decision Date: Jul 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To conserve oxygen by delivering flow during the inspiration cycle

Device Story

DOC-3000 Demand Oxygen Controller is a device designed to conserve oxygen supply. It functions by sensing the patient's respiratory cycle and delivering oxygen flow specifically during the inspiration phase. This mechanism reduces oxygen waste compared to continuous flow systems. The device is intended for use in clinical or home settings under the direction of a physician. By optimizing oxygen delivery, it aims to extend the duration of portable oxygen supplies and improve patient mobility and therapy compliance.

Technological Characteristics

Demand oxygen controller; operates by sensing inspiration to trigger oxygen flow; classified as a noncontinuous ventilator (Product Code: 73 NFB).

Indications for Use

Indicated for patients requiring supplemental oxygen therapy who need oxygen conservation via inspiratory-cycle flow delivery.

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2002

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

K982943 Re:

DOC-3000 Demand Oxygen Controller 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 July 12, 1999, eeganding the DOC-3000
. This is in and the Cases of the tified the product code as 73 BZD. This is This letter corrects our substantaly equivaleit letter of our of any 12, 1974, 1999, 1999, This is in error,
Demand Oxygen Controller. Our letter identified the product code Demand Oxygon Octiation 73 NFB as indicated above.

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > I 0(x) premaintely equivalent (for the indications
referenced above and have determined the devices is substantially equivalent in interstate referenced above and have determined the usedicate devices marketed in interstate
for use stated in the enclosure) to legally marketed previce Amendments, for use stated in the enclosure) to the enatment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment as with the provision of the Feder commerce prior to May 28, 1976, the enactinent and of the Federal Food, Drug, devices that have been reclassified in accordance with the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require applieved on the provisions of the Act. The Act. The
You may, therefore, market the device, subject to the generations of listin You may, therefore, market the device, subject to the general variusl registration, listing of
general controls provisions of the Act include requirements for anging mishran general controls provisions of the Act Include requirements and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
em in the cases of the cases of the Fristing regior regulations affec If your device is classified (see above) mio entire cass if epenlations affecting your device can
may be subject to such additional controls. Existing major regulations affe may be subject to such additional controis: Existing major regal to 898. In addion, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Federal Regulations, True 27, 11, 24, 2017, 1991, 1991, 1991, 1991, 1991, 1991, 1991, 1991, 199

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## Page 2 – Mr. Lewis Ward

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substantal equivacited atterrequirements of the Act
that FDA has made a determination that your device compliss with of the Act that FDA has made a determination that your devece complet Federal agencies. You must
or any Federal statutes and regulations administered by other Fegistration and listin or any Federal statutes and regulations administed to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: regultements as set comply with all the Act s requrements, including, but includes worties requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements CFR Part 807); labeling (21 CFR Part 801), good manhasa20); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applicabl forth in the quality systems (QS) regulation (21 CFRTatober)
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)
I and expension of the TRATE aling of substantial equivalence of your device t This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FD in in a larsifyen for your device and thu premarket notification. The FDA finding of substantial equivaliso 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 If you desire specific advice tor your devices on on adocine of the Office of
additionally 21 CFR Part 809.10 for in vites discrease on the promotion and advertising additionally 21 CFR Part 809.10 for mythonomic de rices); promotion and advertising of
Compliance at [phone]. Additionally, for questions on the promotion and advertis Compliance at [phone]. Additionally, for questions on also, production. Also, please note the your device, please contact the Office of Collipination" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket act may be obtained from the regulation entitled, "Misbranding of responsibilities under the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its t Division of Sinan Manalassis or at its Internet address [phone] or (201) ++5-0397 or arandsmamain html http://www.fda.gov/cdrh/gsma/dsmamain.html

Sincerely yours,

Dalk Mill

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-3000 Demand Oxygen Controller

Indications for Use:

To conserve oxygen by delivering flow during the inspiration cycle

M. Pyne

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices k982943 510(k) Number

Prescription Use Per 21 CFR 801.109